Today, the U.S. Food and Drug Administration approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments.
The most common adverse reactions observed in adult patients treated with Tivicay are insomnia, fatigue and headache. Patients with a hypersensitivity to dolutegravir should not take Tivicay or Tivicay PD. Tivicay and Tivicay PD should not be administered with dofetilide. Some patients reported hypersensitivity reactions such as rash and organ dysfunction. Patients should discontinue Tivicay or Tivicay PD if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Patients taking dolutegravir regimens have reported liver toxicity. Patients with underlying hepatitis B or C may be at increased risk for worsening or elevated liver enzyme levels and should be monitored. Patients in the first trimester of pregnancy should consider an alternative treatment to dolutegravir due to the risk of neural tube defects and should be counseled about using effective contraception. Immune reconstitution inflammatory syndrome (IRIS), where the immune system begins to recover but then responds to a previously acquired infection with an inflammatory response that unexpectedly makes symptoms of the infection worse, has been reported in patients treated with combination antiretroviral therapy, including Tivicay and Tivicay PD. Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable for one another on a milligram per milligram basis.
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