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Triumeq Side Effects

Generic Name: abacavir / dolutegravir / lamivudine

Note: This page contains side effects data for the generic drug abacavir / dolutegravir / lamivudine. It is possible that some of the dosage forms included below may not apply to the brand name Triumeq.

For the Consumer

Applies to abacavir / dolutegravir / lamivudine: oral tablet

As well as its needed effects, abacavir / dolutegravir / lamivudine may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking abacavir / dolutegravir / lamivudine, check with your doctor immediately:

Less common or rare:
  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • nausea and vomiting
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Incidence not known:
  • Abdominal or stomach pain or discomfort
  • blistering, peeling, or loosening of the skin
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • chills
  • confusion
  • cough
  • decreased appetite
  • decreased frequency or amount of urine
  • 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
  • fever
  • general feeling of discomfort or illness
  • headache
  • hives, itching, or rash
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • lower back or side pain
  • 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 of the face, fingers, lower legs
  • swelling or puffiness of the face
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • weight gain

Minor Side Effects

Some abacavir / dolutegravir / lamivudine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Discouragement
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
Less common or rare:
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • full or bloated feeling
  • heartburn
  • indigestion
  • passing gas
  • pressure in the stomach
  • sleepiness or unusual drowsiness
  • stomach upset
  • swelling of the abdominal or stomach area
  • weight loss
Incidence not known:
  • 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.

It is possible that some side effects of Triumeq may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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