FINTEPLA Dosage & Rx Info | Uses, Side Effects

Fintepla Generic Name & Formulations

Legal Class

General Description

Fenfluramine 2.2mg/mL; oral soln; cherry-flavor; gluten-free.

Pharmacological Class

Sympathomimetic.

How Supplied

Soln—30mL, 360mL (w. adapter + oral dosing syringe)

Manufacturer

UCB Inc.

Generic Availability

Mechanism of Action

The mechanisms by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome are unknown. Fenfluramine and the metabolite, norfenfluramine, increase extracellular levels of serotonin through interaction with serotonin transporter proteins, and exhibit agonist activity at serotonin 5HT-2 receptors.

Fintepla Indications

Indications

Seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).

Fintepla Dosage and Administration

Adults and Children

<2yrs: not established. Use calibrated measuring device. ≥2yrs: DS: Initially 0.1mg/kg twice daily, may be increased weekly based on efficacy and tolerability. LGS: Initially 0.1mg/kg twice daily, should be increased weekly based on tolerability. Both: if further seizure reduction is required and 0.1mg/kg twice daily tolerated; may increase dose by titration schedule (see full labeling). For severe renal impairment (eGFR 15–29mL/min/1.73m²) or concomitant strong CYP1A2 or CYP2D6 inhibitors: max total dose of 20mg/day without concomitant stiripentol; and max total dose of 17mg/day with concomitant stiripentol plus clobazam. For mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: max total dose of 20mg/day without concomitant stiripentol; for severe (Child-Pugh C) hepatic impairment: max total dose of 17mg/day without concomitant stiripentol. For mild hepatic impairment: max total dose of 13mg/day with concomitant stiripentol plus clobazam; for moderate or severe hepatic impairment: use not recommended with concomitant stiripentol plus clobazam.

Fintepla Contraindications

Contraindications

During or within 14 days of MAOIs.

Fintepla Boxed Warnings

Boxed Warning

Valvular heart disease. Pulmonary arterial hypertension.

Fintepla Warnings/Precautions

Warnings/Precautions

Risk of heart valvular heart disease and pulmonary arterial hypertension. Obtain echocardiogram prior to initiation, every 6 months during, and once 3–6 months after treatment. Consider treatment benefits vs risks if following seen via echocardiogram: valvular abnormality or new abnormality; VHD as indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional VHD characteristics; PAH as indicated by elevated right heart/pulmonary artery pressure (PASP >35mmHg). Increased risk of suicidal thoughts or behavior; monitor for clinical worsening or unusual changes. Monitor BP, weight regularly; consider dose adjustment if weight loss occurs. Monitor for serotonin syndrome; discontinue immediately if suspected. Glaucoma. Consider discontinuation if visual acuity impairment or ocular pain occurs. Avoid abrupt cessation. Hepatic impairment: see Adults and Children. Renal impairment (eGFR 15–29mL/min/1.73m²): see Adults and Children; (<15mL/min/1.73m²): not studied. Elderly. Pregnancy. Nursing mothers.

REMS

YES

Fintepla Pharmacokinetics

Absorption

Fenfluramine has a time to maximum plasma concentration (T_max) of 3 to 5 hours at steady state. The absolute bioavailability of fenfluramine is ~68-74%.

Distribution

The geometric mean (CV%) apparent volume of distribution (Vz/F) of fenfluramine is 11.9 (16.5%) L/kg following oral administration of Fintepla in healthy subjects. Fenfluramine is 50% bound to human plasma proteins in vitro and binding is independent of drug concentrations.

Metabolism

Major: CYP1A2, CYP2B6, CYP2D6. Minor: CYP2C9, CYP2C19, CYP3A4/5.

Elimination

Renal (>90%), fecal (<5%). Half-life: 20 hours.

Fintepla Interactions

Interactions

Potentiated by stiripentol plus clobazam (± valproate); see full labeling. Antagonized by strong CYP1A2, CYP2B6, or CYP3A inducers (eg, rifampin); avoid; consider dose increase and monitor if unavoidable. Potentiated by strong CYP1A2 or CYP2D6 inhibitors (eg, fluvoxamine, paroxetine); see Adults and Children. Antagonized by cyproheptadine, potent 5-HT1A, 5-HT1D, 5-HT2A, and 5-HT2C serotonin receptor antagonists; monitor. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, TCAs, MAOIs, bupropion, lithium, triptans, tramadol, trazodone, dextromethorphan, St. John’s Wort). Additive somnolence, sedation, lethargy with other CNS depressants (eg, alcohol).

Fintepla Adverse Reactions

Adverse Reactions

Decreased appetite, somnolence, sedation, lethargy, diarrhea, constipation, abnormal echocardiogram, fatigue, malaise, asthenia, ataxia, balance disorder, gait disturbance, blood pressure increased, drooling, salivary hypersecretion, pyrexia, upper respiratory tract infection, vomiting, decreased weight, fall, status epilepticus; rare: hypertensive crisis.

Fintepla Clinical Trials

See Literature

Fintepla Note

Not Applicable

Fintepla Patient Counseling