FDA Approves First Generic Rifapentine for Active and Latent Tuberculosis

The FDA has approved the first generic version of rifapentine (Priftin), expanding access to an important treatment for both active pulmonary tuberculosis (TB) and latent TB infection (LTBI). The oral rifamycin-class antibiotic is approved for use in combination with other anti-TB medications to treat active pulmonary TB caused by Mycobacterium tuberculosis in patients aged 12 years and older with susceptible strains.

For latent TB infection, generic rifapentine is approved for use with isoniazid in patients aged 2 years and older who are at high risk of progressing to active TB disease. The approval is expected to improve treatment accessibility and support TB control efforts by providing a lower-cost alternative to the brand-name medication.

The prescribing information for the generic rifapentine tablets includes the same contraindications, warnings, and precautions as Priftin. Rifapentine tablets are contraindicated in patients with a known history of hypersensitivity to any rifamycin.

Rifapentine carries warnings such as the risk of hepatotoxicity, hypersensitivity and related reactions, severe cutaneous adverse reactions, relapse in treatment of active pulmonary tuberculosis, and drug interactions. Rifapentine tablets may produce a red-orange discoloration of body tissues and fluids.

The most common adverse reactions with the active pulmonary tuberculosis treatment regimen (≥3%) include anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, elevated ALT/AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache.

The most common adverse reaction (≥3%) with the latent tuberculosis infection regimen is hypersensitivity reaction.