Rifapentine - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor for symptoms of liver injury and discontinue PRIFTIN if signs or symptoms or liver injury occur.

Hypersensitivity: Discontinue PRIFTIN if signs or symptoms of hypersensitivity reaction occur.

Severe cutaneous adverse reactions: Discontinue PRIFTIN at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

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 ) Paradoxical Drug Reactions: If worsening of symptoms or signs occur during antimycobacterial treatment, consider paradoxical drug reaction in the differential diagnosis, and monitor or treat accordingly.

Drug Interactions: May interact with drugs metabolized by CYP450. ( 5.6 , 7.1 , 7.4 ) Discoloration of body fluids: May permanently stain contact lenses or dentures red-orange.

Clostridioides difficile –associated diarrhea: Evaluate if diarrhea occurs.

Porphyria: Avoid use in patients with porphyria.

5.1 Hepatotoxicity Elevations of liver transaminases may occur in patients receiving PRIFTIN [see Adverse Reactions ] .

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.

5.2 Hypersensitivity 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 ] .

Monitor patients receiving PRIFTIN therapy for signs and/or symptoms of hypersensitivity reactions.

If these symptoms occur, administer supportive measures and discontinue PRIFTIN.

5.3 Severe 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 ] .

5.4 Relapse 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 ] .

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 ] .

Poor adherence to therapy is associated with high relapse rate.