Priftin rifapentine 150 mg Tablet, Film Coated
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
- TB bacteria are remarkably adaptable. If you take only one antibiotic, the bacteria can develop resistance to it and the treatment fails. Using rifapentine alongside other TB medic...
- Why do I have to take rifapentine with other TB medicines — why can't I just take this one?
- That's actually a very well-known and harmless effect of rifapentine — it turns body fluids red-orange, including urine, sweat, tears, and saliva. It can be startling the first tim...
- My urine has turned red-orange. Is something wrong?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Rifapentine — tap one for details:
Rifapentine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Priftin 150 mgthis 53002-1718-01 | RPK | 8 tablets | — | AB | Discontinued | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 53002-1718-01 You're viewing this | 3 BLISTER PACK in 1 CARTON (53002-1718-1) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2022-01-01 | Inactivated by FDA |
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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. ( 1.1 , 1.2 )
1.1Active Pulmonary Tuberculosis PRIFTIN ® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis . PRIFTIN must always be used in combination with one or more antituberculosis (anti-TB) drugs to which the isolate is susceptible [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . Limitations of Use Do not use PRIFTIN monotherapy in either the initial or the continuation phases of active antituberculous treatment.
PRIFTIN should not be used once weekly in the continuation phase regimen in combination with isoniazid (INH) in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (RIF)-resistant organisms [see Warnings and Precautions (5.4) and Clinical Studies (14.1) ] . PRIFTIN has not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis.
1.2Latent Tuberculosis Infection PRIFTIN is indicated in adults and children 2 years and older for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in patients at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph) [see Clinical Studies (14.2) ] . Limitations of Use Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection.
PRIFTIN must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection [see Dosage and Administration (2.2) and Clinical Studies (14.2) ] . PRIFTIN in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin-resistant or isoniazid-resistant M. tuberculosis .
⏱️ Dosage and Administration ▾
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. ( 2.2 ) Adults and children ≥12 years: PRIFTIN (based on weight, see table below) and isoniazid 15 mg/kg (900 mg maximum). ( 2.2 ) Children 2 to 11 years: PRIFTIN (based on weight, see table below) and isoniazid 25 mg/kg (900 mg maximum).
( 2.2 ) Weight range PRIFTIN dose Number of PRIFTIN tablets 10–14 kg 300 mg 2 14.1–25 kg 450 mg 3 25.1–32 kg 600 mg 4 32.1–50 kg 750 mg 5 >50 kg 900 mg 6 For Latent Tuberculosis Infection, the maximum recommended dose of PRIFTIN is 900 mg once weekly for 12 weeks. ( 2.2 ) Take with food. Tablets may be crushed and added to semi-solid food.
( 2.3 )
2.1Dosage in Active Pulmonary Tuberculosis PRIFTIN is only recommended for the treatment of active pulmonary tuberculosis caused by drug-susceptible organisms as part of regimens consisting of a 2-month initial phase followed by a 4-month continuation phase. PRIFTIN should not be used in the treatment of active pulmonary tuberculosis caused by rifampin-resistant strains. Initial phase (2 Months): PRIFTIN should be administered at a dose of 600 mg twice weekly for two months as directly observed therapy (DOT), with an interval of no less than 3 consecutive days (72 hours) between doses, in combination with other antituberculosis drugs as part of an appropriate regimen which includes daily companion drugs such as isoniazid (INH), ethambutol (EMB) and pyrazinamide (PZA).
Continuation phase (4 Months): Following the initial phase (2 months), continuation phase (4 months) treatment consists of PRIFTIN 600 mg once weekly for 4 months in combination with isoniazid or another appropriate antituberculosis agent for susceptible organisms administered as directly observed therapy.
2.2Dosage in Latent Tuberculosis Infection PRIFTIN should be administered once weekly in combination with isoniazid for 12 weeks as directly observed therapy. Adults and children 12 years and older: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once weekly (see Table 1 ). The recommended dose of isoniazid is 15 mg/kg (rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg once weekly for 12 weeks.
