Fenfluramine

Fenfluramine Brand Name– Fintepla

What is Fenfluramine

Fenfluramine is an oral 5HT-2 receptor agonist indicated for the treatment of seizures associated with Dravet syndrome.

Fenfluramine significantly reduced the monthly convulsive seizure frequency compared to placebo in 2 randomized, controlled trials in pediatric patients (2 to 18 years) with Dravet syndrome.

In a randomized, double-blind trial of patients with Dravet syndrome whose seizures were not adequately controlled on 1 or more antiepileptic drugs (n = 119), the median reduction in seizure frequency was 42.3% and 74.9% in patients treated with adjunctive fenfluramine 0.2 mg/kg/day and 0.7 mg/kg/day, respectively, compared to 19.2% in patients given placebo. Use of fenfluramine 0.2 mg/kg/day resulted in a 32.4% greater reduction in mean monthly convulsive seizure frequency when compared to placebo (95% CI 6.2% to 52.3%, p = 0.0209); fenfluramine 0.7 mg/kg/day was associated with a 62.3% greater reduction in mean monthly convulsive seizure frequency vs. placebo (95% CI 47.7% to 72.8%; p less than 0.0001).

Patients treated with fenfluramine 0.4 mg/kg/day as part of a stable antiepileptic drug regimen containing stiripentol (n = 87) experienced a 54% greater reduction in mean monthly convulsive seizure frequency compared to placebo (95% CI 35.6% to 67.2%; p less than 0.001).

Most patients responded to treatment with fenfluramine within 3 to 4 weeks, and the effect generally remained consistent over the 14- or 15-week treatment period.

Fenfluramine was previously FDA-approved for the treatment of obesity; however, due to cases of valvular heart disease attributed to fenfluramine, it was voluntarily withdrawn from the market for this use.

In patients with Dravet syndrome, echocardiogram monitoring before treatment, every 6 months during treatment, and 3 to 6 months after treatment with fenfluramine is required to evaluate for valvular heart disease and pulmonary hypertension.

Indications

• Dravet syndrome

For the treatment of seizures associated with Dravet syndrome

Side Effects

1. anorexia
2. asthenia
3. ataxia
4. blurred vision
5. cardiac valvulopathy
6. chills
7. constipation
8. cystitis
9. dehydration
10. diarrhea
11. drowsiness
12. fatigue
13. fever
14. headache
15. hypersalivation
16. hypertension
17. hypertensive crisis
18. hypotonia
19. infection
20. insomnia
21. irritability
22. laryngitis
23. lethargy
24. malaise
25. mydriasis
26. ocular pain
27. pulmonary hypertension
28. rash
29. rhinitis
30. serotonin syndrome
31. suicidal ideation
32. tremor
33. urinary incontinence
34. vomiting
35. weight loss

Monitoring Parameters

• blood pressure
• ECG
• weight

Contraindications

• abrupt discontinuation
• breast-feeding
• children
• depression
• driving or operating machinery
• hepatic disease
• hypertension
• MAOI therapy
• pregnancy
• pulmonary hypertension
• renal failure
• renal impairment
• suicidal ideation
• valvular heart disease

Interactions

• Acetaminophen; Butalbital
• Acetaminophen; Butalbital; Caffeine
• Acetaminophen; Butalbital; Caffeine; Codeine
• Acetaminophen; Caffeine; Dihydrocodeine
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
• Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
• Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
• Acetaminophen; Codeine
• Acetaminophen; Dextromethorphan
• Acetaminophen; Dextromethorphan; Doxylamine
• Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
• Acetaminophen; Dextromethorphan; Phenylephrine
• Acetaminophen; Dextromethorphan; Pseudoephedrine
• Acetaminophen; Diphenhydramine
• Acetaminophen; Hydrocodone
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