ABACAVIR - abacavir tablet, film coated 
Aurobindo Pharma Limited



Abacavir Tablets USP
(a bak' a vir)

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

Abacavir tablets can cause serious side effects, including:

If you get a symptom from 2 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.

Group 1
Group 2
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 or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.

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

What are abacavir tablets?

Abacavir tablets are a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

The safety and effectiveness of abacavir tablets has not been established in children under 3 months of age.

When used with other antiretroviral medicines to treat HIV-1 infection, abacavir tablets may help:

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Abacavir tablets do not cure HIV-1 infection or AIDS.
You must keep taking HIV-1 medicines to control HIV- 1 infection and decrease HIV-related illnesses.

Who should not take abacavir tablets?

Do not take abacavir tablet if you:

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

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

Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with abacavir tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take abacavir tablets with other medicines.

Tell your healthcare provider if you take:

How should I take abacavir tablets?

What are the possible side effects of abacavir tablets?

The most common side effects of abacavir tablets in adults include:

The most common side effects of abacavir tablets in children include:

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?

Keep abacavir tablets and all medicines out of the reach of children.

General information for safe and effective use of abacavir tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets 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.

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir tablets that is written for health professionals.

For more information call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in abacavir tablets?

Active ingredient: abacavir

Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, iron oxide yellow, polysorbate 80, titanium dioxide, and triacetin.

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

The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited. The markers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 12/2022

Revised: 4/2023
Aurobindo Pharma Limited