RECENT MAJOR CHANGES

INDICATIONS AND USAGE

VIMPAT is indicated for:

• Partial-onset seizures (1.1): Tablets and oral solution are indicated for adjunctive therapy in patients ≥17 years. Injection is indicated as short term replacement when oral administration is not feasible in these patients.

DOSAGE AND ADMINISTRATION

• Partial-onset seizures (2.1): Initially, give 50 mg twice daily (100 mg/day). The dose may be increased, based on clinical response and tolerability, at weekly intervals by 100 mg/day given as two divided doses to a daily dose of 200 to 400 mg/day. VIMPAT injection may be given without further dilution or mixed in compatible diluent and should be administered intravenously over a period of 30 to 60 minutes. (2.1)
• Oral-Intravenous Replacement therapy (2.1): 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. 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.
  
  See full prescribing information for compatibility and stability (2.1) and dosing in patients with renal impairment (2.2) and hepatic impairment (2.3).

DOSAGE FORMS AND STRENGTHS

• 50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), 200 mg (blue) film-coated tablets (3)
• 200 mg/20 mL single-use vial for intravenous use (3)
• 10 mg/mL oral solution (3)

CONTRAINDICATIONS

• None

WARNINGS AND PRECAUTIONS

• Suicidal Behavior and Ideation (5.1)
• Patients should be advised that VIMPAT may cause dizziness and ataxia. (5.2)
• Caution is advised for patients with known cardiac conduction problems [e.g., second-degree atrioventricular (AV) block], who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease such as myocardial ischemia or heart failure. (5.3)
• Patients should be advised that VIMPAT may cause syncope. (5.4)
• In patients with seizure disorders, VIMPAT should be gradually withdrawn to minimize the potential of increased seizure frequency. (5.5)
• Multiorgan Hypersensitivity Reactions (5.6)
• Phenylketonurics (5.7)

ADVERSE REACTIONS

Most common adverse reactions (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-800-477-7877 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC POPULATIONS

• To enroll in the UCB AED Pregnancy Registry call 1-888-537-7734 (toll free).To enroll in the North American Antiepileptic Drug Pregnancy Registry call 1-888-233-2334 (toll free). (8.1)
• Renal impairment: Dose adjustment is recommended for patients with severe renal impairment (creatinine clearance ≤ 30 mL/min). Dose supplementation should be considered following hemodialysis. (12.3)
• Hepatic impairment

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