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RIFAPENTINE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Rifapentine is a cyclopentyl rifamycin derivative antibiotic with bactericidal activity against mycobacterium tuberculosis.

Specific Substances

    1) DL-473
    2) DL-473-IT
    3) L-11473
    4) MDL-473
    5) Rifapentina
    6) R-773
    7) Antibiotic DL 473IT
    8) KTC 1
    9) Rifamycin AF/ACPP
    10) CAS Registry: 61379-65-5
    11) Molecular Formula: C47H64N4O12
    1.2.1) MOLECULAR FORMULA
    1) C47-H64-N4-O12

Available Forms Sources

    A) FORMS
    1) Rifapentine is available as 150 mg film-coated tablets (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) USES
    1) Rifapentine is indicated for the treatment of pulmonary tuberculosis caused by Mycobacterium tuberculosis in combination with other antituberculosis agents (Prod Info PRIFTIN(R) oral tablets, 2010).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Rifapentine is indicated for the treatment of pulmonary infection caused by Mycobacterium tuberculosis in combination with other antituberculosis agents.
    B) PHARMACOLOGY: Rifapentine is a cyclopentyl rifamycin derivative antibiotic with bactericidal activity against mycobacterium tuberculosis.
    C) EPIDEMIOLOGY: Overdose is uncommon.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: Red-orange discoloration of body tissues and fluids, including skin, teeth, tongue, urine, feces, saliva, sweat and tears, may commonly occur with therapy. Other reported adverse effects or alterations in laboratory studies include: elevated liver enzyme levels, neutropenia, anemia, lymphopenia, proteinuria, hematuria, hypoglycemia, arthralgias and rash.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: Information is limited. Administration of 1200 mg as a single oral dose resulted in minor adverse effects including heartburn, headache, and increased urinary frequency.
    2) MILD TO MODERATE TOXICITY: Nausea, vomiting, anorexia, arthralgias, rash and elevated liver enzymes can develop. Red-orange discoloration of the skin, body tissues and fluids may occur.
    3) SEVERE TOXICITY: Hepatotoxicity, hyperbilirubinemia, and hematologic toxicity may develop following a significant exposure.
    0.2.20) REPRODUCTIVE
    A) Rifapentine is classified as FDA pregnancy category C.

Laboratory Monitoring

    A) Monitor CBC with differential and liver enzyme concentrations after significant overdose.
    B) Obtain a baseline urinalysis.
    C) Plasma rifapentine concentrations are not readily available and are not useful in guiding therapy.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Limited overdose information. Treatment is symptomatic and supportive. Trean persistent vomiting with IV fluids and antiemetics.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Hepatotoxicity has been associated with antituberculous therapy; monitor liver enzymes and assess for hepatic injury following a significant exposure until there is evidence of patient recovery. Monitor CBC with differential; repeat as indicated. Hematologic toxicity (ie, neutropenia, anemia) may develop following a significant exposure. Treat vomiting with IV fluids and antiemetics.
    C) DECONTAMINATION
    1) PREHOSPITAL: Decontamination is unlikely to be necessary following a minor exposure. Consider activated charcoal if a significant recent ingestion or if coingestants are suspected.
    2) HOSPITAL: Administer activated charcoal, if the ingestion is relatively recent and the patient is alert and able to protect their airway. Repeat administration of activated charcoal may be beneficial since rifamycin antibiotics undergo enterohepatic circulation. However, there are no clinical trials documenting the efficacy of this procedure.
    D) AIRWAY MANAGEMENT
    1) Airway management is unlikely to be necessary following mild to moderate toxicity.
    E) ANTIDOTE
    1) None.
    F) ENHANCED ELIMINATION
    1) Rifapentine and its metabolite, 25-desacetyl rifapentine, are highly protein-bound, hemodialysis is not expected to be of any benefit following an overdose.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: An asymptomatic child that has a minor ingestion (1 tablet) can likely be managed at home with adult supervision. An asymptomatic adult or complaint of minor symptoms that has taken an extra dose or has taken rifapentine for several consecutive days inadvertently can likely be managed at home with telephone support.
    2) OBSERVATION CRITERIA: Symptomatic patients and those with a deliberate self-harm ingestion should be evaluated in a healthcare facility and monitored until symptoms resolve. Patients may be discharged to home once symptoms have resolved and laboratory studies are within normal limits.
    3) ADMISSION CRITERIA: Patients with persistent symptoms may need to be admitted for further treatment.
    4) CONSULT CRITERIA: Contact a medical toxicologist or Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.

