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:

• 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. 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 genetic make-up. Your doctor may order a genetic lab test prior to starting abacavir, lamivudine, and zidovudine. Tell your doctor and pharmacist if you are allergic to abacavir or any other medications that contain abacavir. 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. 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. 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 problems. 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. 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. 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.

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

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 (https://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 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 will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications along and making other lifestyle changes may decrease the risk of giving 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.

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.

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 or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• 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, or plan to become pregnant. If you become pregnant while taking abacavir, lamivudine, and zidovudine, call your doctor.

  tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking tell your doctor if you are breastfeeding or plan to breastfeed.

• 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 (https://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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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, lamivudine, and zidovudine on hand. Do not wait until you run out of medication to refill your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.