Skip to Content

Rifapentine

Medically reviewed on Nov 15, 2018

Pronunciation

(rif a PEN teen)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Priftin: 150 mg [contains disodium edta, fd&c blue #2 aluminum lake]

Brand Names: U.S.

  • Priftin

Pharmacologic Category

  • Antitubercular Agent
  • Rifamycin

Pharmacology

Inhibits DNA-dependent RNA polymerase in susceptible strains of Mycobacterium tuberculosis (MTB) (but not in mammalian cells). Rifapentine is bactericidal against both intracellular and extracellular MTB organisms.

Absorption

High-fat meals increase AUC and Cmax by 40% to 50%

In pediatric patients, crushing the tablet results in 26% lower exposure than whole tablets.

Distribution

Vd: ~70 L

Metabolism

Hepatic; hydrolyzed by an esterase enzyme to form the active metabolite 25-desacetyl rifapentine

Excretion

Feces (70%); urine (17%, primarily as metabolites)

In pediatric patients 2 to 18 years of age, clearance decreases with increasing age.

Time to Peak

Serum: 3 to 10 hours

Half-Life Elimination

Rifapentine: ~17 hours; 25-desacetyl rifapentine: ~24 hours

Protein Binding

Rifapentine: ~98%, primarily to albumin; 25-desacetyl rifapentine: ~93%

Use: Labeled Indications

Active pulmonary tuberculosis: Treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis in adults and children 12 years and older; must be used in combination with one or more antituberculosis drugs to which the isolate is susceptible.

Limitations of use: Rifapentine should not be used once weekly in the continuation phase regimen in combination with isoniazid in HIV-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin-resistant organisms. Rifapentine has not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis.

Latent tuberculosis infection: Treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis, in combination with isoniazid, in adults and children 2 years and older at high risk of progression to tuberculosis disease. To identify candidates for latent tuberculosis infection treatment, refer to Centers for Disease Control and Prevention (CDC) guidelines for current recommendations.

Limitations of use: Rifapentine in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin- or isoniazid-resistant M. tuberculosis.

Contraindications

Hypersensitivity to rifapentine, other rifamycins, or any component of the formulation

Dosing: Adult

Tuberculosis, active (drug-susceptible): Oral:

Initial phase: 600 mg twice weekly (with an interval ≥72 hours between doses) by directly observed therapy (DOT) for 2 months as part of multidrug regimen.

Continuation phase: 600 mg once weekly by DOT for 4 months as part of a multidrug regimen. Note: Drug-susceptible TB guidelines recommend against once-weekly therapy; use should only be considered in rare situations in certain HIV-uninfected individuals with no cavitation on chest x-ray (Nahid 2016).

Tuberculosis, latent infection: Oral: Use once weekly for 12 weeks in combination with isoniazid.

25.1 to 32 kg: 600 mg

32.1 to 50 kg: 750 mg

>50 kg: 900 mg

Note: May be administered by DOT or as self-administered therapy. This regimen may only be used in patients who are not pregnant and/or not expecting to become pregnant; if used in HIV-infected patients, it may only be used in those receiving antiretroviral therapy (ART) with acceptable drug-drug interactions with rifapentine (CDC [Borisov 2018]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Rifapentine must always be used in conjunction with at least one other antituberculosis drug to which the isolate is susceptible.

Tuberculosis, treatment; active pulmonary infection: Children ≥12 years and Adolescents:

Initial phase: Oral: 600 mg twice weekly (with an interval ≥72 hours between doses) by directly observed therapy (DOT) for 2 months. Note: Initial phase should include a 3- to 4-drug regimen.

Continuation phase: Oral: 600 mg once weekly by DOT for 4 months in combination with isoniazid or another appropriate agent for susceptible organisms. Note: Drug-susceptible TB guidelines recommend against once-weekly therapy; use should only be considered in rare situations in certain HIV-uninfected individuals with no cavitation on chest x-ray (Nahid 2016).

