Fintepla (fenfluramine HCl)

Dosage of fenfluramine hydrochloride is expressed in terms of fenfluramine.

The initial starting and maintenance dosage of fenfluramine for the treatment of seizures associated with Dravet syndrome in adults and pediatric patients 2 years of age or older is 0.1 mg/kg twice daily. Dosage may be increased weekly based on efficacy and tolerability.

If dosage titration is necessary in patients not receiving concomitant stiripentol, the manufacturer recommends an increase to 0.2 mg/kg twice daily on day 7, and then to 0.35 mg/kg twice daily on day 14 if further increase is needed; the maximum total daily dosage is 26 mg in these patients. For patients not receiving concomitant stiripentol in whom a more rapid titration is warranted, the dose may be increased every 4 days.

If dosage titration of fenfluramine is necessary in patients receiving stiripentol and clobazam concomitantly, the manufacturer recommends an increase to 0.15 mg/kg twice daily on day 7, and then to 0.2 mg/kg twice daily on day 14 if further increase is needed; the maximum total daily dosage is 17 mg in these patients.

Fenfluramine is administered orally twice daily as an oral solution. The drug may be administered with or without food.

A calibrated measuring device (i.e., either a 3- or 6-mL oral dosing syringe) should be used to measure and administer the prescribed dose of fenfluramine oral solution; a household teaspoon or tablespoon is not an adequate measuring device. Any unused portions of the oral solution should be discarded 3 months after the bottle is first opened or if the ''discard after'' date has passed, whichever is sooner.

Fenfluramine oral solution is compatible with commercially available gastric and nasogastric feeding tubes.

No dosing information is available for this tab.

No dosing information is available for this tab.

Fenfluramine is metabolized principally by cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, and 2D6, and to a lesser extent by CYP2C9, 2C19, and 3A4/5.

Fenfluramine does not inhibit or induce CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4 at clinically relevant concentrations.

Fenfluramine and its active metabolite (norfenfluramine) are not inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transport proteins (OATP) 1B1 or OATP1B3, organic anion transporters (OAT) 1 or OAT3, organic cation transporter (OCT) 2, or multidrug and toxin extrusion transporters (MATE) 1 and MATE2K.

Fenfluramine and norfenfluramine are not substrates of P-gp, BCRP, OAT1, OAT3, OCT2, MATE1, or MATE2K transporters.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Fenfluramine is contraindicated in patients with hypersensitivity to fenfluramine or any excipients in the preparation.

Fenfluramine is contraindicated during or within 14 days of administration of monoamine oxidase (MAO) inhibitors due to increased risk of serotonin syndrome. (See Serotonin Syndrome under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 10% of patients with Dravet syndrome receiving fenfluramine in clinical trials and more frequently than placebo include decreased appetite, somnolence, sedation, lethargy, diarrhea, constipation, abnormal echocardiogram, fatigue, malaise, asthenia, ataxia, balance disorder, gait disturbance, increased blood pressure, drooling, salivary hypersecretion, pyrexia, upper respiratory tract infection, vomiting, decreased weight, falls, and status epilepticus.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of fenfluramine in pediatric patients younger than 2 years of age have not been established.

There are no adequate human or animal data on the developmental risks associated with the use of fenfluramine in pregnant women.

Women who are pregnant while receiving fenfluramine should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 or http://www.aedpregnancyregistry.org/.

It is not known whether fenfluramine or its metabolites are distributed into milk, or if the drug affects milk production or the breast-fed infant. The benefits of breast-feeding should be considered along with the importance of fenfluramine to the woman and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Clinical studies of fenfluramine for the treatment of Dravet syndrome did not include patients 65 years of age and over to determine whether they respond differently from younger patients. In general, dosage selection in geriatric patients 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.