UCB (EBR:UCB) UCB Media Room: UCB presents new data highlighting developments across expansive neurology portfolio at 76th AAN Annual Meeting

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12/04/2024 07:01

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3Dqt9z_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgi= oDkTc7NFQmPszJXm4PQc6QX8IilPnJck938b-2BXhC3QFwpT8U5Iqyyp7UScvYb2O4n-2BFiZQR= jqHysww8KIxoo7fWg2Uw029FuwoSkKGiH9vuOsrsGuUnjfA7Zflck7XwLIp7-2Bg0nvNERyivYs= pMJC9nBYIYT1PxbLR-2FJh41kFOQZqji-2F0-3D ** UCB presents new data highlighting developments across expansive neurolo= gy portfolio at 76th American Academy of Neurology (AAN) Annual Meeting ------------------------------------------------------------ =C2=B7 Diverse and patient-focused data set comprises 17 abstracts includin= g one oral presentation =C2=B7 Features new data analyses for UCB=E2=80=99s generalized myasthenia = gravis (gMG) treatments, including post hoc and open-label extension result= s from the pivotal Phase 3 MycarinG study and additional Interim Analyses o= f RAISE-XT for the approved treatments RYSTIGGO^=C2=AE=E2=96=BC (rozanolixi= zumab) and ZILBRYSQ^=C2=AE=E2=96=BC (zilucoplan)=C2=A0 =C2=B7 Data on BRIVIACT^=C2=AE (brivaracetam), FINTEPLA^=C2=AE=E2=96=BC (fe= nfluramine), and STACCATO^=C2=AE alprazolam showcase commitment to patients= and momentum of UCB=E2=80=99s epilepsy and rare syndromes portfolio Brussels (Belgium), 12 April 2024: 07:00 (CET) -=C2=A0UCB (Euronext Brussel= s: UCB), a global biopharmaceutical company, today announced the latest res= earch from its expansive neurology portfolio and pipeline to be presented a= t the 76th American Academy of Neurology (AAN) Annual Meeting, April 13-18,= 2024, in Denver, Colorado, USA.=C2=A0 A total of 17 abstracts, including an oral presentation, will feature data = from studies of four approved and one investigational medicine and technolo= gies for generalized myasthenia gravis (gMG), epilepsies including Dravet s= yndrome and focal (partial) epileptic seizures. Key UCB scientific and patient-focused data to be presented at AAN include:= =C2=A0 gMG =C2=B7 Post hoc and open-label extension analyses from the pivotal Phase 3 = MycarinG study for rozanolixizumab, including impact of treatment on physic= al fatigue and muscle fatigability in adult patients with gMG =C2=B7 An oral presentation on long-term safety and efficacy of zilucoplan = in gMG in an interim analysis of RAISE-XT =C2=B7 An interim analysis of a Phase 3b study on efficacy, and patient pre= ference for subcutaneous zilucoplan in Myasthenia Gravis after switching fr= om intravenous complement component 5 inhibitors =C2=B7 Results from a discrete choice study looking at patient preferences = in gMG treatment attributes Epilepsy and rare epilepsy syndromes =C2=B7 Focal-onset seizures (FOS) - interim results of 12-month real-world = study (BRITOBA) evaluating adjunctive brivaracetam in earlier treatment lin= es in adults =C2=B7 Epilepsy - subgroup data from the international EXPERIENCE analysis = assessing brivaracetam in epilepsy patients with cognitive or learning disa= bility or psychiatric comorbidities =C2=B7 Prolonged seizures - three Phase 1 studies evaluating the safety, to= lerability, and pharmacokinetics of single-use inhaled alprazolam (an inves= tigational treatment for potential termination of prolonged epileptic seizu= res) in different populations =C2=B7 Dravet syndrome - a retrospective analysis using US claims data of h= ealthcare utilization and persistence in patients with Dravet syndrome =C2=B7 Epilepsy disease management - expert consensus recommendations from = the Seizure Termination Project*, highlighting best practice for rapid and = early seizure termination and timing for intervention=C2=A0 =E2=80=9CThe new analyses from the Phase 3 MycarinG and Phase 3 RAISE XT op= en-label extension (OLE) studies being presented at this year=E2=80=99s AAN= meeting reinforce the potential of our recently approved gMG treatments, R= YSTIGGO^=C2=AE=E2=96=BC and ZILBRYSQ^=C2=AE=E2=96=BC, to offer targeted tre= atments for adult gMG =C2=A0patients, tailored to their individual needs an= d preferences,=E2=80=9D commented Donatello Crocetta, Head of Global Rare D= isease & Rare Medical, UCB. =E2=80=9CThese data further underscore UCB=E2= =80=99s innovative approach to evolving science into meaningful treatment s= olutions that help improve long term patient outcomes of people living with= this rare neuromuscular disease, and more widely as part of the integrated= neurology portfolio=E2=80=99s commitment to patient-focused solutions.=E2= =80=9D =E2=80=9CFor people living with epilepsy and rare epilepsy syndromes, the d= ata being presented at this year's AAN meeting showcase how we are transfor= ming experiences and outcomes and redefining the future of epilepsy care,= =E2=80=9D said Mike Davis, Global Head of Epilepsy & Rare Syndromes, UCB. = =E2=80=9CEverything we do is centered around helping people and families li= ving with seizure disorders achieve their ideal and maximize their life opp= ortunities.=E2=80=9D UCB presentations during AAN 2024 https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepb-2FzmqRnzCc1GH9Kp1HYAQz0y7v7m5uRAhf1vmtUGp-2Bx8XRz= i1JYq3TG4GSblIg0nX9BYvBoeR8Q-2FIOvX5p-2FARHr5KZ_2dCLUNbuBjhX746-2FvM63L9Hyn= 3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93D= wfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XC= QI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IitcpucAhiTHAHHpnRv1NmNLdPBso= 5AZUK69Bjbe-2FlZUFWiPa0TJbe4NoGI2YNFytIpCUZhJNT55T0zu2CZgamqvvXGe6Ss4thV8c0= W1qvvhwQ08-2BniRDYnZmtif8AxhZfZ5Os1f8-2BxRZYqf3OWrPKA8-3D https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepb-2FzmqRnzCc1GH9Kp1HYAQzWt1wmeUoWz4rJ0DK7V93bikU-2F= HntsmoGzuDrviSXcD7dYDEbwaoMxzhW5vM0UFJjQB3t_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT= FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx= s8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9j= UV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IiuwFXMVDCQqvvF6-2FLFRkmiqArSmjdU= o8JEiWJ4Mz5yf-2BdAcCOasK14JVLYzxlqdMjsRZrsw2VBP6mU1nNe2LlSr1rRvTFfaJh1eC18R= KKpwuoNjs48APYBHDR-2BPVOGyoBJXixFjbHjDwUnYXrZIxvnI-3D https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepb-2FzmqRnzCc1GH9Kp1HYAQzakBbbHeSyceTjCfIXvnrxCywd8e= -2BR8ckeLWlCwMrFBBs9yIqc1rmsOBaqv30cZLvztwC_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT= FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx= s8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9j= UV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IikrenWaPG5Sd7Sy6ZQWffXqX3bx2pr55= xIbwGYzqsOe-2FY1FWll8vxLsXL0KVKKtLX9To4eL7jkQCv49Qj-2FiFWI6QHEL1ARzrdy7V-2B= RKsAR-2FWwdUd9mPC30gZB6vI9v-2BD8kH5UbZhIUj7UB9dsQdoG-2FQ-3D https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepb-2FzmqRnzCc1GH9Kp1HYAQz0MEUo33NOXctgRe0L3tC066YgRC= paCBtGpgcnADq0-2FZEb6VR2YFgVP9aTPYYPLbfBNpa_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT= FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx= s8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9j= UV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Iitwmtnw0SkQQGRnGcWzi0cGvrwRu2nlB= 7LVuURcTcZ1BfvErJFk4zTPvak4Jak47JGUvbicJGCXLR2lStzbvzXETC-2BrfpnaM0sJk7TgOV= iwQL083KtrieS6Bz63E8W9NGEcin2K2rmL0gf5fyNCqYYw-3D *The Seizure Termination Project was funded by UCB Pharma. **STACCATO=C2=AE alprazolam is an investigational treatment, and its safety= and efficacy has not been established. It is not currently approved for us= e by any regulatory authority worldwide. =C2=A0 For further information, contact UCB:=C2=A0 Global Rare Disease Communications Jim Baxter T+ 32.2.473.78.85.01=C2=A0 email jim.baxter@ucb.com=C2=A0 Global Communications Nick Francis T +44 7769 307745 email nick.francis@ucb.com =C2=A0 Rare Disease Communications Daphne Teo T +1 (770) 880-7655 email daphne.teo@ucb.com =C2=A0 Epilepsy and Rare Syndromes Communications Becky Malone T +1 (919) 605-9600 email becky.malone@ucb.com Corporate Communications, Media Relations Laurent Schots=C2=A0 T+32.2.559.92.64=C2=A0 email Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0=C2=A0 T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com Important Safety Information about RYSTIGGO^=C2=AE=E2=96=BC (rozanolixizuma= b) in the EU=C2=A0 =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals are asked to report any suspected adverse reactions.=C2=A0 Rystiggo is indicated as an add-on to standard therapy for the treatment of= generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) o= r anti-muscle-specific tyrosine kinase (MuSK) antibody positive.^1 The most commonly reported adverse reactions were headache (48.4 %), diarrh= ea (25.0 %) and pyrexia (12.5 %). The adverse reactions from the placebo-co= ntrolled study in gMG are as follow: Very common (=E2=89=A5 1/10) headache,= diarrhea and pyrexia; Common (=E2=89=A5 1/100 to < 1/10) rash, angioedema,= arthralgia and injection site reactions. Headache was the most common reac= tion reported in 31 (48.4 %) and 13 (19.4 %) of the patients treated with r= ozanolixizumab and placebo, respectively. All headaches, except 1 (1.6 %) s= evere headache, were either mild (28.1 % [n=3D18]) or moderate (18.8 % [n= =3D12]) and there was no increase in incidences of headache with repeated c= yclic treatment. Rozanolixizumab is contra-indicated in patients with hypersensitivity to th= e active substance or to any of the excipients. Treatment with rozanolixizumab in patients with impending or manifest myast= henic crisis has not been studied. The sequence of therapy initiation betwe= en established therapies for MG crisis and rozanolixizumab, and their poten= tial interactions, should be considered. Aseptic meningitis (drug induced aseptic meningitis) has been reported foll= owing rozanolixizumab treatment at a higher dose with subsequent recovery w= ithout sequelae after discontinuation. If symptoms consistent with aseptic = meningitis occur, diagnostic workup and treatment should be initiated as pe= r standard of care. Due to its mechanism of action, the use of rozanolixizumab may increase the= patient=E2=80=99s susceptibility to infections. Treatment with rozanolixiz= umab should not be initiated in patients with a clinically important active= infection until the infection is resolved or is adequately treated. During= treatment with rozanolixizumab, clinical signs and symptoms of infections = should be monitored. If a clinically important active infection occurs, wit= hholding rozanolixizumab until the infection has resolved should be conside= red.