Children 2 to 11 years: The recommended dose of PRIFTIN should be determined based on weight of the patient up to a maximum of 900 mg once weekly (see Table 1 ). The recommended dose of isoniazid is 25 mg/kg (rounded to the nearest 50 mg or 100 mg) up to a maximum of 900 mg once weekly for 12 weeks. Table 1: Weight Based Dose of PRIFTIN in the Treatment of Latent Tuberculosis Infection Weight range PRIFTIN dose Number of PRIFTIN tablets 10–14 kg 300 mg 2 14.1–25 kg 450 mg 3 25.1–32 kg 600 mg 4 32.1–50 kg 750 mg 5 >50 kg 900 mg 6
2.3Administration Take PRIFTIN with meals. Administration of PRIFTIN with a meal increases oral bioavailability and may reduce the incidence of gastrointestinal upset, nausea, and/or vomiting [see Clinical Pharmacology (12.3) ] . For patients who cannot swallow tablets, the tablets may be crushed and added to a small amount of semi-solid food, all of which should be consumed immediately [see Clinical Pharmacology (12.3) ] .
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "F" on one side of tablet. 150 mg tablets ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Known hypersensitivity to any rifamycin. ( 4.1 )
4.1Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.
⚠️ Warnings and Cautions ▾
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. ( 5.4 , 14.1 ) Drug Interactions: May interact with drugs metabolized by CYP450.
( 5.5 , 7.1 , 7.4 ) Discoloration of body fluids: May permanently stain contact lenses or dentures red-orange. ( 5.6 ) Clostridioides difficile –associated diarrhea: Evaluate if diarrhea occurs. ( 5.7 ) Porphyria: Avoid use in patients with porphyria.
( 5.8 )
5.1Hepatotoxicity Elevations of liver transaminases may occur in patients receiving PRIFTIN [see Adverse Reactions (6.1) ] . Patients on PRIFTIN should be monitored for symptoms of liver injury. Patients with abnormal liver tests and/or liver disease or patients initiating treatment for active pulmonary tuberculosis should only be given PRIFTIN in cases of necessity and under strict medical supervision.
In such patients, obtain serum transaminase levels prior to therapy and every 2 to 4 weeks while on therapy. Discontinue PRIFTIN if evidence of liver injury occurs.
5.2Hypersensitivity and Related Reactions Hypersensitivity reactions may occur in patients receiving PRIFTIN. Signs and symptoms of these reactions may include hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia or flu-like syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, fever, chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest pain, cough, syncope, palpitations). There have been reports of anaphylaxis [see Patient Counseling Information (17) ] .
Monitor patients receiving PRIFTIN therapy for signs and/or symptoms of hypersensitivity reactions. If these symptoms occur, administer supportive measures and discontinue PRIFTIN.
5.3Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in association with the use of rifapentine (PRIFTIN) treatment regimens in patients with active and latent tuberculosis. Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Patient Counseling Information (17) ] .
5.4Relapse in the Treatment of Active Pulmonary Tuberculosis PRIFTIN has not been evaluated as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary TB. Do not use PRIFTIN as a once-weekly continuation phase regimen in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin-resistant organisms [see Clinical Studies (14.1) ] . Higher relapse rates may occur in patients with cavitary pulmonary lesions and/or positive sputum cultures after the initial phase of active tuberculosis treatment and in patients with evidence of bilateral pulmonary disease.
Monitor for signs and symptoms of TB relapse in these patients [see Clinical Studies (14.1) ] . Poor adherence to therapy is associated with high relapse rate. Emphasize the importance of compliance with therapy [see Patient Counseling Information (17) ] .
5.5Drug Interactions Rifapentine is an inducer of CYP450 enzymes. Concomitant use of rifapentine with other drugs metabolized by these enzymes, such as protease inhibitors, certain reverse transcriptase inhibitors, and hormonal contraception may cause a significant decrease in…
🤒 Adverse Reactions ▾
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) ] Discoloration of Body Fluids [see Warnings and Precautions (5.6) ] Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions (5.7) ] Porphyria [see Warnings and Precautions (5.8) ] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache.
