Lactic Acidosis and Severe Hepatomegaly With Steatosis:įatal cases have been reported with the use of nucleoside analogs, including lamivudine. Individuals of childbearing potential should be counseled on the consistent use of effective contraception Pregnancy testing is recommended before initiation of DOVATO.Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects.Monitoring for hepatotoxicity is recommended.In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO.Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors.Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction.Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury.Do not use DOVATO in patients receiving dofetilide.Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine.Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV otherwise, consider an alternative regimen. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBVĪll patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO.
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