jueves, 23 de noviembre de 2017

FDA Approves Changes to the TRIUMEQ Label

U.S. Food and Drug Administration Header

November 21, 2017

The TRIUMEQ (abacavir, dolutegravir, and lamivudine) label was updated to include the following changes to:
  • expand the patient population to include treatment of HIV-1 infection in patients weighing at least 40 kg.
  • add hepatoxicity and risk of adverse reactions or loss of virologic response due to drug interactions information to WARNINGS AND PRECAUTIONS.
Hepatic adverse events have been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TRIUMEQ [see Adverse Reactions (6.1)]. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Cases of hepatic toxicity including elevated serum liver biochemistries, hepatitis, and acute liver failure have also been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ. Monitoring for hepatotoxicity is recommended.
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
The concomitant use of TRIUMEQ and other drugs may result in known or potentially significant drug interactions, some of which may lead to:
  • loss of therapeutic effect of TRIUMEQ and possible development of resistance.
  • possible clinically significant adverse reactions from greater exposures of concomitant drugs.
See Table 5 in the label for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during therapy with TRIUMEQ; review concomitant medications during therapy with TRIUMEQ; and monitor for the adverse reactions associated with the concomitant drugs.
  • update the ADVERSE REACTIONS, CLINICAL PHARMACOLOGY and Clinical Studies sections to include data in pediatric patients.
  • revise the USE IN SPECIFIC POPULATIONS section based upon the Pregnancy and Lactation Labeling Rule (PLLR) requirements.
  • update Medication Guide to be consistent with the Prescribing Information.
The updated label will soon be available at drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Visit the FDA Patient Network for more Information about the HIV Liaison Program 

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