Triumeq

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart disease or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure)—May increase risk for heart attack.

• Genetic condition (eg, gene variation called HLA-B*5701)—This condition may increase the risk for serious and life-threatening side effects.

• Hepatitis B or C, or history of—Use with caution. May make this condition worse.

• Kidney disease or
• Liver disease, mild—Use is not recommended in patients with these conditions.

• Liver disease, moderate or severe—Should not be used in patients with these conditions.

Serious side effects have been reported with Triumeq including the following:

• serious allergic reactions. Serious allergic reactions have occurred with Triumeq and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701, which can be determined by a blood test from your doctor. If you experience symptoms from 2 or more of the following groups while taking Triumeq, then call your healthcare provider immediately: Group 1 fever; Group 2 rash; Group 3 nausea, vomiting, diarrhea, stomach pain; Group 4 feeling ill, extreme tiredness, achiness; Group 5 shortness of breath, cough, sore throat. Always carry the Warning Card with you listing these symptoms that is provided by your pharmacist.
• lactic acidosis (build-up of acid in your blood). Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you experience any of the following symptoms: feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in arms and legs), feeling dizzy or lightheaded, fast or irregular heartbeat.
• serious liver problems. Serious liver problems can sometimes cause death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider immediately if you experience any of the following symptoms: skin or white part of eyes turns yellow, dark or "tea-colored" urine, light colored stools, loss of appetite for several days or longer, nausea, and pain, aching, or tenderness on the right side of your stomach area.
• worsening of hepatitis B virus (HBV) in people who have HIV-1 infection. If you have HIV-1 and HBV infection, your HBV may get worse if you stop taking Triumeq. Do not run out of Triumeq. Refill your prescription or talk to your healthcare provider before your Triumeq is all gone. Do not stop taking Triumeq without talking to your healthcare provider. If you stop taking Triumeq, then your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
• resistant HBV. If you have HIV-1 and HBV, the HBV can change (mutate) during your treatment with Triumeq and become harder to treat.
• worsening liver disease in people infected with both HIV-1 and hepatitis C. Worsening of liver disease that has caused death has occurred in people taking antiretroviral medicines and also being treated for hepatitis C with interferon with or without ribavirin. If you are taking Triumeq and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.

Do not take Triumeq if you:

• are allergic to Triumeq or to any of its ingredients
• have a certain type of gene variation called the HLA-B*5701 allele
• take dofetilide (Tikosyn). Taking Triumeq and Tikosyn can cause life-threatening side effects.
• have liver problems

Take Triumeq exactly as prescribed.

Triumeq comes in tablet form and is taken once a day by mouth with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Triumeq at the same time.

Stop using Triumeq and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;

• Group 2 - rash;

• Group 3 - nausea, vomiting, diarrhea, stomach pain;

• Group 4 - general ill feeling, extreme tiredness, body aches;

• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to a medicine that contains abacavir or dolutegravir, you must never use it again. If you stop taking Triumeq for any reason, talk to your doctor before you start taking it again.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have other serious side effects:

• liver problems--nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Triumeq may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Triumeq. Tell your doctor if you have:

• fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

• headache, sleep problems (insomnia), tired feeling; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Triumeq is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Limitations of Use

• Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq [see Microbiology (12.4)]. • Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir in Triumeq is insufficient in these subpopulations. See full prescribing information for dolutegravir.

Hypersensitivity Reactions

Hypersensitivity reactions have been reported with the use of abacavir or dolutegravir, components of Triumeq.

Abacavir

Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir containing regimens. See full prescribing information for ZIAGEN® (abacavir).

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 [see Adverse Reactions (6.1)]. 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. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA‑B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.

Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir:

• 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. • Triumeq is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA‑B*5701‑positive patients. • Before starting Triumeq, review medical history for prior exposure to any abacavir-containing product. NEVER restart Triumeq or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA‑B*5701 status. • To reduce the risk of a life‑threatening hypersensitivity reaction, regardless of HLA‑B*5701 status, discontinue Triumeq immediately if a hypersensitivity reaction is suspected, even when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications). Clinical status, including liver chemistries, should be monitored and appropriate therapy initiated. • If a hypersensitivity reaction cannot be ruled out, do not restart Triumeq or any other abacavir-containing products because more severe symptoms, which may include life-threatening hypotension and death, can occur within hours. • Clinically, it is not possible to determine whether a hypersensitivity reaction with Triumeq would be caused by abacavir or dolutegravir. Therefore, never restart Triumeq or any other abacavir- or dolutegravir-containing product in patients who have stopped therapy with Triumeq due to a hypersensitivity reaction. • If a hypersensitivity reaction is ruled out, patients may restart Triumeq. Rarely, patients who have stopped abacavir for reasons other than symptoms of hypersensitivity have also experienced life-threatening reactions within hours of reinitiating abacavir therapy. Therefore, reintroduction of Triumeq, or any other abacavir-containing product, is recommended only if medical care can be readily accessed. • A Medication Guide and Warning Card that provide information about recognition of abacavir hypersensitivity reactions should be dispensed with each new prescription and refill.