The most common adverse reaction (3% and greater) with the regimen for latent tuberculosis infection is hypersensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Active Pulmonary Tuberculosis PRIFTIN was studied in a randomized, open label, active-controlled trial of HIV-negative patients with active pulmonary tuberculosis. The population consisted primarily of male subjects with a mean age of 37 ± 11 years.
In the initial 2-month phase of treatment, 361 patients received PRIFTIN 600 mg twice a week in combination with daily isoniazid, pyrazinamide, and ethambutol and 361 subjects received rifampin in combination with isoniazid, pyrazinamide and ethambutol all administered daily. Ethambutol was discontinued when drug susceptibly testing was known. During the 4-month continuation phase, 317 patients in the PRIFTIN group continued to receive PRIFTIN 600 mg dosed once weekly with isoniazid and 304 patients in the rifampin group received twice weekly rifampin and isoniazid.
Both treatment groups received pyridoxine (Vitamin B6) over the 6-month treatment period. Because PRIFTIN was administered as part of a combination regimen, the adverse reaction profile reflects the entire regimen. Twenty-two deaths occurred in the study, eleven in the rifampin combination therapy group and eleven in the PRIFTIN combination therapy group.
18/361 (5%) rifampin combination therapy patients discontinued the study due to an adverse reaction compared to 11/361 (3%) PRIFTIN combination therapy patients. Three patients (two rifampin combination therapy patients and one PRIFTIN combination therapy patient) were discontinued in the initial phase due to hepatotoxicity. Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine.
All three recovered without sequelae. Five patients had adverse reactions associated with PRIFTIN overdose. These reactions included hematuria, neutropenia, hyperglycemia, ALT increased, hyperuricemia, pruritus, and arthritis.
Table 2 presents selected treatment-emergent adverse reactions associated with the treatment regimens which occurred in at least 1% of patients during treatment and post treatment through the first three months of follow-up. Table 2: Selected Treatment Emergent Adverse Reactions during Treatment of Active Pulmonary Tuberculosis and through Three Months Follow-up Initial Phase Initial phase consisted of therapy with either PRIFTIN twice weekly or rifampin daily combined with daily isoniazid, pyrazinamide, and ethambutol for 60 days.
Continuation Phase Continuation phase consisted of therapy with either PRIFTIN once weekly or rifampin twice weekly combined with daily isoniazid for 120 days. System Organ Class Adverse Re…
🔄 Drug 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 )
7.1Protease Inhibitors and Reverse Transcriptase Inhibitors Rifapentine is an inducer of CYP450 enzymes. Concomitant use of PRIFTIN with other drugs metabolized by these enzymes, such as protease inhibitors and certain reverse transcriptase inhibitors, may cause a significant decrease in plasma concentrations and loss of therapeutic effect of the protease inhibitor or reverse transcriptase inhibitor [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] .
7.2Fixed-Dose Combination of Efavirenz, Emtricitabine, and Tenofovir Once-weekly coadministration of 900 mg PRIFTIN with the antiretroviral fixed-dose combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in HIV-infected patients did not result in any substantial change in steady state exposures of efavirenz, emtricitabine, and tenofovir. No clinically significant change in CD4 cell counts or viral loads were noted [see Clinical Pharmacology (12.3) ] .
7.3Hormonal Contraceptives PRIFTIN may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with PRIFTIN [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.3) ] .
7.4Cytochrome P450 3A4 and 2C8/9 Rifapentine is an inducer of cytochromes P450 3A4 and P450 2C8/9. Therefore, PRIFTIN may increase the metabolism of other coadministered drugs that are metabolized by these enzymes. Induction of enzyme activities by PRIFTIN occurred within 4 days after the first dose.
Enzyme activities returned to baseline levels 14 days after discontinuing PRIFTIN. Rifampin has been reported to accelerate the metabolism and may reduce the activity of the following drugs; hence, PRIFTIN may also increase the metabolism and decrease the activity of these drugs. Dosage adjustments of the drugs in Table 4 or of other drugs metabolized by cytochrome P450 3A4 or P450 2C8/9 may be necessary if they are given concurrently with PRIFTIN.
