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Nucleoside reverse transcriptase inhibitors (NRTIs)
Abacavir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.
Abacavir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Abacavir is not a cure for HIV or AIDS.
Abacavir may also be used for purposes not listed in this medication guide.
Stop using abacavir and call your doctor at once if you have any of these 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.
Read the Warning Card that comes with this medication, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for.
Some people develop lactic acidosis while taking abacavir. Early symptoms may get worse over time and this condition can be fatal. 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.
Abacavir can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have any of these symptoms while taking abacavir: pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Do not allow this medicine to run out completely before you get your prescription refilled. It is important that you not stop taking abacavir once you have started. If you miss several doses in a row, you may have a dangerous or even fatal allergic reaction once you start taking abacavir again. If you stop taking abacavir for any reason, talk to your doctor before you start taking the medication again.
Do not take this medication if you have ever had an allergic reaction to any medicine that contains abacavir, including Ziagen, Epzicom, or Trizivir. Once you have had an allergic reaction to abacavir, you must never use it again.
Some people develop a life-threatening condition called lactic acidosis while taking abacavir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.
Abacavir can also cause severe or life-threatening effects on your liver. You should not take abacavir if you have moderate or severe liver disease.
Do not take abacavir with any other medication that contains abacavir, such as Epzicom or Trizivir.
To make sure you can safely take abacavir, tell your doctor if you have any of these other conditions:
heart disease, high blood pressure;
a risk factor for heart disease such as smoking, diabetes, or high cholesterol; or
if you have used an HIV medication in the past, such as didanosine (Videx), emtricitabine (Atripla, Complera, Emtriva, Truvada), lamivudine (Combivir, Epivir, Epzicom, Trizivir), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).
You may need a blood test before you start taking abacavir for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.
FDA pregnancy category C. It is not known whether abacavir 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 abacavir 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.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Abacavir can be taken with or without food.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Abacavir 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 abacavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
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.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.
Store at room temperature away from moisture and heat.
You may store the oral solution (liquid) in the refrigerator but do not let it freeze.
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 abacavir 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 medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing 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 abacavir 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 abacavir, you must never use it again. If you stop taking abacavir for any reason, talk to your doctor before you start taking the medication again.
Abacavir 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 can cause other 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, chills, 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 may include:
headache, ear pain;
cold symptoms such as stuffy nose, sneezing, sinus pain; 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:
300 mg orally twice a day or 600 mg orally once a day
Usual Adult Dose for Nonoccupational Exposure:
(Not approved by FDA)
Centers for Disease Control and Prevention recommendations: 300 mg orally twice a day or 600 mg orally once a day
Duration: 28 days
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure. The alternative regimens recommended for nonoccupational postexposure HIV prophylaxis include abacavir as part of nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, protease inhibitor (PI)-based, or triple nucleoside reverse transcriptase inhibitor (NRTI) regimens.
Usual Pediatric Dose for HIV Infection:
3 months or older:
Oral solution: 8 mg/kg orally twice a day, not to exceed 600 mg/day
14 to 21 kg: 150 mg orally twice a day
22 to less than 30 kg: 150 mg orally in the morning and 300 mg in the evening
30 kg or more: 300 mg orally twice a day
Tell your doctor about all other medicines you use, especially methadone (Diskets, Dolophine, Methadose).
There may be other drugs that can interact with abacavir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Copyright 1996-2012 Cerner Multum, Inc. Version: 10.02. Revision Date: 2012-11-13, 11:37:22 AM.
Not all side effects for abacavir 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: oral solution, oral tablet
In addition to its needed effects, some unwanted effects may be caused by abacavir. 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:Less common
Some of the side effects that can occur with abacavir 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: oral solution, oral tablet
Patients receiving once-daily abacavir had a significantly higher incidence of severe hypersensitivity reactions and severe diarrhea than patients on the twice-daily regimen.[Ref]
Common (1% to 10%): Drug hypersensitivity (Grades 2 to 4; 9%), hypersensitivity reaction (Grades 2 to 4; 8%)
Rare (less than 0.1%): Abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia (at least 1 case)
Frequency not reported: Serious and sometimes fatal hypersensitivity reactions (including fever, skin rash [maculopapular, urticarial, or variable appearance], malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, 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, lymphopenia)[Ref]
Serious and sometimes fatal hypersensitivity reactions have been reported. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, 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.
In one case report a 57-year-old HIV positive male presented to medical attention with a 2-day history of fever, malaise, and diarrhea related to initiation of abacavir. Six days prior to the onset of symptoms the patient's antiretroviral therapy was switched from efavirenz and lamivudine-zidovudine to zidovudine, abacavir, and lopinavir-ritonavir after a drop in his CD4 cell count. The patient developed acute dyspnea and severe hypoxemia, hemoptysis, and diffuse bilateral pulmonary infiltrates within 72 hours of admission and abacavir was discontinued due to suspicion of a hypersensitivity reaction. Three days following discontinuation of abacavir the patient's status improved and chest films showed resolution of infiltrates.