=C2=A0 Hypersensitivity reactions including mild to moderate rash or angioedema we= re observed in patients treated with rozanolixizumab. Patients should be mo= nitored during treatment with rozanolixizumab and for 15 minutes after the = administration is complete for clinical signs and symptoms of hypersensitiv= ity reactions. If a hypersensitivity reaction occurs during administration,= rozanolixizumab infusion should be discontinued and appropriate measures s= hould be initiated if needed. Once resolved, administration may be resumed Immunization with vaccines during rozanolixizumab therapy has not been stud= ied. The safety of immunization with live or live-attenuated vaccines and t= he response to immunization with vaccines are unknown. All vaccines should = be administered according to immunization guidelines and at least 4 weeks b= efore initiation of treatment. For patients that are on treatment, vaccinat= ion with live or live attenuated vaccines is not recommended. For all other= vaccines, they should take place at least 2 weeks after the last infusion = of a treatment cycle and 4 weeks before initiating the next cycle. Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. https://u7061146.ct.sendgrid.ne= t/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba= -2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQc3F9ewc5VRq5B-2BXotAk5NyhPeFI6i= kKxpfhDAAVc6P8A60tl89nGwOo7TYHt9-2Fujg-3D-3DO89r_2dCLUNbuBjhX746-2FvM63L9Hy= n3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93= DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5X= CQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Iis3L5GmITuTb-2BHzalFphyVuJQ= UebJr4eAxXr2dIi2-2BUQmm5qa8dypKU9bhMcDibyOCl4oZyJK9T5-2F-2FdJeHkLNkdNKOtgCH= RBwoUCs78jhCSsj8xRDFfg6OA6bBexu1s9NjxA97W-2BUaeO-2B6mZPCNNC-2FI-3D Important Safety Information about ZILBRYSQ^=C2=AE=E2=96=BC (zilucoplan) in= the EU^2 =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals are asked to report any suspected adverse reactions.=C2=A0 Zilbrysq is indicated as an add-on to standard therapy for the treatment of= generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) a= ntibody positive.^2 =C2=A0 The most frequently reported adverse reactions were injection site reaction= s (injection site bruising (13.9%) and injection site pain (7.0%) and upper= respiratory tract infections (nasopharyngitis (5.2%), upper respiratory tr= act infection (3.5%) and sinusitis (3.5%). The adverse reactions from the p= ooled placebo controlled (n=3D115) and open-label extension (n=3D213) studi= es in gMG are as follows: Very common adverse reactions: (=E2=89=A5 1/10): = Upper respiratory tract infections and Injection site reactions; Common adv= erse reactions (=E2=89=A5 1/100 to < 1/10) Diarrhea, Lipase increased, Amyl= ase increased and Morphea; Uncommon adverse reaction (=E2=89=A5 1/1000 to <= 1/100) blood eosinophils increased. Zilucoplan is contra-indicated in pati= ents with hypersensitivity to the active substance or to any of the excipie= nts, in patients who are not currently vaccinated against Neisseria meningi= tidis and in patients with unresolved Neisseria meningitidis infection. Due= to its mechanism of action, the use of zilucoplan may increase the patient= =E2=80=99s susceptibility to infections with Neisseria meningitidis. As a p= recautionary measure, all patients must be vaccinated against meningococcal= infections, at least 2 weeks prior to the start of treatment. If treatment= needs to start less than 2 weeks after vaccination against meningococcal i= nfections, the patient must receive appropriate prophylactic antibiotic tre= atment until 2 weeks after the first vaccination dose. Meningococcal vaccin= es reduce but do not completely eliminate the risk of meningococcal infecti= ons. Vaccines against serogroups A, C, Y, W, and where available, serogroup= B, are recommended for preventing the commonly pathogenic meningococcal se= rogroups. Vaccination and prophylactic antibiotic treatment should occur ac= cording to most current relevant guidelines. During treatment, patients sho= uld be monitored for signs and symptoms of meningococcal infection and eval= uated immediately if infection is suspected. In case of a suspected meningo= coccal infection, appropriate measures such as treatment with antibiotics a= nd discontinuation of treatment, should be taken until the meningococcal in= fection can be ruled out. Patients should be instructed to seek immediate m= edical advice if signs or symptoms of meningococcal infections occur. Presc= ribers should be familiar with the educational materials for the management= of meningococcal infections and provide a patient alert card and patient/c= arer guide to patients treated with zilucoplan. In addition to Neisseria me= ningitidis, patients treated with zilucoplan may also be susceptible to inf= ections with other Neisseria species, such as gonococcal infections. Patien= ts should be informed on the importance of gonorrhea prevention and treatme= nt. Prior to initiating zilucoplan therapy, it is recommended that patients= initiate immunizations according to current immunization guidelines. Refer= to the European Summary of Product Characteristics for other adverse react= ions and full prescribing information. https://u7061146.ct.sendgrid.net/ls/= click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1= r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQTPy5FLbNXMNW6cEFF7eEF7765DcFrK41E-2F= LVrKK5zzrEOLQNmbh8Hy6I-2BiFKrCqDA-3D-3D2WYJ_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT= FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx= s8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9j= UV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Iim2jIs-2BeLP9klMXF8dPN6h4pUwywYn= LeY-2B9nCDo8Ws7-2FiHGz5hbQWwqw90d8lQpSl2mebrhWy5Uyn-2FSlRFmmsejWiAuMHwOr9WE= vXRjgEnXIwNnTs8jSkeP3RVOpz0nsXmGwXxFO1DH7z0dBOjhlXNA-3D EC Date of approval= 01 Dec 2023. Important Safety Information about FINTEPLA=C2=AE=E2=96=BC (fenfluramine) i= n the EU^3 =E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. = This will allow quick identification of new safety information. Healthcare = professionals are asked to report any suspected adverse reactions. Indications: Treatment of seizures associated with Dravet syndrome and Lenn= ox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines = for patients 2 years of age and older.=C2=A0 Dosage and Administration: Please refer to SmPC for full information. Shoul= d be initiated and supervised by physicians with experience in the treatmen= t of epilepsy. Fintepla is prescribed and dispensed according to the Fintep= la controlled access programme. Dravet syndrome: Patients who are not takin= g stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). Afte= r 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/= kg/day). After an additional 7 days, if tolerated and further seizure reduc= tion required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.= 7 mg/kg/day), which is the recommended maintenance dose. Patients requiring= more rapid titration may increase the dose every 4 days. Do not exceed max= imum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiri= pentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 day= s, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day)= , which is the recommended maintenance dose. Patients requiring more rapid = titration may increase the dose every 4 days. Do not exceed a total dose of= 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 = mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increas= ed to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additio= nal 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice dail= y (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed= maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When dis= continuing treatment, decrease the dose gradually. As with all anti-epilept= ic medicines, avoid abrupt discontinuation when possible to minimize the ri= sk of increased seizure frequency and status epilepticus. A final echocardi= ogram should be conducted 3-6 months after the last dose of treatment with = fenfluramine. Renal impairment: Generally, no dose adjustment is recommende= d when administered to patients with mild to severe renal impairment, howev= er, a slower titration may be considered. If adverse reactions are reported= , a dose reduction may be needed. Has not been studied in patients with end= -stage renal disease. Not known if fenfluramine or its active metabolite, n= orfenfluramine, is dialyzable. Hepatic impairment: Hepatic impairment: Gene= rally, no dose adjustment is recommended when Fintepla is administered with= out concomitant stiripentol to patients with mild and moderate hepatic impa= irment (Child-Pugh Class A and B). In patients with severe hepatic impairme= nt (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage= is 0.2mg/kg twice daily, and the maximal total daily dose is 17 mg. There = are limited clinical data on the use of Fintepla with stiripentol in patien= ts with mild impaired hepatic function. A slower titration may be considere= d in patients with hepatic impairment and a dose reduction may be needed if= adverse reactions are reported. No clinical data is available on the use o= f Fintepla with stiripentol in moderate and severe hepatic impairment, ther= efore not recommended for use. Elderly: No data available. Pediatric popula= tion: Safety and efficacy in children below 2 years of age not yet establis= hed. No data available. Contraindications: Hypersensitivity to active subst= ance or any excipients. Aortic or mitral valvular heart disease and pulmona= ry arterial hypertension. Within 14 days of the administration of monoamine= oxidase inhibitors due to an increased risk of serotonin syndrome. Warnings and Precautions: Aortic or mitral valvular heart disease and pulmo= nary arterial hypertension: Prior to starting treatment, patients must unde= rgo an echocardiogram to establish a baseline and exclude any pre-existing = valvular heart disease or pulmonary hypertension. Conduct echocardiogram mo= nitoring every 6 months for the first 2 years and annually thereafter. If a= n echocardiogram indicates pathological valvular changes, consider follow-u= p earlier to evaluate whether the abnormality is persistent. If pathologica= l abnormalities seen on echocardiogram, evaluate the benefit versus risk of= continuing fenfluramine treatment with the prescriber, caregiver and cardi= ologist. Once treatment is discontinued for any reasons, a final echocardio= gram should be conducted 3-6 months after the last dose of treatment with f= enfluramine. If echocardiogram findings suggestive of pulmonary arterial hy= pertension, perform a repeat echocardiogram as soon as possible and within = 3 months to confirm these findings. If echocardiogram finding is confirmed = suggestive of an increased probability of pulmonary arterial hypertension