Rifabutin

Rifabutin is indicated for: - the prophylaxis of Mycobacterium avium complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl. - the treatment of Nontuberculous mycobacteria (NTM) infections (such as that caused by MAC and M.

xenopi). - pulmonary tuberculosis.

INDICATIONS AND USAGE

Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

and 7 WARNING AND PRECAUTIONS). ANTI-TB (Tuberculosis) Ethambutol ND No significant change in AUC or Cmax Isoniazid ND Pharmacokineti cs not affected Pyrazinamide No significant change in AUC or Cmax No significant change in AUC or Cmax No dose adjustment needed Bedaquiline ND No change in bedaquiline kinetics.

0-fold  in M3 metabolites of bedaquiline. If the drugs are co-administered, patients should be monitored for adverse events associated with bedaquiline administration. ORAL CONTRACEPTIVES Ethinylestradiol/ Norethindrone ND Ethinylestradiol: 20% ↓ in Cmax, 35% ↓ in AUC.

Norethindrone: 32% ↓ in Cmax, 46% ↓ in AUC. Patients should be advised to use other additional non-hormonal methods of contraception. OTHER Methadone ND No significant effect No apparent effect of rifabutin on either peak levels of methadone or systemic exposure based upon AUC.

Rifabutin kinetics not evaluated. Ethinylestradiol ND 35%↓ AUC 20%↓ Cmax Patients should be advised to use other methods of contraception. MYCOBUTIN (rifabutin) – Product Monograph Page 20 of 41 Coadministered Drugs Effect on Rifabutin Effect on Coadministered Drug Comments Norethindrone ND 46%↓ AUC Patients should be advised to use other methods of contraception.