Abacavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Abacavir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). abacavir is for adults and children who are at least 3 months old. Abacavir is not a cure for HIV or AIDS.

Abacavir may also be used for purposes not listed in this medication guide.

You should not take abacavir if you have ever had an allergic reaction to any medicine that contains abacavir, if you have moderate to severe liver disease, or if you have a gene variation called HLA-B*5701 allele.

Stop using abacavir 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.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, 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 pain or swelling in your upper stomach, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Abacavir comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

Abacavir doses are based on weight in children and/or teenagers. Your child's dose needs may change if the child gains or loses weight.

Abacavir can be taken with or without food.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You will need frequent medical tests.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

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.

Usual Adult Dose for HIV Infection:

300 mg orally twice a day or 600 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 300 mg orally twice a day or 600 mg orally once a day
Duration of therapy: 28 days

Comments:
-Recommended as part of alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI) for nonoccupational postexposure prophylaxis of HIV infection
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 300 mg orally twice a day or 600 mg orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

3 months or older:
Oral solution: 8 mg/kg orally twice a day or 16 mg/kg orally once a day
Maximum dose: 600 mg/day

Tablets:
14 to less than 20 kg: 150 mg orally twice a day or 300 mg orally once a day
20 to less than 25 kg: 150 mg orally in the morning and 300 mg in the evening, or 450 mg orally once a day
25 kg or more: 300 mg orally twice a day or 600 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

You should not use abacavir if:

• you have moderate or severe liver disease;

• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or

• you have had an allergic reaction to any medicine that contains abacavir (such as Ziagen, Epzicom, Triumeq, or Trizivir).

Many combination HIV medicines have abacavir as an ingredient. Ziagen should not be taken together with any other medicine that contains abacavir.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a risk factor for heart disease such as smoking, diabetes, or high cholesterol;

• liver disease; or

• if you have used any other HIV medication in the past.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking abacavir again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid drinking alcohol. It may increase your risk of liver damage.

Taking abacavir 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 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 can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

• severe upper stomach pain, nausea, vomiting, loss of appetite;

• swelling around your midsection;

• dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);

• unusual tiredness; or

• chest pain or pressure, pain spreading to your jaw or shoulder.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Abacavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of abacavir may include:

• feeling tired;

• sleep problems, strange dreams;

• headache, tiredness, fever, chills, general ill feeling;

• nausea or vomiting;

• rash; or

• (in children) stuffy nose, sneezing, sore throat, ear pain.

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.

Tell your doctor about all your other medicines, especially:

• riociguat;

• methadone; or

• any other HIV medicines.

This list is not complete. Other drugs may affect abacavir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of abacavir on hand. Do not wait until you run out of medication to refill 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.

• Epzicom® (containing Abacavir, Lamivudine)
• Triumeq® (containing Abacavir, Dolutegravir, Lamivudine)
• Trizivir® (containing Abacavir, Lamivudine, Zidovudine)