MEDICATION GUIDE

Abacavir Tablets , USP

(ah-BAH-kah-veer)What is the mos t important information I s hould know about abacavir

tablets ?

Abacavir can cause serious side effects, including:

•Serious allergic reaction (hypers ens itivity reaction) that can cause death have happened with

abacavir tablets and other abacavir-containing products. 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 s ymptom from 2 or more of the following groups while taking abacavir tablets , call

your healthcare provider right away to find out if you s hould s top taking abacavir tablets .

Symptom(s )

Group 1 Fever

Group 2 Ras h

Group 3 Naus ea, vomiting, diarrhea, abdominal (s tomach

area) pain

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Group 4 Generally ill feeling, extreme tirednes s , or

achines s

Group 5 Shortnes s of breath, cough, s ore 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 s top abacavir tablets becaus e of an allergic reaction, never take abacavir tablets or any

other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.

• If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to

properly dispose of medicines.

• 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 s ymptoms that may include very low

blood pres s ure 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 tablets again, s tart taking it when

you are around medical help or people who can call a healthcare provider if you need one.

What is abacavir tablet?

Abacavir tablet is 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 has not been established in children under 3 months of age.

When us ed with other antiretroviral medicines to treat HIV-1 infection, abacavir tablet may help:

• reduce the amount of HIV-1 in your blood. This is called ''viral load''.

• increase the number of CD4+ (T) cells in your blood, that help fight off other infections.

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 does 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 s hould not take abacavir tablets ?

Do not take abacavir tablets if you:

• have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will

test you for this before prescribing treatment with abacavir.

• 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 liver problems.

What s hould 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 or have had liver problems, including hepatitis B or C virus infection.

• have heart problems, smoke, or have diseases that increase your risk of heart disease such as high

blood pressure, high cholesterol, or diabetes.

• drink alcohol or take medicines that contain alcohol.

• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan

to become pregnant.

• Pregnancy Regis try. 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 have been tested and know whether

or not you have a particular gene variation called HLA-B*5701.

• have or have had liver problems, including hepatitis B or C virus infection.

• have heart problems, smoke, or have diseases that increase your risk of heart disease such as high

blood pressure, high cholesterol, or diabetes.

• drink alcohol or take medicines that contain alcohol.

• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan

to become pregnant.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter

medicines, vitamins, and herbal supplements.

Some medicines interact with abacavir. Keep a lis t of your medicines to s how your healthcare

provider and pharmacis t. You can ask your healthcare provider or pharmacist for a list of medicines

that interact with abacavir. Do not s tart taking a new medicine without telling your healthcare

provider. Your healthcare provider can tell you if it is safe to take abacavir with other medicines.

Tell your healthcare provider if you take:

• any other medicine to treat HIV-1

• methadone

How s hould I take abacavir tablet?

• Take abacavir tablet exactly as your healthcare provider tells you.

• Do not change your dose or stop taking abacavir tablets without talking with your healthcare provider.

If you miss a dose of abacavir tablets, take it as soon as you remember. Do not take 2 doses at the same

time. If you are not sure about your dosing, call your healthcare provider.

• Stay under the care of a healthcare provider while taking abacavir tablets.

• Abacavir tablet may be taken with or without food.

• For children aged 3 months and older, your healthcare provider will prescribe a dose of abacavir

based on your child’s body weight.

• Tell your healthcare provider if you or your child has trouble swallowing tablets. Abacavir comes as

a tablet or as a liquid (oral solution).

• Do not run out of abacavir tablets. The virus in your blood may increase and the virus may become

harder to treat. When your supply starts to run out, get more from your healthcare provider or pharmacy.

• If you take too much abacavir, call your healthcare provider or go to the nearest hospital emergency

room right away.

What are the possible side effects of abacavir tablets?

• Abacavir can cause serious side effects including:

• See ''What is the mos t important information I s hould know about abacavir tablets ?''

• Build-up of acid in your blood (lactic acidos is ). Lactic acidosis can happen in some people who take

abacavir tablets. Lactic acidosis is a serious medical emergency that can cause death. Call your

healthcare provider right away if you get any of the following s ymptoms that could be s igns of

lactic acidos is :

o feel very weak or tired o feel cold, especially in your arms and legs

o unusual (not normal) muscle pain o feel dizzy or light-headed

o trouble breathing o have a fast or irregular heartbeat

o stomach pain with nausea and vomiting

• Serious liver problems can happen in people who take abacavir. In some cases, these serious liver

problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in

your liver (steatosis) when you take abacavir tablets. Call your healthcare provider right away if you

have any of the following s igns of liver problems :

o your skin or the white part of your eyes turns yellow (jaundice) o loss of appetite for several days or

longer

o dark or ''tea-colored'' urine o nausea

o light-colored stools (bowel movements) o pain, aching, or tenderness on the right side of your

stomach area

You may be more likely to get lactic acidos is or s erious liver problems if you are female, very

overweight (obes e).

• Changes in your immune s ys tem (Immune Recons titution Syndrome) can happen when you start

taking HIV-1 medicines. 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 right away if you start having

new symptoms after you start taking abacavir tablets.

• Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir tablet may increase

your risk of heart attack.

The mos t common s ide effects of abacavir tablets in adults include:

• nausea • tiredness

• headache • vomiting

• generally not feeling well • bad dreams or sleep problems

The mos t common s ide effects of abacavir tablets in children include:

• fever and chills • rash

• nausea • ear, nose, or throat infections

• vomiting

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 s hould I s tore abacavir tablets ?

• Store abacavir tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

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

General information for s afe and effective us e 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 that is written for healthcare professionals.

For more information, call AvKARE at 1-855-361-3993.

What are the ingredients in abacavir tablets ?

Tablets

Active ingredient: Abacavir sulfate, USP

Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide,

magnesium stearate. The tablets are coated with opadry yellow which contains hypromellose, titanium

dioxide, triacetin, iron oxide yellow, and polysorbate 80.

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 08/19

AV 03/20 (P)

AvPAK

All brand names listed are the registered trademarks of their respective owners and are not trademarks

of AvKARE.

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

Guide available at http://camberpharma.com/medication-guides

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