Latent tuberculosis infection: Note: For HIV-positive patients, including those with AIDS, rifapentine in combination with isoniazid is recommended if receiving highly active antiretroviral therapy (HAART) with acceptable drug-drug interactions with rifapentine when guided by experienced clinicians (CDC [Borisov 2018]). Children ≥2 years and Adolescents: Oral: Administer by DOT or self-administered therapy at the clinician's discretion based on local practice, patient attributes/preferences, and other factors, including risk for TB disease progression (CDC [Borisov 2018]) for 12 weeks (12 doses) in combination with isoniazid:

10 to 14 kg: 300 mg/dose once weekly

>14 to 25 kg: 450 mg/dose once weekly

>25 to 32 kg: 600 mg/dose once weekly

>32 to 50 kg: 750 mg/dose once weekly

>50 kg: 900 mg/dose once weekly

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution. Pharmacokinetics in varying degrees of hepatic impairment were similar to those in healthy volunteers.

Administration

Administer with meals. For patients who cannot swallow tablets, the tablets may be crushed and added to a small amount of semi-solid food and consumed immediately.

Dietary Considerations

Take with food.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from excessive heat and humidity.

Drug Interactions

Abemaciclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Abemaciclib. Avoid combination

Abiraterone Acetate: Rifapentine may decrease the serum concentration of Abiraterone Acetate. Monitor therapy

Alfentanil: Rifamycin Derivatives may decrease the serum concentration of Alfentanil. Management: Monitor closely for decreased alfentanil effectiveness. Increased alfentanil doses will likely be needed. Alternatively, changing from alfentanil to a different opioid anesthetic (e.g., sufentanil) may also be considered. Consider therapy modification

Antifungal Agents (Azole Derivatives, Systemic): May increase the serum concentration of Rifamycin Derivatives. Only rifabutin appears to be affected. Rifamycin Derivatives may decrease the serum concentration of Antifungal Agents (Azole Derivatives, Systemic). Management: Avoid these combinations when possible. Voriconazole and isavuconazonium are considered contraindicated. Consider therapy modification

Antihepaciviral Combination Products: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Antihepaciviral Combination Products. Avoid combination

Asunaprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Asunaprevir. Avoid combination

Atovaquone: Rifamycin Derivatives may decrease the serum concentration of Atovaquone. Avoid combination

Axitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Axitinib. Avoid combination

Barbiturates: Rifamycin Derivatives may increase the metabolism of Barbiturates. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bedaquiline: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bedaquiline. Avoid combination

Benzhydrocodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Benzhydrocodone. Specifically, the serum concentrations of hydrocodone may be reduced. Monitor therapy

Beta-Blockers: Rifamycin Derivatives may decrease the serum concentration of Beta-Blockers. Exceptions: Atenolol; Carteolol (Ophthalmic); Levobunolol; Metipranolol; Nadolol. Monitor therapy

Bictegravir: Rifapentine may decrease the serum concentration of Bictegravir. Avoid combination

Bosutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bosutinib. Avoid combination

Cabozantinib: Rifapentine may decrease the serum concentration of Cabozantinib. Monitor therapy

Calcium Channel Blockers: Rifamycin Derivatives may decrease the serum concentration of Calcium Channel Blockers. This primarily affects oral forms of calcium channel blockers. Management: The labeling for some US and Canadian calcium channel blockers contraindicate use with rifampin, however recommendations vary. Consult appropriate labeling. Exceptions: Clevidipine. Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Clarithromycin: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Clarithromycin. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Clarithromycin. Management: Consider alternative antimicrobial therapy for patients receiving a CYP3A inducer. Drugs that enhance the metabolism of clarithromycin into 14-hydroxyclarithromycin may alter the clinical activity of clarithromycin and impair its efficacy. Consider therapy modification

CloZAPine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of CloZAPine. Monitor therapy

Cobicistat: Rifapentine may decrease the serum concentration of Cobicistat. Avoid combination

Cobimetinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cobimetinib. Avoid combination

Codeine: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Codeine. Monitor therapy

