FDA News

FDA updates Complera label for use in children aged older than 12 years

The FDA recently updated the label indication for Complera, expanding the patient population to include children aged 12 to 18 years, according to a news release.

For children aged older than 12 years who weigh at least 35 kg, the recommended dose of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate, Gilead Sciences; FTC/RPV/TDF) is one tablet taken orally once per day with food. Tablets contain 200 mg Emtriva (emtricitabine, Gilead Sciences), 25 mg Edurant (rilpivirine, Janssen Therapeutics) and 300 mg Viread (tenofovir disoproxil fumarate, Gilead Sciences).

According to the release, pediatric clinical trials of fixed-dose FTC/RPV/TDF have not been conducted. The updated warnings and precautions label indication is based on trials of the individual tablet components. These included updates to include information on potential depressive disorder side effects. In a phase 2 trial of rilpivirine with a cohort of children (n = 36) aged 12 to 18 years, 19.4% experienced a depressive disorder; most of these events were mild to moderate. Grade 3 and 4 depressive disorders, however, were recorded in 5.6% of the cohort. No study participants discontinued rilpivirine due to depressive symptoms.

Information regarding clinical trial experience in pediatric subjects also was added to the label indication. According to the release, 7% of pediatric participants in a larger emtricitabine trial (n = 116) experienced anemia, and 32% experienced hyperpigmentation. In addition, pediatric patients in a phase 2 rilpivirine trial did not experience any additional adverse events not observed in adult patients. The most common adverse events reported in this trial were headache, depression, somnolence, nausea, dizziness, abdominal pain, vomiting and rash.

Other updates were made to the label for consistency with rilpivirine.

The FDA recently updated the label indication for Complera, expanding the patient population to include children aged 12 to 18 years, according to a news release.

For children aged older than 12 years who weigh at least 35 kg, the recommended dose of Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate, Gilead Sciences; FTC/RPV/TDF) is one tablet taken orally once per day with food. Tablets contain 200 mg Emtriva (emtricitabine, Gilead Sciences), 25 mg Edurant (rilpivirine, Janssen Therapeutics) and 300 mg Viread (tenofovir disoproxil fumarate, Gilead Sciences).

According to the release, pediatric clinical trials of fixed-dose FTC/RPV/TDF have not been conducted. The updated warnings and precautions label indication is based on trials of the individual tablet components. These included updates to include information on potential depressive disorder side effects. In a phase 2 trial of rilpivirine with a cohort of children (n = 36) aged 12 to 18 years, 19.4% experienced a depressive disorder; most of these events were mild to moderate. Grade 3 and 4 depressive disorders, however, were recorded in 5.6% of the cohort. No study participants discontinued rilpivirine due to depressive symptoms.

Information regarding clinical trial experience in pediatric subjects also was added to the label indication. According to the release, 7% of pediatric participants in a larger emtricitabine trial (n = 116) experienced anemia, and 32% experienced hyperpigmentation. In addition, pediatric patients in a phase 2 rilpivirine trial did not experience any additional adverse events not observed in adult patients. The most common adverse events reported in this trial were headache, depression, somnolence, nausea, dizziness, abdominal pain, vomiting and rash.

Other updates were made to the label for consistency with rilpivirine.