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.

• If TIVICAY is used with carbamazepine adjust dose of TIVICAY to 50 mg twice daily in treatment-naïve or treatment-experienced, INSTI-naïve patients. Use alternative treatment that does not include carbamazepine where possible for INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance.

• If TRIUMEQ is used with carbamazepine adjust dolutegravir dose to 50 mg twice daily. An additional dolutegravir 50 mg dose (TIVICAY 50 mg) should be taken, separated by 12 hours from TRIUMEQ

• When TIVICAY is used with metformin, limit the total daily dose of metformin to 1,000 mg either when starting metformin or TIVICAY. When stopping TIVICAY, the metformin dose may require an adjustment. Monitoring of blood glucose when initiating concomitant use and after withdrawal of TIVICAY is recommended.

• When TRIUMEQ is used with metformin, limit the total daily dose of metformin to 1,000 mg either when starting metformin or TRIUMEQ. When stopping TRIUMEQ, the metformin dose may require an adjustment. Monitoring of blood glucose when initiating concomitant use and after withdrawal of TIVICAY is recommended.

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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