CycloSPORINE (Systemic): Rifamycin Derivatives may increase the metabolism of CycloSPORINE (Systemic). Consider therapy modification

CYP2C9 Substrates (High risk with Inducers): Rifapentine may decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Substrates (High risk with Inducers): CYP3A4 Inducers (Moderate) may decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Daclatasvir: Rifapentine may decrease the serum concentration of Daclatasvir. Management: US labeling recommends increasing the daclatasvir dose to 90 mg once daily if used with rifapentine. Canadian labeling states that the combination of daclatasvir and rifapentine is contraindicated. Consider therapy modification

Dapsone (Systemic): Rifamycin Derivatives may decrease the serum concentration of Dapsone (Systemic). Monitor therapy

Darunavir: Rifapentine may decrease the serum concentration of Darunavir. Avoid combination

Dasabuvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dasabuvir. Avoid combination

Deflazacort: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Deflazacort. Avoid combination

Delavirdine: Rifamycin Derivatives may increase the metabolism of Delavirdine. Delavirdine may increase the serum concentration of Rifamycin Derivatives. Specifically, Rifabutin serum concentration may be increased. Avoid combination

Doravirine: Rifapentine may decrease the serum concentration of Doravirine. Avoid combination

Elbasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elbasvir. Avoid combination

Elvitegravir: Rifapentine may decrease the serum concentration of Elvitegravir. Avoid combination

Encorafenib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Encorafenib. Avoid combination

Enzalutamide: Rifapentine may decrease the serum concentration of Enzalutamide. Monitor therapy

Erlotinib: Rifapentine may decrease the serum concentration of Erlotinib. Management: Avoid combination if possible. If combination must be used, increase erlotinib dose by 50 mg increments every 2 weeks as tolerated, to a maximum of 450 mg/day. Consider therapy modification

Estriol (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Estriol (Systemic). Monitor therapy

Estriol (Topical): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Estriol (Topical). Monitor therapy

Estrogen Derivatives (Contraceptive): Rifamycin Derivatives may decrease the serum concentration of Estrogen Derivatives (Contraceptive). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Etravirine: Rifamycin Derivatives may decrease the serum concentration of Etravirine. Avoid combination

Everolimus: Rifapentine may decrease the serum concentration of Everolimus. Monitor therapy

FentaNYL: CYP3A4 Inducers (Moderate) may decrease the serum concentration of FentaNYL. Monitor therapy

Flibanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Flibanserin. Avoid combination

Glecaprevir and Pibrentasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Glecaprevir and Pibrentasvir. Monitor therapy

Grazoprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Grazoprevir. Avoid combination

GuanFACINE: CYP3A4 Inducers (Moderate) may decrease the serum concentration of GuanFACINE. Management: Increase the guanfacine dose by up to double when initiating concomitant therapy with moderate CYP3A4 inducers. Increase guanfacine dose gradually over 1-2 weeks if moderate CYP3A4 inducer therapy is just beginning. Consider therapy modification

HMG-CoA Reductase Inhibitors (Statins): Rifamycin Derivatives may decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Consider use of noninteracting antilipemic agents (note: pitavastatin concentrations may increase with rifamycin treatment). Monitor for altered HMG-CoA reductase inhibitor effects. Rifabutin and fluvastatin, or possibly pravastatin, may pose lower risk. Exceptions: Pitavastatin; Rosuvastatin. Consider therapy modification

HYDROcodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of HYDROcodone. Monitor therapy

Ibrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ibrutinib. Monitor therapy

Ifosfamide: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Ifosfamide. CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Ifosfamide. Monitor therapy

Imatinib: Rifamycin Derivatives may decrease the serum concentration of Imatinib. Management: Avoid concurrent use of imatinib with the rifamycin derivatives when possible. If such a combination must be used, increase imatinib dose by at least 50% and monitor the patient's clinical response closely. Consider therapy modification

