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FDA Approves First Generic of Priftin (rifapentine) tablets
The U.S. Food and Drug Administration approved the first generic of Priftin (rifapentine) tablets, a medication for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis drugs to which the isolate is susceptible in patients 12 years of age and older; and the treatment of latent tuberculosis infection caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease.
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.
Healthcare providers should review the full prescribing information for complete safety and dosing information.
Please check FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) for a list of approved drug products and contact the manufacturer for information about a medicine’s availability.
For more information about generic drugs, visit https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs.
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