Range Of Toxicity

    A) TOXICITY: A minimum toxic dose has not been established. Single oral doses of 1200 mg have resulted in minor adverse effects including heartburn, headache, and increased urinary frequency.
    B) THERAPEUTIC: ADULT and CHILDREN 12 YEARS OF AGE AND OLDER: PULMONARY TUBERCULOSIS: INTENSIVE PHASE: 600 mg orally twice weekly for 2 months in combination with other antituberculosis drugs. CONTINUATION PHASE: 600 mg once weekly for 4 months in combination with isoniazid or another antituberculosis agent.

Clinical Effects

Summary Of Exposure

    A) USES: Rifapentine is indicated for the treatment of pulmonary infection caused by Mycobacterium tuberculosis in combination with other antituberculosis agents.
    B) PHARMACOLOGY: Rifapentine is a cyclopentyl rifamycin derivative antibiotic with bactericidal activity against mycobacterium tuberculosis.
    C) EPIDEMIOLOGY: Overdose is uncommon.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: Red-orange discoloration of body tissues and fluids, including skin, teeth, tongue, urine, feces, saliva, sweat and tears, may commonly occur with therapy. Other reported adverse effects or alterations in laboratory studies include: elevated liver enzyme levels, neutropenia, anemia, lymphopenia, proteinuria, hematuria, hypoglycemia, arthralgias and rash.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: Information is limited. Administration of 1200 mg as a single oral dose resulted in minor adverse effects including heartburn, headache, and increased urinary frequency.
    2) MILD TO MODERATE TOXICITY: Nausea, vomiting, anorexia, arthralgias, rash and elevated liver enzymes can develop. Red-orange discoloration of the skin, body tissues and fluids may occur.
    3) SEVERE TOXICITY: Hepatotoxicity, hyperbilirubinemia, and hematologic toxicity may develop following a significant exposure.

Heent

    3.4.3) EYES
    A) WITH THERAPEUTIC USE
    1) Rifapentine can cause a red-orange discoloration of body fluids, including tears, which may permanently stain soft contact lenses (Prod Info PRIFTIN(R) oral tablets, 2010).
    3.4.6) THROAT
    A) WITH THERAPEUTIC USE
    1) Rifapentine can cause a red-orange discoloration of the teeth, saliva, and tongue. Dentures may become permanently stained (Prod Info Priftin(R) , 2002).

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) HYPERTENSIVE DISORDER
    1) WITH THERAPEUTIC USE
    a) Hypertension was reported infrequently during therapeutic use of rifapentine (Prod Info PRIFTIN(R) oral tablets, 2010).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) HEADACHE
    1) WITH POISONING/EXPOSURE
    a) Headache was reported in 2 of 8 healthy volunteers who received 1200 mg rifapentine as a single oral dose (Prod Info PRIFTIN(R) oral tablets, 2010).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) NAUSEA AND VOMITING
    1) WITH POISONING/EXPOSURE
    a) Nausea and vomiting were reported infrequently during therapy (intensive or continuation phases) with rifapentine (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) LOSS OF APPETITE
    1) WITH THERAPEUTIC USE
    a) Anorexia was reported in 3.9% (14 of 361) of patients during the intensive phase and 2.5% (8 of 304) of patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).

