Fenfluramine

فن‌فلورامین

⚠ Unverified

🧠 Nervous SystemAntiseizure (serotonergic agent)

Market / country: 🇺🇸 USA

Fintepla (US)

🧮 Dose calculator

Dravet syndrome · Regimen source: FDA Fintepla · 2.2

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🛡️ 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

👥 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) ] .”

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