The most common adverse reactions (incidence ≥2%, Grades 2-4) in treatment-naïve adults receiving TIVICAY in a combination regimen were insomnia (3%), headache (2%), and fatigue (2%) If a patient switches from one formulation to the other, the dose must be adjusted TIVICAY and TIVICAY PD are not bioequivalent and are not interchangeable on a milligram-per-milligram basis. Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of dolutegravirĭifferent Formulations Are Not Interchangeable: Adolescents and adults of childbearing potential should be counseled on the consistent use of effective contraceptionĪdverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of dolutegravir and other drugs may occur (see Contraindications and Drug Interactions) Pregnancy testing is recommended before use of TIVICAY or TIVICAY PD.Assess the risks and benefits of TIVICAY and TIVICAY PD 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reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of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 dolutegravir.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
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |