The FDA has approved the first generic version of Priftin (rifapentine) tablets, manufactured by Macleods Pharmaceuticals Ltd., for use in treating both active pulmonary tuberculosis and latent tuberculosis infection in specific patient groups. The generic rifapentine is indicated, in combination with other appropriate antituberculosis drugs, for active pulmonary TB caused by Mycobacterium tuberculosis in patients 12 years and older, and for latent TB infection in combination with isoniazid in patients 2 years and older who are at high risk of progressing to active disease.
According to its prescribing information, the generic rifapentine tablets carry the same contraindications, warnings and precautions as the branded Priftin product. The drug is contraindicated in patients with a known history of hypersensitivity to any rifamycin, and labeling highlights risks including hepatotoxicity, hypersensitivity and related reactions, severe cutaneous adverse reactions, relapse in treatment of active pulmonary TB, and significant drug interactions. Rifapentine may also cause a red‑orange discoloration of body tissues and fluids.
Safety data for the approved regimens show a range of common adverse reactions. In the active pulmonary TB regimen, the most frequently reported reactions (occurring in at least 3% of patients) include anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, elevated ALT/AST, back pain, rash, anorexia, arthralgia, increased blood urea and headache. For the latent TB infection regimen, hypersensitivity reaction is the most common adverse event at or above the 3% threshold.
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