CONTRAINDICATIONS FOR TRIUMEQ AND EPZICOM

• Do not use TRIUMEQ or EPZICOM in patients who have the HLA-B*5701 allele
• Do not use TRIUMEQ in patients with prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine
• Do not use EPZICOM in patients with prior hypersensitivity reaction to abacavir 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 TRIUMEQ or EPZICOM in patients with moderate or severe hepatic impairment

WARNINGS AND PRECAUTIONS FOR TRIUMEQ

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immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn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

WARNINGS AND PRECAUTIONS FOR TRIUMEQ AND EPZICOM

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 or EPZICOM 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 or EPZICOM 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; however, 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. EPZICOM contains fixed doses of 2 nucleoside analogue reverse transcriptase inhibitors (abacavir and lamivudine), and should not be administered concomitantly with other products containing abacavir or lamivudine. In addition, do not administer EPZICOM in combination with products containing emtricitabine.

ADVERSE REACTIONS WITH TRIUMEQ

• 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%)

ADVERSE REACTIONS WITH EPZICOM

• The most commonly reported (≥3%) adverse reactions of at least moderate intensity in treatment-naïve adults receiving abacavir and lamivudine dosed once daily in one study were drug hypersensitivity (9%), insomnia (7%), depression/depressed mood (7%), headache/migraine (7%), fatigue/malaise (6%), dizziness/vertigo (6%), nausea (5%), diarrhea (5%), rash (5%), pyrexia (5%), abdominal pain/gastritis (4%), abnormal dreams (4%), and anxiety (3%)

DRUG INTERACTIONS WITH TRIUMEQ

• Coadministration of TRIUMEQ with certain inducers of UGT1A and/or CYP3A may result in reduced plasma concentrations of dolutegravir. Consult the full Prescribing Information for TRIUMEQ for more information
• 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 FOR TRIUMEQ

• 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

USE IN SPECIFIC POPULATIONS FOR EPZICOM

• Pregnancy: An Antiretroviral Pregnancy Registry has been established. Available data from this registry show no difference in the risk of overall major birth defects for abacavir or lamivudine compared with the background rate for major birth defects in a reference population from the United States
• Lactation: Breastfeeding is not recommended due to the potential for HIV transmission
• Pediatric Use: In pediatric patients weighing <55 pounds (25 kg), use of abacavir and lamivudine as single products is recommended to achieve appropriate dosing
• Patients with Impaired Renal Function: EPZICOM 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 EPZICOM, is required for patients with mild hepatic impairment, then the individual components should be used

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1‑888‑825‑5249 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

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

©2016 ViiV Healthcare group of companies. All rights reserved. Produced in USA.