Vimpat Oral Solution

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Vimpat Oral Solution Generic Name & Formulations

General Description

Lacosamide 10mg/mL; strawberry-flavored; contains phenylalanine 0.32mg/20mL.

Pharmacological Class

Sodium channel inactivator.

How Supplied

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

Manufacturer

Generic Availability

NO

Vimpat Oral Solution Indications

Indications

Treatment of partial-onset seizures in patients ≥1month. Adjunctive therapy in primary generalized tonic-clonic seizures in patients ≥4yrs.

Vimpat Oral Solution Dosage and Administration

Adult

See full labeling. Tabs: swallow whole. Oral soln: use calibrated measuring device. Injection: can give without diluting, or may be mixed with appropriate diluent and give by IV infusion preferably over 30–60mins (or over 15mins if needed). For oral and IV: ≥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 IV: give same dosing regimens as that described for oral dosing. 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

<1month (partial-onset seizures) or <4yrs (primary tonic-clonic seizures): not established. See full labeling. Tabs: swallow whole. Oral soln: use calibrated measuring device. Injection: can give without diluting, or may be mixed with appropriate diluent and give by IV infusion preferably over 30–60mins. ≥1month: Partial-onset seizures: (<6kg): Oral: initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 7.5–15mg/kg/day; IV: 0.66mg/kg 3 times daily; may increase at weekly intervals by 2mg/kg/day in 3 divided doses; maintenance dose: 7.5–15mg/kg/day; (6–<11kg): Oral and IV: initially 1mg/kg twice daily; may increase at weekly intervals by 2mg/kg/day in 2 divided doses; maintenance dose: 6–12mg/kg/day. Partial-onset or tonic-clonic seizures (4–<17yrs): Oral and IV: (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). Switching from oral to IV (≥6kg): give same dosing regimens as that described for oral dosing; <6kg: follow IV dosing above. 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).

Vimpat Oral Solution Contraindications

Not Applicable

Vimpat Oral Solution Boxed Warnings

Not Applicable

Vimpat Oral Solution Warnings/Precautions

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.

Vimpat Oral Solution Pharmacokinetics

See Literature

Vimpat Oral Solution Interactions

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.

Vimpat Oral Solution Adverse Reactions

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).

Vimpat Oral Solution Clinical Trials

See Literature

Vimpat Oral Solution Note

Notes

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

Vimpat Oral Solution Patient Counseling

See Literature