Source: FDA, National Drug Code (US) Revision Year: 2020
BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Obtain the following prior to treatment with BAFIERTAM:
The starting dosage for BAFIERTAM is 95 mg twice a day orally for 7 days. After 7 days, the dosage should be increased to the maintenance dosage of 190 mg (administered as two 95 mg capsules) twice a day orally. Temporary dosage reductions to 95 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 190 mg twice a day should be resumed. Discontinuation of BAFIERTAM should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to BAFIERTAM dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3)].
Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix the contents with food. BAFIERTAM can be taken with or without food.
Obtain a complete blood cell count (CBC), including lymphocyte count, 6 months after initiation of BAFIERTAM and then every 6 to 12 months thereafter, as clinically indicated [see Warnings and Precautions (5.3)].
Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels during treatment with BAFIERTAM, as clinically indicated [see Warnings and Precautions (5.4)].
Unopened Bottle: Store unopened bottles in refrigerator at 2°C to 8°C (35°F to 46°F). Do not freeze.Under these conditions, BAFIERTAM is stable until the expiration date indicated on the package.
Opened Bottle: Opened bottles bottles may be store at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) permitted [see USP Controlled Room Temperature]. Protect the capsules from light. Store in original container. Under these conditions, BAFIERTAM is stable for 3 months.
Capsules may become deformed if kept at high temperatures.
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