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. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.[Ref]
The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.
Increased gamma-glutamyltransferase was observed in the expanded access program.
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.[Ref]
Common (1% to 10%): Elevated ALT (greater than 5 times ULN; 6%), elevated AST (greater than 5 times ULN; up to 6%)
Frequency not reported: Increased gamma-glutamyltransferase, severe hepatomegaly with steatosis
Postmarketing reports: Lactic acidosis, hepatic steatosis[Ref]
Pancreatitis was observed in the expanded access program.[Ref]
Very common (10% or more): Nausea (at least moderate intensity: up to 19%), nausea and vomiting (at least moderate intensity: 10%)
Common (1% to 10%): Diarrhea (at least moderate intensity: 7%), abdominal pain/gastritis/gastrointestinal signs and symptoms (at least moderate intensity: 6%), vomiting (at least moderate intensity: 2%)
Frequency not reported: Loss of appetite/anorexia, pancreatitis[Ref]
Very common (10% or more): Headache (at least moderate intensity: 13%)
Common (1% to 10%): Headaches/migraine (at least moderate intensity: 7%), dizziness (at least moderate intensity: 6%)
Frequency not reported: Insomnia, other sleep disorders[Ref]
Very common (10% or more): Malaise and fatigue (at least moderate intensity: 12%)
Common (1% to 10%): Fatigue/malaise (at least moderate intensity: 7%), fever and/or chills (at least moderate intensity: 6%), ear/nose/throat infections (at least moderate intensity: 5%)
Uncommon (0.1% to 1%): Non-site-specific pain (at least moderate intensity: less than 1%)
Frequency not reported: Asthenia, reduced alcohol tolerance, disulfiram-like reaction[Ref]
In one case report, a 31-year-old HIV-infected male patient switched to abacavir and experienced a disulfiram-like reaction with nausea, facial flushing, and tachycardia following alcohol consumption. When the patient was rechallenged with a shot of vodka, the same reaction occurred.
In another case, a 27-year-old HIV-infected male patient switched to abacavir and noticed reduced alcohol tolerance. The patient reported that he felt as if he had ingested 1.5 bottles of wine following 3 glasses, with loss of memory until the next morning and vomiting. The patient was able to tolerate small quantities of alcohol or alcohol consumed with food.[Ref]
Very common (10% or more): Dreams/sleep disorders (at least moderate intensity: 10%)
Common (1% to 10%): Depressive disorders (at least moderate intensity: 6%), anxiety (at least moderate intensity: 5%)
Frequency not reported: Mania, worsening of preexisting depression, lethargy[Ref]
Common (1% to 10%): Rashes (at least moderate intensity: 6%), skin rashes (at least moderate intensity: 5%)
Frequency not reported: Sweet's syndrome
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme[Ref]
Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.[Ref]
Common (1% to 10%): Elevated creatine phosphokinase (greater than 4 times ULN; up to 8%), hypertriglyceridemia (greater than 750 mg/dL; up to 6%), hyperamylasemia (greater than 2 times ULN; up to 4%)
Uncommon (0.1% to 1%): Hyperglycemia (greater than 13.9 mmol/L; less than 1%)
Rare (less than 0.1%): Hypoglycemia (at least 1 case)
Frequency not reported: Mild elevations of blood glucose
Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[Ref]
The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.
Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.[Ref]
Common (1% to 10%): Neutropenia (ANC less than 750/mm3; up to 5%), thrombocytopenia (platelets less than 50,000/mm3; 1%)
Uncommon (0.1% to 1%): Anemia (Hgb 6.9 g/dL or less; less than 1%), leukopenia (WBC 1500/mm3 or less; less than 1%)
Rare (less than 0.1%): Eosinophilia
Frequency not reported: Agranulocytosis, increased platelet reactivity[Ref]
Common (1% to 10%): Musculoskeletal pain (at least moderate intensity: up to 6%)[Ref]
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome)
Common (1% to 10%): Viral respiratory infections (at least moderate intensity: 5%), bronchitis (at least moderate intensity: 4%)
Frequency not reported: Tachypnea, cough, pharyngitis[Ref]
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.[Ref]
Rare (less than 0.1%): Peripheral arterial disease (at least 2 cases), coronary bypass surgery (at least 1 case), ischemic stroke (at least 1 case), deep venous thrombosis (at least 1 case), angina (at least 1 case), transient ischemic attack (at least 1 case)
Frequency not reported: Endothelial dysfunction
Postmarketing reports: Myocardial infarction[Ref]
Uncommon (0.1% to 1%): Renal signs/symptoms (at least moderate intensity: less than 1%)
Frequency not reported: Acute renal failure, interstitial nephritis[Ref]
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