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 less than 1% of subjects receiving TIVICAY® in Phase 3 clinical trials. Discontinue Triumeq and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with Triumeq or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction.

Clinically, it is not possible to determine whether a hypersensitivity reaction with Triumeq would be caused by abacavir or dolutegravir. Therefore, never restart Triumeq or any other abacavir- or dolutegravir-containing product in patients who have stopped therapy with Triumeq due to a hypersensitivity reaction.

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 and other antiretrovirals. See full prescribing information for ZIAGEN (abacavir) and EPIVIR® (lamivudine). Treatment with Triumeq should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Patients with Hepatitis B or C Virus Co-infection

Effects on Serum Liver Biochemistries

Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of Triumeq [see Adverse Reactions (6.1)]. See full prescribing information for TIVICAY® (dolutegravir). 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.

Posttreatment Exacerbations of Hepatitis

Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine. See full prescribing information for EPIVIR (lamivudine). Patients should be closely monitored with both clinical and laboratory follow‑up for at least several months after stopping treatment.

Emergence of Lamivudine‑Resistant HBV

Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV. Emergence of hepatitis B virus variants associated with resistance to lamivudine has been reported in HIV‑1‑infected subjects who have received lamivudine‑containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. See full prescribing information for EPIVIR-HBV® (lamivudine).

Use with Interferon- and Ribavirin-Based Regimens

Patients receiving interferon alfa with or without ribavirin and Triumeq should be closely monitored for treatment‑associated toxicities, especially hepatic decompensation. See full prescribing information for EPIVIR (lamivudine). Discontinuation of Triumeq should be considered as medically appropriate. Dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child‑Pugh greater than 6) (see full prescribing information for interferon and ribavirin).

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Triumeq. 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.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

Myocardial Infarction

In a published prospective, observational, epidemiological trial designed to investigate the rate of myocardial infarction (MI) in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of MI. In a sponsor‑conducted pooled analysis of clinical trials, no excess risk of MI was observed in abacavir‑treated subjects as compared with control subjects. In totality, the available data from the observational cohort and from clinical trials are inconclusive.

As a precaution, 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 (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking).

Related Products that are Not Recommended

Triumeq contains fixed doses of an INSTI (dolutegravir) and 2 nucleoside analogue reverse transcriptase inhibitors (abacavir and lamivudine); concomitant administration of Triumeq with other products containing abacavir or lamivudine is not recommended.

There is no known specific treatment for overdose with Triumeq. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.

Dolutegravir

As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Abacavir

It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

Lamivudine

Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.

You should not use Triumeq if you are allergic to abacavir, dolutegravir, or lamivudine, or if you have:

• moderate or severe liver disease;

• a gene variation called HLA-B*5701 allele (your doctor will test you for this); or

• a history of allergic reaction to Combivir, Dutrebis, Epivir, Epzicom, Tivicay, Trizivir, or Ziagen.

Once you have had an allergic reaction to abacavir or dolutegravir, you must never use these medicines again.

Some medicines can cause unwanted or dangerous effects when used with Triumeq. You should not take Triumeq if you also use:

• dofetilide (Tikosyn);

• abacavir (Epizicom, Trizivir, Ziagen);

• lamivudine (Combivir, Dutrebis, Epivir, Epzicom, Trizivir); or

• emtricitabine (Emtriva, Atripla, Complera, Stribild, Truvada).

Triumeq can cause severe or life-threatening effects on your liver, especially if you have hepatitis C.

To make sure Triumeq is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);

• kidney disease;

• risk factors for heart disease (such as diabetes, smoking, high blood pressure, high cholesterol); or

• if you drink alcohol.

Some people taking Triumeq develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

It is not known whether Triumeq will harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Triumeq is not approved for use by anyone younger than 18 years old.

Take Triumeq exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Triumeq comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Carry this Warning Card with you at all times so you will know what symptoms to watch for.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

While using this medicine, you may need frequent blood tests. You may need a blood test before you start taking this medicine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

If you have ever had hepatitis B, this condition may come back or get worse during treatment or after you stop taking Triumeq. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking the following medicines within 6 hours before or 2 hours after you take Triumeq:

• antacids or laxatives that contain aluminum or magnesium (such as Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others);

• the ulcer medicine sucralfate (Carafate);

• buffered medicine;

• vitamin or mineral supplements that contain calcium or iron.

