Seizure disorders:

Indications for FINTEPLA:

Treatment of seizures associated with Dravet syndrome.

Adults and Children:

<2yrs: not established. Use calibrated measuring device. ≥2yrs: Initially 0.1mg/kg twice daily, may be increased weekly based on response. If further seizure reduction is required and 0.1mg/kg twice daily tolerated: may increase dose (see full labeling for titration schedule).

Contraindications:

During or within 14 days of MAOIs.

Boxed Warning:

Valvular heart disease. Pulmonary arterial hypertension.

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. 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, moderate or severe renal impairment: not recommended. Elderly. Pregnancy. Nursing mothers.

Pharmacologic Class:

Sympathomimetic.

Interactions:

Potentiated by stiripentol plus clobazam (± valproate); see full labeling. Antagonized by rifampin or strong CYP1A2 and CYP2B6 inducers (consider dose increase). 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 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 $15652
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