Priftin

Priftin Warnings

rifapentine

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Warnings
Hepatotoxicity: Antitubercular multidrug treatments including the rifamycin class may cause serious hepatic reactions. Patients with abnormal liver tests and/or liver disease should only be given Priftin if absolutely necessary, and then with caution and under strict medical supervision.
In such patients, careful monitoring of liver parameters (especially serum transaminases and bilirubin) should be carried out prior to therapy and then every 2 to 4 weeks during therapy. If there are indications of a liver reaction or of the hepatic condition worsening, Priftin should be discontinued. Hepatotoxicity of other antituberculosis drugs (e.g., isoniazid, pyrazinamide) used in combination with rifapentine should also be taken into account.
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) (see Adverse Reactions).
Monitor patients receiving Priftin therapy for signs and/or symptoms of hypersensitivity reactions. If these symptoms occur, administer supportive measures and discontinue Priftin.
Drug interactions: Rifapentine is an inducer of CYP3A4 and CYP2C8/9. 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 (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Rifapentine has also been shown to inhibit and to induce P-gp which could modify plasma exposure of digoxin (a P-gp substrate with narrow therapeutic index). Appropriate monitoring and dose adjustment of digoxin may be necessary in case of co-administration with rifapentine (see Interactions and Pharmacology: Pharmacokinetics under Actions).
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