Rifapentine
Generic Name: rifapentine
Brand Names:
Priftin
11 DESCRIPTION PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet. The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.
Overview
11 DESCRIPTION PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet. The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.
Uses
1 INDICATIONS AND USAGE PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) PRIFTIN is indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease. ( 1.2 ) See Full Prescribing Information for Limitations of Use.
Dosage
2 DOSAGE AND ADMINISTRATION Active pulmonary tuberculosis: PRIFTIN should be used in regimens consisting of an initial 2 month phase followed by a 4 month continuation phase. ( 2.1 ) Initial phase (2 Months): 600 mg twice weekly for two months as directly observed therapy (DOT), with no less than 72 hours between doses, in combination with other antituberculosis drugs. ( 2.1 ) Continuation phase (4 Months): 600 mg once weekly for 4 months as directly observed therapy with isoniazid or another appropriate antituberculosis agent. ( 2.1 ) Latent tuberculosis infection: PRIFTIN should be administered in combination with isoniazid once weekly for 12 weeks as directly observed therapy.
Side Effects
6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Drug Reactions [see Warnings and Precautions (5.5) ] Discoloration of Body Fluids [see Warnings and Precautions (5.7) ] Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions (5.8) ] Porphyria [see Warnings and Precautions (5.9) ] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, incr...
Interactions
7 DRUG INTERACTIONS Protease Inhibitors and Reverse Transcriptase Inhibitors. ( 5.2 , 7.1 ) Hormonal Contraceptives: Use an effective non-hormonal method of contraception or add a barrier method of contraception during treatment with PRIFTIN. ( 7.3 ) May increase metabolism and decrease the activity of drugs metabolized by cytochrome P450 3A4 and 2C8/9. Dosage adjustments may be necessary if given concomitantly. ( 7.4 ) 7.1 Protease Inhibitors and Reverse Transcriptase Inhibitors Rifapentine is an inducer of CYP450 enzymes.
Warnings
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor for symptoms of liver injury and discontinue PRIFTIN if signs or symptoms or liver injury occur. ( 5.1 ) Hypersensitivity: Discontinue PRIFTIN if signs or symptoms of hypersensitivity reaction occur. ( 5.2 ) Severe cutaneous adverse reactions: Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. ( 5.3 ) Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regimen with isoniazid in HIV-infected patients. Monitor for signs or symptoms of relapse in patients with cavitary lesions or bilateral disease. 4 CONTRAINDICATIONS Known hypersensitivity to any rifamycin. ( 4.1 ) 4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.
Pregnancy
8.1 Pregnancy Risk Summary Based on animal data, PRIFTIN may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with PRIFTIN use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant.
Storage
Storage Store at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.
Frequently Asked Questions
What is Rifapentine used for?▼
1 INDICATIONS AND USAGE PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible. ( 1.1 ) PRIFTIN is indicated for the treatment of latent tuberculosis infection (LTBI) caused by M. tuberculosis in combination with isoniazid in patients 2 years of age and older at high risk of progression to TB disease. ( 1.2 ) See Full Prescribing Information for Limitations of Use.
What are the side effects of Rifapentine?▼
6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Drug Reactions [see Warnings and Precautions (5.5) ] Discoloration of Body Fluids [see Warnings and Precautions (5.7) ] Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions (5.8) ] Porphyria [see Warnings and Precautions (5.9) ] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, incr...
Can I take Rifapentine during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal data, PRIFTIN may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience with PRIFTIN use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. In two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant.
What are the important warnings for Rifapentine?▼
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor for symptoms of liver injury and discontinue PRIFTIN if signs or symptoms or liver injury occur. ( 5.1 ) Hypersensitivity: Discontinue PRIFTIN if signs or symptoms of hypersensitivity reaction occur. ( 5.2 ) Severe cutaneous adverse reactions: Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. ( 5.3 ) Relapse in the treatment of active pulmonary tuberculosis: Do not use as a once-weekly continuation phase regimen with isoniazid in HIV-infected patients. Monitor for signs or symptoms of relapse in patients with cavitary lesions or bilateral disease. 4 CONTRAINDICATIONS Known hypersensitivity to any rifamycin. ( 4.1 ) 4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.