Indinavir: Rifapentine may decrease the serum concentration of Indinavir. Management: Consider avoiding the combination of indinavir and rifapentine whenever possible due to the risk for decreased indinavir concentrations, reduced efficacy, and development of resistance. If combined, monitor for indinavir treatment failure. Consider therapy modification

Irinotecan Products: Rifapentine may decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be reduced. Rifapentine may decrease the serum concentration of Irinotecan Products. Monitor therapy

Isoniazid: Rifamycin Derivatives may enhance the hepatotoxic effect of Isoniazid. Even so, this is a frequently employed combination regimen. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Ledipasvir: Rifapentine may decrease the serum concentration of Ledipasvir. Avoid combination

Lurasidone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lurasidone. Management: Monitor for decreased lurasidone effects if combined with moderate CYP3A4 inducers and consider increasing the lurasidone dose if coadministered with a moderate CYP3A4 inducer for 7 or more days. Consider therapy modification

Methadone: Rifamycin Derivatives may decrease the serum concentration of Methadone. Management: Seek alternatives when possible. If used concomitantly, monitor closely for symptoms of methadone withdrawal upon rifamycin derivative initiation, and for excess sedation upon rifamycin derivative discontinuation. Consider therapy modification

Mirodenafil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mirodenafil. Monitor therapy

Mycophenolate: Rifamycin Derivatives may decrease the serum concentration of Mycophenolate. Specifically, rifamycin derivatives may decrease the concentration of the active metabolite mycophenolic acid. Avoid combination

Naldemedine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Naldemedine. Monitor therapy

Neratinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Neratinib. Avoid combination

Nilotinib: Rifapentine may decrease the serum concentration of Nilotinib. Monitor therapy

Nisoldipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nisoldipine. Avoid combination

Olaparib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olaparib. Avoid combination

Palbociclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Palbociclib. Management: The US label does not provide specific recommendations concerning use with moderate CYP3A4 inducers, but the Canadian label recommends avoiding use of moderate CYP3A4 inducers. Consider therapy modification

Perampanel: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Perampanel. Management: Increase the perampanel starting dose to 4 mg/day when perampanel is used concurrently with moderate and strong CYP3A4 inducers. Consider therapy modification

Pitavastatin: Rifamycin Derivatives may increase the serum concentration of Pitavastatin. Management: Limit pitavastatin dose to a maximum of 2 mg/day with concurrent rifampin. Consider therapy modification

Progestins (Contraceptive): Rifamycin Derivatives may decrease the serum concentration of Progestins (Contraceptive). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

QuiNIDine: Rifamycin Derivatives may decrease the serum concentration of QuiNIDine. Management: Consider alternatives to combination treatment with quinidine and rifampin due to large potential decreases in quinidine concentrations. Monitor for decreased quinidine concentrations/effects with initiation/dose increase of any rifamycin derivative. Consider therapy modification

Raltegravir: Rifapentine may increase the serum concentration of Raltegravir. Rifapentine may decrease the serum concentration of Raltegravir. Monitor therapy

Ranolazine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ranolazine. Avoid combination

Rilpivirine: Rifamycin Derivatives may decrease the serum concentration of Rilpivirine. Avoid combination

Rolapitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Rolapitant. Monitor therapy

RomiDEPsin: Rifapentine may decrease the serum concentration of RomiDEPsin. Monitor therapy

Simeprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Simeprevir. Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Sofosbuvir: Rifapentine may decrease the serum concentration of Sofosbuvir. Avoid combination

Sonidegib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sonidegib. Avoid combination

Tacrolimus (Systemic): Rifamycin Derivatives may decrease the serum concentration of Tacrolimus (Systemic). Management: Consider alternatives when possible. If these combination are used, monitor for reduced tacrolimus concentrations/effects following rifamycin initiation/dose increase, or increased concentrations/effects following rifamycin discontinuation/dose decrease. Consider therapy modification

Tamoxifen: Rifamycin Derivatives may increase the metabolism of Tamoxifen. Consider therapy modification

