SPL MEDGUIDE

MEDICATION GUIDE
ABACAVIR TABLETS, USP
(a bak′ a vir sul′ fate)
300 mg

Read this Medication Guide before you start taking abacavir tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to carry your Abacavir Tablets Warning Card with you at all times.

What is the most important information I should know about abacavir tablets?

1. Serious allergic reaction (hypersensitivity reaction). Abacavir tablets contain abacavir (also contained in EPZICOM ®** and TRIZIVIR ®**). Patients taking abacavir tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation.

If you get a symptom from two or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets.

	Symptom(s)
Group 1	Fever
Group 2	Rash
Group 3	Nausea, vomiting, diarrhea, abdominal (stomach area) pain
Group 4	Generally ill feeling, extreme tiredness, or achiness
Group 5	Shortness of breath, cough, sore throat

 

A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.

If you stop abacavir tablets because of an allergic reaction, never take abacavir tablets (abacavir sulfate) or any other abacavir-containing medicine (EPZICOM ®** and TRIZIVIR ®**) again. If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life threatening symptoms that may include very low blood pressure or death. If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking abacavir tablets again can cause a serious allergic or life threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take abacavir again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.

2. Lactic Acidosis (buildup of acid in the blood). Some human immunodeficiency virus (HIV) medicines, including abacavir tablets, can cause a rare but serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death and must be treated in the hospital.

Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

• you feel very weak or tired
• you have unusual (not normal) muscle pain
• you have trouble breathing
• you have stomach pain with nausea and vomiting
• you feel cold, especially in your arms and legs
• you feel dizzy or light-headed
• you have a fast or irregular heartbeat

3. Serious liver problems. Some people who have taken medicines like abacavir tablets have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

• your skin or the white part of your eyes turns yellow (jaundice)
• your urine turns dark
• your bowel movements (stools) turn light in color
• you don’t feel like eating food for several days or longer
• you feel sick to your stomach (nausea)
• you have lower stomach area (abdominal) pain

You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines for a long time.

What is abacavir?

Abacavir is a prescription medicine used to treat HIV infection. Abacavir is a medicine called a nucleoside analogue reverse transcriptase inhibitor (NRTI). Abacavir is always used with other anti-HIV medicines. When used in combination with these other medicines, abacavir helps lower the amount of HIV in your blood.

• Abacavir does not cure HIV infection or AIDS.
• It is not known if abacavir will help you live longer or have fewer of the medical problems that people get with HIV or AIDS.
• It is very important that you see your doctor regularly while you are taking abacavir tablets.

Who should not take abacavir tablets?

Do not take abacavir tablets if you:

• are allergic to abacavir or any of the ingredients in abacavir tablets. See the end of this Medication Guide for a complete list of ingredients in abacavir tablets.
• have certain liver problems.

What should I tell my healthcare provider before taking abacavir tablets?

Before you take abacavir tablets, tell your healthcare provider if you:

• have been tested and know whether or not you have a particular gene variation called HLA-B*5701
• have hepatitis B virus infection or have other liver problems
• have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
• are pregnant or plan to become pregnant. It is not known if abacavir will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• Pregnancy Registry. If you take abacavir tablets while you are pregnant, talk to your healthcare provider about how you can take part in the Pregnancy Registry for abacavir tablets. The purpose of the pregnancy registry is to collect information about the health of you and your baby.
• are breast-feeding or plan to breast-feed. Do not breast-feed. We do not know if abacavir can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breast-feed because HIV-1 can be passed to the baby in the breast milk.
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• alcohol
• methadone
• TRIZIVIR ®** (abacavir sulfate, lamivudine, and zidovudine)
• EPZICOM ®** (abacavir sulfate and lamivudine)

Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

Abacavir tablets may affect the way other medicines work, and other medicines may affect how abacavir tablets work.

Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take abacavir tablets?

• Take abacavir exactly as your healthcare provider tells you to take it.
• Abacavir is taken by mouth as a tablet or a liquid.
• Abacavir tablets may be taken with or without food.
• Do not skip doses.
• Children aged 3 months and older can also take abacavir. The child’s healthcare provider will decide the right dose and whether the child should take the tablet or liquid, based on the child’s weight. The dose should not be more than the recommended adult dose.
• Do not let your abacavir tablets run out. If you stop your anti-HIV medicines, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat. If you take too much abacavir, call your healthcare provider or poison control center or go to the nearest hospital emergency room right away.

What are the possible side effects of abacavir tablets?

• Abacavir tablets can cause serious side effects including allergic reactions, lactic acidosis, and liver problems. See “What is the most important information I should know about abacavir tablets?”
• Changes in immune system (Immune Reconstitution Syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking abacavir tablets.
• Changes in body fat (fat redistribution). Changes in body fat (lipoatrophy or lipodystrophy) can happen in some people taking antiretroviral medicines including abacavir tablets.

These changes may include:

• more fat in or around your trunk, upper back and neck (buffalo hump), breast, or chest
• loss of fat in your legs, arms, or face
• Heart attack (myocardial infarction). Some HIV medicines including abacavir tablets may increase your risk of heart attack.

The most common side effects of abacavir in adults include:

• bad dreams or sleep problems
• nausea
• headache
• tiredness
• vomiting

The most common side effects of abacavir in children include:

• fever and chills
• nausea
• vomiting
• rash
• ear, nose, or throat infections

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of abacavir tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store abacavir tablets?

• Store abacavir tablets at room temperature, at 20° to 25°C (68° to 77°F).
• Do not freeze abacavir tablets.
• Keep abacavir tablets and all medicines out of the reach of children.

General information for safe and effective use of abacavir tablets

Avoid doing things that can spread HIV-1 infection to others.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir for a condition for which it was not prescribed. Do not give abacavir tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about abacavir tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information that is written for healthcare professionals.

For more information call Mylan Pharmaceuticals Inc. at 1-877-4-INFO-RX (1-877-446-3679).

What are the ingredients in abacavir tablets?

Active ingredient: abacavir sulfate, USP

Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, sodium starch glycolate, titanium dioxide and yellow iron oxide.

This Medication Guide has been approved by the US Food and Drug Administration.

** The brand names mentioned are registered trademarks of their respective manufacturers.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad — 500 034, India
Code No.: MH/DRUGS/25/NKD/89

75050142
REVISED JULY 2012
MX:ABCV:R3m