On August 22, 2014, FDA approved a new fixed-dose combination product: TRIUMEQ, a combination of dolutegravir (integrase strand transfer inhibitor), abacavir sulfate and lamivudine (both nucleoside analogue reverse transcriptase inhibitors) for the treatment of HIV-1 infection.
- TRIUMEQ alone is not recommended for use in patients with current or past history of resistance to any components of TRIUMEQ.
- TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. See full prescribing information for dolutegravir.
The recommended dosage regimen of TRIUMEQ in adults is one tablet once daily orally with or without food.
TRIUMEQ is contraindicated in patients:
- who have the HLA-B*5701 allele.
- with previous hypersensitivity reaction to abacavir. Before starting TRIUMEQ, review medical history for prior exposure to any abacavir-containing product. NEVER restart TRIUMEQ or any other abacavir containing product following a hypersensitivity reaction to abacavir, regardless of HLA B*5701 status.
- with previous hypersensitivity reaction to dolutegravir or lamivudine.
- receiving dofetilide, due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir.
- with moderate or severe hepatic impairment .
The complete label can be viewed at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
