In quarter 2 2020, a notice was sent that a nitrosamine impurity, 1-cyclopentyl-4-nitrosopiperazine (CPNP), detected in Priftin® 150mg tablets manufactured by Sanofi. At that time, health care professionals treating patients with latent tuberculosis infections were advised not to begin new patients on Priftin® until further notice. Since then, a benefit-risk assessment was conducted and batches of Priftin® over the limit was removed.
The CPNP impurity levels range from 12 ppm to 25 ppm. These levels exceed the acceptable concentration limit of 0.11 ppm. At WHO PQT request, Sanofi has committed to test lots prior to release and to further test lots currently on the market. The interim limit of ≤20 ppm at release, and ≤ 25 ppm at the end of shelf life, is in effect until Sanofi can reduce CPNP in Priftin to within the acceptable limit of ≤ 0.11 ppm. The IMPAACT4TB Consortium has put measures in place to monitor progress closely and expects Sanofi to make every necessary effort to reduce the level of the impurity to at, or below, the acceptable concentration limit of 0.11 ppm as soon as possible.
Rifapentine API impurity ADULTS
Rifapentine API impurity Pediatric