Taking Triumeq will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Applies to abacavir / dolutegravir / lamivudine: oral tablet

General

The most common side effects were insomnia, headache, fatigue, nausea, and dizziness.

Many of the side effects listed occurred commonly in patients with abacavir hypersensitivity (e.g., nausea, vomiting, diarrhea, fever, lethargy, rash).[Ref]

Hypersensitivity

Hypersensitivity reactions were reported with abacavir and dolutegravir and shared some common features (e.g., fever and/or rash with other symptoms that indicated multi-organ involvement). In general, time to onset was 10 to 14 days for both abacavir- and dolutegravir-associated reactions.

Serious and sometimes fatal hypersensitivity reactions have been reported with abacavir. Such reactions have included multi-organ failure and anaphylaxis and usually occurred within the first 6 weeks of abacavir therapy; however, abacavir hypersensitivity reactions have occurred any time during therapy.

Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. Abacavir hypersensitivity was reported in about 8% of patients in 9 clinical trials with abacavir-containing products where patients were not screened for the HLA-B*5701 allele; incidence of suspected abacavir hypersensitivity reactions was 1% in clinical trials where HLA-B*5701 carriers were excluded.

Abacavir hypersensitivity reactions have been characterized by at least 2 of the following key signs/symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, achiness); (5) respiratory symptoms (including dyspnea, cough, pharyngitis). Almost all reactions have included fever and/or rash (usually maculopapular or urticarial); however, reactions also reported without fever or rash. Signs/symptoms reported in at least 10% of patients with hypersensitivity reaction have included rash, nausea, vomiting, diarrhea, abdominal pain, dyspnea, cough, fever, fatigue/lethargy, malaise, headache, elevated liver function tests, and myalgia. Other signs/symptoms of hypersensitivity have included mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, edema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, myolysis, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings (mainly infiltrates, which were localized), and death.

Symptoms of abacavir hypersensitivity reaction worsened with continued therapy and generally resolved when abacavir was discontinued. Restarting abacavir after a hypersensitivity reaction has resulted in more severe symptoms within hours and included life-threatening hypotension and death. Rarely, life-threatening reactions have occurred within hours after restarting abacavir in patients who stopped it for reasons other than symptoms of hypersensitivity (or who stopped it with only 1 key symptom of hypersensitivity).[Ref]

Common (1% to 10%): Hypersensitivity
Frequency not reported: Hypersensitivity reaction (with rash and severe liver effects)

Abacavir and/or lamivudine:
-Postmarketing reports: Sensitization reactions (including anaphylaxis)

Abacavir:
-Common (1% to 10%): Hypersensitivity reactions (including fever, rash [maculopapular, urticarial], generalized malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, lethargy, headache, myalgia, myolysis, edema, abnormal chest x-ray findings [mainly localized infiltrates], arthralgia, paresthesia, anaphylaxis, hepatitis, liver failure, renal failure, hypotension, sore throat, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions [conjunctivitis, mouth ulcerations], erythema multiforme, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, lymphopenia)

Dolutegravir:
-Frequency not reported: Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)[Ref]

Hepatic

Very common (10% or more): ALT abnormalities (up to 15%)
Common (1% to 10%): Elevated AST, elevated ALT, AST abnormalities
Uncommon (0.1% to 1%): Hepatitis

Abacavir and/or lamivudine:
-Frequency not reported: Liver function test abnormalities, severe hepatomegaly with steatosis

Abacavir:
-Frequency not reported: Liver function test abnormalities, elevated liver chemistries (AST, ALT, alkaline phosphatase, bilirubin)

Dolutegravir:
-Frequency not reported: Transaminase elevations consistent with immune reconstitution syndrome

Lamivudine:
-Frequency not reported: Elevated bilirubin, hepatic decompensation, severe acute exacerbations of hepatitis[Ref]

Grade 2 and grade 3 to 4 elevations in AST were reported in 3% and less than 1% of therapy-naive patients, respectively, at week 96. Grade 2 and grade 3 to 4 elevations in ALT were reported in 2% and less than 1% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.

