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- Epzicom®(as a combination product containing Abacavir, Lamivudine)
- Trizivir®(as a combination product containing Abacavir, Lamivudine, Zidovudine)
[Posted 03/01/2011]ISSUE:FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir (Ziagen) treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.
FDA 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.
BACKGROUND:Abacavir is an antiviral medication used in combination with other antiretroviral drugs [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] for the treatment of HIV-1 infection.
RECOMMENDATION:Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional. For more information visit the FDA website at: Web Siteand Web Site.
Abacavir may cause a serious or life-threatening allergic reaction. Call your doctor immediately if you develop one symptom from two or more of the following groups to see if you should stop taking abacavir:
- Group 1: fever
- Group 2: rash
- Group 3: nausea, vomiting, diarrhea, or stomach area pain
- Group 4: generally ill feeling, extreme tiredness, or achiness
- Group 5: shortness of breath, cough, or sore throat
Your pharmacist will give you a Warning Card when you receive your medication. The Warning Card contains a list of the symptoms above. Carry the card with you.
Some people may be more likely to have an allergic reaction to abacavir based on their heredity or genetic make-up. Your doctor may order a lab test to determine if you are more likely to have an allergic reaction to abacavir.
Tell your doctor and pharmacist if you are allergic to abacavir or any other medications that contain abacavir. Do not take this medication if you have had a previous allergic reaction to abacavir or any other medication containing abacavir.
If your doctor tells you to stop taking abacavir because you had an allergic reaction, never take abacavir or a medication containing abacavir again. If you stop taking abacavir for any other reason, including missing several doses in a row or running out of medication, do not start taking it again without first talking to your doctor. You will need to be around people who can provide or call for emergency medical care, if needed, when you restart this medication.
Abacavir may cause serious liver damage and a condition called lactic acidosis (build up of acid in the blood) that may be life-threatening. Tell your doctor if you drink large amounts of alcohol and if you have or have ever had liver disease, including hepatitis. If you experience any of the following symptoms, call your doctor immediately: shortness of breath; fast breathing; changes in heartbeat; nausea; vomiting; loss of appetite; weight loss;diarrhea; pain, aching, swelling, or tenderness on your right side just below your ribs; unusual bleeding or bruising; yellowing of the skin or eyes; dark-colored urine; light-colored bowel movements; extreme tiredness; or cold or blue-colored hands and feet. Your doctor may tell you to stop taking abacavir.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to abacavir.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) and a Warning Card when you begin treatment with abacavir and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide and Warning Card.
Talk to your doctor about the risks of taking abacavir.
WHY is this medicine prescribed?
Abacavir is used in combination with other medications to treat human immunodeficiency virus (HIV) infection. Abacavir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by slowing the spread of HIV in the body. Abacavir does not cure HIV infection and may not prevent you from developing HIV-related illnesses. Abacavir does not prevent you from spreading HIV infection to other people.
HOW should this medicine be used?
Abacavir comes as a tablet and a solution (liquid) to take by mouth. It is usually taken one or two times a day with or without food. Take abacavir at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take abacavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Abacavir helps to control HIV infection, but does not cure it. Continue to take abacavir even if you feel well. Do not stop taking abacavir without talking to your doctor. If you stop taking abacavir or skip doses, your condition may become more difficult to treat or you could have an allergic reaction when restarting the medication (See Important Warning section). Do not run out of medication. When your supply of abacavir starts to run low, get more from your doctor or pharmacist.
Are there OTHER USES for this medicine?
Abacavir is also used in combination with other antiviral medications to prevent HIV infection in people who have been exposed to it. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking abacavir,
- tell your doctor and pharmacist if you are allergic to any medications or any of the ingredients in abacavir tablets or solution. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the following: methadone (Dolophine); and other medications to treat HIV. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the condition listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had depression, diabetes, high blood pressure,; high cholesterol, or heart disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking abacavir, call your doctor. You should not breast-feed while taking abacavir.
- talk to your doctor about the safe use of alcohol while taking this medication.
- tell your doctor if you smoke.
- you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body, such as pneumonia, herpes virus, tuberculosis, hepatitis, or a fungal infection. If you have new symptoms after starting treatment with abacavir, be sure to tell your doctor.
- you should know that while you are taking abacavir your body fat may increase or move to different areas of your body, such as the back of your neck and upper shoulders ('buffalo hump'), stomach, and breasts. Your body may lose fat from your arms, legs, face, and buttocks. Talk to your doctor if you notice any of these changes in your body fat.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss several doses of abacavir, call your doctor before starting to take this medication again. (See Important Warning section).
What SIDE EFFECTS can this medicine cause?
Abacavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- difficulty falling asleep or staying asleep
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- blisters or peeling skin
- difficulty swallowing or breathing
Abacavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store liquid medication at room temperature or in the refrigerator. Do not freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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