Hepatic

    3.9.2) CLINICAL EFFECTS
    A) LIVER ENZYMES ABNORMAL
    1) WITH THERAPEUTIC USE
    a) In clinical trials, rifapentine was associated with elevations of alanine transaminase (ALT) and aspartate transaminase (AST) in 5% or less of patients. Other concomitantly administered drugs included isoniazid, pyrazinamide, and ethambutol (Prod Info PRIFTIN(R) oral tablets, 2010; Anon, 2002).
    b) Elevated liver enzyme levels occurred in 3 patients, who received combination therapy, for 3 to 6 months, with rifapentine and isoniazid (900 mg rifapentine in one patient and 1200 mg of rifapentine in 2 patients). The AST levels were 227 U/L and 358 U/L in the patients receiving 900 mg and 1200 mg rifapentine, respectively, and the ALT level, in the patient who received 1200 mg rifapentine, was 745 U/L (Bock et al, 2002).
    B) HYPERBILIRUBINEMIA
    1) WITH THERAPEUTIC USE
    a) Hyperbilirubinemia may result from competition for excretory pathways between rifapentine and bilirubin, which has occurred with rifampin (Prod Info PRIFTIN(R) oral tablets, 2010).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) URINE COLOR ABNORMAL
    1) WITH THERAPEUTIC USE
    a) Red-orange discoloration of urine and feces may commonly occur with therapeutic administration of rifapentine (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) ABNORMAL URINE
    1) WITH THERAPEUTIC USE
    a) The incidence of proteinuria, pyuria, urinary casts, and hematuria was 10% (36 of 361), 10.8% (39 of 361), 5.5% (20 of 361), and 10.8% (39 of 361), respectively, during the intensive phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) NEUTROPENIA
    1) WITH THERAPEUTIC USE
    a) Neutropenia was reported in 6.1% (22 of 361) of patients during the intensive phase and in 8.5% (27 of 304) patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) ANEMIA
    1) WITH THERAPEUTIC USE
    a) Anemia was reported in 11.4% (41 of 361) of patients during the intensive phase and in 1.6% (5 of 304) patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).
    C) LEUKOPENIA
    1) WITH THERAPEUTIC USE
    a) Leukopenia was reported in 4.4% (16 of 361) of patients during the intensive phase and in 3.5% (11 of 304) patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) ERUPTION
    1) WITH THERAPEUTIC USE
    a) Rash was observed in 4.2% (15 of 361) of patients during the intensive phase and 2.5% (8 of 304) of patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) ITCHING OF SKIN
    1) WITH THERAPEUTIC USE
    a) Pruritus was observed in 2.8% (10 of 361) of patients during the intensive phase and in 3 patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).
    C) DISCOLORATION OF SKIN
    1) WITH THERAPEUTIC USE
    a) Rifapentine can cause a red-orange discoloration of the skin (Prod Info PRIFTIN(R) oral tablets, 2010).

Musculoskeletal

    3.15.2) CLINICAL EFFECTS
    A) JOINT PAIN
    1) WITH THERAPEUTIC USE
    a) Arthralgia was reported in 3.6% (13 of 361) of patients during the intensive phase and in 3 patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).

Endocrine

    3.16.2) CLINICAL EFFECTS
    A) HYPOGLYCEMIA
    1) WITH THERAPEUTIC USE
    a) Hypoglycemia was reported in 6.1% (22 of 361) of patients during the intensive phase and 4.7% (15 of 304) of patients in the continuation phase of rifapentine therapy during clinical trials (Prod Info PRIFTIN(R) oral tablets, 2010).

