Dutrebis™ (Lamivudine/Raltegravir) — New Drug Approval

Dutrebis™ (lamivudine/raltegravir) — New Drug Approval

• On February 6, 2015, the FDA approved Merck’s Dutrebis (lamivudine/raltegravir) for combination use with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV- 1) infection.

• Dutrebis is a fixed-dose combination product, containing a nucleoside reverse transcriptase inhibitor (lamivudine) and an HIV-1 integrase strand transfer inhibitor (raltegravir).

— Other combination products containing lamivudine include Combivir® (lamivudine/zidovudine), Epzicom® (abacavir/lamivudine), Triumeq® (abacavir/dolutegravir/lamivudine), and Trizivir® (abacavir/lamivudine/zidovudine).

— Raltegravir is also available as a non-combination product, Isentress®.

• Clinical trials have not been specifically performed with Dutrebis. The indication of Dutrebis is based on efficacy and safety data demonstrated in clinical trials with the individual components, lamivudine and raltegravir.

• Dutrebis carries a boxed warning regarding the risk of lactic acidosis/severe hepatomegaly and post-treatment exacerbations of hepatitis B in co-infected patients.

• Other warnings and precautions of Dutrebis include pancreatitis, hepatic decompensation when used with interferon- and ribavirin-based regimens, severe skin and hypersensitivity reactions, immune reconstitution syndrome, fat redistribution, and antiretrovirals not recommended.

• The most common adverse events (≥ 15%) with lamivudine use in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. The most common reported adverse reactions (≥15%) in pediatric patients were fever and cough.

• The most common adverse events of moderate to severe intensity (≥ 2%) with raltegravir use were insomnia, headache, dizziness, nausea and fatigue. Creatine kinase elevations were observed in subjects who received raltegravir. Myopathy and rhabdomyolysis have been reported.

• In patients ≥ 16 years of age and pediatric patients 6 through 16 years of age weighing ≥ 30 kg, the recommended dose of Dutrebis is 150 mg lamivudine/300 mg raltegravir orally twice daily.

— Dutrebis should be administered in conjunction with other antiretroviral agents.

• According to Merck, Dutrebis will not be commercially available in the U.S. at this time. Dutrebis is a tablet containing 150 mg of lamivudine and 300 mg of raltegravir.

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