PRIFTIN®: Part of the 12-Dose Regimen to Treat Latent TB Infection (LTBI)
The combination regimen of PRIFTIN® (rifapentine) and isoniazid (INH) consists of 3 months of 12 weekly doses of isoniazid (H) and PRIFTIN (rifapentine) (P) administered by directly observed therapy (designated as 3RPT/INH), also known as 3HP. It is indicated for the treatment of LTBI in people at high risk of progression to TB disease.1
PRIFTIN® – Used in a 3 Month Regimen for LTBI Treatment
In 2014, the Food and Drug Administration approved PRIFTIN® (rifapentine) in combination with the antibiotic isoniazid (INH) as directly observed therapy for the treatment of latent TB infection in people 2 years of age and older at high risk of progression to TB disease.2
LTBI – The Importance of Tackling Latent TB Infection
In the US, up to 13 million people have latent TB infection (LTBI), meaning they are infected with TB bacteria that is inactive.3 Although people with LTBI cannot spread TB to others, the bacteria can become active, multiply and turn into TB disease. In fact, 80 percent of TB diagnoses in the US are linked to individuals who lived for years with untreated latent TB infection.3 This is why the World Health Organization (WHO)4 and Centers for Disease Control and Prevention (CDC)5 recommend treating LTBI in people at high risk of progression to TB disease, including those with HIV.
Important Safety Information for PRIFTIN® (rifapentine)
Priftin is contraindicated in patients with a history of hypersensitivity to rifamycins.
Elevations of liver transaminases may occur in patients receiving Priftin. Patients should be monitored for symptoms of liver injury. Patients with abnormal liver function 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. Discontinue Priftin if evidence of liver injury occurs.
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. There have been reports of anaphylaxis. Monitor patients for signs and/or symptoms of hypersensitivity reactions. If these symptoms occur, administer supportive measures and discontinue Priftin.
Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome 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.
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 relapse in these patients.
Rifapentine is an inducer of Cytochrome P450 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 plasma concentrations and loss of therapeutic effect of these drugs. Dosage adjustment of the drugs may be necessary.
Priftin may produce a red-orange discoloration of body tissues and/or fluids and may permanently stain contact lenses or dentures red-orange.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with the use of nearly all systemic antibacterial agents, including Priftin, with severity ranging from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibacterial use. If CDAD is suspected or confirmed, discontinue antibacterial use not directed against C. difficile if possible and institute appropriate treatment measures.
Avoid the use of Priftin in patients with porphyria.
In Priftin studies, the most common adverse reactions with the regimen for active pulmonary tuberculosis (≥3%) are anemia, lymphopenia, hemoptyis, 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%) with the regimen for latent tuberculosis infection is hypersensitivity reaction.
Indications
Active Pulmonary Tuberculosis
Priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis. Priftin must always be used in combination with one or more antituberculosis drugs to which the isolate is susceptible.
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-resistant organisms.
- Priftin has not been studied as part of the initial phase treatment regimen in HIV-infected patients with active pulmonary tuberculosis.
Latent 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).
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 INH as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection. Priftin in combination with INH is not recommended for Individuals presumed to be exposed to rifamycin- or - INH resistant M. tuberculosis.
Read Full Prescribing Information for PRIFTIN (rifapentine)
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