Abacavir / lamivudine Side Effects

Not all side effects for abacavir / lamivudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abacavir / lamivudine: oral tablet

Stop using this medication 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 this medication, you must never use it again. If you stop taking abacavir and lamivudine for any reason, talk to your doctor before you start taking it again.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: 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.

Abacavir and lamivudine can cause serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;

  • signs of a new infection such as flu symptoms, easy bruising or unusual bleeding, loss of appetite, mouth sores;

  • severe pain in your upper stomach spreading to your back;

  • itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (enlarged thyroid);

  • weakness or prickly feeling in your fingers or toes;

  • problems with walking, breathing, speech, swallowing, or eye movement; or

  • severe lower back pain, loss of bladder or bowel control.

Less serious side effects include:

  • strange dreams;

  • headache, dizziness, depression, anxiety;

  • mild nausea or diarrhea; or

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

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to abacavir / lamivudine: oral tablet

Hypersensitivity

Hypersensitivity side effects associated with abacavir have included serious and sometimes fatal hypersensitivity reactions. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), nausea, vomiting, diarrhea, abdominal pain, pharyngitis, malaise, fatigue, achiness, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia. Lamivudine has been associated with angioedema, urticaria, and anaphylactoid reactions. Sensitization reactions (including anaphylaxis) and urticaria have been reported during postmarketing experience with abacavir and lamivudine.

Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(1) Fever
(2) Rash
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)

A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.

Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction.

Hepatic

Hepatic side effects associated with abacavir have included liver function test abnormalities and elevated gamma-glutamyltransferase. Elevated hepatic enzymes, elevated bilirubin, and rare cases of hepatic decompensation have been reported with lamivudine. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents. Lactic acidosis, hepatic steatosis, and posttreatment exacerbation of hepatitis B have been reported during postmarketing experience with abacavir and lamivudine.

Hepatic decompensation, sometimes fatal, has been reported in patients coinfected with HIV-1 and hepatitis C virus. These patients were receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis, including fatalities, have been reported in patients coinfected with hepatitis B virus and HIV-1 who have discontinued antihepatitis B therapy, including lamivudine. The causal relationship to stopping lamivudine treatment is unknown.

Gastrointestinal

Pancreatitis has been rarely reported in adults (less than 0.5%), but may be more common in pediatric patients (up to 15% in 2 limited studies) receiving lamivudine.

Gastrointestinal side effects of at least moderate intensity have included nausea (up to 6%), diarrhea (up to 6%), and abdominal pain/gastritis (up to 5%) with abacavir / lamivudine/efavirenz therapy. Pancreatitis has been reported with abacavir and lamivudine. Stomatitis has been reported during postmarketing experience with abacavir and lamivudine.

Dermatologic

Dermatologic side effects of at least moderate intensity have included rash (5%) with abacavir / lamivudine/efavirenz therapy. Sweet's syndrome has been reported with abacavir. Lamivudine has been associated with rash, pruritus, and alopecia. Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience with abacavir (alone or in combination with other drugs). Alopecia, erythema multiforme, and Stevens-Johnson syndrome have been reported during postmarketing experience with abacavir and lamivudine.

Hematologic

Hematologic side effects associated with abacavir have included anemia, neutropenia, and agranulocytosis. Thrombocytopenia has been reported with lamivudine. Aplastic anemia, anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, and splenomegaly have been reported during postmarketing experience with abacavir and lamivudine.

Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.

Nervous system

Nervous system side effects of at least moderate intensity have included insomnia (up to 9%), headache/migraine (up to 7%), and dizziness/vertigo (6%) with abacavir / lamivudine/efavirenz combination therapy. Peripheral neuropathy, paresthesia, and seizures have been reported during postmarketing experience with abacavir and lamivudine.

Other

Other side effects of at least moderate intensity have included fatigue/malaise (up to 8%) and pyrexia (up to 5%) with abacavir / lamivudine/efavirenz therapy. Weakness has been reported during postmarketing experience with abacavir and lamivudine.

Psychiatric

Psychiatric side effects of at least moderate intensity have included depression/depressed mood (7%), abnormal dreams (up to 5%), and anxiety (up to 5%) with abacavir / lamivudine/efavirenz therapy.

Metabolic

Metabolic side effects associated with abacavir have included elevated blood glucose and triglycerides. Elevated amylase and lipase have been reported with lamivudine. Redistribution and/or accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients taking antiretroviral agents; however, a causal relationship has not been established. Hyperglycemia and redistribution/accumulation of body fat have been reported during postmarketing experience with abacavir and lamivudine.

Musculoskeletal

Musculoskeletal side effects associated with abacavir have included elevated creatine phosphokinase (CPK). Muscle weakness, CPK elevation, and rhabdomyolysis have been reported during postmarketing experience with abacavir and lamivudine.

Cardiovascular

Cardiovascular side effects have included myocardial infarction during postmarketing experience with abacavir.

A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Autoimmune disorders (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome) have been reported in the setting of immune reconstitution. The emergence of lamivudine-resistant hepatitis B virus (HBV) has been reported in HIV-1-infected patients who were treated with lamivudine-containing regimens in the presence of coinfection with HBV.

Respiratory

Respiratory side effects have included abnormal breath sounds/wheezing during postmarketing experience with abacavir and lamivudine.

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