United States - English - NLM (National Library of Medicine)

ucb, inc. - fenfluramine (unii: 2ds058h2cf) (fenfluramine - unii:2ds058h2cf) - 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. fintepla is contraindicated in patients with: - hypersensitivity to fenfluramine or any of the excipients in fintepla [see description (11)] - concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome [see warnings and precautions (5.7)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fintepla, during pregnancy. encourage women who are taking fintepla during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no data on fintepla use in pregnant women. available data from epidemiologic studies with fenfluramine or dexfenfluramine are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. fintepla can cause decreased appetite and decreased weight [see warnings and precautions (5.3)]; monitor for adequate weight gain during pregnancy. in animal studies, administration of fenfluramine throughout organogenesis (rat and rabbit) or throughout gestation and lactation (rat) resulted in adverse effects on development (fetal malformations, embryofetal and offspring mortality and growth impairment) in the presence of maternal toxicity at clinically relevant maternal plasma levels of fenfluramine and its major active metabolite (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of fenfluramine (0, 4.5, 8.6, or 34.6 mg/kg/day) to pregnant rats during organogenesis resulted in decreased fetal body weights and marked increases in fetal malformations (external, visceral, and skeletal) at the highest dose tested, which was associated with maternal toxicity. at the no-effect dose (8.6 mg/kg/day) for adverse effects on embryofetal development in rats, maternal plasma exposures (auc) of fenfluramine and norfenfluramine (the major metabolite) were approximately 2 and 5 times, respectively, those in humans at the maximum recommended human dose (mrhd) of 26 mg/day. oral administration of fenfluramine (0, 4.3, 8.6, 13.0 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in increased embryofetal mortality at all doses and increases in fetal malformations (external and skeletal) at the highest dose tested, which was associated with maternal toxicity. a no-adverse-effect dose for adverse effects on embryofetal development in rabbits was not identified. at the lowest dose tested in rabbits (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were lower than those in humans at the mrhd. oral administration of fenfluramine (0, 4.3, 8,6, or 34.6 mg/kg/day) to female rats throughout gestation and lactation resulted in marked increases in stillborn pups and neonatal offspring deaths at the highest dose tested and delayed growth and reflex development during the pre- weaning period at all doses. maternal body weight gain was decreased at all doses during pregnancy and at the two highest doses during lactation. a no-effect dose for adverse effects on pre- and postnatal development in rats was not determined. at the lowest dose tested in rats (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were approximately 0.5 and 3 times, respectively, those in humans at the mrhd. risk summary there are no data on the presence of fenfluramine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fintepla and any potential adverse effects on the breastfed infant from fintepla or from the underlying maternal condition. infertility in animal studies, oral administration of fenfluramine resulted in adverse reproductive effects in males and females at clinically relevant doses in the presence of parental toxicity [see nonclinical toxicology (13.1)] . the safety and effectiveness of fintepla for the treatment of seizures associated with ds and lgs have been established in patients 2 years of age and older. use of fintepla for the treatment of seizures associated with ds in patients 2 years of age and older is supported by two randomized, double-blind, placebo-controlled trials in 202 patients 2 to 18 years of age. use of fintepla for the treatment of seizures associated with lgs is supported by a randomized, double-blind, placebo-controlled study in 263 patients aged 2 to 35 years, including 187 patients less than 18 years [see boxed warning, warnings and precautions (5), adverse reaction (6.1), and clinical studies (14)]. fintepla can cause decreases in appetite and weight. the growth of pediatric patients treated with fintepla should be carefully monitored. safety and effectiveness in patients less than 2 years of age have not been established. juvenile animal data oral administration of fenfluramine (0, 3.0, 7,8, or 17.3 mg/kg/day) to young rats for 10 weeks starting on postnatal day 7 resulted in reduced body weight and neurobehavioral changes (decreased locomotor activity and learning and memory deficits) at all doses tested. neurobehavioral effects persisted after dosing was discontinued. bone size was decreased at the mid and high doses; brain size was decreased at the highest dose. partial or complete recovery was seen for these endpoints. a no-effect dose for postnatal developmental toxicity was not identified. the lowest dose tested (3.0 mg/kg/day) was associated with plasma fenfluramine exposures (auc) less than that in humans at the maximum recommended human dose (mrhd) of 26 mg/day and norfenfluramine (metabolite) exposures (auc) approximately 2 times that in humans at the mrhd. clinical studies of fintepla for the treatment of ds or lgs did not include patients 65 years of age and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with estimated glomerular filtration rate (egfr) 15 to 29 ml/min/1.73m2 , do not exceed the maximum daily dosage of fintepla of 20 mg. in patients with egfr 15 to 29 ml/min/1.73m2 and concomitant stiripentol use, do not exceed the maximum daily dosage of fintepla of 17 mg [see dosage and administration (2.4) and clinical pharmacology (12.3)]. fintepla has not been studied in patients with egfr < 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 [see dosage and administration (2.5) and clinical pharmacology (12.3)] . be sure that you read, understand, and follow these instructions before you start using fintepla oral solution and each time you get a refill. there may be new information. this instructions for use contains information on how to take fintepla. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is included with fintepla? the following items are included to prepare and give an oral dose of fintepla: - 1 bottle of fintepla oral solution (2.2 mg/ml) - 2 reusable oral syringes 1 bottle of fintepla oral solution (2.2 mg/ml)    2 oral syringes call the pharmacist at 1-844-288-5007 if you did not receive the items listed above, or if you need help using them. important information about fintepla - fintepla is an oral medicine (taken by mouth) and is given 2 times each day . follow your healthcare provider's instructions for taking or giving doses of fintepla. - if you have questions about how to prepare or give fintepla, contact your healthcare provider or call your pharmacist. - always use the oral syringes provided with fintepla to make sure the right dose is given. if you need a new syringe contact your pharmacist. do not use a household teaspoon or tablespoon. oral syringes provided with fintepla by the pharmacy. with fintepla you will receive 2 reusable oral syringes. call the pharmacist at 1-844-288-5007 if you have any questions about the syringes provided with fintepla. - the bottle of fintepla oral solution, and - a clean, dry reusable oral syringe that was provided with fintepla. - do not use the medicine if the "throw away" (discard) date has passed. - if the date is near, contact your pharmacy or healthcare provider to get a refill or new prescription. - if the date has passed, dispose of any unused fintepla. - set the cap aside (do not throw away). - if the bottle does not have an adapter, contact the pharmacist. - always leave the adapter in place in the bottle of medicine. - use the other oral syringe provided, or - contact the pharmacist to get a new one. - if you draw out too much medicine: leave the oral syringe in the adapter. push the plunger slowly back into the syringe until you reach the prescribed dose. - leave the oral syringe in the adapter. - push the plunger slowly back into the syringe until you reach the prescribed dose. - if you see air bubbles in the medicine: leave the oral syringe in the adapter. pull the plunger further down. allow the bubbles to rise to the tip of the syringe. push the plunger in all the way. slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - leave the oral syringe in the adapter. - pull the plunger further down. - allow the bubbles to rise to the tip of the syringe. - push the plunger in all the way. - slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - put the syringe back into adapter. - see steps 9 to 11 to adjust the dose, as needed. - do not squirt or forcefully push the medicine into the back of the throat. this may cause choking. - always leave the adapter in place in the bottle - the cap will fit over it. - rinse the oral syringe with clean tap water and allow it to air dry after each use. - make sure you rinse the inside of the syringe and the plunger. - pull clean tap water into the syringe with the plunger and push it out several times to clean the syringe. - remove the plunger from the barrel of the oral syringe - rinse both parts under tap water - make sure the syringe and plunger are completely dry before the next use. - the syringe is also safe to clean in the dishwasher. how should i store fintepla? - store fintepla at room temperature between 68°f to 77°f (20°c to 25°c). - do not refrigerate or freeze. - keep the cap tightly closed and the bottle upright. - store the fintepla bottle and syringe together in a clean area. - throw away (discard) any unused fintepla 3 months after first opening the bottle or if the discard after date on the package or bottle has passed. whichever one comes first. - keep fintepla and all medicines out of the reach of children. manufactured for: ucb, inc., smyrna, ga 30080 fintepla® is a registered trademark of the ucb group of companies. ©2023. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 9/2023