Reproductive

    3.20.1) SUMMARY
    A) Rifapentine is classified as FDA pregnancy category C.
    3.20.2) TERATOGENICITY
    A) ANIMAL STUDIES
    1) CONGENITAL ANOMALY
    a) Animal studies have shown rifapentine to be teratogenic when administered at doses less than and similar to those used in humans (on basis of body surface area). Cleft palate, right aortic arch, increased incidence of delayed ossification, and increased number of ribs were seen in rat pups with oral doses of 40 mg/kg/day (0.6 times the human dose of 600 mg) given to mothers during organogenesis. Pup weights and gestational survival were reduced and resorptions and post-implantation losses were increased with oral doses of 20 mg/kg/day (0.3 times the human dose) given to mated female rats late in gestation. Rabbits displayed major malformations, including ovarian agenesis, pes varus, arhinia, microphthalmia and irregularities of ossified facial tissues with oral doses of 10 to 40 mg/kg (0.3 to 1.3 times the human dose) given to mothers. Increased post-implantation losses and stillborn pups also occurred with the 40-mg/kg dose (Prod Info PRIFTIN(R) oral tablets, 2014).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) Rifapentine is classified, by the manufacturer, as FDA pregnancy category C (Prod Info PRIFTIN(R) oral tablets, 2014).
    B) ABORTION
    1) Limited data from women who became pregnant while being treated with multiple anti-tuberculosis drugs, including rifapentine, clinical studies showed that the rate of spontaneous abortion following rifapentine exposure was not significantly increase over the background rate of spontaneous abortion in the general population. Of the 14 women who became pregnant during clinical studies, 6 delivered healthy infants, 4 had first-trimester spontaneous abortions (one of whom abused alcohol and another was HIV-infected), 1 had an elective abortion, and 3 patients had an unknown outcome. In a trial comparing rifapentine and isoniazid with isoniazid alone, 45 women (2.5%) in the rifapentine/isoniazid arm and 71 (4.1%) in the isoniazid arm became pregnant. Of the 46 total pregnancies in the rifapentine/isoniazid arm, 31 live births (21 healthy infants and 10 with no further details), 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes were reported. The rate of spontaneous abortion in the rifapentine/isoniazid arm (15%) was similar to that in the isoniazid arm (19%) and was not increased over the background rate of 15% to 20% (Prod Info PRIFTIN(R) oral tablets, 2014).
    C) HEMORRHAGE
    1) When rifampin (another rifamycin product) is given during the last several weeks of pregnancy, postnatal hemorrhages may occur in the mother and infant, and this may require vitamin K therapy. The same may occur with rifapentine. Pregnant women and neonates exposed to rifapentine during the last few weeks of pregnancy should have their prothrombin time monitored (Prod Info PRIFTIN(R) oral tablets, 2014).
    D) LACK OF EFFECT
    1) There are no adequate and well-controlled studies of rifapentine in pregnant women. However, limited data from women who became pregnant while being treated with multiple anti-tuberculosis drugs, including rifapentine, in clinical studies show that the rate of spontaneous abortion following rifapentine exposure is not a significant increase over the background rate of spontaneous abortion in the general population. Of the 14 women who became pregnant during clinical studies, six delivered healthy infants, four had first-trimester spontaneous abortions (one of whom abused alcohol and another was HIV-infected), one had an elective abortion, and 3 patients had an unknown outcome. In a trial comparing the rifapentine and isoniazid combination with isoniazid alone, 45 women (2.5%) in the rifapentine/isoniazid arm and 71 (4.1%) in the isoniazid arm became pregnant. Of the 46 total pregnancies in the rifapentine/isoniazid arm, 31 live births (21 healthy infants and 10 with no further details), 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes were reported. The rate of spontaneous abortion in the rifapentine/isoniazid arm (15%) was similar to that in the isoniazid arm (19%) and was not increased over the background rate of 15% to 20% (Prod Info PRIFTIN(R) oral tablets, 2014).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) It is not known whether rifapentine is excreted into human breast milk and the potential for adverse effects in the nursing infant from exposure to the drug are unknown. In animal studies, a slight increase in rat pup mortality occurred during lactation when dams were dosed late in gestation through lactation. Because many drugs are excreted in human milk and the potential for serious adverse reactions in nursing infants exists, it is recommended that either rifapentine or nursing be discontinued. There is potential for red-orange discoloration of breast milk due to maternal use of rifapentine (Prod Info PRIFTIN(R) oral tablets, 2014).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) Male and female rats that received oral rifapentine at doses up to 20 mg/kg/day (one-third of the human dose based on body surface area) were not adversely affected in terms of fertility or reproductive performance (Prod Info PRIFTIN(R) oral tablets, 2014).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS61379-65-5 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor CBC with differential and liver enzyme concentrations after significant overdose.
    B) Obtain a baseline urinalysis.
    C) Plasma rifapentine concentrations are not readily available and are not useful in guiding therapy.

