Seizure disorders:

Indications for: FINTEPLA

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

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 (0.2mg/kg twice daily) with concomitant stiripentol plus clobazam.

FINTEPLA Contraindications:

During or within 14 days of MAOIs.

Boxed Warning:

Valvular heart disease. Pulmonary arterial hypertension.

FINTEPLA 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: not recommended. Renal impairment (eGFR 15–29mL/min/1.73m2): see Adults and Children; (<15mL/min/1.73m2): not studied. Elderly. Pregnancy. Nursing mothers.

FINTEPLA Classification:

Sympathomimetic.

FINTEPLA 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).

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.

REMS:

YES

Generic Drug Availability:

NO

How Supplied:

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

Pricing for FINTEPLA

360ml of 2.2mg/ml bottle of oral solution (Qty: 1)
Appx. price $16569
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