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Abacavir and lamivudine are antiviral medicines that prevent human immunodeficiency virus (HIV) cells from multiplying in your body.
Abacavir and lamivudine is a combination medicine used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS, and will not prevent you from passing HIV to other people.
Abacavir and lamivudine may also be used for purposes not listed in this medication guide.
Stop using this medicine and call your doctor at once if you have signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.
Once you have had an allergic reaction to abacavir, you must never use it again.
Lamivudine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms 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.
If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine.
Do not allow your medicine to run out. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking the medicine again. If you stop taking abacavir and lamivudine, talk to your doctor before you start taking the medicine again.
Do not take this medicine if you have ever had an allergic reaction to Epzicom or any medicine that contains abacavir or lamivudine (Combivir, Epivir, Triumeq, Trizivir, Ziagen). Once you have had an allergic reaction to abacavir, you must never use it again.
Abacavir and lamivudine can also cause severe or fatal liver problems. You should not take this medicine if you have liver disease, especially hepatitis B.
Do not take abacavir and lamivudine with any of the following HIV medications: Atripla, Combivir, Complera, Emtriva, Epivir, Triumeq, Trizivir, Truvada, Zerit, or Ziagen.
Some people taking lamivudine 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.
To make sure abacavir and lamivudine is safe for you, tell your doctor if you have:
hepatitis C (especially if you are treated with interferon and/or ribavirin);
a history of hepatitis or other liver problems;
heart disease or high blood pressure;
a risk factor for heart disease (such as smoking, diabetes, high cholesterol); or
if you have ever tested positive for a gene variation called HLA-B*5701.
You may need a blood test before you start taking abacavir and lamivudine for the first time, or if you are restarting the medicine after stopping for reasons not related to an allergic reaction.
It is not known whether abacavir and lamivudine will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of this medication on the baby.
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.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Abacavir and lamivudine may be taken with or without food.
This medicine comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.
Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat.
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.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using abacavir and lamivudine. Visit your doctor regularly.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid drinking alcohol. It may increase your risk of liver damage.
Taking this medicine 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.
Stop using this medicine 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 an allergic reaction to abacavir, you must never use it again. If you stop taking this medicine 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.
Abacavir and lamivudine can also 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; or
liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Abacavir and lamivudine 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 abacavir and lamivudine. Tell your doctor if you have:
signs of a new infection--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 include:
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. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
Usual Adult Dose for HIV Infection:
1 tablet orally once every 24 hours
Usual Adult Dose for Nonoccupational Exposure:
(Not approved by FDA)
Centers for Disease Control and Prevention recommendations: 1 tablet orally once every 24 hours
Duration: 28 days
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. In general, the alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include abacavir-lamivudine as part of nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, protease inhibitor (PI)-based, or triple nucleoside reverse transcriptase inhibitor (NRTI) regimens.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with abacavir and lamivudine, especially:
interferon or ribavirin (to treat hepatitis C);
any other HIV medicines.
This list is not complete. Other drugs may interact with abacavir and lamivudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision Date: 2015-01-09, 6:14:27 PM.
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.
Applies to abacavir / lamivudine: oral tablet
In addition to its needed effects, some unwanted effects may be caused by abacavir / lamivudine. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking abacavir / lamivudine:More common
Some of the side effects that can occur with abacavir / lamivudine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to abacavir / lamivudine: oral tablet
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.[Ref]
Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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 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 side effects have included abnormal breath sounds/wheezing during postmarketing experience with abacavir and lamivudine.[Ref]
1. Eron J Jr, Yeni P, Gathe J Jr, et al. "The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial." Lancet 368 (2006): 476-82
2. "Product Information. Epzicom (abacavir-lamivudine)." GlaxoSmithKline, Research Triangle Park, NC.
3. Toerner JG, Cvetkovich T "Kawasaki-like Syndrome: Abacavir Hypersensitivity?" Clin Infect Dis 34 (2002): 131-2
4. Hetherington S, McGuirk S, Powell G, et al. "Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir." Clin Ther 23 (2001): 1603-14
5. Loeliger AE, Steel H, McGuirk S, Powell WS, Hetherington SV "The abacavir hypersensitivity reaction and interruptions in therapy." Aids 15 (2001): 1325
6. HHS Panel on Antiretroviral Guidelines for Adults and Adolescents â€“ A Working Group of the Office of AIDS Research Advisory Council (OARAC). NIH. National Institutes of Health "Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: URL: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf." ([2011 Oct 14]):
7. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33
8. Cutrell AG, Hernandez JE, Fleming JW, et al. "Updated clinical risk factor analysis of suspected hypersensitivity reactions to abacavir." Ann Pharmacother 38 (2004): 2171-2
9. Del Giudice P, Vandenbos F, Perrin C, Bernard E, Marq L, Dellamonica P "Sweet's syndrome following abacavir therapy." J Am Acad Dermatol 51 (2004): 474-5
10. Sankatsing SU, Prins JM "Agranulocytosis and fever seven weeks after starting abacavir." AIDS 15 (2001): 2464-5
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