Abacavir Sulfate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• Your pharmacist will give you a Warning Card when you receive your medicine. Always carry the Warning Card with you that describes the symptoms of an allergic reaction to this medicine.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This medicine may also cause severe or life-threatening liver problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nucleoside reverse transcriptase inhibitor; antiretroviral (anti-HIV)

Generic and brand names: abacavir sulfate, oral; Ziagen

What is this medicine used for?

This medicine is taken by mouth to treat HIV infection. It is usually taken with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Heart disease or chest pain (angina)
• High blood pressure
• High cholesterol or triglycerides
• Liver disease

Make sure your healthcare provider knows if you are taking or have ever taken any other anti-HIV or antiviral medicine.

Tell your provider if you have ever taken abacavir before or if you have had a blood test to find out if you carry the HLA-B*5701 allele. If you have never taken abacavir or have not had this blood test, your healthcare provider may recommend you have the blood test to find out if you carry the HLA-B*5701 allele. If the test is positive, you are at higher risk for an allergic reaction.

Tell your healthcare provider if you smoke, regularly drink alcohol, or have a history of alcohol abuse.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it more often than directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.

Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

Check with your healthcare provider before using this medicine in children under age 3 months.

You may take this medicine with or without food.

The medicine is available in tablets or liquid. If you have the liquid medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

Do not allow this medicine to run out before you get your prescription refilled. If you miss several doses, you could have a serious or life-threatening allergic reaction when you start taking the medicine again. If you stop taking this medicine for any reason, talk to your healthcare provider before you start taking the medicine again. You need to be around people who can provide or call for emergency medical care, if needed, when you start taking this medicine again.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Some people have had allergic reactions (some fatal) with medicines that contain abacavir. If you develop fever, rash, extreme tiredness, nausea, vomiting, diarrhea, shortness of breath, severe muscle pain or weakness, an unexplained cough or sore throat, or severe stomach pain, call your healthcare provider right away to find out if you should stop taking this medicine. If you stop taking a medicine that contains abacavir because you had an allergic reaction, never take any medicine that contains abacavir again.

This medicine may increase your risk of heart attack. Talk with your provider if you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments.

This medicine may cause a severe or life-threatening condition called lactic acidosis (a buildup of acid in your blood). Contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling very tired or weak
• Unusual muscle pain
• Trouble breathing
• Stomach pain with nausea and vomiting
• Feel cold, especially in your arms or legs
• Feel dizzy or lightheaded
• Fast or irregular heartbeat

This medicine may cause severe or life-threatening liver problems. Contact your healthcare provider right away if you have:

• Yellowing of your skin or eyes
• Dark urine or light-colored bowel movements
• Stomach pain or stomach swelling
• Nausea and vomiting
• Loss of appetite

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine is not a cure for HIV infection. This medicine does not reduce the risk of infecting other people through sexual contact or blood contamination. There is no information about the effects of long-term treatments.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Your pharmacist will give you a Warning Card when you receive your medicine. Always carry the Warning Card with you that describes the symptoms of an allergic reaction to this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Slow, fast, or irregular heartbeat; chest pain; severe muscle pain; trouble breathing; unusual tiredness or weakness; severe stomach pain; nausea and vomiting; feeling cold (especially in arms and legs); dizziness; dark urine; fever; light-colored bowel movements; unusual loss of appetite; unexplained fever, cough, or sore throat; unusual bruising or bleeding; yellowing of your skin or eyes; increasing drowsiness; skin redness, peeling, or blisters.

Other: diarrhea, headache, dizziness, trouble sleeping, changes in body fat, ear infections, nervousness, depression, abnormal dreams.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antiviral medicines such as adefovir (Hepsera), delavirdine (Rescriptor), didanosine (Videx), emtricitabine (Emtriva), lamivudine (Epivir, Epivir-HBV), nelfinavir (Viracept), ribavirin (Copegus, Rebetol, Ribasphere, Virazole), ritonavir (Norvir), stavudine (Zerit), tenofovir (Viread), valganciclovir (Valcyte), and zidovudine (Retrovir)
• Interferon medicines such as interferon alfa-2b (Intron-A), interferon alfa-n3 (Alferon N), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), peginterferon alfa-2a (Pegasys), peginterferon alfa-2b (Sylatron), and peginterferon beta-1a (Plegridy)
• Methadone (Dolophine, Methadose)
• Other medicines that contain abacavir such as abacavir/lamivudine (Epzicom) or abacavir/lamivudine/zidovudine (Trizivir)

Do not drink alcohol while you are taking this medicine. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. You may store the liquid medicine at room temperature or in the refrigerator. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.