Table 4: Drug Interactions with PRIFTIN: Dosage Adjustment May be Necessary Drug Class Examples of Drugs Within Class Antiarrhythmics Disopyramide, mexiletine, quinidine, tocainide Antibiotics Chloramphenicol, clarithromycin, dapsone, doxycycline; Fluoroquinolones (such as ciprofloxacin) Oral Anticoagulants Warfarin Anticonvulsants Phenytoin Antimalarials Quinine Azole Antifungals Fluconazole, itraconazole, ketoconazole Antipsychotics Haloperidol Barbiturates Phenobarbital Benzodiazepines Diazepam Beta-Blockers Propranolol Calcium Channel Blockers Diltiazem, nifedipine, verapamil Cardiac Glycoside Preparations Digoxin Corticosteroids Prednisone Fibrates Clofibrate Oral Hypoglycemics Sulfonylureas (e.g., glyburide, glipizide) Hormonal Contraceptives/Progestins Ethinyl estradiol, levonorgestrel Immunosuppressants Cyclosporine, tacrolimus Methylxanthines Theophylline Narcotic analgesics Methadone Phosphodiesterase-5 (PDE-5) Inhibitors Sildenafil Thyroid preparations Levothyroxine Tricyclic antidepressants Amitriptyline, nortriptyline
7.5Other Interactions The conversion of PRIFTIN to 25-desacetyl rifapentine is mediated by an esterase enzyme. There is minimal potential for PRIFTIN metabolism to be inhibited or induced by another drug, based upon the characteristics of the esterase enzymes. Since PRIFTIN is highly bound to albumin, drug displacement interactions may also occur [see Clinical Pharmacology (12.3) ] .
7.6 Interactions with Laboratory Tests Therapeutic concen…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Lactation: Monitor infants exposed to PRIFTIN through breast milk for irritability, prolonged unexplained crying, yellowing of the eyes, changes in color of the urine or stool. ( 8.2 ) Pediatrics: Safety and effectiveness in treating active pulmonary tuberculosis in children under the age of 12 years have not been established. ( 8.4 )
8.1Pregnancy 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.
Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data ) . There are risks associated with active tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, PRIFTIN may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see Clinical Considerations ) .
In animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see Data ) . Based on animal data, advise pregnant women of the risk for fetal harm. As rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Labor or delivery When administered during the last few weeks of pregnancy, PRIFTIN may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. Monitor prothrombin time of pregnant women and neonates who are exposed to PRIFTIN during the last few weeks of pregnancy.
Treatment with Vitamin K may be indicated. Data Human data Fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including PRIFTIN became pregnant during clinical studies. Six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was HIV-infected), one had an elective abortion, and outcome was unknown in three patients.
These data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. In the trial that compared the safety and effectiveness of PRIFTIN in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the PRIFTIN/isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. Among the 46 total pregnancies in th…
🤰 Pregnancy ▾
8.1Pregnancy 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.
Overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see Data ) . There are risks associated with active tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, PRIFTIN may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see Clinical Considerations ) .
In animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see Data ) . Based on animal data, advise pregnant women of the risk for fetal harm. As rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. Labor or delivery When administered during the last few weeks of pregnancy, PRIFTIN may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. Monitor prothrombin time of pregnant women and neonates who are exposed to PRIFTIN during the last few weeks of pregnancy.
Treatment with Vitamin K may be indicated. Data Human data Fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including PRIFTIN became pregnant during clinical studies. Six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was HIV-infected), one had an elective abortion, and outcome was unknown in three patients.
These data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. In the trial that compared the safety and effectiveness of PRIFTIN in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the PRIFTIN/isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. Among the 46 total pregnancies in the PRIFTIN/isoniazid arm, there were 31 live births, 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes.
