Rifapentine

DEA Class; Rx

Common Brand Names; Priftin

  • Antitubercular Agents

Oral cyclopentyl rifamycin antimycobacterial drug
Used for treatment of active pulmonary tuberculosis (TB) in combination with 1 or more anti-TB drugs and treatment of latent TB infection in patients at high risk of progression to TB disease
Hepatotoxicity and drug-drug interactions may limit use

Indicated for treatment of pulmonary TB caused by Mycobacterium tuberculosis in combination with 1 or more antituberculosis drugs
Indicated for treatment of latent TB infection caused by M. tuberculosis in adults and children aged ≥2 yr at high risk of progression to TB disease (including those in close contact with active TB patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph)

Limitations of use

  • Active TB disease should be ruled out before initiating
  • Must always be used in combination with isoniazid as a 12-wk once-weekly regimen
  • Rifapentine in combination with isoniazid is not recommended for rifamycin or isoniazid resistant M tuberculosis

Treatment of Mycobacterium avium complex (MAC) in patients with AIDS

Hypersensitivity to rifamycins

  • Hyperuricemia (most likely d/t pyrazinamide from initial phase combo Tx)
  • Hypertension
  • Headache
  • Dizziness
  • Rash
  • Pruritus
  • Acne
  • Anorexia
  • Nausea/vomiting
  • Dyspepsia
  • Diarrhea
  • Neutropenia
  • Lymphopenia
  • Anemia
  • Leukopenia
  • Thrombocytosis
  • Increased ALT/AST
  • Arthralgia
  • Pain
  • Pyuria
  • Proteinuria
  • Hematuria
  • Urinary casts
  • Hemoptysis

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 treatment regimens in patients with active and latent tuberculosis; discontinue therapy at first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity

May increase liver enzymes; initiation in patients with existing abnormal liver tests and/or liver disease only in cases of necessity and under strict medical supervision; monitor LFTs every 2-4 week and discontinue if evidence of liver injury occurs

Hypersensitivity or anaphylaxis reported including hypotension, urticaria, angioedema, acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia, or flu-like syndrome

Not for use as initial phase treatment in HIV-infected individuals with active pulmonary TB

Higher relapse rate may occur in patients with cavitary pulmonary lesions and/or positive sputum cultures after the initial phase of active TB treatment, and in patients with bilateral pulmonary disease

Induces CYP450 isoenzymes; coadministration with drugs metabolized by these enzymes (eg, protease inhibitors, certain NRTIs, hormonal contraception) may result in significant decreased plasma concentrations and loss of therapeutic effect

May produce a red-orange discoloration of body tissues/fluids (eg, skin, teeth, tongue, urine, feces, saliva, sputum, tears, sweat, CSF); contact lenses or dentures may become permanently stained

No adequate and well-controlled studies have been performed in pregnant women

There are limited pregnancy outcome data reported from women enrolled in clinical trials of various rifapentine treatment regimens for active tuberculosis and latent tuberculosis infection

Unknown if excreted in human milk

May produce a red-orange discoloration of body fluids; potential for discoloration of breast milk

Adults

600 mg PO twice weekly is the FDA-approved maximum dosage for active tuberculosis infection treatment. Maximum dosages are delineated by weight for latent tuberculosis infection.
Weighing 50 kg or more: 900 mg/dose PO.
Weighing 32.1 to 49.9 kg: 750 mg/dose PO.

Geriatric

600 mg PO twice weekly is the FDA-approved maximum dosage for active tuberculosis infection treatment. Maximum dosages are delineated by weight for latent tuberculosis infection.
Weighing 50 kg or more: 900 mg/dose PO.
Weighing 32.1 to 49.9 kg: 750 mg/dose PO.

Adolescents

600 mg PO twice weekly is the FDA-approved maximum dosage for active tuberculosis infection treatment. Maximum dosages are delineated by weight for latent tuberculosis infection.
Weighing 50 kg or more: 900 mg/dose PO.
Weighing 32.1 to 49.9 kg: 750 mg/dose PO.
Weighing 25.1 to 32 kg: 600 mg/dose PO.

Children

Maximum dosages are delineated by weight for latent tuberculosis infection.
2 to 12 years weighing 50 kg or more: 900 mg/dose PO.
2 to 12 years weighing 32.1 to 49.9 kg: 750 mg/dose PO.
2 to 12 years weighing 25.1 to 32 kg: 600 mg/dose PO.
2 to 12 years weighing 14.1 to 25 kg: 450 mg/dose PO.
2 to 12 years weighing 10 to 14 kg: 300 mg/dose PO.
2 to 12 years weighing less than 10 kg: Safety and efficacy have not been established.
1 year: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Rifapentine

tablet

  • 150mg

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