d= efined as intermediate probability, conduct a benefit-risk evaluation of co= ntinuation of Fintepla by the prescriber, carer and cardiologist. If echoca= rdiogram suggests a high probability, it is recommended fenfluramine treatm= ent should be stopped. Decreased appetite and weight loss: Fenfluramine can= cause decreased appetite and weight loss - an additive effect can occur in= combination with other anti-epileptic medicines such as stiripentol. Monit= or the patient=E2=80=99s weight. Undertake risk-benefit evaluation before s= tarting treatment if history of anorexia nervosa or bulimia nervosa. Fintep= la controlled access programme: A controlled access programme has been crea= ted to 1) prevent off-label use in weight management in obese patients and = 2) confirm that prescribing physicians have been informed of the need for p= eriodic cardiac monitoring in patients taking Fintepla. Somnolence: Fenflur= amine can cause somnolence which could be potentiated by other central nerv= ous system depressants. Suicidal behaviour and ideation: Suicidal behaviour= and ideation have been reported in patients treated with anti-epileptic me= dicines in several indications. Advise patients and caregivers to seek medi= cal advice should any signs of suicidal behaviour and ideation emerge. Sero= tonin syndrome: Serotonin syndrome, a potentially life-threatening conditio= n, may occur with fenfluramine treatment, particularly with concomitant use= of other serotonergic agents; with agents that impair metabolism of seroto= nin such as MAOIs; or with antipsychotics that may affect the serotonergic = neurotransmitter systems. Carefully observe the patient, particularly durin= g treatment initiation and dose increases. Increased seizure frequency: A c= linically relevant increase in seizure frequency may occur during treatment= , which may require adjustment in the dose of fenfluramine and/or concomita= nt anti-epileptic medicines, or discontinuation of fenfluramine, should the= benefit-risk be negative. Cyproheptadine: Cyproheptadine is a potent serot= onin receptor antagonist and may therefore decrease the efficacy of fenflur= amine. If cyproheptadine is added to treatment with fenfluramine, monitor p= atient for worsening of seizures. If fenfluramine treatment is initiated in= a patient taking cyproheptadine, fenfluramine=E2=80=99s efficacy may be re= duced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle= closure glaucoma. Discontinue therapy in patients with acute decreases in = visual acuity. Consider discontinuation if ocular pain of unknown origin. E= ffect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 in= ducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations,= which may lower the efficacy of fenfluramine. If co-administration is cons= idered necessary, the patient should be monitored for reduced efficacy and = a dose increase of fenfluramine could be considered provided that it does n= ot exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or C= YP2B6 inducer is discontinued during maintenance treatment with fenfluramin= e, consider gradual reduction of the fenfluramine dosage to the dose admini= stered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibito= rs: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhi= bitor may result in higher exposure and, therefore, adverse events should b= e monitored, and a dose reduction may be needed in some patients. Excipient= s: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl par= a-hydroxybenzoate (E 219) - may cause allergic reactions (possibly delayed)= . It also contains sulfur dioxide (E 220) which may rarely cause severe hyp= ersensitivity reactions and bronchospasm. Patients with rare glucose-galact= ose malabsorption should not take this medicine. The product contains less = than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially= =E2=80=98sodium-free=E2=80=99. Contains glucose - may be harmful to teeth.= Interactions: Pharmacodynamic interactions with other CNS depressants incr= ease the risk of aggravated central nervous system depression. An increase = in dose may be necessary when coadministered with rifampicin or a strong CY= P1A2 or CYP2B6 inducer. In in vitro studies co-administration with a strong= CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 = of the SmPC). Co-administration with CYP2D6 substrates or MATE1 substrates = may increase their plasma concentrations. Co-administration with CYP2B6 or = CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and l= actation: Limited data in pregnant women. As a precaution, avoid use of Fin= tepla in pregnancy. It is unknown whether fenfluramine/metabolites are excr= eted in human milk. Animal data have shown excretion of fenfluramine/metabo= lites in milk. A decision must be made whether to discontinue breast-feedin= g or to discontinue/abstain from Fintepla taking into account the benefit o= f breast-feeding for the child and the benefit of therapy for the woman. Dr= ive and use machines.: Fintepla has moderate influence on the ability to dr= ive/ use machines as it may cause somnolence and fatigue. Advise patients n= ot to drive or operate machinery until they have sufficient experience to g= auge whether it adversely affects their abilities.=C2=A0 Adverse effects: Dravet syndrome: Very common (=E2=89=A51/10): Upper respir= atory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, = fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of tra= ce and mild mitral regurgitation, and trace aortic regurgitation, which are= considered physiologic). Common (=E2=89=A51/100 to <1/10): Bronchitis, abn= ormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypo= tonia, lethargy, seizure, status epilepticus, tremor, constipation, salivar= y hypersecretion, weight decreased and blood prolactin increased. Not known= (cannot be estimated from the available data): Pulmonary arterial hyperten= sion. Lennox-Gastaut syndrome: Very common (=E2=89=A51/10): Upper respirato= ry tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fa= tigue. Common (=E2=89=A51/100 to <1/10): Bronchitis, influenza, pneumonia, = aggression, seizure, status epilepticus, lethargy, tremor, constipation, sa= livary hypersecretion, blood prolactin increased, weight decreased, fall. R= efer to SmPC for other adverse reactions. =C2=A0 Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information.=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= aFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58GnH1fk5gg70icujQcJqxcsLpcg-3D-3D= v74u_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TS= az3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIb= QHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6= QX8IihbNco1wYPONHm3Dx71PtnIufDE9ssN9G5BHd0xAglfBjdyseKQWMwR0ok4-2F4fIB6Jtad= OqPj4VeYEt0hDo2hk-2BQCjlvLM77wybRyyDH4ohFVbYQGfGuB4yVR8yLEo3JVCkm1t0dJ-2Bdb= 5VS5HLNoG3Y-3D Important Safety Information about BRIVIACT=C2=AE (brivaracetam) in the EU^= 4 Therapeutic indications: BRIVIACT is indicated as adjunctive therapy in the= treatment of partial-onset seizures with or without secondary generalisati= on in adults, adolescents and children from 2 years of age with epilepsy.= =C2=A0 Posology and method of administration: The physician should prescribe the m= ost appropriate formulation and strength according to weight and dose. It i= s recommended to parent and care giver to administer BRIVIACT oral solution= with the measuring device (10 ml or 5 ml oral dosing syringe) provided in = the carton box. BRIVIACT solution for injection/infusion is an alternative = route of administration for patients when oral administration is temporaril= y not feasible. There is no experience with twice daily intravenous adminis= tration of brivaracetam for a period longer than 4 days. Adults: The recomm= ended starting dose is 50 or 100 mg/day based on physician=E2=80=99s assess= ment of required for seizure reduction versus potential side effects. Briva= racetam can be taken with or without food. Based on individual patient resp= onse and tolerability, the dose may be adjusted in the effective dose range= of 50 mg/day to 200 mg/day. Children and adolescents weighing 50 kg or mor= e: The recommended starting dose is 50 mg/day. Brivaracetam may also be ini= tiated at 100 mg/day based on physician=E2=80=99s assessment of need for se= izure control. The recommended maintenance dose is 100 mg/day. Based on ind= ividual patient response, the dose may be adjusted in the effective dose ra= nge of 50 mg/day to 200 mg/day. Children and adolescents weighing from 20 k= g to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivara= cetam may also be initiated at doses up to 2 mg/kg/day based on physician= =E2=80=99s assessment of need for seizure control. The recommended maintena= nce dose is 2 mg/kg/day. Based on individual patient response, the dose may= be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day. Chi= ldren weighing from 10 kg to less than 20 kg: The recommended starting dose= is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/k= g/day based on physician=E2=80=99s assessment of need for seizure control. = The recommended maintenance dose is 2.5 mg/kg/day. Based on individual pati= ent response, the dose may be adjusted in the effective dose range of 1 mg/= kg/day to 5 mg/kg/day. For adults, adolescents and children from 2 years of= age, the dose should be administered in two equally divided doses, approxi= mately 12 hours apart. If patients miss one dose or more, it is recommended that they take a singl= e dose as soon as they remember and take the following dose at the usual mo= rning or evening time. Brivaracetam oral solution can be diluted in water o= r juice shortly before swallowing; a nasogastric tube or a gastrostomy tube= may also be used. Brivaracetam may be initiated with either intravenous or= oral administration. When converting from oral to intravenous administrati= on or vice versa, the total daily dose and frequency of administration shou= ld be maintained. Brivaracetam may be administered as an intravenous bolus = without dilution or diluted in a compatible diluent and administered as a 1= 5-minute intravenous infusion. This medicinal product must not be mixed wit= h other medicinal products. Brivaracetam bolus injection or intravenous inf= usion has not been studied in acute conditions, e.g. status epilepticus, an= d is therefore not recommended for such conditions For patients from 16 yea= rs of age, if brivaracetam has to be discontinued, it is recommended that t= he dose is reduced gradually by 50 mg/day on a weekly basis. For patients b= elow the age of 16 years, if brivaracetam has to be discontinued, it is rec= ommended that the dose is reduced by a maximum of half the