Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was updated

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Title: Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was updated

The Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was updated with drug-drug interaction information.

Section 7 Drug Interactions was updated to include a statement that in vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. Additionally, the following information was added to section 7.

Additionally, the TRIUMEQ label, section 6.1 Less Common Adverse Reactions Observed in Clinical Trials section was updated to be consistent with the TIVICAY label as follows: Psychiatric: Suicidal ideation, attempt, behavior, or completion. These events were observed primarily in subjects with a pre-existing history of depression or other psychiatric illness.

You can view the complete label at drugs@fda or dailymed.

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

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