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Indications and Usage Limitations of Use Limitations of Use (cont)
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Triumeq
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Important Safety Information:

BOXED WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, and EXACERBATIONS OF HEPATITIS B VIRUS (HBV): See full Prescribing Information for complete boxed warning.

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 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 with TRIUMEQ 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

  • Do not use in patients who have the HLA-B*5701 allele
  • Do not use in patients with prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine
  • Coadministration of TRIUMEQ with dofetilide (antiarrhythmic) is contraindicated due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events with concomitant use of dolutegravir
  • Do not use in patients with moderate or severe hepatic impairment

WARNINGS AND PRECAUTIONS

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
  • Never restart TRIUMEQ or any other abacavir- or dolutegravir-containing product in patients who have stopped therapy with TRIUMEQ due to a hypersensitivity reaction

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 for treatment-associated toxicities, especially hepatic decompensation. Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation. Discontinue TRIUMEQ as medically appropriate.

Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.

Fat Redistribution: Redistribution/ accumulation of body fat 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 contains fixed doses of an INSTI (dolutegravir) and 2 nucleoside analogue reverse transcriptase inhibitors (abacavir and lamivudine), and should not be administered concomitantly with other products containing abacavir or lamivudine.

ADVERSE REACTIONS

  • The most commonly reported (≥2%) adverse reactions of at least moderate intensity in treatment-naïve adult subjects receiving TRIUMEQ were insomnia (3%), headache (2%), and fatigue (2%)

DRUG INTERACTIONS

  • Coadministration of TRIUMEQ with drugs that are strong inducers of UGT1A1 and/or CYP3A may result in reduced plasma concentrations of dolutegravir. Consult the full Prescribing Information for TRIUMEQ for more information
  • Coadministration of TRIUMEQ with efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin requires an additional dolutegravir 50-mg tablet, separated by 12 hours from TRIUMEQ
  • TRIUMEQ should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, TRIUMEQ and supplements containing calcium or iron can be taken together with food

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Pregnancy Category C. TRIUMEQ should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established
  • Nursing Mothers: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants
  • Pediatric Patients: Safety and effectiveness of TRIUMEQ in pediatric patients have not been established
  • Patients with Impaired Renal Function: TRIUMEQ is not recommended in patients with creatinine clearance <50 mL per min
  • Patients with Impaired Hepatic Function: If a dose reduction of abacavir, a component of TRIUMEQ, is required for patients with mild hepatic impairment, then the individual components should be used

TRIUMEQ and TIVICAY are registered trademarks of the ViiV Healthcare group of companies.

©2015 ViiV Healthcare group of companies.
All rights reserved. Produced in USA. June 2015

Prescribing Information