dose every week = until a dose of 1 mg/kg/day (for patients with a body weight less than 50 k= g) or 50 mg/day (for patients with body weight of 50 kg or more) is reached= . After 1 week of treatment at 50 mg/day, a final week of treatment at 20 m= g/day is recommended. No dose adjustment is needed for elderly patients (= =E2=89=A565 years of age) or for those with renal impairment. Based on data= in adults, no dose adjustment is necessary in pediatric patients with impa= ired renal function. No clinical data are available on pediatric patients w= ith renal impairment. Brivaracetam is not recommended for patients with end= -stage renal disease undergoing dialysis due to lack of data. Exposure to b= rivaracetam was increased in patients with chronic liver disease. In patien= ts with hepatic impairment, the following adjusted doses, administered in 2= divided doses, approximately 12 hours apart, are recommended for all stage= s of hepatic impairment: In adults, adolescents and children weighing =E2= =89=A550 kg, a 50 mg/day starting dose is recommended, with a maximum daily= dose of 150 mg/day. For adolescents and children weighing from 20 kg to <5= 0 kg, a 1 mg/kg/day is recommended, with a maximum daily dose of 3 mg/kg/da= y. For children weighing from 10 kg to <20 kg, a 1 mg/kg/day is recommended= , with a maximum daily dose of 4 mg/kg/day. No clinical data are available = in pediatric patients with hepatic impairment. The efficacy of brivaracetam= in pediatric patients aged less than 2 years has not yet been established. Contraindications: Hypersensitivity to the active substance, other pyrrolid= one derivatives or any of the excipients. Special warnings and precautions = for use: Suicidal ideation and behavior have been reported in patients trea= ted with anti-epileptic drugs (AEDs) in several indications, including briv= aracetam. Patients should be monitored for signs of suicidal ideation and b= ehaviors and appropriate treatment should be considered. Patients (and care= givers) should be advised to seek medical advice should any signs of suicid= al ideation or behavior emerge. Clinical data on the use of brivaracetam in= patients with pre-existing hepatic impairment are limited. Dose adjustment= s are recommended for patients with hepatic impairment. Brivaracetam film-c= oated tablets contain lactose. Patients with rare hereditary problems of ga= lactose intolerance, total lactase deficiency or glucose-galactose malabsor= ption should not take brivaracetam. Brivaracetam film-coated tablets, solut= ion for injection/infusion and oral solution contain less than 1 mmol sodiu= m (23mg) per tablet/vial/ml respectively, that is to say essentially =E2=80= =98sodium free=E2=80=99. Brivaracetam oral solution contains 168 mg sorbito= l (E420) in each ml. Patients with hereditary fructose intolerance (HFI) sh= ould not take this medicinal product. The oral solution contains methyl par= ahydroxybenzoate (E218), which may cause allergic reactions (possibly delay= ed). Brivaracetam oral solution contains propylene glycol (E1520). Interact= ion with other medicinal products and other forms of interaction: In clinic= al studies, although patient numbers were limited, brivaracetam had no obse= rved benefit over placebo among patients taking concomitant levetiracetam. = No additional safety or tolerability concern was observed. In an interactio= n study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continu= ous infusion in healthy volunteers, there was no pharmacokinetic interactio= n, but the effect of alcohol on psychomotor function, attention and memory = was approximately doubled with the intake of brivaracetam. Intake of brivar= acetam with alcohol is not recommended. In vitro data suggest that brivarac= etam has a low interaction potential. The main disposition pathway of briva= racetam=C2=AE is by CYP-independent hydrolysis; a second pathway involves h= ydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may in= crease when co-administered with CYP2C19 strong inhibitors (e.g. fluconazol= e, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated int= eraction is considered to be low. Limited clinical data are available imply= ing that coadministration of cannabidiol may increase the plasma exposure o= f brivaracetam, possibly through CYP2C19 inhibition, but the clinical relev= ance is uncertain. In healthy subjects, co-administration with the strong e= nzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam ar= ea under the plasma concentration curve (AUC) by 45%. Prescribers should co= nsider adjusting the dose of brivaracetam in patients starting or ending tr= eatment with rifampicin. Brivaracetam plasma concentrations are decreased w= hen co-administered with strong enzyme-inducing AEDs (carbamazepine, phenob= arbital, phenytoin) but no dose adjustment is required. Other strong enzyme= inducers such as St John=E2=80=99s wort (Hypericum perforatum) may decreas= e the systemic exposure of brivaracetam. Starting or ending treatment with = St John=E2=80=99s wort should be done with caution. Brivaracetam at 50 or 1= 50 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4). The = risk of clinically relevant CYP3A4 interactions is considered low. In vitro= studies have shown that brivaracetam exhibits little or no inhibition of C= YP450 isoforms except for CYP2C19 and may therefore increase plasma concent= rations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, om= eprazole, diazepam). Brivaracetam did not induce CYP1A1/2 but induced CYP3A= 4 and CYP2B6 in vitro. No CYP3A4 induction was found in vivo. CYP2B6 induct= ion has not been investigated in vivo and brivaracetam may decrease plasma = concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz)= . In vitro interaction studies to determine the potential inhibitory effect= s on transporters concluded that there were no clinically relevant effects,= except for OAT3. In vitro, brivaracetam inhibits OAT3 with a half maximal = inhibitory concentration 42-fold higher than the Cmax at the highest clinic= al dose. Brivaracetam 200 mg/day may increase plasma concentrations of medi= cinal products transported by OAT3. Brivaracetam is a moderate reversible i= nhibitor of epoxide hydrolase, resulting in an increased concentration of c= arbamazepine epoxide, an active metabolite of carbamazepine. In controlled = clinical studies, carbamazepine epoxide plasma concentration increased by a= mean of 37%, 62% and 98% with little variability at Brivaracetam doses of = 50 mg/day, 100 mg/day and 200 mg/day, respectively. No safety risks were ob= served. There was no additive effect of brivaracetam and valproate on the A= UC of carbamazepine epoxide. No dose adjustment is needed when brivaracetam= is co-administered with carbamazepine, phenobarbital or phenytoin. Brivara= cetam had no clinically relevant effect on the plasma concentrations of clo= bazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, p= henobarbital, phenytoin, pregabalin, topiramate, valproic acid or zonisamid= e. There are no data available on the effects of clobazam, clonazepam, laco= samide, pregabalin or zonisamide on brivaracetam plasma concentrations. Co-= administration of brivaracetam (100 mg/day) with an oral contraceptive cont= aining ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not infl= uence the pharmacokinetics of either substance. However, when brivaracetam = was co-administered at a dose of 400 mg/day (twice the recommended maximum = daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, res= pectively, was observed without impact on suppression of ovulation. Pregnan= cy: Data on the use of brivaracetam in pregnant women are limited. There ar= e no data on placental transfer in humans, but brivaracetam was shown to re= adily cross the placenta in rats. The potential risk for humans is unknown.= Animal studies did not detect any teratogenic potential of brivaracetam. I= n clinical studies, adjunctive brivaracetam used concomitantly with carbama= zepine induced a dose-related increase in the concentration of the active m= etabolite, carbamazepine-epoxide. There are insufficient data to determine = the clinical significance of this effect in pregnancy. Brivaracetam should = not be used during pregnancy unless clinically necessary. Breast-feeding: B= rivaracetam is excreted in human breast milk. The decision to discontinue e= ither breastfeeding or brivaracetam should be made based on the benefit of = the medicinal product to the mother. In case of co-administration of brivar= acetam and carbamazepine, the amount of carbamazepine-epoxide excreted in b= reast milk could increase. The clinical significance remains unknown. Ferti= lity: No human data on the effect of brivaracetam on fertility are availabl= e. There was no effect on fertility in rats. Effects on ability to drive an= d use machines: Brivaracetam has minor or moderate influence on the ability= to drive and use machines. Patients should be advised not to drive a car o= r to operate other potentially hazardous machines until they are familiar w= ith the effects of brivaracetam on their ability to perform such activities= . Undesirable effects: The most frequently reported adverse reactions with = brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usual= ly mild-to-moderate in intensity. Somnolence and fatigue were reported at a= higher incidence with increasing dose. Very common adverse reactions (=E2= =89=A51%-<10%) were influenza, decreased appetite, depression, anxiety, ins= omnia, irritability, convulsion, vertigo, upper respiratory tract infection= s, cough, nausea, vomiting, constipation and fatigue. Neutropenia was repor= ted in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treate= d patients. Four of these subjects had decreased neutrophil counts at basel= ine. None of the neutropenia cases were severe, required any specific treat= ment or led to discontinuation of brivaracetam and none had associated infe= ctions. Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and= 0.7% (3/459) of placebo-treated patients. In short-term clinical studies o= f brivaracetam in patients with epilepsy, there were no cases of completed = suicide and suicide attempt; however, both were reported in open-label exte= nsion studies. The safety profile of brivaracetam observed in children from= 1 month of age was consistent with the safety profile observed in adults. = In the open label, uncontrolled, long-term studies suicidal ideation was re= ported in 4.7 % of pediatric patients (assessed from 6 years onwards, more = common in adolescents) compared with 2.4 % of adults and behavioral disorde= rs were reported in 24.8 % of pediatric patients compared with 15.1 % of ad= ults. The majority of events were mild or moderate in intensity, were non-s= erious, and did not lead to discontinuation of study drug. An additional ad= verse reaction reported in children was psychomotor hyperactivity (4.7 %). = No specific pattern of adverse event (AE) was identified in children from 1= month to < 4 years of age when compared to older pediatric age groups. No = significant safety information was identified indicating the increasing inc= idence of a particular AE in this age group. As data available in children = younger than 2 years of age are limited, brivaracetam is not indicated in t= his age range. Limited clinical data are available in neonates. Reactions s= uggestive of immediate (Type I) hypersensitivity have been reported in a sm= all number of brivaracetam patients (9/3022) during clinical development. O= verdose: There is limited clinical experience with brivaracetam overdose in= humans. Somnolence and dizziness have been reported in a healthy subject t= aking a single dose of 1,400 mg of brivaracetam. The following adverse reac= tions were reported with brivaracetam overdose: nausea, vertigo, balance di= sorder, anxiety, fatigue, irritability, aggression, insomnia, depression, a= nd suicidal ideation in the post-marketing experience. In general, the adve= rse reactions associated with brivaracetam overdose were consistent with th= e known adverse reactions. There is no specific antidote for overdose with = brivaracetam. Treatment of an overdose should include general supportive me= asures. Since <10% of brivaracetam is excreted in urine, haemodialysis is n= ot expected to significantly enhance brivaracetam clearance. Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information.=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= eCvoMjYP04nywf0gfc5zs5nImJZj0FAQTroWJHzWu5LpXvq460F0G67I5LgJKUCCw-3D-3Dl08V= _2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3m= plcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHof= t-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8I= iukXkbxM-2FSPQmhaGsiz2Fv8l-2B9wSxn1KYMcOKQJwkgEuOB27x-2F0nkpd6wYUnZN-2FvnuW= 9vef13moEeobTg7x2dKR4F2jz9o1x7odGXLK2Mn9sGcVmtU10W1Ox-2Bn8Y7N8WXew8Yj38NwFc= zWpeWWZZnhU-3D Important Safety Information about VIMPAT^=C2=AE (lacosamide) in the EU^5= =C2=A0 Therapeutic indications: VIMPAT^=C2=AE is indicated as monotherapy in the t= reatment of partial-onset seizures with or without secondary generalization= in adults, adolescents and children from 2 years of age with epilepsy. VIM= PAT^=C2=AE is indicated as adjunctive therapy in the treatment of partial-o= nset seizures with or without secondary generalization in adults, adolescen= ts and children from 2 years of age with epilepsy and in the treatment of p= rimary generalized tonic-clonic seizures in adults, adolescents and childre= n from 4 years of age with idiopathic generalized epilepsy.=C2=A0 Posology and method of administration: Lacosamide therapy can be initiated = with either oral administration (either tablets or syrup) or IV administrat= ion (solution for infusion). The physician should prescribe the most approp= riate formulation and strength according to weight and dose. A loading dose= may be initiated in patients in situations when the physician determines t= hat rapid attainment of lacosamide steady state plasma concentration and th= erapeutic effect is warranted. It should be administered under medical supe= rvision with consideration of the potential for increased incidence of seri= ous cardiac arrhythmia and Central Nervous System (CNS) adverse reactions. = Administration of a loading dose has not been studied in acute conditions s= uch as status epilepticus. Administration of a loading dose has not been st= udied in children. Use of a loading dose is not recommended in adolescents = and children weighing less than 50 kg. No dose adjustment is necessary in m= ildly and moderately renally impaired adult and pediatric patients (CLCR > = 30 ml/min). In pediatric patients weighing 50 kg or more and in adult patie= nts with mild or moderate renal impairment, a loading dose of 200 mg may be= considered, but further dose titration (>200 mg daily) should be performed= with caution. In pediatric patients weighing 50 kg or more and in adult pa= tients with severe renal impairment (CLCR =E2=89=A4 30 ml/min) or with end-= stage renal disease, a maximum dose of 250 mg/day is recommended and the do= se titration should be performed with caution. In pediatric patients weighi= ng less than 50 kg with severe renal impairment (CLCR =E2=89=A4 30 ml/min) = and in those with end-stage renal disease, a reduction of 25 % of the maxim= um dose is recommended. A maximum dose of 300 mg/day is recommended for ped= iatric patients weighing 50 kg or more and for adult patients with mild to = moderate hepatic impairment. Based on data in adults, in pediatric patients= weighing less than 50 kg with mild to moderate hepatic impairment, a reduc= tion of 25 % of the maximum dose should be applied. Lacosamide should be ad= ministered to adult and pediatric patients with severe hepatic impairment o= nly when the expected therapeutic benefits are anticipated to outweigh the = possible risks. The dose may need to be adjusted while carefully observing = disease activity and potential side effects in the patient. In adolescents = and adults weighing 50 kg or more with mild to moderate hepatic impairment = a loading dose of 200mg may be considered, but further dose titration (>200= mg daily) should be performed with caution. Lacosamide is not recommended = for use in children below the age of 4 years in the treatment of primary ge= neralized tonic-clonic seizures and below the age of 2 years in the treatme= nt of partial-onset seizures as there are limited data on safety and effica= cy in these age groups. Contraindications: Hypersensitivity to the active s= ubstance or any of the excipients; known second- or third-degree atrioventr= icular (AV) block. Special warnings and precautions for use: Suicidal ideat= ion and behavior have been reported in patients treated with antiepileptic = medicinal products in several indications. Therefore, patients should be mo= nitored for signs of suicidal ideation and behavior and appropriate treatme= nt should be considered. Patients (and caregivers of patients) should be ad= vised to seek medical advice should signs of suicidal ideation or behavior = emerge. Dose-related prolongations in PR interval with lacosamide have been= observed in clinical studies. Lacosamide should be used with caution in pa= tients with underlying proarrhythmic conditions such as known cardiac condu= ction problems or severe cardiac diseases (e.g. myocardial ischemia/infarct= ion, heart failure, structural heart disease or cardiac sodium channelopath= ies) or patients treated with medicinal products affecting cardiac conducti= on, including antiarrhythmics and sodium channel blocking antiepileptic med= icinal products, as well as in elderly patients. In these patients it shoul= d be considered to perform an electrocardiogram (ECG) before a lacosamide d= ose increase above 400mg/day and after lacosamide is titrated to steady-sta= te. In the placebo-controlled clinical studies of lacosamide in epilepsy pa= tients, atrial fibrillation or flutter were not reported; however both have= been reported in open-label epilepsy studies and in post-marketing experie= nce. In post-marketing experience, AV block (including second degree or hig= her AV block) has been reported. In patients with proarrhythmic conditions,= ventricular tachyarrhythmia has been reported. In rare cases, these events= have led to asystole, cardiac arrest and death in patients with underlying= proarrhythmic conditions. Patients should be made aware of the symptoms of= cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, sho= rtness of breath, feeling lightheaded, fainting). Patients should be counse= lled to seek immediate medical advice if these symptoms occur. Treatment wi= th lacosamide has been associated with dizziness which could increase the o= ccurrence of accidental injury or falls. Therefore, patients should be advi= sed to exercise caution until they are familiar with the potential effects = of the medicine. New onset or worsening of myoclonic seizures has been repo= rted in both adult and pediatric patients with primary generalized tonic-cl= onic seizures (PGTCS), in particular during titration. In patients with mor= e than one seizure type, the observed benefit of control for one seizure ty= pe should be weighed against any observed worsening in another seizure type= . The safety and efficacy of lacosamide in pediatric patients with epilepsy= syndromes in which focal and generalized seizures may coexist have not bee= n determined. VIMPAT=C2=AE syrup contains sodium methyl parahydroxybenzoate= (E219) which may cause allergic reactions (possibly delayed). Vimpat Syrup= contains sorbitol (E420). Patients with rare hereditary problems of fructo= se intolerance should not take this medicine. Sorbitol may cause gastrointe= stinal discomfort and mild laxative effect. The syrup contains aspartame (E= 951), a source of phenylalanine, which may be harmful for people with pheny= lketonuria. Neither non-clinical nor clinical data are available to assess = aspartame use in infants below 12 weeks of age. Vimpat syrup contains propy= lene glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, equ= ivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium= for an adult. VIMPAT=C2=AE solution for infusion contains 59.8 mg sodium p= er vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 = g sodium for an adult. Effects on ability to drive and use machines: Lacosa= mide may have minor to moderate influence on the ability to drive and use m= achines. Lacosamide treatment has been associated with dizziness or blurred= vision. Accordingly, patients should be advised not to drive a car or to o= perate other potentially hazardous machinery until they are familiar with t= he effects of lacosamide on their ability to perform such activities. Undes= irable effects: The most frequently reported adverse reactions (=E2=89=A510= %) are dizziness, headache, nausea and diplopia. They were usually mild to = moderate in intensity. Some were dose-related and could be alleviated by re= ducing the dose. Incidence and severity of CNS and gastrointestinal (GI) ad= verse reactions usually decreased over time. Incidence of CNS adverse react= ions such as dizziness may be higher after a loading dose. Other common adv= erse reactions (=E2=89=A51% - <10%) are depression, confusional state, inso= mnia, balance disorder, myoclonic seizures, ataxia, memory impairment, cogn= itive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, di= sturbance in attention, paresthesia, vision blurred, vertigo, tinnitus, vom= iting, constipation, flatulence, dyspepsia, dry mouth, diarrhea, pruritus, = rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, fee= ling drunk, injection site pain or discomfort (local adverse events associa= ted with intravenous administration), irritation (local adverse events asso= ciated with intravenous administration), fall, and skin laceration and cont= usion. The use of lacosamide is associated with dose-related increase in th= e PR interval. Adverse reactions associated with PR interval prolongation (= e.g. atrioventricular block, syncope, bradycardia) may occur. Multiorgan Hy= persensitivity Reactions: Multiorgan hypersensitivity reactions (also known= as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been= reported in patients treated with some antiepileptic medicinal products. T= hese reactions are variable in expression but typically present with fever = and rash and can be associated with involvement of different organ systems.