Triumeq FDA Approval History
FDA Approved: Yes (First approved August 22, 2014)
Brand name: Triumeq
Generic name: abacavir, dolutegravir and lamivudine
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection
Triumeq (abacavir, dolutegravir and lamivudine) is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine for the treatment of HIV-1 infection.
- Triumeq works by interfering with the action of two enzymes (reverse transcriptase and integrase) to prevent the virus from replicating and further infecting cells.
- Triumeq is administered once a day.
- Triumeq tablets (abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg) are indicated for the treatment of HIV-1 infection in adults.
- Triumeq PD tablets for oral suspension (abacavir 60 mg, dolutegravir 5 mg, and of lamivudine 30 mg) are indicated for the treatment of HIV-1 infection in pediatric patients weighing at least 10 kg.
- The Triumeq product label carries a boxed warning for serious hypersensitivity reactions and exacerbations of hepatitis B virus (HBV). Triumeq is associated with the following warnings and precautions: hepatotoxicity; lactic acidosis and severe hepatomegaly with steatosis; embryo-fetal toxicity; and immune reconstitution syndrome.
- Common adverse reactions include insomnia, headache, and fatigue.
Development timeline for Triumeq
Further information
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