Risks and Side Effects

Contraindications:

  • Do not use TIVICAY in patients with previous hypersensitivity reaction to dolutegravir
  • Do not use TIVICAY in patients receiving dofetilide

Hypersensitivity Reactions:

  • Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
  • Discontinue TIVICAY immediately if signs or symptoms of hypersensitivity reaction develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

  • 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
  • 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 TIVICAY. 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reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Monitoring for hepatotoxicity is recommended

Embryofetal Toxicity:

  • Avoid use of TIVICAY at the time of conception through the first trimester due to the risk of neural tube defects
  • Perform pregnancy testing before use of TIVICAY and advise that consistent use of effective contraception is recommended while using TIVICAY in adolescents and adults of childbearing potential

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

The concomitant use of TIVICAY and other drugs may result in known or potentially significant drug interactions (see Contraindications or Drug Interactions)

Immune Reconstitution Syndrome

, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of TIVICAY.

SINGLE, SPRING-2, and FLAMINGO—Grades 2 to 4 treatment-emergent adverse drug reactions (≥2% frequency)1

Grade 1 insomnia rates:

  • 7% and 4% in patients receiving TIVICAY and efavirenz/TDF/FTC, respectively
  • These events were not treatment limiting

*Includes pooled terms: rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and drug eruption.

Grade 1 insomnia rates:

  • 1% and <1% in patients receiving TIVICAY and raltegravir, respectively
  • These events were not treatment limiting

*Includes pooled terms: rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and drug eruption.

Grade 1 insomnia rates:

  • 1% and 2% in patients receiving TIVICAY and darunavir/ritonavir, respectively1
  • These events were not treatment limiting

*Includes pooled terms: rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and drug eruption.

* Includes pooled terms: rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and drug eruption.

SAILING—Grades 2 to 4 treatment-emergent adverse drug reactions

  • At 48 weeks, the only treatment-emergent adverse drug reaction of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in patients receiving TIVICAY 50 mg once daily + BR and 1% (5 of 361) in patients receiving raltegravir 400 mg twice daily + BR

BR was investigator selected and consisted of up to 2 agents including at least 1 fully active agent.

BR=background regimen.


  • Direct comparisons across trials should not be made due to differing trial designs

Please see full Prescribing Information for TIVICAY.

Reference

  1. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.