FDA Approves First Generic Version of Priftin for Tuberculosis

The FDA approved the first generic version of rifapentine (Priftin) tablets. This approval introduces a more accessible alternative for the treatment of both active pulmonary tuberculosis caused by Mycobacterium tuberculosis and latent tuberculosis infection.¹

For the treatment of active disease, the medication is indicated for use in combination with 1 or more antituberculosis drugs for patients 12 years and older. In the context of latent infection, rifapentine is approved for use alongside isoniazid in patients as young as 2 years old who are at a high risk of progressing to active disease.¹

The introduction of a generic option comes as data from the Centers for Disease Control and Prevention indicates that millions of people in the United States currently live with latent tuberculosis infection. Experts emphasize that more than 80% of active tuberculosis cases in the country originate from longstanding, untreated latent infections. Providing affordable treatment options is essential for national efforts to track and treat those at risk, as the CDC estimates that up to 13 million people may be affected by the latent form of the disease. Without intervention, these individuals remain at a persistent risk of developing active tuberculosis, which is a nationally notifiable disease.²

From a clinical perspective, pharmacists should be aware that the generic rifapentine tablets carry the same prescribing information, contraindications, and warnings as the brand name equivalent. The drug is strictly contraindicated in patients with a history of hypersensitivity to any rifamycins. Safety remains a paramount concern, as rifapentine is associated with risks of hepatotoxicity, severe cutaneous adverse reactions, and drug-reaction with eosinophilia and systemic symptoms, also known as DRESS.^1,3

Health care providers are advised to monitor patients for symptoms such as jaundice, loss of appetite, or nausea, which may signal serious liver problems. During active pulmonary tuberculosis treatment, the most common adverse reactions reported include anemia, lymphopenia, neutropenia, and increased sweating, and hypersensitivity reactions are the most frequent complication seen in latent infection regimens.^1,3

Pharmacists play a role in patient counseling for this medication, particularly regarding its distinct physiological effects and administration requirements. Patients must be informed that rifapentine may cause a red-orange discoloration of body tissues and fluids, including urine, sweat, and tears. This effect can permanently stain soft contact lenses and dentures, so patients are often advised to avoid wearing them during the course of treatment.^1,3

To ensure optimal absorption, the tablets should be taken with food. Although the tablets are intended to be swallowed whole, they may be crushed and added to a small amount of semi-solid food if the patient has difficulty swallowing, provided the mixture is consumed immediately.^3,4

The dosing complexity of rifapentine necessitates careful oversight, especially given the weight-based requirements for pediatric patients and varying schedules for different indications. For active tuberculosis, the typical adult regimen begins with 600 milligrams twice weekly for 2 months, followed by a once-weekly phase for 4 months alongside other medications like isoniazid.^3,4

For latent infection, the standard is a 12-week course of once-weekly doses, which for adults is typically 900 milligrams. Pediatric latent TB doses are strictly determined by weight, ranging from 300 milligrams for children weighing 10 to 14 kilograms to a full 900-milligram dose for those weighing over 50 kilograms.³

The drug is a potent inducer of several cytochrome P450 enzymes, including CYP3A4, CYP2C8, and CYP2C9, which can significantly reduce the plasma concentrations and efficacy of various coadministered medications. This induction can render hormonal birth control ineffective, requiring patients to use non-hormonal contraceptive methods throughout their treatment.^3,4

Furthermore, use with certain antiretroviral medications, such as protease inhibitors or reverse transcriptase inhibitors, is often not recommended due to these metabolic interactions. Pharmacists must conduct thorough medication record reviews to identify potential interactions with drugs like warfarin, phenytoin, or various heart medications, as dosage adjustments or alternative therapies may be required to maintain therapeutic levels.^3,4

REFERENCES

1. FDA approves first generic of Priftin (rifapentine) tablets. News release. FDA. June 23, 2026. Accessed June 24, 2026. https://content.govdelivery.com/accounts/USFDA/bulletins/41d514b

2. CDC. Latent TB infection in the United States – published estimates. October 18, 2024. Accessed June 24, 2026. https://www.cdc.gov/tb-data/latent-tb-infection-estimates/index.html

3. Mayo Clinic. Rifapentine (oral route). June 1, 2026. Accessed June 24, 2026. https://www.mayoclinic.org/drugs-supplements/rifapentine-oral-route/description/drg-20065831

4. Rifapentine (Priftin). Prescribing Information. Sanofi; 1998. Accessed June 24, 2026. https://rsc.niaid.nih.gov/sites/default/files/rifapentine-priftin-pi_may-2025.pdf