Fenfluramine + ClobazamModerate
Coadministration with stiripentol increases fenfluramine plasma concentrations. Dose adjustment required; maximum daily dosage of FINTEPLA is 0.2 mg/kg twice daily (max 17 mg).
Source: NLP:fenfluramine
Fenfluramine Interactions
Brand names: Fintepla
Route: Oral
FDA Black Box Warning
WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings [see Dosage and Administration (2.1 , 2.6 ) and Warnings and Precautions (5.1) ]. Because of the risks of valvular heart disease and pulmonary arterial hypertension, FINTEPLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FINTEPLA REMS [see Warnings and Precautions (5.2) ]. WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION See full prescribing information for complete boxed warning. FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension. ( 5.1 ) Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. ( 2.1 , 2.6 , 5.1 ) FINTEPLA is available only through a restricted program called the FINTEPLA REMS. ( 5.2 )
Contraindications
4 CONTRAINDICATIONS 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) ] Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA ( 4 ) Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy 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 ) . 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. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality. The risk of maternal or fetal injury may be greatest for patients with untreated or poorly contro
3 interactions on record
Fenfluramine + CyproheptadineModerate
Serotonin receptor antagonist may decrease efficacy of FINTEPLA. Monitor patients appropriately if coadministered.
Source: NLP:fenfluramine
Fenfluramine + StiripentolModerate
Coadministration increases fenfluramine plasma concentrations. Dose adjustment required; maximum daily dosage of FINTEPLA is 0.2 mg/kg twice daily (max 17 mg).
Source: NLP:fenfluramine