Methods

    A) CHROMATOGRAPHY
    1) High-performance liquid chromatographic methods have been described for the determination of rifapentine and its metabolite, 25-desacetyl rifapentine, in human serum. The limit of determination was 0.2 mcg/mL(He et al, 1996; Riva et al, 1991).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients with persistent symptoms may need to be admitted for further treatment.
    6.3.1.2) HOME CRITERIA/ORAL
    A) An asymptomatic child that has a minor ingestion (1 tablet) can likely be managed at home with adult supervision. An asymptomatic adult or complaint of minor symptoms that has taken an extra dose or has taken rifapentine for several consecutive days inadvertently can likely be managed at home with telephone support.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Contact a medical toxicologist or Poison Center for assistance in managing patients with severe toxicity or in whom the diagnosis is unclear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Symptomatic patients and those with a deliberate self-harm ingestion should be evaluated in a healthcare facility and monitored until symptoms resolve. Patients may be discharged to home once symptoms have resolved and laboratory studies are within normal limits.

Monitoring

    A) Monitor CBC with differential and liver enzyme concentrations after significant overdose.
    B) Obtain a baseline urinalysis.
    C) Plasma rifapentine concentrations are not readily available and are not useful in guiding therapy.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) In case of rifapentine overdose, treatment should be symptomatic and supportive.
    2) Gastrointestinal symptoms (eg, nausea, vomiting, anorexia) may develop following a significant exposure; monitor fluid status and administer IV fluids as necessary.
    3) Hepatotoxicity has been associated with antituberculous therapy; monitor liver enzymes and assess for hepatic injury following a significant exposure until there is evidence of patient recovery.
    4) Monitor CBC with differential; repeat as indicated. Hematologic toxicity (ie, neutropenia, anemia) may develop following a significant exposure.
    B) MONITORING OF PATIENT
    1) Monitor CBC with differential and liver enzyme concentrations following a significant exposure.
    2) Obtain a baseline urinalysis in symptomatic patients.

Enhanced Elimination

    A) HEMODIALYSIS
    1) Rifapentine and its metabolite, 25-desacetyl rifapentine, are highly protein-bound. Enhanced elimination techniques, including hemodialysis or forced diuresis, are not expected to be of any benefit following an overdose (Prod Info PRIFTIN(R) oral tablets, 2010).

Range Of Toxicity

Summary

    A) TOXICITY: A minimum toxic dose has not been established. Single oral doses of 1200 mg have resulted in minor adverse effects including heartburn, headache, and increased urinary frequency.
    B) THERAPEUTIC: ADULT and CHILDREN 12 YEARS OF AGE AND OLDER: PULMONARY TUBERCULOSIS: INTENSIVE PHASE: 600 mg orally twice weekly for 2 months in combination with other antituberculosis drugs. CONTINUATION PHASE: 600 mg once weekly for 4 months in combination with isoniazid or another antituberculosis agent.

