Frequently Asked Questions

abacavir/lamivudine

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Epzicom

Antiviral combinations


Abacavir/lamivudine has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough, sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take abacavir/lamivudine again or take any other medicine that contains abacavir if you have had an allergic reaction to abacavir/lamivudine. You may be at risk for an even more severe allergic reaction. If you stop taking abacavir/lamivudine for any other reason, even for a few days, and you are not allergic to it, check with your doctor before restarting it.

Patients who have a certain gene type called HLA-B*5701 have an increased risk of having an allergic reaction to abacavir. A lab test may be performed before you start abacavir/lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.

High levels of lactic acid in the blood (lactic acidosis) and severe liver problems, including fatal cases, have been reported in patients taking certain HIV medicines, such as abacavir/lamivudine. The risk may be greater in women, in patients who are very overweight, or in patients who have a history of liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Tell your doctor immediately if you have dark urine; fast or irregular heartbeat; pale stools; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain (with or without nausea or vomiting); unusual muscle pain or tenderness; unusual tiredness or weakness; or yellowing of the eyes and skin. Contact your doctor right away if you start to feel unusually cold, especially in your arms and legs, or if you have a general feeling of being unwell.

Severe worsening of hepatitis B virus (HBV) has been reported in patients who have both HIV and HBV infection and have stopped taking lamivudine. Patients who have both HIV and HBV infection need close medical follow-up to check for worsening liver problems for at least several months after stopping lamivudine. Be sure to keep all doctor and lab appointments.


Abacavir/ lamivudine is used for:

Treating HIV infection. Abacavir/lamivudine is used in combination with other medicines.

Abacavir/lamivudine is a nucleoside analog reverse transcriptase inhibitor (NRTI) combination. It works by blocking HIV from reproducing.

Do NOT use abacavir/ lamivudine if:

  • you are allergic to any ingredient in abacavir/lamivudine
  • you have liver problems (eg, an enlarged liver), abnormal liver function tests, severe kidney problems, or high levels of lactic acid in the blood (lactic acidosis)
  • you are taking another medicine that contains abacavir, emtricitabine, or lamivudine
  • you are taking zalcitabine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using abacavir/ lamivudine:

Some medical conditions may interact with abacavir/lamivudine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, heart problems (eg, a heart attack), high blood pressure, high cholesterol, diabetes, pancreatitis, hepatitis B infection, or nerve problems
  • if you have a history of high levels of lactic acid in the blood or are at risk of liver problems
  • if you smoke, drink alcohol, or are very overweight
  • if you are taking any other medicine for HIV infection
  • if you have been tested and know whether or not you have a gene type called HLA-B*5701

Some MEDICINES MAY INTERACT with abacavir/lamivudine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Interferon alfa or trimethoprim/sulfamethoxazole (TMP-SMZ) because they may increase the risk of abacavir/lamivudine's side effects
  • Ribavirin or zalcitabine because their effectiveness may be decreased
  • Methadone because its effectiveness may be decreased by abacavir/lamivudine
  • Other medicines that contain abacavir, emtricitabine, or lamivudine because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if abacavir/lamivudine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use abacavir/ lamivudine:

Use abacavir/lamivudine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Abacavir/lamivudine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get abacavir/lamivudine refilled.
  • Abacavir/lamivudine comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking abacavir/lamivudine.
  • Take abacavir/lamivudine by mouth with or without food.
  • Taking abacavir/lamivudine at the same time each day will help you remember to take it.
  • Take abacavir/lamivudine on a regular schedule to get the most benefit from it.
  • Continue to take abacavir/lamivudine even if you feel well. Do not miss any doses.
  • If you miss a dose of abacavir/lamivudine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use abacavir/lamivudine.

