FDA Updates Labeling for Dolutegravir/Rilpivirine

Prescription pills
Prescription pills
The FDA has updated labeling for Juluca to correct dosing separation between Juluca and oral calcium and 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.

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Reference

Juluca® [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2017.

This article originally appeared on MPR