FDA Updates Labeling for Dolutegravir/Rilpivirine
Juluca should be taken 4 hours before or 6 hours after taking calcium or iron supplements.
The Food and Drug Administration (FDA) has approved an update to the labeling for Juluc (dolutegravir/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.
Juluca® [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2017.