Of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. The rate of spontaneous abortion in the PRIFTIN/isoniazid arm (15%) and the rate of spontaneous abortion in the isoniazid arm (19%) did not represent an increase over the background rate of 15 t…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PRIFTIN in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. The safety and effectiveness of PRIFTIN in combination with isoniazid once-weekly regimen has been evaluated in pediatric patients (2 to 17 years of age) for the treatment of latent tuberculosis infection. In clinical studies, the safety profile in children was similar to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .
In a pharmacokinetic study conducted in 2 to 11-year-old pediatric patients with latent tuberculosis infection, PRIFTIN was administered once weekly based on weight (15 mg/kg to 30 mg/kg, up to a maximum of 900 mg). Exposures (AUC) in children 2 to 11 years old with latent tuberculosis infection were higher (average 31%) than those observed in adults receiving PRIFTIN 900 mg once weekly [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with PRIFTIN did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In a pharmacokinetic study with PRIFTIN, no substantial differences in the pharmacokinetics of rifapentine and 25-desacetyl metabolite were observed in the elderly compared to younger adults [see Clinical Pharmacology (12.3) ] .
🆘 Overdosage ▾
10 OVERDOSAGE While there is no experience with the treatment of acute overdose with PRIFTIN, clinical experience with rifamycins suggests that gastric lavage to evacuate gastric contents (within a few hours of overdose), followed by instillation of an activated charcoal slurry into the stomach, may help adsorb any remaining drug from the gastrointestinal tract. Rifapentine and 25-desacetyl rifapentine are 97.7% and 93.2% plasma protein bound, respectively. Rifapentine and related compounds excreted in urine account for only 17% of the administered dose, therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifapentine from the body of a patient with PRIFTIN overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology (12.4) ] .
12.3Pharmacokinetics When oral doses of PRIFTIN were administered once daily or once every 72 hours to healthy volunteers for 10 days, single dose AUC (0–∞) of rifapentine was similar to its steady-state AUC ss (0–24h) or AUC ss (0–72h) values, suggesting no significant auto-induction effect on steady-state pharmacokinetics of rifapentine. Steady-state conditions were achieved by day 10 following daily administration of PRIFTIN 600 mg. No plasma accumulation of rifapentine and 25-desacetyl rifapentine (active metabolite) is expected after once weekly administration of PRIFTIN.
The pharmacokinetic parameters of rifapentine and 25-desacetyl rifapentine on day 10 following oral administration of 600 mg PRIFTIN every 72 hours to healthy volunteers are described in Table 5. Table 5: Pharmacokinetics and Rifapentine and 25-Desacetyl Rifapentine in Healthy Volunteers Parameter Rifapentine 25-desacetyl Rifapentine Mean ± SD (n=12) C max (µg/mL) 15.05 ± 4.62 6.26 ±
2.06AUC (0–72h) ( µg∙h/mL) 319.54 ± 91.52 215.88 ±
85.96T 1/2 (h) 13.19 ± 1.38 13.35 ±
2.67T max (h) 4.83 ± 1.80 11.25 ±
2.73Cl/F (L/h) 2.03 ± 0.60 -- The pharmacokinetic parameters of rifapentine and 25-desacetyl rifapentine following single-dose oral administration of 900 mg PRIFTIN in combination with 900 mg isoniazid in fed conditions are described in Table 6. Table 6: Mean ± SD Pharmacokinetic Parameters of Rifapentine and 25-Desacetyl Rifapentine in Healthy Volunteers When PRIFTIN is Coadministered with Isoniazid Under Fed Conditions (N=16) Parameter Rifapentine 25-desacetyl Rifapentine C max (µg/mL) 25.8 ± 5.83 13.3 ±
4.83AUC (µg∙h/mL) 817 ± 128 601 ± 187 T 1/2 (h) 16.6 ± 5.02 17.5 ±
7.42T max (h) Median (Min–Max). 8 (3–10) 24 (10–36) Cl/F (L/h) 1.13 ± 0.174 NA Not Applicable. Absorption The absolute bioavailability of PRIFTIN has not been determined.
