EATG » Juluca labeling updated to correct dosing separation information

Juluca labeling updated to correct dosing separation information

The Food and Drug Administration (FDA) has approved an update to the labeling for Juluca (dolutegrair/rilpivirine; Janssen) to correct dosing separation between Juluca and oral calcium and iron supplements.

The update now states that Juluca and calcium- or iron-containing supplements (including multivitamins containing calcium or iron) should be administered together with a meal or Juluca should be taken 4 hours before or 6 hours after taking the supplements.

Juluca, approved by the FDA in November 2017, is a combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). It was approved as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Juluca is available as 50mg/25mg fixed-dose tablets in 30-count bottles.

By Da Hee Han

News categories: HIV treatment, EMA/FDA