Therapeutic Dose

    7.2.1) ADULT
    A) ACTIVE TUBERCULOSIS
    1) INITIAL PHASE: 600 mg orally twice weekly for 2 months as directly observed therapy, with an interval of no less than 3 consecutive days (72 hours) between doses; given in combination with isoniazid or other antituberculosis agent (Prod Info PRIFTIN(R) oral tablets, 2014)
    2) CONTINUATION PHASE: 600 mg orally once a week for 4 months as directly observed therapy, given in combination with isoniazid or other antituberculosis agent (Prod Info PRIFTIN(R) oral tablets, 2014)
    B) LATENT TUBERCULOSIS
    1) ADULTS AND CHILDREN 12 YEARS AND OLDER: The recommended dose is based on weight of the patient: 300 mg (10 to 14 kg), 450 mg (14.1 to 25 kg), 600 mg (25.1 to 32 kg), 750 mg (32.1 to 50 kg), or 900 mg (greater than 50 kg) ORALLY once weekly (MAX 900 mg) in combination with isoniazid 15 mg/kg (rounded up to the nearest 50 or 100 mg; MAX, 900 mg) ORALLY once weekly for 12 weeks; give only as directly-observed-therapy (Prod Info PRIFTIN(R) oral tablets, 2014)
    C) INACTIVE TB IN HIV-INFECTED PATIENTS
    1) CDC GUIDELINE RECOMMENDATIONS: INACTIVE TB IN HIV-INFECTED PATIENTS: Isoniazid daily for 9 months is the drug of first choice for the prevention of active tuberculosis (TB) (ie, treatment of latent tuberculosis infection (LTBI)) in adults and adolescents with human immunodeficiency virus (HIV) who have no evidence of active infection and have: 1) a positive skin test but no history of treatment for TB, 2) a negative skin test for latent TB but are in close contact with a person with infectious pulmonary TB, or 3) a history of healed TB that was not treated or was inadequately treated (ie, old fibrotic lesions on chest radiography) (Centers for Disease Control and Prevention, 2011).
    a) DOSING: As an equal alternative to a 9-month isoniazid course for HIV-infected, nonpregnant adolescents (12 years and older) who are otherwise healthy and are not receiving antiretroviral therapy, the CDC recommends a combination regimen of isoniazid plus rifapentine orally once weekly (given as directly-observed-therapy) for 12 weeks. The isoniazid dose is 15 mg/kg (rounded up to the nearest 50 or 100 mg; maximum, 900 mg) and the rifapentine dose is as follows: 300 mg (10 to 14 kg), 450 mg (14.1 to 25 kg), 600 mg (25.1 to 32 kg), 750 mg (32.1 to 49.9 kg), or 900 mg (50 kg or greater). Due to lack of drug interaction data, this regimen is not recommended in HIV-infected patients receiving antiretroviral therapy (Centers for Disease Control and Prevention, 2011).
    7.2.2) PEDIATRIC
    A) ACTIVE TUBERCULOSIS
    1) INITIAL PHASE: 12 YEARS AND OLDER: 600 mg ORALLY twice weekly for 2 months as directly observed therapy, with an interval of no less than 3 consecutive days (72 hours) between doses; given in combination with isoniazid or other antituberculosis agents (Prod Info PRIFTIN(R) oral tablets, 2014).
    2) CONTINUATION PHASE: 12 YEARS AND OLDER: 600 mg ORALLY once a week for 4 months given in combination with isoniazid or other antituberculosis agent; give only as directly-observed-therapy (Prod Info PRIFTIN(R) oral tablets, 2014)
    3) Safety and efficacy in the infant population have not been established (Prod Info PRIFTIN(R) oral tablets, 2014).
    B) LATENT TUBERCULOSIS
    1) 12 YEARS AND OLDER: The recommended dose is based on weight of the patient: 300 mg (10 to 14 kg), 450 mg (14.1 to 25 kg), 600 mg (25.1 to 32 kg), 750 mg (32.1 to 50 kg), or 900 mg (greater than 50 kg) ORALLY once weekly (MAX 900 mg) in combination with isoniazid 15 mg/kg (rounded up to the nearest 50 or 100 mg; MAX, 900 mg) ORALLY once weekly for 12 weeks; give only as directly-observed-therapy (Prod Info PRIFTIN(R) oral tablets, 2014)
    2) 2 TO 11 YEARS: The recommended dose is based on weight of the patient: 300 mg (10 to 14 kg), 450 mg (14.1 to 25 kg), 600 mg (25.1 to 32 kg), 750 mg (32.1 to 50 kg), or 900 mg (greater than 50 kg) ORALLY once weekly (MAX 900 mg) in combination with isoniazid 25 mg/kg (rounded up to the nearest 50 or 100 mg; MAX, 900 mg) ORALLY once weekly for 12 weeks; give only as directly-observed-therapy (Prod Info PRIFTIN(R) oral tablets, 2014)
    3) Safety and efficacy in the infant population have not been established (Prod Info PRIFTIN(R) oral tablets, 2014).
    C) INACTIVE TB IN HIV-INFECTED PATIENTS
    1) CDC GUIDELINE RECOMMENDATIONS: INACTIVE TB IN HIV-INFECTED PATIENTS: Isoniazid daily for 9 months is the drug of first choice for the prevention of active tuberculosis (TB) (ie, treatment of latent tuberculosis infection (LTBI)) in adults and adolescents with human immunodeficiency virus (HIV) who have no evidence of active infection and have: 1) a positive skin test but no history of treatment for TB, 2) a negative skin test for latent TB but are in close contact with a person with infectious pulmonary TB, or 3) a history of healed TB that was not treated or was inadequately treated (ie, old fibrotic lesions on chest radiography) (Centers for Disease Control and Prevention, 2011).
    a) DOSING: As an equal alternative to a 9-month isoniazid course for HIV-infected, nonpregnant adolescents (12 years and older) who are otherwise healthy and are not receiving antiretroviral therapy, the CDC recommends a combination regimen of isoniazid plus rifapentine orally once weekly (given as directly-observed-therapy) for 12 weeks. The isoniazid dose is 15 mg/kg (rounded up to the nearest 50 or 100 mg; maximum, 900 mg) and the rifapentine dose is as follows: 300 mg (10 to 14 kg), 450 mg (14.1 to 25 kg), 600 mg (25.1 to 32 kg), 750 mg (32.1 to 49.9 kg), or 900 mg (50 kg or greater). Due to lack of drug interaction data, this regimen is not recommended in HIV-infected patients receiving antiretroviral therapy (Centers for Disease Control and Prevention, 2011).

