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Vimpat

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Vimpat

Vimpat

INDICATIONS

Partial-Onset Seizures

VIMPAT (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

VIMPAT (lacosamide) injection for intravenous use is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible.

DOSAGE AND ADMINISTRATION

VIMPAT may be taken with or without food.

When using VIMPAT oral solution, it is recommended that a calibrated measuring device be obtained and used. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare providers should recommend a device that can measure and deliver the prescribed dose accurately, and provide instructions for measuring the dosage.

Partial-Onset Seizures

VIMPAT can be initiated with either oral or intravenous administration. The initial dose should be 50 mg twice daily (100 mg per day). Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 100 mg per day given as two divided doses . The recommended maintenance dose is 200 mg to 400 mg/day, given as two divided doses. In clinical trials, the 600 mg daily dose was not more effective than the 400 mg daily dose, and was associated with a substantially higher rate of adverse reactions. [See Clinical Studies]

A gradual withdrawal of VIMPAT over at least 1 week is recommended. [See Withdrawal of Antiepileptic Drugs]

Switching from Oral to Intravenous Dosing

When switching from oral VIMPAT, the initial total daily intravenous dosage of VIMPAT should be equivalent to the total daily dosage and frequency of oral VIMPAT and should be infused intravenously over a period of 30 minutes to 60 minutes. There is experience with twice daily intravenous infusion for up to 5 days.

Switching from Intravenous to Oral Dosing

At the end of the intravenous treatment period, the patient may be switched to VIMPAT oral administration at the equivalent daily dosage and frequency of the intravenous administration.

Compatibility and Stability

VIMPAT injection can be administered intravenously without further dilution or may be mixed with diluents. VIMPAT injection was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or polyvinyl chloride (PVC) bags at ambient room temperature 15°C to 30°C (59°F to 86°F).

Diluents

Sodium Chloride Injection 0.9% (w/v)
Dextrose Injection 5% (w/v)
Lactated Ringer's Injection

The stability of VIMPAT injection in other infusion solutions has not been evaluated. Product with particulate matter or discoloration should not be used.

Any unused portion of VIMPAT injection should be discarded.

Patients With Renal Impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment. A maximum dose of 300 mg per day VIMPAT is recommended for patients with severe renal impairment [creatinine clearance (CLCR) less than or equal to 30 mL/min] and in patients with endstage renal disease. VIMPAT is effectively removed from plasma by hemodialysis. Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered. In all renally impaired patients, the dose titration should be performed with caution. Patients with renal impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients. [See Use in Specific Populations and CLINICAL PHARMACOLOGY]

Patients With Hepatic Impairment

The dose titration should be performed with caution in patients with hepatic impairment. A maximum dose of 300 mg per day is recommended for patients with mild or moderate hepatic impairment.

VIMPAT use is not recommended in patients with severe hepatic impairment. Patients with hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to VIMPAT. Dose reduction may be necessary in these patients. [See Use In Specific Populations and CLINICAL PHARMACOLOGY]

HOW SUPPLIED

Dosage Forms And Strengths

50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), and 200 mg (blue) film-coated tablets

200 mg/20 mL injection

10 mg/mL oral solution

Storage And Handling

VIMPAT (lacosamide) Tablets 50 mg are pink, oval, film-coated tablets debossed with “SP” on one side and “50” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2477-35
Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2477-60

VIMPAT (lacosamide) Tablets 100 mg are dark yellow, oval, film-coated tablets debossed with “SP” on one side and “100” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2478-35
Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2478-60

VIMPAT (lacosamide) Tablets 150 mg are salmon, oval, film-coated tablets debossed with “SP” on one side and “150” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2479-35
Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2479-60

VIMPAT (lacosamide) Tablets 200 mg are blue, oval, film-coated tablets debossed with “SP” on one side and “200” on the other. They are supplied as follows:

Bottles of 60 NDC 0131-2480-35
Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2480-60

VIMPAT (lacosamide) injection 200 mg/20 mL is a clear, colorless sterile solution supplied in 20 mL colorless single-use glass vials.

200 mg/20 mL vial in cartons of 10 vials NDC 0131-1810-67

VIMPAT (lacosamide) oral solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied in PET bottles as follows:

200 mL bottles NDC 0131-5410-71
465 mL bottles NDC 0131-5410-70

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]

Do not freeze VIMPAT injection or oral solution. Discard any unused VIMPAT oral solution remaining after seven (7) weeks of first opening the bottle.

Manufactured for UCB, Inc. Smyrna, GA 30080. Issued 09/2013

Last reviewed on RxList: 1/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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