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Triumeq Side Effects

Generic Name: abacavir / dolutegravir / lamivudine

Note: This document contains side effect information about abacavir / dolutegravir / lamivudine. Some of the dosage forms listed on this page may not apply to the brand name Triumeq.

For the Consumer

Applies to abacavir / dolutegravir / lamivudine: oral tablet

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

  • Changes in weight
  • dark or bloody urine
  • decreased frequency or amount of urine
  • fever
  • general tiredness and weakness
  • 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
  • troubled breathing
  • unusual drowsiness, dullness, or feeling of sluggishness
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • yellow eyes and skin

Rare

  • 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
  • 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 sex organs
  • 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
  • tightness in the chest

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

  • Belching
  • discouragement
  • excess air or gas in the stomach or intestines
  • 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 abdominal or stomach area
  • thoughts or attempts of killing oneself
  • trouble concentrating
  • trouble sleeping

Rare

  • Abnormal dreams

Incidence Not Known

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

For Healthcare Professionals

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Triumeq (abacavir/dolutegravir/lamiVUDine)." ViiV Healthcare, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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