The rates of AST and ALT abnormalities were higher in patients coinfected with hepatitis B and/or C virus (HBV and/or HCV). ALT abnormalities (grade 2 to 4) were reported in 15% and 2% of HIV/HCV-coinfected patients and HIV-monoinfected patients, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Transaminase elevations were consistent with immune reconstitution syndrome or hepatitis B reactivation in some patients with underlying hepatitis B and/or C, especially when antihepatitis therapy was stopped.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and HCV receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine.[Ref]

Gastrointestinal

Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Elevated lipase, abdominal pain, abdominal distention, abdominal discomfort, dyspepsia, flatulence, gastroesophageal reflux disease, upper abdominal pain, vomiting
Rare (0.01% to 0.1%): Pancreatitis

Abacavir and/or lamivudine:
-Postmarketing reports: Stomatitis

Abacavir:
-Postmarketing reports: Pancreatitis (rare)

Lamivudine:
-Frequency not reported: Elevated lipase
-Postmarketing reports: Elevated amylase (rare), pancreatitis (rare)[Ref]

Grade 2 and grade 3 to 4 elevations in lipase were reported in 9% and 4% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Uncommon (0.1% to 1%): Hypertriglyceridemia
Frequency not reported: Anorexia, fasted lipid values increased (including cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, triglycerides)

Abacavir and/or lamivudine:
-Frequency not reported: Lactic acidosis
-Postmarketing reports: Hyperlactemia, anorexia (common)

Abacavir:
-Frequency not reported: Elevated blood glucose, elevated triglycerides
-Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare)

Lamivudine:
-Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare)

Combination antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)[Ref]

Grade 2 and grade 3 hyperglycemia were reported in 7% and 2% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.[Ref]

Musculoskeletal

Grade 2 and grade 3 to 4 elevations in CPK were reported in 4% and 5% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.

Asymptomatic CPK elevations, mainly associated with exercise, have been reported with dolutegravir.[Ref]

Common (1% to 10%): Elevated creatine phosphokinase (CPK), arthralgia
Frequency not reported: Myositis
Rare (0.01% to 0.1%): Rhabdomyolysis

Abacavir and/or lamivudine:
-Postmarketing reports: Muscle weakness, elevated CPK

Abacavir:
-Frequency not reported: Elevated CPK

Dolutegravir:
-Frequency not reported: Asymptomatic CPK elevations

Lamivudine:
-Postmarketing reports: Muscle disorders (common), arthralgia (common), rhabdomyolysis (rare)

Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]

Hematologic

Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in 3% and 2% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Common (1% to 10%): Decreased total neutrophils

Abacavir and/or lamivudine:
-Postmarketing reports: Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly

Abacavir:
-Uncommon (0.1% to 1%): Anemia, neutropenia
-Frequency not reported: Thrombocytopenia, low WBC count

Lamivudine:
-Uncommon (0.1% to 1%): Thrombocytopenia
-Postmarketing reports: Pure red cell aplasia (very rare)[Ref]

Psychiatric

Suicidal ideation, attempt, behavior, and completion have been reported, mainly in patients with history of depression or other psychiatric illness.[Ref]

Very common (10% or more): Insomnia
Common (1% to 10%): Depression, abnormal dreams, nightmare, sleep disorder
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt
Frequency not reported: Suicidal behavior, suicide completion[Ref]

Nervous system

Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence, lethargy

Abacavir and/or lamivudine:
-Postmarketing reports: Paresthesia (very rare), peripheral neuropathy (very rare), seizures[Ref]

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Fever, asthenia, malaise

Abacavir and/or lamivudine:
-Postmarketing reports: Weakness[Ref]

Dermatologic

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients using abacavir primarily in combination with agents known to be associated with SJS and TEN, respectively.

Cases of erythema multiforme, SJS, or TEN have been reported very rarely when abacavir hypersensitivity could not be ruled out.[Ref]

Common (1% to 10%): Rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption), pruritus, alopecia

Abacavir and/or lamivudine:
-Postmarketing reports: Urticaria, alopecia, erythema multiforme

Abacavir:
-Postmarketing reports: Rash without systemic symptoms (common), erythema multiforme (very rare), Stevens-Johnson syndrome (very rare), toxic epidermal necrolysis (very rare)

Lamivudine:
-Postmarketing reports: Alopecia (common)[Ref]

Renal

Frequency not reported: Renal impairment, increased serum creatinine (due to inhibition of tubular secretion of creatinine)[Ref]

Dolutegravir was shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported within the first 4 weeks of therapy and remained stable through 24 to 96 weeks. In 1 trial, a mean change from baseline of 0.14 mg/dL (range: -0.32 to 0.59 mg/dL) was reported after 96 weeks of therapy in therapy-naive patients. Creatinine increases were similar in therapy-experienced patients.[Ref]

Immunologic

Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]

Respiratory

Common (1% to 10%): Cough

Abacavir and/or lamivudine:
-Postmarketing reports: Abnormal breath sounds/wheezing, nasal symptoms (common)[Ref]

Cardiovascular

An observational study investigating the rate of MI in patients on combination antiretroviral therapy showed an increased risk of MI with the use of abacavir within the previous 6 months. A sponsor-conducted pooled analysis of clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from the observational cohort and from clinical trials were inconclusive.[Ref]

Abacavir:
-Frequency not reported: Myocardial infarction (MI)[Ref]

Some side effects of Triumeq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.