PRIFTIN

When oral doses of PRIFTIN were administered once daily or once every 72 hours to healthy volunteers for 10 days, single dose AUC (0–∞) of rifapentine was similar to its steady-state AUC ss (0–24h) or AUC ss (0–72h) values, suggesting no significant auto-induction effect on steady-state pharmacokinetics of rifapentine. Steady-state conditions were achieved by day 10 following daily administration of PRIFTIN 600 mg. No plasma accumulation of rifapentine and 25-desacetyl rifapentine (active metabo...

14.1 Active Pulmonary Tuberculosis PRIFTIN was studied in two randomized, open-label controlled clinical trials in the treatment of active pulmonary tuberculosis. The first trial was an open-label, prospective, parallel group, active-controlled trial in HIV-negative patients with active pulmonary tuberculosis. The population mostly comprised Black (approximately 60%) or multiracial (approximately 31%) patients. Treatment groups were comparable for age and sex and consisted primarily of male subjects with a mean age of 37 ± 11 years. In the initial 2-month phase of treatment, 361 patients recei...

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Drug Reactions [see Warnings and Precautions (5.5) ] Discoloration of Body Fluids [see Warnings and Precautions (5.7) ] Clostridioides Difficile –A...

Known hypersensitivity to any rifamycin. ( 4.1 ) 4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.

Hepatotoxicity: Monitor for symptoms of liver injury and discontinue PRIFTIN if signs or symptoms or liver injury occur. ( 5.1 ) Hypersensitivity: Discontinue PRIFTIN if signs or symptoms of hypersensitivity reaction occur. ( 5.2 ) Severe cutaneous adverse reactions: Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. ( 5.3 ) Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regi...

7 DRUG INTERACTIONS Protease Inhibitors and Reverse Transcriptase Inhibitors. ( 5.2 , 7.1 ) Hormonal Contraceptives: Use an effective non-hormonal method of contraception or add a barrier method of contraception during treatment with PRIFTIN. ( 7.3 ) May increase metabolism and decrease the activity of drugs metabolized by cytochrome P450 3A4 and 2C8/9. Dosage adjustments may be necessary if given...