Seizure disorders:

Indications for VIMPAT INJECTION:

When oral administration is not feasible: for treatment of partial-onset seizures in patients ≥4yrs; or adjunctive therapy in primary generalized tonic-clonic seizures in patients ≥4yrs.

Adult:

See full labeling. Tabs: swallow whole. Oral soln: use calibrated measuring device. Injection: may give without diluting, or mix in appropriate diluent and give by IV infusion preferably over 30–60mins (or over 15mins if needed). For oral and injection: ≥17yrs: Monotherapy (partial-onset seizures): initially 100mg twice daily (alternatively, may initiate with a 200mg single loading dose, followed 12hrs later by 100mg twice daily for 1 week); may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 300–400mg/day. Conversion from a single antiepileptic to lacosamide monotherapy: wait until the therapeutic dose is achieved and given for at least 3 days before withdrawing concomitant antiepileptic; should withdraw gradually over at least 6 weeks. Adjunct (partial-onset or tonic-clonic seizures): initially 50mg twice daily (alternatively, may initiate with a 200mg single loading dose, followed 12hrs later by 100mg twice daily for 1 week); may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 200–400mg/day. Switching from oral to inj: give same initial dosing regimen as that used in orally administered. Severe renal impairment (CrCl<30mL/min), ESRD, mild to moderate hepatic impairment: reduce max dose by 25%; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over ≥1 week).

Children:

<4yrs: not established. Tabs: swallow whole. Oral soln: use calibrated measuring device. Injection: may give without diluting, or mix in appropriate diluent and give by IV infusion preferably over 30–60mins. For oral and injection: 4–<17yrs: Monotherapy or adjunct (11–<30kg): initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 6–12mg/kg/day; (30–<50kg): initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 4–8mg/kg/day; (≥50kg): initially 50mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses; maintenance dose: 300–400mg/day (monotherapy for partial-onset seizures) or 200–400mg/day (adjunct for partial-onset or tonic-clonic seizures). Severe renal impairment (CrCl<30mL/min), ESRD, mild to moderate hepatic impairment: reduce max dose by 25%; if concomitant strong CYP3A4/CYP2C9 inhibitors: may need dose reduction. Consider supplemental dose (up to 50%) after hemodialysis. Avoid abrupt cessation (withdraw over ≥1 week).

Warnings/Precautions:

Severe hepatic impairment: not recommended. Increased risk of suicidal thinking and behavior; monitor for clinical worsening or unusual changes. Cardiac conduction disturbances (eg, marked 1st or 2nd degree AV block, sick sinus syndrome unless paced), sodium channelopathies (eg, Brugada Syndrome), or severe cardiac disease (eg, myocardial ischemia, HF, structural heart disease); obtain ECG before therapy and after titration; monitor closely esp. with IV route. Diabetic neuropathy. Phenylketonuria (oral soln). Elderly. Pregnancy. Nursing mothers.

Pharmacologic Class:

Sodium channel inactivator.

Interactions:

Caution with concomitant drugs that affect cardiac conduction (eg, sodium or potassium channel blockers, β-blockers, CCBs) or prolong PR interval. May be potentiated by strong CYP3A4/2C9 inhibitors in patients with renal or hepatic impairment.

Adverse Reactions:

Dizziness, headache, diplopia, blurred vision, nausea, ataxia, somnolence, fatigue; PR interval prolongation, AV block, syncope; rare: DRESS/multiorgan hypersensitivity reaction (discontinue if occurs).

Note:

To enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry call (888) 233-2334.

How Supplied:

Tabs—60; Oral soln—200mL, 465mL; Single-use vials (20mL)—10