= If multiorgan hypersensitivity reaction is suspected, lacosamide should be= discontinued. The safety profile of lacosamide in adjunctive therapy in pe= diatric patients with partial-onset seizures was consistent with the safety= profile observed in adults. The additional adverse reactions observed in t= he pediatric population were pyrexia, nasopharyngitis, pharyngitis, decreas= ed appetite, abnormal behavior and lethargy. Somnolence was reported more f= requently in the pediatric population (=E2=89=A5 1/10) compared to the adul= t population (=E2=89=A5 1/100 to < 1/10). Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information.=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= dKH6uwvLMA1emtIUD0lioda9u0qXspIFbBSnu16nfiDo41A1VZyCV3I6j6KIIyLsA-3D-3DuFnV= _2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3m= plcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHof= t-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8I= ivwNq9vxqzEQC4XF34GqNgSChWkODLLq-2BGchMMyDh4iDzy9CdFWXt4fXaWIr6unGUKZCP8xo-= 2FP-2FWHykrqcBSw-2FYXBs-2BCdCJh1F1T5P0vBXk2UK8oQRMd-2BDBwsm9BSj3cA5AupYprej= vn-2FN1PgeKckBg-3D Important Safety Information about RYSTIGGO=C2=AE (rozanolixizumab-noli) in= the US^6 RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated= for the treatment of generalized myasthenia gravis (gMG) in adult patients= who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine= kinase (MuSK) antibody positive.^6 WARNINGS AND PRECAUTIONS=C2=A0 Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO adm= inistration in patients with an active infection until the infection is res= olved. During treatment with RYSTIGGO, monitor for clinical signs and sympt= oms of infection. If serious infection occurs, administer appropriate treat= ment and consider withholding RYSTIGGO until the infection has resolved. Immunization Immunization with vaccines during RYSTIGGO treatment has not been studied. = The safety of immunization with live or live-attenuated vaccines and the re= sponse to immunization with any vaccine are unknown. Because RYSTIGGO cause= s a reduction in IgG levels, vaccination with live-attenuated or live vacci= nes is not recommended during treatment with RYSTIGGO. Evaluate the need to= administer age-appropriate vaccines according to immunization guidelines b= efore initiation of a new treatment cycle with RYSTIGGO. Aseptic Meningitis: Serious adverse reactions of aseptic meningitis (also c= alled drug-induced aseptic meningitis) have been reported in patients treat= ed with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, d= iagnostic workup and treatment should be initiated according to the standar= d of care. Hypersensitivity Reactions: Hypersensitivity reactions, including angioedem= a and rash, were observed in patients treated with RYSTIGGO. Management of = hypersensitivity reactions depends on the type and severity of the reaction= . Monitor patients during treatment with RYSTIGGO and for 15 minutes after = for clinical signs and symptoms of hypersensitivity reactions. If a reactio= n occurs, institute appropriate measures if needed. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported = in at least 10% of RYSTIGGO-treated patients) were headache, infections, di= arrhea, pyrexia, hypersensitivity reactions, and nausea. Serious infections= were reported in 4% of patients treated with RYSTIGGO. Three fatal cases o= f pneumonia were identified, caused by COVID-19 infection in two patients a= nd an unknown pathogen in one patient. Six cases of infections led to disco= ntinuation of RYSTIGGO. The full Prescribing Information is available at https://u7061146.ct.sendgr= id.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLuLRRIcxGl3OV= Su7DRu3DqZ9JCtf3-2FdaMXLXW20O7qWKz6aeTPMRZqsiIE2JV4aN9B4DPGToJs0Xmk-3DWvJl_= 2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mp= lcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft= -2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Ii= qq961PlGdLPxtmRmMLyQ6-2FPBPOimnHcXAz-2FAwITXKXBdygzprpk0aW8-2FgdHy2zyfIP-2B= JRRfWlfc3MlemXWn90moBGow8BChHzOtN254fsoflGUHut4fhAwOIbkFcCqY3Lg-2BNnovoD52i= 7vfREXiHNI-3D Important Safety Information about ZILBRYSQ^=C2=AE (zilucoplan) in the US^7 IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING ZILBRYSQ is a complement inhibitor indicated for the treatment of generaliz= ed myasthenia gravis (gMG) in adult patients who are anti-acetylcholine rec= eptor (AChR) antibody positive.7=C2=A0 INDICATION ZILBRYSQ (zilucoplan) is indicated for the treatment of generalized myasthe= nia gravis (gMG) in adult patients who are anti-acetylcholine receptor (ACh= R) antibody positive. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Life-threatening and fatal meningococcal infections have occurred in patien= ts treated with complement inhibitors; ZILBRYSQ is a complement inhibitor. = Meningococcal infection may become rapidly life-threatening or fatal if not= recognized and treated early. =E2=80=A2=C2=A0=C2=A0 =C2=A0Complete or update meningococcal vaccination (f= or serogroups A, C, W, and Y, and serogroup B) at least 2 weeks prior to ad= ministering the first dose of ZILBRYSQ, unless the risk of delaying therapy= outweighs the risk of developing a meningococcal infection. Comply with th= e most current Advisory Committee on Immunization Practices (ACIP) recommen= dations for meningococcal vaccinations in patients receiving a complement i= nhibitor. =E2=80=A2=C2=A0=C2=A0 =C2=A0Persons receiving ZILBRYSQ are at increased ris= k for invasive disease caused by N. meningitidis, even if they develop anti= bodies following vaccination. Monitor patients for signs of meningococcal i= nfections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, ZILBRYSQ is availa= ble only through a restricted program under a Risk Evaluation and Mitigatio= n Strategy (REMS) called ZILBRYSQ REMS. CONTRAINDICATIONS ZILBRYSQ is contraindicated in patients with unresolved Neisseria meningiti= dis infection. WARNINGS AND PRECAUTIONS Serious Meningococcal Infections Life-threatening and fatal meningococcal infections have occurred in both v= accinated and unvaccinated patients treated with complement inhibitors; ZIL= BRYSQ is a complement inhibitor. The use of ZILBRYSQ increases a patient=E2= =80=99s susceptibility to serious and life-threatening meningococcal infect= ions (septicemia and/or meningitis) caused by any serogroup, including non-= groupable strains. Complete or update meningococcal vaccination (for both serogroups A, C, W, = and Y [MenACWY] and serogroup B [MenB]) at least 2 weeks prior to administe= ring the first dose of ZILBRYSQ, according to current ACIP recommendations = for meningococcal vaccinations in patients receiving a complement inhibitor= . If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date = with both MenACWY and MenB vaccines according to ACIP recommendations, admi= nister meningococcal vaccine(s) as soon as possible and provide the patient= with antibacterial drug prophylaxis. Closely monitor patients for early signs and symptoms of meningococcal infe= ction and evaluate patients immediately if infection is suspected. Withhold= administration of ZILBRYSQ in patients who are undergoing treatment for me= ningococcal infection until the infection is resolved. ZILBRYSQ REMS Due to the risk of meningococcal infections, ZILBRYSQ is available only thr= ough a restricted program under a REMS called ZILBRYSQ REMS. Under the ZILBRYSQ REMS, prescribers must enroll in the program. Prescriber= s must counsel patients about the risk of meningococcal infection, provide = the patients with the REMS educational materials, and ensure patients are v= accinated with meningococcal vaccines. Additional information on the REMS r= equirements is available at www.ZILBRYSQREMS.com (https://u7061146.ct.sendg= rid.net/ls/click?upn=3Du001.b00YhNV2Nr0-2BaZn7eVNAdTlygTA3p3pHftcDhJ4XgvKfj= k5DY262sTClti1hGslFiyBR_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FK= l1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-= 2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioD= kTc7NFQmPszJXm4PQc6QX8IiuOGBKol6TZI8dZchOFkgCq3WPxJDYFVsoFiuBCrQX0IXDbZD7bZ= nVVMqZLoWgf8u6Y3Fr349QRICK4BQ0aF07Sh-2B36t0Dnd-2FVzQTBOpm3EJj0-2F-2FmR9iICt= -2BCkEeyJsCIsS5i-2BBXzJ8B98KgFWhvv1c-3D or 1-877-414-8353. Other Infections ZILBRYSQ blocks terminal complement activation; therefore, patients may hav= e increased susceptibility to infections, especially with encapsulated bact= eria, such as infections caused by Neisseria meningitidis but also Streptoc= occus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria= gonorrhoeae. Administer vaccinations for the prevention of Streptococcus p= neumoniae and Haemophilus influenzae type b (Hib) infections according to A= CIP guidelines. Persons receiving ZILBRYSQ are at increased risk for infect= ions due to these bacteria, even after vaccination. Pancreatitis And Other Pancreatic Conditions Pancreatitis and pancreatic cysts have been reported in patients treated wi= th ZILBRYSQ. Patients should be informed of this risk before starting ZILBR= YSQ. Obtain lipase and amylase levels at baseline before starting treatment= with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatiti= s and initiate appropriate management until pancreatitis is ruled out or ha= s resolved. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported = in at least 10% of gMG patients treated with ZILBRYSQ) were injection site = reactions, upper respiratory tract infections, and diarrhea. The full Prescribing Information is available at https://u7061146.ct.sendgr= id.