Fenfluramine
فنفلورامین
🧠 Nervous SystemAntiseizure (serotonergic agent)
Market / country: 🇺🇸 USA
Fintepla (US)
🧮 Dose calculator
Dravet syndrome · Regimen source: FDA Fintepla · 2.2
- • With stiripentol + clobazam: max 0.2 mg/kg twice daily (17 mg/day). Strong CYP1A2/2D6 inhibitors: max 20 mg/day (17 with stiripentol). Hepatic impairment per Table 2. Echocardiogram before, every 6 months and after. FDA Fintepla · 2.2FDA Fintepla · 2.3FDA Fintepla · 2.5FDA Fintepla · 2.6
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to fenfluramine; MAOIs concomitantly or within 14 days (serotonin syndrome). FDA Fintepla · 4
Warnings
- • Boxed warning: valvular heart disease and pulmonary arterial hypertension — echocardiograms required; available only through a REMS. FDA Fintepla · Boxed Warning
- • Decreased appetite and weight; somnolence; suicidal thoughts; serotonin syndrome; increased blood pressure; glaucoma. FDA Fintepla · 5
Renal adjustment
- • eGFR < 30: eGFR 15–29: max 20 mg/day (17 with stiripentol + clobazam). FDA Fintepla · 2.4
Formulations
- 2.2 mg/mL oral solution — solution 🇺🇸 USA FDA Fintepla · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Fintepla · 8.1
“Risk Summary There are no data on FINTEPLA use in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Fintepla · 8.2
“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.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Fintepla · 8.4
“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.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Fintepla · 8.5
“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.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Fintepla · 8.3
“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) ] .”
🔗 Reference links
- FDA (approval record)NDA212102
- DailyMed (FDA label)FDA Fintepla
- MedlinePlus (NIH)Fenfluramine
- WHO ATC/DDDN03AX26
- Darooyab (Iran)Fenfluramine
🇮🇷 Registered in Iran Darooyab · G-3384/Fenfluramine
Dosage forms with Iranian generic codes, per Darooyab.
- 00529 · FENFLURAMINE HCL 20MG TAB · قرص فنفلورامین هیدروکلراید ۲۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Fintepla · 3FDA Fintepla · 2.2FDA Fintepla · 2.3FDA Fintepla · 2.5FDA Fintepla · 2.6FDA Fintepla · 4FDA Fintepla · Boxed WarningFDA Fintepla · 5FDA Fintepla · 2.4FDA Fintepla · SPL approval / marketing categoryFDA Fintepla · 8.1FDA Fintepla · 8.2FDA Fintepla · 8.4FDA Fintepla · 8.5FDA Fintepla · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-3384/Fenfluramine
- Clinical review⚠ Unverified