Priftin

Priftin Adverse Reactions

rifapentine

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
The following CIOMS frequency rating is used, when applicable: Very common ≥ 10%; Common ≥ 1 and < 10%; Uncommon ≥ 0.1 and < 1%; Rare ≥ 0.01 and < 0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).
Clinical trials experience: The safety profile of rifapentine in combination with isoniazid given once-weekly is based on the study TBTC-S26. In this study, rifapentine in combination with isoniazid given once-weekly for 3 months (3RPT/INH ) was compared to isoniazid given once daily for 9 months (9INH) in an open-label, randomized trial in patients with a positive tuberculin skin test, and at high risk for progression from latent tuberculosis infection to active tuberculosis disease.
A total of 4040 patients received at least one dose of the 3RPT/INH regimen, including 348 children 2 - 17 years of age and 105 HIV-infected individuals. A total of 3759 received at least one dose of the 9INH regimen, including 342 children 2 years - 17 years of age and 95 HIV-infected individuals.
Patients were followed for 33 months from the time of enrollment (see Pharmacology: Pharmacodynamics under Actions). (See Table 8.)

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The following adverse drug reactions were reported in less than 3 patients (frequency: rare): pancreatitis, oesophageal irritation, pneumonia.
Pediatric population: Six-hundred and ninety children 2 years - 17 years of age received at least one dose of study drugs in the main study. An additional 342 children 2 years - 17 years of age received at least one dose in the pediatric extension study (total 1032 children; 539 received 3RPT/INH and 493 received 9INH).
No children in either treatment arm developed hepatotoxicity. Children in the 3RPT/INH group experienced less rifamycin hypersensitivity reaction (7 (1.3%)) than adults. Adverse reactions in children 2 years - 11 years of age and 12 years - 17 years of age were similar.
HIV population: Two-hundred HIV-infected patients with latent tuberculosis infection received at least one dose of study drugs in the main study and an additional 193 patients received at least one dose in the extension study (total of 393; 207 received 3RPT/INH and 186 received 9INH). Compared to the HIV-negative patients enrolled in the main study, a higher proportion of HIV-infected patients in each treatment arm experienced a treatment emergent adverse reaction, including a higher incidence of hepatotoxicity. Hepatotoxicity occurred less frequently in patients in the 3RPT/INH arm (3/207 (1.5%)) than in the 9INH arm (14/186 (7.5%)).
Rifamycin hypersensitivity occurred in only one HIV-infected patient in 3RPT/INH arm.
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