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLuLRRIcxGl3OV= SaglaHbBZEsazHv34oHd3VWjzSiXX-2FIVWz0PTK-2FNouhuBiau3s62jkNtd9WK8vp4g-3DKV2= i_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3= mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHo= ft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8= Iihz9Oh9QNCMHvL97vvl0loYIB4OqcVvw1H0-2B0M4y2p87k3cGyZN7sMnc-2Fz1XGhHfX3JPot= mT68po5deJtZtX0-2BaIxar45EAf772U4oO-2FfzFau3G7LHJgKQ8s8F4Uufcf-2BKaG6-2FCD-= 2FPKDX0eXuZCXqmU-3D Important Safety Information about FINTEPLA=C2=AE (fenfluramine) in the US^= 8 INDICATIONS AND USAGE FINTEPLA is indicated for the treatment of seizures associated with Dravet = syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age = and older.^8 IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION =E2=80=A2=C2=A0=C2=A0 =C2=A0There is an association between serotonergic dr= ugs with 5-HT2B receptor agonist activity, including fenfluramine (the acti= ve ingredient in FINTEPLA), and valvular heart disease and pulmonary arteri= al hypertension.=C2=A0 =E2=80=A2=C2=A0=C2=A0 =C2=A0Echocardiogram assessments are required before,= during, and after treatment with FINTEPLA.=C2=A0 =E2=80=A2=C2=A0=C2=A0 =C2=A0FINTEPLA is available only through a restricted= program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenflurami= ne or any of the excipients in FINTEPLA and with concomitant use, or within= 14 days of the administration, of monoamine oxidase inhibitors because of = an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warni= ng): Because of the association between serotonergic drugs with 5 HT2B rece= ptor agonist activity, including fenfluramine (the active ingredient in FIN= TEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertensio= n (PAH), cardiac monitoring via echocardiogram is required prior to startin= g treatment, during treatment, and after treatment with FINTEPLA concludes.= Cardiac monitoring via echocardiogram can aid in early detection of these = conditions. In clinical trials for DS and LGS of up to 3 years in duration,= no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardi= ogram to evaluate for VHD and PAH. Echocardiograms should be repeated every= 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or= continuing treatment with FINTEPLA if any of the following signs are obser= ved via echocardiogram: valvular abnormality or new abnormality; VHD indica= ted by mild or greater aortic regurgitation or moderate or greater mitral r= egurgitation, with additional characteristics of VHD (eg, valve thickening = or restrictive valve motion); PAH indicated by elevated right heart/pulmona= ry artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only throu= gh a restricted distribution program called the FINTEPLA Risk Evaluation an= d Mitigation Strategy (REMS) Program. Prescribers must be certified by enro= lling in the FINTEPLA REMS. Prescribers must counsel patients receiving FIN= TEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of= VHD and PAH, the need for baseline (pretreatment) and periodic cardiac mon= itoring via echocardiogram during FINTEPLA treatment, and cardiac monitorin= g after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and c= omply with ongoing monitoring requirements. The pharmacy must be certified = by enrolling in the FINTEPLA REMS and must only dispense to patients who ar= e authorized to receive FINTEPLA. Wholesalers and distributors must only di= stribute to certified pharmacies. Further information is available at www.F= inteplaREMS.com or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in ap= petite and weight. Decreases in weight appear to be dose related. Approxima= tely half of the patients with LGS and most patients with DS resumed the ex= pected measured increases in weight during the open-label extension studies= . Weight should be monitored regularly during treatment with FINTEPLA, and = dose modifications should be considered if a decrease in weight is observed= .=C2=A0 Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation= , and lethargy. Other central nervous system (CNS) depressants, including a= lcohol, could potentiate these effects of FINTEPLA. Prescribers should moni= tor patients for somnolence and sedation and should advise patients not to = drive or operate machinery until they have gained sufficient experience on = FINTEPLA to gauge whether it adversely affects their ability to drive or op= erate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTE= PLA, increase the risk of suicidal thoughts or behaviors in patients taking= these drugs for any indication. Patients treated with an AED for any indic= ation should be monitored for the emergence or worsening of depression, sui= cidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the r= isk of suicidal thoughts or behaviors with the risks of untreated illness. = Epilepsy and many other illnesses for which AEDs are prescribed are themsel= ves associated with morbidity and mortality and an increased risk of suicid= al thoughts and behaviors. Should suicidal thoughts and behaviors emerge du= ring treatment, consider whether the emergence of these symptoms in any giv= en patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should gener= ally be withdrawn gradually because of the risk of increased seizure freque= ncy and status epilepticus. If withdrawal is needed because of a serious ad= verse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening cond= ition, may occur with FINTEPLA, particularly during concomitant administrat= ion of FINTEPLA with other serotonergic drugs, including, but not limited t= o, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selectiv= e serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), = bupropion, triptans, dietary supplements (eg, St. John=E2=80=99s Wort, tryp= tophan), drugs that impair metabolism of serotonin (including monoamine oxi= dase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextrome= thorphan, lithium, tramadol, and antipsychotics with serotonergic agonist a= ctivity. Patients should be monitored for the emergence of signs and sympto= ms of serotonin syndrome, which include mental status changes (eg, agitatio= n, hallucinations, coma), autonomic instability (eg, tachycardia, labile bl= ood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoor= dination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea= ). If serotonin syndrome is suspected, treatment with FINTEPLA should be st= opped immediately and symptomatic treatment should be started.=C2=A0 Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressur= e. Rare cases of significant elevation in blood pressure, including hyperte= nsive crisis, has been reported in adult patients treated with fenfluramine= , including patients without a history of hypertension. In clinical trials = for DS and LGS of up to 3 years in duration, no pediatric or adult patient = receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in= patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closur= e glaucoma. Consider discontinuing treatment with FINTEPLA in patients with= acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at leas= t 10% and greater than placebo) were decreased appetite; somnolence, sedati= on, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, mal= aise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure = increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tr= act infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at l= east 10% and greater than placebo) were diarrhea; decreased appetite; fatig= ue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1= A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrati= ons. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with = FINTEPLA is necessary, monitor the patient for reduced efficacy and conside= r increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, = or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA= , consider gradual reduction in the FINTEPLA dosage to the dose administere= d prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or = CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINT= EPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum= daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor = is discontinued during maintenance treatment with FINTEPLA, consider gradua= l increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or= CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a st= rong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17= mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular= filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are rec= ommended. FINTEPLA has not been studied in patients with kidney failure (eG= FR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased= in subjects with various degrees of hepatic impairment (Child-Pugh Class A= , B, and C), necessitating a dosage adjustment in these patients.=C2=A0 To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1 844-599-2273 = or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full Prescribing Information is available at https://u7061146.ct.sendgr= id.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC5rB1kxObAU1e99kHD7BUidVPS= GoTF5FxrwLFsh8z1WJKUs12a-2B7UEiLfhhcxHgnjIxVem34lONCj9m8c1RchcX4IGC6jxadj-2= BwMZA-2B-2Fwz17wgu5_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2= nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6F= ohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7= NFQmPszJXm4PQc6QX8IigU9xBllIwNDhMlwyey2xJayXayJI24bhhjVcPa-2Br4a-2BXFOiOqB3= kq6sb5xhNHgrvhNXA4S2dlb0Td1nmOtWXLQYOIO7Cjj2FULCU6nVtDDCh42ILxjoJweC7Ijtm3q= lJz-2B-2BRcBx3PW4snuHFRyM-2B10-3D Important Safety Information about BRIVIACT^=C2=AE (brivaracetam) CV in the= US^9 INDICATION BRIVIACT^=C2=AE (brivaracetam) CV is indicated for the treatment of partial= -onset seizures in patients 1 month of age and older.^11=C2=A0 IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, in= crease the risk of suicidal behavior and ideation. Monitor patients taking = BRIVIACT for the emergence or worsening of depression; unusual changes in m= ood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patie= nts, their caregivers, and/or families to be alert for these behavioral cha= nges and report them immediately to a healthcare provider. Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizzin= ess, and disturbance in coordination. Monitor patients for these signs and = symptoms and advise them not to drive or operate machinery until they have = gained sufficient experience on BRIVIACT. Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reaction= s, including non-psychotic and psychotic symptoms in adult and pediatric pa= tients. Advise patients to report these symptoms immediately to a healthcar= e provider. Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospa= sm and angioedema have been reported. Discontinue BRIVIACT if a patient dev= elops a hypersensitivity reaction after treatment. BRIVIACT is contraindica= ted in patients with a prior hypersensitivity reaction to brivaracetam or a= ny of the inactive ingredients. Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIAC= T should generally be withdrawn gradually because of the risk of increased = seizure frequency and status epilepticus. DOSING CONSIDERATIONS Dose adjustments are recommended for patients with all stages of hepatic im= pairment. When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT= dose is recommended. ADVERSE REACTIONS In adult adjunctive therapy placebo-controlled clinical trials, the most co= mmon adverse reactions (at least 5% for BRIVIACT and at least 2% more frequ= ently than placebo) were somnolence and sedation, dizziness, fatigue, and n= ausea and vomiting symptoms. Adverse reactions reported in clinical studies= of pediatric patients were generally similar to those in adult patients. A= dverse reactions with BRIVIACT injection in adult and pediatric patients we= re generally similar to those observed with BRIVIACT tablets. Other adverse= events that occurred in adult patients who received BRIVIACT injection inc= luded dysgeusia, euphoric mood, feeling drunk, and infusion site pain. BRIVIACT is a Schedule V controlled substance. The full Prescribing Information is available at: https://u7061146.ct.sendg= rid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCwCHPiZ6ZfdvbB048Xe4f782D= ZG3Z4xoFxmz0eUDmr-2FvV1N36GZGBv-2F2yCuyWRF7jR7od9HewK1ZTaU3achyarNcAlLpnw17= Q6ps-2FUvTdVG1qs-2FlZqaLo6cboTNixkFn4ggjMViCzazgmb-2FaM4uvncU-3DFLTs_2dCLUN= buBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6Z= opJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiU= HSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Iip2Wwh9= booUbYpStNc5SnZFl78nfnOLlUX2U0ljWfKuFaXNXI8Qsna3L-2FbIR8LDFSmWEtMNZUr1jJxX9= UdQaEIRuOsm5B929AdhLMwyTKW4t8PzHp4BZpLPlCXo-2Fiuzyj-2B3ydDX1KDPa2mnqqKNswGM= -3D Important Safety Information about VIMPAT^=C2=AE (lacosamide) CV in the US^= 10 INDICATION VIMPAT^=C2=AE is indicated for the treatment of partial-onset seizures in p= atients 1 month of age and older. VIMPAT is indicated as adjunctive therapy= in the treatment of primary generalized tonic-clonic seizures in patients = 4 years of age and older.^13=C2=A0 VIMPAT IMPORTANT SAFETY INFORMATION VIMPAT is associated with important warnings and precautions including suic= idal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduc= tion abnormalities, syncope, and Drug Reaction with Eosinophilia and System= ic Symptoms (DRESS), also known as multi-organ hypersensitivity.=C2=A0 Partial-Onset Seizures In the adult adjunctive placebo-controlled trials for partial-onset seizure= s, the most common adverse reactions (=E2=89=A510% and greater than placebo= ) were dizziness, headache, nausea, and diplopia. In the adult monotherapy = clinical trial, adverse reactions were generally similar to those observed = and attributed to drug in adjunctive placebo-controlled trials, with the ex= ception of insomnia (observed at a higher rate of =E2=89=A52%). Pediatric a= dverse reactions were similar to those seen in adult patients. Primary Generalized Tonic-Clonic Seizures In the adjunctive therapy placebo-controlled trial for primary generalized = tonic-clonic seizures, the adverse reactions were generally similar to thos= e that occurred in the partial-onset seizures trials. The adverse reactions= most commonly reported were dizziness, somnolence, headache, and nausea. The adverse reactions associated with VIMPAT injection in adult patients wi= th primary generalized tonic-clonic seizures are expected to be similar to = those seen in adults with partial-onset seizures. The adverse reactions ass= ociated with VIMPAT injection in pediatric patients are expected to be simi= lar to those noted in adults. Infusion times less than 30 minutes were not = adequately studied in pediatric patients. VIMPAT contains lacosamide, a Schedule V controlled substance.=C2=A0 Please refer to the full Prescribing Information (https://u7061146.ct.sendg= rid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLuLRRIcxGl3O= VQesDUC5RLC8PudYympUfH4E5EEg93m7Vi2lQ7-2F5LJ2s92HAz-2Bdzluju6EP4MlaTno-3Dyr= iw_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz= 3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQH= oft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX= 8IihNCsnFM7iA5mSfsgc8orfkp2dWUNCrx2BztvbUUnHMs-2B3xcxPpmTBSchzuuAwlriFe5UCw= K7r-2F-2Fd4zMoR6n3l5vBRnLSHjSLGM0dblNEHBAzoS-2BZoa1nqX2RQK9Bbhy-2Fvp8uXvpWz= wKPUkiSY7oBx4-3D . =C2=AC=C2=AC BRIVIACT^=C2=AE, FINTEPLA^=C2=AE, RYSTIGGO^=C2=AE, and ZILBRYSQ^=C2=AE are = registered trademarks of the UCB Group of Companies. VIMPAT^=C2=AE is a reg= istered trademark used under license from Harris FRC Corporation. Staccato^= =C2=AE is a registered trademark of Alexza Pharmaceuticals, Inc., and is us= ed by UCB Pharma under license.=C2=A0 About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8,600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e actual results, financial condition, performance or achievements of UCB, = or industry results, to differ materially from those that may be expressed = or implied by such forward-looking statements contained in this press relea= se. Important factors that could result in such differences include: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t liability claims, challenges to patent protection for products or product= candidates, competition from other products including biosimilars, changes= in laws or regulations, exchange rate fluctuations, changes or uncertainti= es in tax laws or the administration of such laws, and hiring and retention= of its employees. There is no guarantee that new product candidates will b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products, which are the subject of partners= hips, joint ventures or licensing collaborations may be subject to differen= ces disputes between the partners or may prove to be not as safe, effective= or commercially successful as UCB may have believed at the start of such p= artnership. UCB=E2=80=99s efforts to acquire other products or companies an= d to integrate the operations of such acquired companies may not be as succ= essful as UCB may have believed at the moment of acquisition. Also, UCB or = others could discover safety, side effects or manufacturing problems with i= ts products and/or devices after they are marketed. The discovery of signif= icant problems with a product similar to one of UCB=E2=80=99s products that= implicate an entire class of products may have a material adverse effect o= n sales of the entire class of affected products. Moreover, sales may be im= pacted by international and domestic trends toward managed care and health = care cost containment, including pricing pressure, political and public scr= utiny, customer and prescriber patterns or practices, and the reimbursement= policies imposed by third-party payers as well as legislation affecting bi= opharmaceutical pricing and reimbursement activities and outcomes. Finally,= a breakdown, cyberattack or information security breach could compromise t= he confidentiality, integrity and availability of UCB=E2=80=99s data and sy= stems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 References: 1. =C2=A0 RYSTIGGO^=C2=AE EU SmPC. https://u7061146.ct.sendgrid.net/ls/clic= k?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B= 0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQc3F9ewc5VRq5B-2BXotAk5NyhPeFI6ikKxpfhDAA= Vc6P8sBVSZkcKwTGRslpFD-2FKQzg-3D-3DgBMF_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-= 2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV= 3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9I= WG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8Iigx2YzDJv8bKRvRZuuNu6htExlrPmTGgQD2q= oavRDpErKs0NhWgQYc4-2FgNlp5bpNOFAZbyI9kzVcA9wkClEj3x8hfOhfEo9wWNBhXQNBd8Dgo= ryXRKqz5pGPJfcZZqoJMHfu-2BgzmDp7FPqiYiUMFNGk-3D (Accessed April 2024). 2. ZILBRYSQ^=C2=AE EU SmPC. https://u7061146.ct.sendgrid.net/ls/click?upn= =3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-= 2FtfvSeD3KLQsazq58-2BxwfyV7LSQTPy5FLbNXMNW6cEFF7eEF7765DcFrK41E-2FLVrKK5zzr= EOLQNmbh8Hy6I-2BiFKrCqDA-3D-3D1jPP_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPG= CjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33S= bkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8Hm= aKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IirysPWxT1XwLXjgWOIJlIzxgftoHOj0kubH4Ezkgz= VJ9P1WbyyAlRdRSiMNf6HIiZvL5DWbHshY9UJoJWv8t7cC5GD-2BxzE5gLT9Wllb-2Fo5x-2FpT= SYsSnne4dnqs9J-2Frm4ZzHzWhblQ4zpyZghOB9zDss-3D (Accessed April 2024). 3. FINTEPLA^=C2=AE EU SmPC. https://u7061146.ct.sendgrid.net/ls/click?upn= =3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-= 2FtfvSeD3KLQsazq58-2BxwfyV7LSQaFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58Gn= H1T27RJn16IWmxyZWsDIvi2A-3D-3DMOn9_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPG= CjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33S= bkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8Hm= aKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IisYw1y9tPyOIGUSMFcWgfaZvMDfrYcovsfOxa8DwY= CJHgiVFUWXeGjk1-2FFJPYgPpYUCaluOhL5UCx7JLeFPtk9pHaIgxmider-2Fg0x16ibrv84NCT= 4k3ESBgMer4CJ5dqwAPNBULUOdSLqHNLSsOTjy0-3D (Accessed April 2024). 4. 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RYSTIGGO^=C2=AE US PI. https://u7061146.ct.sendgrid.net/ls/click?upn=3Du= 001.gqh-2BaxUzlo7XKIuSly0rC5rB1kxObAU1e99kHD7BUidVPSGoTF5FxrwLFsh8z1WJudYHp= R8nhBSdNNKTRdEKP1Wz-2BiyVWKqOA3UAQClgCE1rJG8xtt6TEWlbmAoUcZmNla-2BwnEys8tWd= s4d9ltPqIQ-3D-3DIgd7_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z= 2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6= FohpNoV33lcwxaIbQHoft-2BkiUHSTCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc= 7NFQmPszJXm4PQc6QX8Iiuxz5M6tKD-2BJuBOSNqj00QVlwXagSKr-2BLiZJqne4A9sR1roomOt= rrTl1K0NxFAs-2FZcc7oZ0RAzGG0xSR4-2Fn4LWFnxqDWhqsUeA1NQnRCx02gyMZGPpuylMYZG1= FUP3Um03g-2BNfZYHNU58pd23bnXTdE-3D (Accessed: April 2024). 7. ZILBRYSQ^=C2=AE US PI. https://u7061146.ct.sendgrid.net/ls/click?upn=3Du= 001.gqh-2BaxUzlo7XKIuSly0rC5rB1kxObAU1e99kHD7BUidVPSGoTF5FxrwLFsh8z1WJUAoVR= h4g9A-2FmEMyuSUrclZgksYq9JKAlvC1UecQXBhkBSFUI1i0AsvFL0j-2FpZPZVEQNl_2dCLUNb= uBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6Zo= pJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33lcwxaIbQHoft-2BkiUH= STCUP4cwcW59CwizO5XCQI9jUV9IWG8HmaKwDfgwgioDkTc7NFQmPszJXm4PQc6QX8IiinuBJnU= ItnUMfHnPNemywyH38fav9B9DIkhL-2Fs9fHXXXwor0UP4Kyb1wcH6AIruQR7Ldh9SQcH5oc7JR= YPRSkFY7Wh-2BDTnXFFT61lJiJ7Df5SAFPtKOtQ-2FkUSjlhj-2FvfDBYEmuWKvfdHXa-2FyQ0v= XdQ-3D (Accessed: April 2024). 8. 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