Temsirolimus: Rifamycin Derivatives may decrease the serum concentration of Temsirolimus. Rifamycins will likely cause an even greater decrease in the concentration of the active metabolite sirolimus. Management: Temsirolimus prescribing information recommends against coadministration with strong CYP3A4 inducers such as rifampin; however, if concurrent therapy is necessary, an increase in temsirolimus adult dose to 50 mg/week should be considered. Consider therapy modification

Tenofovir Alafenamide: Rifapentine may decrease the serum concentration of Tenofovir Alafenamide. Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Velpatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Velpatasvir. Avoid combination

Venetoclax: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Venetoclax. Avoid combination

VinCRIStine (Liposomal): Rifapentine may decrease the serum concentration of VinCRIStine (Liposomal). Monitor therapy

Vitamin K Antagonists (eg, warfarin): Rifamycin Derivatives may increase the metabolism of Vitamin K Antagonists. Monitor therapy

Voriconazole: May increase the serum concentration of Rifamycin Derivatives. Rifamycin Derivatives may decrease the serum concentration of Voriconazole. Avoid combination

Zidovudine: Rifamycin Derivatives may decrease the serum concentration of Zidovudine. Monitor therapy

Zolpidem: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zolpidem. Monitor therapy

Test Interactions

Rifampin has been shown to inhibit standard microbiological assays for serum folate and vitamin B12; this should be considered for rifapentine; therefore, alternative assay methods should be considered.

Adverse Reactions

Frequency may vary based on treatment phase; adverse reaction data is based on rifapentine combination therapy.

>10%:

Endocrine & metabolic: Hyperuricemia (≤32%; most likely due to pyrazinamide from initiation phase)

Genitourinary: Pyuria (11% to 22%), hematuria (10% to 18%), urinary tract infection (7% to 13%)

Hematologic & oncologic: Neutropenia (6% to 13%), lymphocytopenia (3% to 13%), anemia (2% to 11%)

1% to 10%:

Cardiovascular: Chest pain (3% to 6%), edema (1%)

Central nervous system: Pain (3% to 6%), headache (≤3%), dizziness (≤1%), fatigue (≤1%)

Dermatologic: Diaphoresis (2% to 5%), skin rash (3% to 4%), acne vulgaris (≤3%), pruritus (≤3%), maculopapular rash (≤2%)

Endocrine & metabolic: Hypoglycemia (5% to 10%), hyperglycemia (1% to 4%), increased nonprotein nitrogen (1% to 3%), gout (1%), hyperphosphatemia (1%)

Gastrointestinal: Anorexia (3% to 4%), nausea (≤3%), constipation (1% to 2%), dyspepsia (1% to 2%), abdominal pain (≤2%), diarrhea (≤2%), vomiting (≤2%), hemorrhoids (1%)

Genitourinary: Casts in urine (4% to 8%), cystitis (1%)

Hematologic & oncologic: Leukopenia (4% to 7%), thrombocytosis (≤6%), leukocytosis (2% to 3%), neutrophilia (1% to 3%), thrombocythemia (1% to 3%), polycythemia (≤2%), lymphadenopathy (≤1%)

Hepatic: Increased serum ALT (2% to 7%), increased serum AST (2% to 6%), hepatotoxicity (≤2%)

Hypersensitivity: Hypersensitivity reaction (≤4%; children & adolescents 1%)

Infection: Influenza (3% to 8%), herpes zoster (1%), infection (1%)

Neuromuscular & skeletal: Back pain (4% to 7%), arthralgia (≤4%), osteoarthrosis (1%), tremor (1%)

Ophthalmic: Conjunctivitis (≤3%)

Respiratory: Hemoptysis (2% to 8%), cough (3% to 6%), bronchitis (3%), pharyngitis (1% to 2%), epistaxis (1%), pleurisy (1%)

Miscellaneous: Accidental injury (1% to 5%), fever (≤1%)

