Blood Tests Prior to Initiation of BAFIERTAM

Obtain the following prior to treatment with BAFIERTAM:

• A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions (5.3)].
• Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions (5.4)].

Dosing Information

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)].

Administration Instructions

Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix the contents with food. BAFIERTAM can be taken with or without food.

Blood Tests to Assess Safety After Initiation of BAFIERTAM

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)].