European Union - English - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptics, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Israel - English - Ministry of Health

medison pharma ltd - fenfluramine as hydrochloride - oral solution - fenfluramine as hydrochloride 2.2 mg / 1 ml - fenfluramine - fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older

Canada - English - Health Canada

ayerst laboratories - fenfluramine hydrochloride - tablet - 20mg - fenfluramine hydrochloride 20mg - anorexigenic agents & respiratory and cns stimulants

Canada - English - Health Canada

wyeth-ayerst canada inc. - fenfluramine hydrochloride - tablet - 20mg - fenfluramine hydrochloride 20mg - anorexigenic agents & respiratory and cns stimulants

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - fenfluramine hydrochloride 20mg - tablet - 20 mg - active: fenfluramine hydrochloride 20mg

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - fenfluramine hydrochloride 40mg - tablet - 40 mg - active: fenfluramine hydrochloride 40mg

New Zealand - English - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - fenfluramine hydrochloride 60mg - modified release capsule - 60 mg - active: fenfluramine hydrochloride 60mg

New Zealand - English - Medsafe (Medicines Safety Authority)

servier laboratories nz ltd - dexfenfluramine 15mg - capsule - 15 mg - active: dexfenfluramine 15mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nippon shinyaku co., ltd. - fenfluramine hydrochloride - limpid and colorless oral solution