Abacavir

IMPORTANT WARNING:

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 will 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.

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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) 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 along 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 decreasing the amount of HIV in the blood. Although abacavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

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.

HOW should this medicine be used?

Abacavir comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once or twice daily 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.

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 or plan to take while taking abacavir. 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 liver or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking abacavir, call your doctor. You should not breastfeed if you are infected with HIV or if you are 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.

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:

• headache
• depression
• anxiety
• 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
• hives
• itching
• difficulty swallowing or breathing
• excessive tiredness; weakness, dizziness or lightheadedness; fast or irregular heartbeat; muscle pain; stomach pain with nausea and vomiting; shortness of breath or difficulty breathing; flu-like symptoms such as fever, chills, or cough; or feeling cold, especially in the arms or legs
• light-colored bowel movements; yellowing of the skin or eyes; loss of appetite; unusual bleeding or bruising; dark yellow or brown urine; or pain in the upper right part of stomach

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 (http://www.fda.gov/Safety/MedWatch) 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.

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call 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.

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.