Risks and Side Effects

BOXED WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS B VIRUS (HBV):

Hypersensitivity Reactions:

  • Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir-containing products
  • Hypersensitivity to abacavir is a multi-organ clinical syndrome
  • Patients who carry the HLA‐B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA‐B*5701 allele
  • TRIUMEQ is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA‐B*5701-positive patients. All patients should be screened for the HLA‐B*5701 allele prior to initiating therapy or reinitiation of therapy with TRIUMEQ, unless patients have a previously documented HLA‐B*5701 allele assessment
  • Discontinue TRIUMEQ as soon as hypersensitivity reaction is suspected. Regardless of HLA‐B*5701 status, permanently discontinue TRIUMEQ if hypersensitivity cannot be ruled out, even when other diagnoses are possible
  • Following a hypersensitivity reaction to TRIUMEQ, NEVER restart TRIUMEQ or any other abacavir-containing product

Lactic Acidosis and Severe Hepatomegaly with Steatosis:

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues

Exacerbations of Hepatitis B:

  • Severe acute exacerbations of HBV have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued lamivudine, a component of TRIUMEQ. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment

CONTRAINDICATIONS

TRIUMEQ is contraindicated in patients:

  • who have the HLA‐B*5701 allele
  • with prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine
  • receiving dofetilide (antiarrhythmic)
  • with moderate or severe hepatic impairment

Hypersensitivity Reactions to Dolutegravir:

  • Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in <1% of subjects receiving TIVICAY® in Phase 3 clinical trials
  • Clinically, it is not possible to determine whether a hypersensitivity reaction with TRIUMEQ would be caused by abacavir or dolutegravir. Discontinue TRIUMEQ and other suspect agents immediately if signs or symptoms of hypersensitivity reaction develop

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:

  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TRIUMEQ. 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
  • Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TRIUMEQ are recommended in patients with underlying hepatic disease such as hepatitis B or C

Use with Interferon- and Ribavirin-based Regimens:

Hepatic decompensation, some fatal, has occurred in HIV-1/hepatitis C virus (HCV) co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and TRIUMEQ should be closely monitored.

Immune Reconstitution Syndrome

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

Fat Redistribution

or accumulation has been observed in patients receiving antiretroviral therapy.

Myocardial Infarction (MI):

  • An observational study showed an increase in MI with abacavir; a sponsor-conducted, pooled analysis did not show increased risk. In totality, the available data are inconclusive
  • The underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking)

Use with Certain Antiretroviral Products:

TRIUMEQ should not be administered concomitantly with other products containing abacavir or lamivudine.

SINGLE—Grades 2 to 4 treatment-emergent adverse drug reactions (≥2% frequency)

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

TDF/FTC=tenofovir/emtricitabine.

ARIA—Grades 2 to 4 treatment-emergent adverse drug reactions (≥2% frequency)1

*Includes rash, rash generalized, rash maculopapular, rash papular, and rash pruritic.

TDF/FTC=tenofovir/emtricitabine.

 

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

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.

Reference

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