Rilpivirine Dosing Information Updated for Pregnant Women With HIV
No new safety findings were observed vs the known safety profile of rilpivirine in HIV-1 infected adults.
The prescribing information for Edurant (rilpivirine; Janssen) has been updated to include dosing recommendations for pregnant women who are already on a stable Edurant regimen prior to getting pregnant and who are virologically suppressed (HIV-1 RNA <50 copies/mL).
The Dosage and Administration section states that for these pregnant patients, one 25mg tablet once daily with a meal is recommended. Viral load should be monitored closely as lower exposures of rilpivirine have been observed during pregnancy.
The Pregnancy subsection under Use in Specific Populations now states that no dose adjustments are needed for pregnant patients who are already on a stable Edurant regimen prior to pregnancy and who are virologically suppressed.
This was based on the data involving HIV-1 infected pregnant women who completed a clinical trial during the postpartum period with a rilpivirine-based regimen. Prospective reports of more than 390 exposures to rilpivirine during pregnancy resulting in live births indicated no significant difference between the overall risk of birth defects with rilpivirine (1st trimester: 1.2%, 2nd/3rd trimester: 1.4%) vs the background birth defect rate (2.7%) in the US reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).
Moreover, a clinical study (N=19) evaluated rilpivirine + background regimen in HIV-1 infected pregnant women during the 2nd/3rd trimesters and postpartum. The data indicated exposure (C0h and AUC) of total rilpivirine was approximately 30–40% lower during pregnancy vs postpartum (6–12 weeks). No new safety findings were observed vs the known safety profile of rilpivirine in HIV-1 infected adults.
Edurant, an HIV-1 specific non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive patients aged ≥12 years weighing ≥35kg with HIV-1 RNA ≤100,000 copies/mL.
Edurant is available as 25mg strength tablets in 30-count bottles.