The relative bioavailability (with an oral solution as a reference) of PRIFTIN after a single 600 mg dose to healthy adult volunteers was 70%. The maximum concentrations were achieved from 5 hours to 6 hours after administration of the 600 mg PRIFTIN dose. The administration of PRIFTIN with a high fat meal increased rifapentine C max and AUC by 40% to 50% over that observed when PRIFTIN was administered under fasting conditions.
The administration of PRIFTIN (900 mg single dose) and isoniazid (900 mg single dose) with a low fat, high carbohydrate breakfast, led to a 47% and 51% increase in rifapentine C max and AUC, respectively. In contrast, the ingestion of the same meal decreased isoniazid C max and AUC by 46% and of 23%, respectively. Distribution In a population pharmacokinetic analysis in 351 tuberculosis patients who received 600 mg PRIFTIN in combination with isoniazid, pyrazinamide and ethambutol, the estimated apparent volume of distribution was 70.2 ±
9.1L. In healthy volunteers, rifapentine and 25-desacetyl rifapentine were 97.7% and 93.2% bound to plasma proteins, respectively. Rifapentine was mainly bound to albumin.
Similar extent of protein binding was observed in healthy volunteers, asymptomatic HIV-infected subjects and hepatically impaired subjects. Metabolism/Excretion Following a single 600 mg oral dose of radiolabeled rifapentine to healthy volunteers (n=4), 87% of the total 14 C-rifapentine was recovered in the urine (17%) and feces (70%). Greater than 80% of the total 14 C-rifapentine dose was excreted from the body within 7 days.
Rifapentine was hydrolyzed by an esterase enzyme to form a microbiologically active 25-desacetyl rifapentine. Rifapentine and 25-desacetyl rifapentine accounted for 99% of the total radioactivity in plasma. Plasma AUC (0–∞) and C max values of the 25-desacetyl rifapentine metabolite were one-half and one-third those of the rifapentine, respectively.
Based upon relative in vitro activities and AUC (0–∞) values, rifapent…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 53002-1718 NDC: 53002-1718-1 8 TABLET, FILM COATED in a BLISTER PACK / 3 in a CARTON
📋 Description ▾
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.
Rifapentine is a rifamycin derivative antimicrobial and has a similar profile of microbiological activity to rifampicin. The molecular weight is 877.04. The molecular formula is C 47 H 64 N 4 O 12 .
The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]- or 3-[N-(4-cyclopentyl-1-piperazinyl)formimidoyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure: Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patient to read FDA-approved patient labeling (Medication Guide). Treatment Adherence Emphasize the importance of compliance with the full course of therapy, and the importance of not missing any doses of PRIFTIN or companion medications in the treatment of active pulmonary tuberculosis or the treatment of latent tuberculosis infection. Hypersensitivity Reactions Inform patients that PRIFTIN may cause hypersensitivity reactions.
Signs and symptoms of this reaction may include a flu-like illness, hypotension, urticaria, angioedema, bronchospasm, conjunctivitis, thrombocytopenia or neutropenia. Anaphylaxis may also occur [see Warnings and Precautions (5.2) ] . Inform patients of signs and symptoms of hypersensitivity reactions and advise them to stop the medication and contact their healthcare provider if they experience any of these symptoms.
Severe Cutaneous Adverse Reactions Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking PRIFTIN immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.3) ] . Hepatitis Instruct patients to stop the medication and notify their physician promptly if they experience any of the following: fever, loss of appetite, malaise, nausea and vomiting, darkened urine, yellowish discoloration of the skin and eyes, and pain or swelling of the joints [see Warnings and Precautions (5.1) ] .
Drug Interactions Rifapentine may increase the metabolism and decrease the activity of other drugs that are metabolized by the P450 3A4 and 2C8/9 pathways. Dosage adjustments of the coadministered drugs may be necessary. Advise patients to discuss with their physician any other medications they are taking before starting treatment with PRIFTIN [see Warnings and Precautions (5.5) , Drug Interactions (7.1 , 7.4) ] .
