TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 10 kg.

Do not interchange TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles for the dolutegravir component.

Do not use TRIUMEQ PD in adults.

Perform pregnancy testing before initiation of TRIUMEQ in adolescents and adults of childbearing potential.

TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. 

Screen for the HLA-B*5701 allele prior to initiating therapy with TRIUMEQ or TRIUMEQ PD.

All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with TRIUMEQ or TRIUMEQ PD or reinitiation of therapy with TRIUMEQ or TRIUMEQ PD, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue TRIUMEQ or TRIUMEQ PD immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible.

Following a hypersensitivity reaction to TRIUMEQ or TRIUMEQ PD, NEVER restart TRIUMEQ or TRIUMEQ PD or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.

All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating TRIUMEQ or TRIUMEQ PD. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If TRIUMEQ or TRIUMEQ PD is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

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

Because TRIUMEQ and TRIUMEQ PD are fixed-dose tablets and cannot be dose adjusted, TRIUMEQ and TRIUMEQ PD are not recommended in:
• patients with creatinine clearance <30 mL/min 
• patients with mild hepatic impairment. TRIUMEQ and TRIUMEQ PD are contraindicated in patients with moderate or severe hepatic impairment

TRIUMEQ and TRIUMEQ PD are contraindicated in patients:
• who have the HLA-B*5701 allele 
• with prior hypersensitivity reaction to abacavir, dolutegravir or lamivudine
• receiving dofetilide due to the potential for increased dofetilide plasma concentrations and
the risk for serious and/or life-threatening events with concomitant use of dolutegravir 
• with moderate or severe hepatic impairment

Patients with a creatinine clearance between 30 and 49 mL per min receiving TRIUMEQ may experience a 1.6- to 3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance greater than or equal to 50 mL per min. There are no safety data from randomized, controlled trials comparing TRIUMEQ to the individual components in patients with a creatinine clearance between 30 and 49 mL per min who received dose-adjusted lamivudine.

Patients with a sustained creatinine clearance between 30 and 49 mL per min who receive TRIUMEQ should be monitored for hematologic toxicities. If new or worsening neutropenia or anemia develop, dose adjustment of lamivudine, per lamivudine prescribing information, is recommended. If lamivudine dose adjustment is indicated, TRIUMEQ should be discontinued and the individual components should be used to construct the treatment regimen.

Abacavir hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment. Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions.

Hepatic adverse events have been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TRIUMEQ or TRIUMEQ PD.

Cases of hepatotoxicity including elevated serum liver biochemistries, hepatitis, and acute liver failure have also been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors.

Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir and lamivudine (components of TRIUMEQ and TRIUMEQ PD). A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues.

The use of abacavir within the previous 6 months was correlated with an increased risk of MI.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including TRIUMEQ or TRIUMEQ PD. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also 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.

Use of TRIUMEQ or TRIUMEQ PD with etravirine without co-administration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended.

Avoid co-administration of nevirapine with TRIUMEQ or TRIUMEQ PD because there are insufficient data to make dosing recommendations.

Co-administration of Dofetilide is contraindicated with TRIUMEQ and TRIUMEQ PD.

Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with TRIUMEQ or TRIUMEQ PD should be considered against the risk of seizures in these patients.

Co-administration with TRIUMEQ resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions. The riociguat dose may need to be reduced.

When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines.

Avoid co-administration of oxcarbazepine, phenytoin, phenobarbital, or st. john’s wort with TRIUMEQ  or TRIUMEQ PD because there are insufficient data to make dosing recommendations.

Concomitant use with protease inhibitors (Fosamprenavir/ritonavir,Tipranavir/ritonavir), adjust dolutegravir dose to 50 mg twice daily. An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from TRIUMEQ.

Concomitant use with carbamazepine, adjust dolutegravir dose to 50 mg twice daily. An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from TRIUMEQ.

Concomitant use with rifampin, adjust dolutegravir dose to 50 mg twice daily. An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from TRIUMEQ.

Administer TRIUMEQ or TRIUMEQ PD 2 hours before or 6 hours after taking medications containing polyvalent cations.

Under fasting conditions, TRIUMEQ or TRIUMEQ PD should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron.

With concomitant use of metformin limit the total daily dose of metformin to 1,000 mg either when starting metformin or TRIUMEQ. When stopping TRIUMEQ, the metformin dose may require an adjustment.

Adolescents and adults of childbearing potential should avoid use of TRIUMEQ at the time of conception through the first trimester of pregnancy because of the potential risk of neural tube defect.

Preliminary data from an observational study has identified a possible increased risk of neural tube defects when dolutegravir, a component of TRIUMEQ, is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. As defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. In addition, 2 of the 4 birth defects (encephalocele and iniencephaly), which have been observed with dolutegravir use, although often termed neural tube defects, may occur post-neural tube closure, the time period of which may be later than 6 weeks of gestation, but within the first trimester. Due to the limited understanding of the types of reported neural tube defects associated with dolutegravir use and because the date of conception may not be determined with precision, avoid use of TRIUMEQ at the time of conception through the first trimester of pregnancy.

Animal studies: Fetal malformations, increased incidences of fetal anasarca and skeletal malformations or developmental toxicity and decreased fetal body weight were observed.

The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Abacavir and lamivudine are present in human milk. When administered to lactating rats, dolutegravir was present in milk.

GoToSource

• Amyotrophic lateral sclerosis. GoToSource

• Use in pediatric patients weighing less than 40 kg. GoToSource

⚠️  Patients with the HLA-B*5701 gene are at a higher risk of abacavir hypersensitivity reactions.

Hypersensitivity reactions (a particular condition causing immune system to overreact). GoToSource

Lactic acidosis (too much lactic acid in the body). GoToSource

Hepatomegaly with steatosis (enlarged fatty liver). GoToSource

Rash, abnormal dreams, anxiety, dizziness and somnolence. GoToSource

Exacerbations of hepatitis B. GoToSource

Insomnia, depression and suicidality. GoToSource

Immune reconstitution inflammatory syndrome (clinical worsening of a known condition or the appearance of a new condition after initiating therapy). GoToSource

Hyperinsulinemia (excess levels of insulin) and insulin resistance, dyslipidemia (abnormal amount of lipids (fats) in the blood) and body fat redistribution. GoToSource 

Mitochondrial myopathy (group of neuromuscular diseases). GoToSource

Kidney stones and interstitial nephritis (spaces between the kidney tubules become swollen). GoToSource

Hepatotoxicity (toxic damage to the liver) and decreased bone mineral density. GoToSource

Lawsuits filed for hepatitis B reactivation and birth defects.