<1%, postmarketing, and/or case reports: Ageusia, allergic skin reaction, alopecia, anaphylaxis, anxiety, asthma, azotemia, bronchial hyperactivity, bronchospasm, chills, confusion, convulsions, decreased appetite, depression, diabetes mellitus, disorientation, drowsiness, dyspnea, dysuria, enlargement of salivary glands, erythematous rash, esophagitis, facial edema, fungal infection, gastritis, hematoma, hepatitis, hepatomegaly, hyperbilirubinemia, hypercalcemia, hyperhidrosis, hyperkalemia, hyperlipidemia, increased blood urea nitrogen, increased serum alkaline phosphatase, jaundice, jitteriness, laryngeal edema, laryngitis, leukorrhea, lymphocytosis, myalgia, myasthenia, myositis, oropharyngeal pain, orthostatic hypotension, palpitations, pancreatitis, paresthesia, pericarditis, peripheral neuropathy, pneumonitis, pulmonary fibrosis, pulmonary tuberculosis (exacerbation), purpura, pyelonephritis, rhabdomyolysis, seizure, skin discoloration, suicidal ideation, syncope, tachycardia, thrombosis, urinary incontinence, urticaria, vaginal hemorrhage, vaginitis, viral infection, voice disorder, vulvovaginal candidiasis, vulvovaginal pruritus, weakness, weight gain, weight loss, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, may occur. Discontinue therapy and administer supportive measures if hypersensitivity occurs.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Patients with abnormal liver tests and/or liver disease should only be given rifapentine when absolutely necessary and under strict medical supervision. Monitoring of liver function tests (eg, serum transaminases) should be carried out prior to therapy and then every 2 to 4 weeks during therapy. Combination therapy should be discontinued if ALT is ≥5 times the upper limit of normal (ULN) even in the absence of liver dysfunction symptoms or ≥3 times ULN in the presence of symptoms (CDC, 2012).

• Porphyria: Use is not recommended in patients with porphyria; exacerbation is possible due to enzyme-inducing properties.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• HIV-seropositive patients: Use of rifapentine during the initial phase of treatment in HIV–seropositive patients has not been evaluated. Rifapentine should not be used during the continuation phase of treatment in HIV-seropositive patients; a higher rate of failure and/or relapse with rifampin-resistant organisms has been reported.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Appropriate use: Use with caution in patients with cavitary pulmonary lesions and/or positive sputum cultures after initial treatment phase and patients with bilateral pulmonary disease; higher relapse rates may occur in these patients.

• Compliance: Compliance with dosing regimen is absolutely necessary for successful drug therapy.

• Contact lenses: Remove soft contact lenses during therapy since permanent staining may occur.

• Red/orange discoloration: Urine, feces, saliva, sweat, tears, skin, teeth, tongue, and CSF may be discolored to red/orange. Advise patients with dentures that permanent staining of dentures may occur.

Monitoring Parameters

Patients with preexisting hepatic problems should have liver function tests monitored (eg, serum transaminases) prior to therapy and then every 2 to 4 weeks during therapy. In treatment of latent infection with rifapentine and isoniazid combination therapy, patients with HIV infection, liver disorders, immediate postpartum (≤ 3 months after delivery), or regular ethanol use should have liver function (at least alanine aminotransferase [ALT]) monitored prior to therapy and then at subsequent clinical visits whose baseline testing is abnormal or for others at risk for liver disease (CDC, 2012).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Information related to the use of rifapentine in pregnant women is limited. Postnatal hemorrhages have been reported in the infant and mother with rifampin (another rifamycin) administration during the last few weeks of pregnancy. Monitoring of the prothrombin time in the mother and neonate is recommended following exposure late in pregnancy; treatment with vitamin K may be needed.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, lack of appetite, joint pain, nausea, vomiting, body tissue or body fluid discoloration, or denture discoloration. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), abnormal heartbeat, severe loss of strength and energy, chills, pharyngitis, bruising, bleeding, angina, tachycardia, dizziness, passing out, flu-like symptoms, muscle pain, swollen glands, cough, eye redness, shortness of breath, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide