Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start Abacavir to see if you have this gene type. Discuss any questions or concerns with your doctor.
Abacavir may cause severe and sometimes fatal liver problems or high blood acid levels (lactic acidosis). Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; slow or irregular heartbeat; unusual weakness or tiredness; muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); or unusual drowsiness, dizziness, or lightheadedness.
Abacavir is used for:
Treating HIV infection with other medications.
Abacavir is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.
Do NOT use Abacavir if:
you are allergic to any ingredient in Abacavir
you have had a recent abnormal liver function test or have moderate to severe liver problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using Abacavir :
Some medical conditions may interact with Abacavir . 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 or thinking about 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 heart problems (eg, heart attack), high blood pressure, high cholesterol, diabetes, or smoking
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 . Tell your health care provider if you are taking any other medicines, especially any of the following:
Alcohol because it may increase the risk of Abacavir 's side effects and toxic effects
Methadone because its effectiveness may be decreased by Abacavir
How to use Abacavir :
Use Abacavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
• Abacavir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abacavir refilled.
• Abacavir 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 .
• Take Abacavir by mouth with or without food.
• Using Abacavir at the same times each day will help you remember to take it.
• Continue to take Abacavir even if you feel well. Do not miss any doses.
• If you miss a dose of Abacavir , 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 .
Important safety information:
• Talk to your doctor before you take Abacavir if you drink more than 3 drinks with alcohol per day.
• Tell your doctor or dentist that you take Abacavir before you receive any medical or dental care, emergency care, or surgery.
• If you must stop taking Abacavir for any reason other than a serious allergic reaction, do not start taking Abacavir again without talking with your health care provider. If your health care provider decides that you may take Abacavir again, you should do so only in a setting with other people in case you need immediate access to a doctor.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Abacavir , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• 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 . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• Abacavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Abacavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Lab tests, including liver function and monitoring for hypersensitivity reactions, may be performed while you use Abacavir . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Abacavir with caution in the ELDERLY; they may be more sensitive to its effects, especially liver, kidney, or heart problems.
• Caution is advised when using Abacavir in CHILDREN; they may be more sensitive to its effects, especially fever; chills; rash; or ear, nose, or throat infection.
• Abacavir should not be used in CHILDREN younger than 3 months 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 using Abacavir while you are pregnant. It is not known if Abacavir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Abacavir to the baby.
Possible side effects of Abacavir :
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:
Headache; lack of energy; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain or discomfort, numbness of an arm or leg, or sudden vision changes; ear pain; eye pain, redness, or swelling; fainting; fever or chills; general feeling of being unwell; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; muscle pain; unusual cold feeling in the arms or legs; sluggishness; unusual drowsiness, dizziness, or lightheadedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, loss of appetite, severe or persistent tiredness); unusual achiness or swelling.
Proper storage of Abacavir :
Store Abacavir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Abacavir out of the reach of children and away from pets.
DA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.
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