Concomitant use of PRIFTIN with protease inhibitors or reverse transcriptase inhibitors may cause a significant decrease in plasma concentrations and loss of therapeutic effect of the protease inhibitor or reverse transcriptase inhibitor [see Warnings and Precautions (5.5) and Drug Interactions (7.4) ] . Discoloration of Body Fluids Inform the patient that PRIFTIN produces a red-orange discoloration of the urine, sweat, sputum, tears, and breast milk. Contact lenses or dentures may be permanently stained [see Warnings and Precautions (5.6) ] .
Administration with Food Advise patients to take PRIFTIN with food. Lactation Monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity to include irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, and changes in color of the urine (darkening) or stool (lightening, pale or light brown) [see Use in Specific Populations (8.2) ] . Contraception Advise patients that use of PRIFTIN may reduce the efficacy of hormonal contraceptives.
Advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment [see Warning and Precautions (5.5) , Drug Interactions (7.3) , and Use in Specific Populations (8.3) ] .
💬 Medication Guide ▾
Medication Guide PRIFTIN (prif - tin) (rifapentine) Tablets This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: June 2020 Read this Medication Guide before you start taking PRIFTIN and each time you get a refill.
There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about PRIFTIN?
PRIFTIN may cause serious side effects, including: Liver problems. PRIFTIN may cause serious liver problems. Your doctor may do a blood test to check your liver function before and while you take PRIFTIN.
Stop taking PRIFTIN and call your doctor right away if you have any of the following signs and symptoms of liver problems: nausea stomach pain tiredness, yellowing skin or whites of your eyes vomiting loss of appetite dark urine Allergic reactions and flu-like symptoms. Allergic reactions and flu-like symptoms have happened in some people taking PRIFTIN. Signs and symptoms of an allergic reaction may include: low blood pressure (hypotension) hives cough with wheezing difficulty breathing red eyes (conjunctivitis) lower blood platelet levels Signs and symptoms of a flu-like reaction may include: weakness nausea and vomiting chills itching shortness of breath fainting tiredness headache aches sweats chest pain fast heartbeat muscle pain fever rash dizziness cough Severe skin reactions.
Serious skin reactions such as Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have happened in some people taking PRIFTIN. Stop taking PRIFTIN right away and call your doctor or get emergency help if you have any of the following symptoms: rash red and painful skin peeling or bleeding skin sores or blisters on the inside of your mouth or lips swollen face, lips, mouth tongue or throat flu-like symptoms What is PRIFTIN? PRIFTIN is a prescription medicine used with other anti-tuberculosis (TB) medicines to: treat active tuberculosis disease of the lung in people age 12 years and older. prevent progression of inactive (latent) tuberculosis infection to active tuberculosis disease in people age 2 years and older.
PRIFTIN should not be used: alone to treat people with active or latent TB in people with active TB who had taken the medicines rifampin or isoniazid in the past and did not respond (resistant) in people who had been exposed to patients with TB that cannot be treated with isoniazid or rifampin PRIFTIN is safe and effective in children older than 2 years of age who have inactive (latent TB), but it is not known if PRIFTIN is safe and effective for use in the treatment of active TB in children under 12 years of age. Who should not take PRIFTIN?
Do not take PRIFTIN if you are allergic to a group of medicines called rifamycins. What should I tell my doctor before taking PRIFTIN? Before taking PRIFTIN, tell your doctor about all of your medical conditions, including if you: have active TB disease. know that you have TB that is resistant to treatment with some medicines. have HIV infection or taking medicines to treat HIV infection. have liver problems. have a condition called porphyria. are pregnant or planning to become pregnant.
It is not known if PRIFTIN will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if PRIFTIN passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking PRIFTIN.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using PRIFTIN with other medicines may affect each other causing serious side effects. PRIFTIN may affect the way other medicines work, and other medicines may affect how PRIFTIN works.
Especially tell your doctor if you take medicines to treat HIV infection or oral contraceptives. Ask your doctor or pharmacist for a list of t…