VIMPAT is indicated for:
- Treatment of partial-onset seizures in patients 1 month of age and older
Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older
IMPORTANT SAFETY INFORMATION
VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity.
In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). Pediatric adverse reactions were similar to those seen in adult patients.
Primary Generalized Tonic-Clonic Seizures
In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea.
VIMPAT is a Schedule V controlled substance.
- Dosage should be increased based on clinical response and tolerability, no more frequently than once per week
- Gradually withdraw VIMPAT (over a minimum of 1 week) to minimize the potential for increased seizure frequency
200 mg LOADING DOSE FOR ADULT PATIENTS |
Use the VIMPAT loading dose when your adult patients need to get to a therapeutic dose more rapidly than standard titration allows. The use of a loading dose in pediatric patients has not been studied.
A single loading dose of 200 mg approximates steady-state concentrations comparable to the 100 mg twice-daily oral administration.
Loading dose administration2
VIMPAT may be initiated in adult patients with a single loading dose of 200 mg (oral or injection) followed approximately 12 hours later by 100 mg twice-daily (200 mg/day).
- Based on individual response and tolerability, the dose can be increased at weekly intervals by 50 mg twice-daily (100 mg/day), as needed, up to the recommended monotherapy* (300 mg/day to 400 mg/day) or adjunctive therapy (200 mg/day to 400 mg/day) maintenance dose
- The loading dose should be administered with medical supervision considering the VIMPAT pharmacokinetics and increased incidence of CNS adverse reactions
When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia may be higher with 15-minute administration than over a 30- to 60-minute period.
*Monotherapy for partial-onset seizures only.
INTRAVENOUS DOSING |
Special considerations when using injection
(Formulation not shown at actual size.)
VIMPAT injection for intravenous use—indicated as
short-term replacement when oral administration is not feasible.
- VIMPAT injection can be administered intravenously to adult and pediatric patients weighing 6 kg or more with the same dosing regimens described for oral dosing. For pediatric patients weighing less than 6 kg, VIMPAT injection may be initiated with a dose of 0.66 mg/kg three times daily. See table above.
- The recommended infusion duration is 30 to 60 minutes; however, infusions as rapid as 15 minutes can be administered in adults if required
- Infusion durations less than 30 minutes are generally not recommended in pediatric patients
- Intravenous infusion of VIMPAT may cause bradycardia, AV blocks, and ventricular tachyarrhythmia. Obtaining an ECG before beginning VIMPAT and after VIMPAT is titrated to steady-state maintenance dose is recommended in patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction
- Cmax reached by end of infusion time
- Adverse reactions with IV administration generally appeared similar to those observed with the oral formulation, although IV administration was associated with local adverse events, such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%)
Intravenous injection solution preparation
- VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. The diluted solution should not be stored for more than 4 hours at room temperature
- Diluents: Sodium Chloride Injection 0.9% (w/v), Dextrose Injection 5% (w/v), Lactated Ringer’s Injection
- Product with particulate matter or discoloration should not be used
- VIMPAT injection is for single-dose only—any unused portion of VIMPAT injection should be discarded
ORAL SOLUTION DOSING |
Special considerations when using oral solution
VIMPAT oral solution—a dosing option for patients who cannot swallow tablets2
- Does not need to be refrigerated or shaken prior to administration
- For accurate dosing, healthcare providers should offer a calibrated measuring device to patients prescribed VIMPAT oral solution
- Any unused oral solution should be discarded after 6 months of first opening the bottle
- VIMPAT oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine
IMPORTANT SAFETY INFORMATION
Risks in Patients with Phenylketonuria:
VIMPAT oral solution contains aspartame, a source of phenylalanine which can be harmful in patients with phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.
SELECT DOSING IN SPECIAL POPULATIONS2 |
- Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Dose titration should be performed with caution in all patients with renal and/or hepatic impairment
Dose supplementation: Following a 4-hour hemodialysis treatment, a dose supplementation of up to 50% of the last dose administered should be considered
- Patients with hepatic or renal impairment taking strong inhibitors of CYP3A4 or CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients
- Caution should be exercised for dose titration in elderly patients
Tablets: 60-count bottles
VIMPAT tablets should be
swallowed whole with liquid. Do not divide VIMPAT tablets
200 mg/20 mL:
10 mg/mL: 200 mL
6 cards, 10 tablets each
Convenient for the healthcare provider
- Available in dosage strengths of 50 mg, 100 mg, 150 mg, and 200 mg
- Multiple formulations
- IV formulation requires no diluent, reconstitution, or refrigeration
- Can be administered with or without common diluents
- Oral solution may also be administered using a nasogastric or gastrostomy tube
- No blood-level monitoring required
- Approximately 100% oral bioavailability
- VIMPAT injection is bioequivalent to oral VIMPAT when infused over 30 to 60 minutes*
- Linear pharmacokinetics
- Low protein binding (<15%)
Food and VIMPAT
- Can be given with or without food
- Food does not affect the rate or extent of absorption
For the 15-minute intravenous infusion, bioequivalence was met for AUC(0-tz) but not for Cmax. The point estimate of Cmax was 20% higher than Cmax for oraltablet and the 90% CI for Cmax exceeded the upper boundary of the bioequivalence range.
- 2.VIMPAT® (lacosamide): US prescribing information. Smyrna (GA): UCB, Inc.