FDA Greenlights Generic Rifapentine for Tuberculosis

The FDA approved the first generic version of rifapentine (Priftin) to treat active pulmonary tuberculosis (TB) in adolescents and adults, as well as latent TB infection in patients as young as 2 years.

The generic rifamycin-class oral antibiotic is approved only in combination with one or more anti-tuberculosis drugs to treat active pulmonary TB caused by Mycobacterium tuberculosis in patients ages 12 years or older with susceptible isolates. In latent TB cases caused by M. tuberculosis, generic rifapentine is approved in combination with isoniazid to treat patients ages 2 years or older who are at high risk of progressing to TB disease.

The FDA approved rifapentine in June 1998 to treat pulmonary TB. Warnings and precautions in generic rifapentine’s prescribing information match those of rifapentine, including the potential for hepatotoxicity, hypersensitivity reactions, and severe cutaneous reactions. In addition, the antibiotic can’t be used in combination with isoniazid as a once-weekly continuation phase regimen in HIV-infected patients because of an increased risk of treatment failure or TB relapse.

When used to treat active pulmonary TB, the most common adverse reactions (3% of patients or greater) include elevated alanine aminotransferase/aspartate aminotransferase, anemia, anorexia, arthralgia, back pain, increased blood urea, cough, headache, hemoptysis, lymphopenia, neutropenia, rash, increased sweating, and thrombocytosis. Hypersensitivity reaction is the most common adverse reaction (3% or greater) with the latent TB infection regimen.