Dolutegravir

Hypersensitivity reactions reported; characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury (see Contraindications)

Hepatic adverse events reported; patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations; in some cases, transaminase elevations were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where antihepatitis therapy was withdrawn

Hepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure reported without pre-existing hepatic disease or other identifiable risk factors; drug-induced liver injury leading to liver transplant reported; monitoring for hepatotoxicity recommended

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy; may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis) or autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome)

Dosage forms (ie, tablets and tablets for oral suspension) are not bioequivalent and are not interchangeable on a mg-per-mg basis; if a pediatric patient switches from one formulation to the other, the dose must be adjusted for the new dosage formulation; incorrect dosing of a given formulation may result in underdosing and loss of therapeutic effect and possible resistance or clinically significant adverse reactions from greater exposure of dolutegravir

Dosage forms are not interchangeable on a milligram per milligram basis; dose must be adjusted for new dosage formulation; incorrect dosing may lead to loss of therapeutic effect when underdosing and clinically significant adverse reactions when overdosing