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Triumeq Side Effects

Generic name: abacavir / dolutegravir / lamivudine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 16, 2024.

Note: This document provides detailed information about Triumeq Side Effects associated with abacavir / dolutegravir / lamivudine. Some dosage forms listed on this page may not apply specifically to the brand name Triumeq.

Applies to abacavir / dolutegravir / lamivudine: oral tablet, oral tablet for suspension.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet for suspension)

Hypersensitivity Reactions. Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of the abacavir, dolutegravir, and lamivudine combination.

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.The abacavir, dolutegravir, and lamivudine combination 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 abacavir, dolutegravir, and lamivudine or reinitiation of therapy with abacavir, dolutegravir, and lamivudine, unless patients have a previously documented HLA-B*5701 allele assessment.

Discontinue abacavir, dolutegravir, and lamivudine combination 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 abacavir, dolutegravir, and lamivudine combination, never restart abacavir, dolutegravir, and lamivudine 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.Exacerbations of Hepatitis BAll patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating abacavir, dolutegravir, and lamivudine combination.

Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported.

If abacavir, dolutegravir, and lamivudine combination is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate chronic HBV; otherwise, consider an alternative regime.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 abacavir, dolutegravir, and lamivudine combination.

Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You should not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first 12 weeks of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious allergic reactions may occur while taking this medicine. These usually occur within 6 weeks after the medicine is started, but may occur at any time. Check with your doctor right away if you or your child have a severe rash or rash with fever, blistering or peeling skin, diarrhea, nausea, vomiting, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

When you begin taking this medicine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by Triumeq®. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

If you must stop using this medicine because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notices any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine may cause you to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

This medicine may increase your risk of having a heart attack. This is more likely if you smoke regularly or if you have diabetes, heart disease, high blood pressure, or high cholesterol. Call your doctor right away if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, nausea, sweating, or vomiting.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Triumeq

Along with its needed effects, abacavir/dolutegravir/lamivudine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking abacavir / dolutegravir / lamivudine:

Less common side effects

  • changes in weight
  • dark or bloody urine
  • decreased frequency or amount of urine
  • fever
  • increased blood pressure
  • increased thirst
  • itching skin
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea
  • stomach discomfort, upset, or pain
  • swelling of the face, fingers, or lower legs
  • trouble breathing
  • unusual drowsiness, dullness, or feeling of sluggishness
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • yellow eyes and skin

Rare side effects

  • rash

Incidence not known

  • blistering, peeling, or loosening of the skin
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • chest tightness
  • chills
  • confusion
  • cough
  • decreased appetite
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • discharge or excessive tearing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • fast, shallow breathing
  • general feeling of discomfort or illness
  • headache
  • hives
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • muscle pain, cramping, or stiffness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • red, irritated eyes
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • sweating
  • swelling or puffiness of the face
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

Other side effects of Triumeq

Some side effects of abacavir / dolutegravir / lamivudine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

  • belching
  • discouragement
  • excess air or gas in the stomach or bowels
  • feeling sad or empty
  • full or bloated feeling
  • heartburn
  • indigestion
  • irritability
  • loss of interest or pleasure
  • passing gas
  • pressure in the stomach
  • swelling of the stomach area
  • thoughts or attempts of killing oneself
  • trouble concentrating
  • trouble sleeping

Rare side effects

  • abnormal dreams

Incidence not known

  • anxiety
  • loss or thinning of the hair
  • weight gain around your neck, upper back, breast, or waist

For healthcare professionals

Applies to abacavir / dolutegravir / lamivudine: oral tablet, oral tablet dispersible.

General adverse events

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

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Dolutegravir:

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]

Hepatic

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Dolutegravir:

Lamivudine:

Grade 2 and grade 3 to 4 elevations in AST were reported in up to 3% and up to 1% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in ALT were reported in up to 3% and up to 1% of therapy-naive patients, respectively. 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.

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

Gastrointestinal

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Lamivudine:

Grade 2 and grade 3 to 4 elevations in lipase were reported in up to 11% and up to 5% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Psychiatric

Abacavir, dolutegravir, and/or lamivudine:

Dolutegravir:

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

Nervous system

Abacavir, dolutegravir, and/or lamivudine:

Lamivudine:

Other

Abacavir, dolutegravir, and/or lamivudine:

Dolutegravir:

Antiretroviral therapy:

Metabolic

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Lamivudine:

Antiretroviral therapy:

Grade 2 and grade 3 hyperglycemia were reported in up to 9% and up to 2% of therapy-naive patients, respectively. 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.[Ref]

Musculoskeletal

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Dolutegravir:

Lamivudine:

Combination antiretroviral therapy:

Grade 2 and grade 3 to 4 elevations in CPK were reported in up to 5% and up to 7% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.

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

Hematologic

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Lamivudine:

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

Dermatologic

Abacavir, dolutegravir, and/or lamivudine:

Abacavir:

Lamivudine:

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]

Respiratory

Abacavir, dolutegravir, and/or lamivudine:

Immunologic

Renal

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 144 weeks. In 1 trial, a mean change from baseline of 0.14 mg/dL (range: -0.25 to 0.81 mg/dL) was reported after 144 weeks of therapy in therapy-naive patients. Creatinine increases were similar in therapy-experienced patients.[Ref]

Cardiovascular

Abacavir:

Several prospective, observational, epidemiological studies reported an association with the use of abacavir and the risk of MI. Meta-analysis of randomized, controlled clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from observational studies and controlled clinical trials showed inconsistency; evidence for causal relationship between abacavir and risk of MI was inconclusive.[Ref]

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2014) "Product Information. Triumeq (abacavir / dolutegravir / lamivudine)." ViiV Healthcare

Frequently asked questions

Further information

Triumeq side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.