Abacavir, Lamivudine, and Zidovudine

IMPORTANT WARNING:

Abacavir, lamivudine, and zidovudine 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, lamivudine, and zidovudine:

• 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 each time you receive your medication. The Warning Card lists the symptoms mentioned above to make it easy for you and the people around you to recognize if you are having an allergic reaction. Be sure to carry this Warning Card with you at all times.

Some people may be more likely to have an allergic reaction to abacavir, based on their heredity or genetic make-up. Your doctor may order a genetic lab test prior to starting abacavir, lamivudine, and zidovudine 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 or if you know that you have that particular genetic makeup. If your doctor tells you to stop taking abacavir, lamivudine, and zidovudine because you had an allergic reaction, never take abacavir, lamivudine, and zidovudine or a medication containing abacavir again. If you stop taking abacavir, lamivudine, and zidovudine 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. Restarting abacavir, lamivudine, and zidovudine increases your risk of experiencing an allergic reaction, even if you never had a reaction to it before. You will need to be around people who can provide or call for emergency medical care, if needed, when you restart this medication.

Abacavir, lamivudine, and zidovudine may stop your body from making enough blood cells. Tell your doctor if you have or have ever had a low number of any type of blood cells or any blood disorders such as anemia or bone marrow problems. If you experience any of the following symptoms, call your doctor immediately: unusual bleeding or bruising; shortness of breath; pale skin; fever, sore throat, chills, and other signs of infection; or unusual tiredness or weakness.

Abacavir, lamivudine, and zidovudine may cause muscle disorders. Tell your doctor if you have or have ever had any muscular disease or swelling of the muscles. If you experience muscle pain or weakness, call your doctor immediately.

Abacavir, lamivudine, and zidovudine may cause life-threatening damage to the liver and a potentially life-threatening condition called lactic acidosis (buildup of lactic acid in the blood). Tell your doctor if you have or have ever had liver disease. If you have liver disease, your doctor will probably tell you not to take abacavir, lamivudine, and zidovudine. You may also be at an increased risk of developing lactic acidosis if you are female, very overweight, or have been taking nucleoside reverse transcriptase inhibitor medications like abacavir, lamivudine, and zidovudine for a long time. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: nausea, vomiting, pain in the upper right part of your stomach, loss of appetite, flu-like symptoms, extreme tiredness, unusual bleeding or bruising, weakness, dizziness, lightheadedness, fast or irregular heartbeat, trouble breathing, dark yellow or brown urine, light-colored bowel movements, yellowing of the skin or eyes, feeling cold, especially in the arms or legs, or muscle pain that is different from any muscle pain you usually experience.

Abacavir, lamivudine, and zidovudine should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with abacavir, lamivudine, and zidovudine. If you have HBV and you take abacavir, lamivudine, and zidovudine, your condition may suddenly worsen when you stop taking this medication. Your doctor will examine you and order lab tests regularly for several months after you stop taking this medication to see if your HBV has worsened.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with abacavir, lamivudine, and zidovudine 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) to obtain the Medication Guide.

Talk to your doctor about the risks of taking abacavir, lamivudine, and zidovudine.

WHY is this medicine prescribed?

The combination of abacavir, lamivudine and zidovudine is used alone or along with other medications to treat human immunodeficiency virus (HIV) infection. Abacavir, lamivudine and zidovudine are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). They work by decreasing the amount of HIV in the blood. Although the combination of abacavir, lamivudine and zidovudine 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?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

The combination of abacavir, lamivudine, and zidovudine comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take abacavir, lamivudine, and zidovudine at around the same times 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, lamivudine, and zidovudine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Abacavir, lamivudine, and zidovudine helps to control HIV infection but does not cure it. Continue to take abacavir, lamivudine, and zidovudine even if you feel well. Do not stop taking abacavir, lamivudine, and zidovudine without talking to your doctor. If you stop taking abacavir, lamivudine, and zidovudine, 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).

What SPECIAL PRECAUTIONS should I follow?

Before taking abacavir, lamivudine, and zidovudine,

• tell your doctor and pharmacist if you are allergic to any of the ingredients in abacavir, lamivudine, and zidovudine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking abacavir, lamivudine, and zidovudine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you smoke or drink alcohol, or if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section; high blood pressure; high cholesterol; diabetes; or heart or kidney disease.

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

• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

• 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 or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with abacavir, lamivudine, and zidovudine, 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.

What SIDE EFFECTS can this medicine cause?

Abacavir, lamivudine, and zidovudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• anxiety
• depression
• headache

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.

Abacavir, lamivudine, and zidovudine 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).

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.

Symptoms of overdose may include the following:

• headache
• vomiting
• extreme tiredness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to abacavir, lamivudine, and zidovudine.

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

Keep a supply of abacavir, lamivudine, and zidovudine 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.