Minimum Lethal Exposure

    A) A minimum lethal dose has not been established.

Maximum Tolerated Exposure

    A) Minor adverse effects, including heartburn, headache, and increased urinary frequency, have been reported following 1200 mg rifapentine as a single oral dose (Prod Info PRIFTIN(R) oral tablets, 2010).

Workplace Standards

    A) ACGIH TLV Values for CAS61379-65-5 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS61379-65-5 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS61379-65-5 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS61379-65-5 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (INTRAPERITONEAL)MOUSE:
    1) 710 mg/kg (RTECS, 2003)
    B) LD50- (ORAL)MOUSE:
    1) 3300 mg/kg (RTECS, 2003)
    C) LD50- (INTRAPERITONEAL)RAT:
    1) Greater than 2 g/kg (RTECS, 2003)
    D) LD50- (ORAL)RAT:
    1) Greater than 4 g/kg (RTECS, 2003)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Rifapentine, an antimycobacterial agent, is a cyclopentyl rifamycin derivative (Prod Info PRIFTIN(R) oral tablets, 2010; Grassi & Peona, 1995; Varaldo et al, 1985; Easmon & Crane, 1984). Rifapentine inhibits DNA-dependent RNA polymerase in susceptible Mycobacterium tuberculosis strains, but not in mammalian cells (Prod Info PRIFTIN(R) oral tablets, 2010).
    B) Rifapentine exhibits bactericidal activity against both intracellular and extracellular Mycobacterium tuberculosis organisms at therapeutic levels. Accumulates in human monocyte-derived macrophages with intracellular/extracellular ratios of approximately 24:1 for rifapentine and 7:1 for its 25-desacetyl metabolite (Prod Info PRIFTIN(R) oral tablets, 2010).

Physicochemical

Molecular Weight

    A) 877.04 (Prod Info Priftin(R) , 2002)

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