Vimpat Dosage

Generic name: lacosamide
Dosage form: tablet, film coated; injection; oral solution

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Dosage for VIMPAT Tablet and Oral solution

Monotherapy

The initial recommended dose of VIMPAT is 100 mg twice daily (200 mg per day); the dose should be increased by 50 mg twice daily (100 mg per day) every week, up to a recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). Alternatively, VIMPAT may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by 100 mg twice daily (200 mg per day); this dose regimen should be continued for one week. Based on individual response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the recommended maintenance dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)].

For patients who are already on a single antiepileptic and will convert to VIMPAT monotherapy, the therapeutic dose of 150 mg twice daily to 200 mg twice daily (300 mg to 400 mg per day) should be maintained for at least 3 days before initiating withdrawal of the concomitant antiepileptic drug. A gradual withdrawal of the concomitant antiepileptic drug over at least 6 weeks is recommended.

Adjunctive Therapy

The initial recommended dose is 50 mg twice daily (100 mg per day). Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day). The recommended maintenance dose is 100 mg twice daily to 200 mg twice daily (200 mg to 400 mg per day). In clinical trials, the 300 mg twice daily (600 mg per day) dose was not more effective than the 200 mg twice daily dose (400 mg per day), but was associated with a substantially higher rate of adverse reactions [see Clinical Studies (14.1)].

Alternatively, VIMPAT may be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg per day); this maintenance dose regimen should be continued for one week. Based on individual patient response and tolerability, the dose can be increased at weekly intervals by 50 mg twice daily (100 mg per day), as needed, up to the maximum recommended maintenance dose of 200 mg twice daily (400 mg per day). The loading dose should be administered with medical supervision because of the increased incidence of CNS adverse reactions [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)]. When discontinuing VIMPAT, a gradual withdrawal over at least 1 week is recommended [see Warnings and Precautions (5.5)].

Dosage for Vimpat Injection

Intravenous VIMPAT can be administered in the same dosing regimens described for oral dosing, including the loading dose. These dosages may be infused intravenously over a period of 15 minutes to 60 minutes. Intravenous infusion of 30 to 60 minutes is preferable, and should be used when a 15 minute administration is not required [see Clinical Pharmacology (12.3) and Adverse Reactions (6.1)].

Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g., myocardial ischemia, heart failure), as intravenous infusion of VIMPAT may cause bradycardia or AV blocks in these patients [see Warnings and Precautions (5.3)].

When switching from oral to intravenous VIMPAT, the initial total daily intravenous dosage regimen of VIMPAT should be equivalent to the dosage regimen of oral VIMPAT. The clinical study experience of intravenous VIMPAT is limited to 5 days of consecutive treatment. 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.

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 (8.6) and Clinical Pharmacology (12.3)].

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 (8.7) and Clinical Pharmacology (12.3)].

Administration Instructions

VIMPAT may be taken with or without food.

VIMPAT Oral Solution

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device.

VIMPAT Injection

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.

Any unused portion of VIMPAT injection should be discarded.

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