Important safety information:

  • Abacavir/lamivudine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use abacavir/lamivudine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tell your doctor or dentist that you take abacavir/lamivudine before you receive any medical or dental care, emergency care, or surgery.
  • Drinking alcohol while taking abacavir/lamivudine may cause an increased risk of side effects. Talk to your doctor before drinking alcohol while you are taking abacavir/lamivudine.
  • Abacavir/lamivudine is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking abacavir/lamivudine, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • If you stop taking abacavir/lamivudine even for a few days (eg, if you run out of your medicine and do not get it refilled right away), contact your doctor before you start taking it again. You may experience a serious allergic reaction if you stop taking abacavir/lamivudine and then start again.
  • Abacavir/lamivudine does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Abacavir/lamivudine may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start abacavir/lamivudine.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking abacavir/lamivudine. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Diabetes patients - Abacavir/lamivudine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Patients who have a certain gene type called HLA-B*5701 have an increased risk of a severe or even fatal allergic reaction to abacavir/lamivudine. A lab test may be performed before you start abacavir/lamivudine to see if you have this gene type. Discuss any questions or concerns with your doctor.
  • Lab tests, including CD4 counts, complete blood cell counts, and liver function, may be performed while you use abacavir/lamivudine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Abacavir/lamivudine should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking abacavir/lamivudine while you are pregnant. Abacavir/lamivudine is found in breast milk. Do not breast-feed while taking abacavir/lamivudine. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or abacavir/lamivudine to the baby.

Possible side effects of abacavir/ lamivudine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or arm pain or discomfort; decreased urination; fainting; fever, chills, or persistent sore throat; mental or mood problems (eg, depression); mouth ulcers; muscle pain, cramping, or weakness; numbness, tingling, or pain in the hands and feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness; shortness of breath; sudden, unusual sweating; swelling; symptoms of lactic acidosis (eg, fast or irregular heartbeat; feeling cold, especially in your arms and legs; rapid or difficult breathing; severe or unusual drowsiness, dizziness, or light-headedness; sluggishness; stomach pain with nausea and vomiting; unusual tiredness or weakness); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the eyes or skin).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of abacavir/lamivudine:

Store abacavir/lamivudine at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep abacavir/lamivudine out of the reach of children and away from pets.

General information:

  • If you have any questions about abacavir/lamivudine, please talk with your doctor, pharmacist, or other health care provider.
  • Abacavir/lamivudine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take abacavir/lamivudine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abacavir/lamivudine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir/lamivudine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using abacavir/lamivudine.

Issue Date: February 4, 2015
Database Edition 15.1.1.002
Copyright © 2015 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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

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
  • Hypersensitivity reaction, including abdominal or stomach pain; cough; diarrhea; fever; headache; nausea; numbness or tingling of the face, feet, or hands; pain in the joints; pain in the muscles; shortness of breath; skin rash; sore throat; swelling of the feet or lower legs; unusual feeling of discomfort or illness; unusual tiredness or weakness; or vomiting
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloating
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • constipation
  • convulsions
  • dark urine
  • decreased appetite
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fast, shallow breathing
  • feeling of fullness
  • general feeling of discomfort
  • hives or welts
  • indigestion
  • itching
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • muscle cramping
  • muscle spasm or jerking of all extremities
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • redness of the skin
  • red skin lesions, often with a purple center
  • sleepiness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of consciousness
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing with exertion
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • weakness in the arms, hands, legs, or feet
  • wheezing
  • yellow eyes and skin

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
  • Abnormal dreams
  • burning feeling in the chest or stomach
  • fear
  • feeling of constant movement of self or surroundings
  • lightheadedness
  • nervousness
  • sensation of spinning
  • severe and throbbing headache
  • sleeplessness
  • stomach upset
  • tenderness in the stomach area
  • trouble with sleeping
  • unable to sleep
Incidence not known
  • Abnormal breathing sounds
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • gaining weight around your neck, upper back, breast, face, or waist
  • hair loss
  • increased hunger
  • increased thirst
  • increased urination
  • muscle weakness
  • sweating
  • swelling or inflammation of the mouth
  • thinning of the hair
  • unexplained weight loss

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.[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:
(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.[Ref]

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.[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]

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.[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

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

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

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

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

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

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

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

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.[Ref]

References

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 – 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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