Abacavir/Lamivudine/Zidovudine

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Trizivir with or without food.

Trizivir comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Read this information carefully and carry the Warning Card with you at all times so you will know what symptoms to watch for.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking Trizivir. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not allow your medicine to run out completely before you get your prescription refilled. It is important that you not stop taking the medicine once you have started. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medicine again.

Trizivir causes the same side effect as its component drugs, abacavir, lamivudine and zidovudine. The most common side effects are:

• nausea,
• diarrhea,
• vomiting,
• weight loss, and
• difficulty sleeping.

Serious and sometimes fatal hypersensitivity reactions involving several organs have been associated with abacavir, a component of Trizivir. Symptoms include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, aches, shortness of breath, cough, and sore throat. Patients should discontinue Trizivir if a hypersensitivity reaction is suspected. Patients who carry a certain genetic marker called HLA-B 5701 are at high risk for experiencing a hypersensitivity reaction to abacavir. Screening for the HLA-B 5701 allele is recommended prior to initiating therapy with abacavir.

Other important side effects of the abacavir component include:

• pancreatitis,
• liver failure
• metabolic disturbance (lactic acidosis)
• decrease in blood cells,
• muscle pain
• weakness and nerve damage in the extremities (peripheral neuropathy).

Tablets: 300 mg abacavir/150 mg lamivudine/300 mg zidovudine.

Capsules and powder should be stored at room temperature, 15 C to 30 C (59 F to 86 F).

Abacavir/lamivudine/zidovudine is a prescription medication used to treat human immunodeficiency virus (HIV). It is a single tablet containing 3 medications, abacavir, lamivudine, and zidovudine. All 3 of these medicines are called nucleoside analogue reverse transcriptase inhibitors (NRTIs). When used together, they help lower the amount of HIV in your blood.

This medication comes in tablet form and is taken twice daily, with or without food.

Common side effects of this medication include nausea, headaches, tiredness, and diarrhea.

Abacavir & Lamivudine & Zidovudine may be found in some form under the following brand names:

• Trizivir

Abacavir/lamivudine/zidovudine can cause serious side effects:

• Serious Allergic Reaction to abacavir. Patients taking abacavir/lamivudine/zidovudine may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not. Your doctor can determine with a blood test if you have this gene variation.

If you get a symptom from 2 or more of the following groups while taking abacavir/lamivudine/zidovudine, call your doctor right away to determine if you should stop taking this medicine:

• Group 1 Fever
• Group 2 Rash
• Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain
• Group 4 Generally ill feeling, extreme tiredness, or achiness
• Group 5 Shortness of breath, cough, sore throat

If you stop abacavir/lamivudine/zidovudine because of an allergic reaction, NEVER take this medication or any other abacavir-containing medicine, such as Ziagen and Epzicom, again. If you take this medication or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.

If you stop abacavir/lamivudine/zidovudine, for any other reason, even for a few days, and you are not allergic to this medication, talk with your doctor before taking it again. Taking abacavir/lamivudine/zidovudine again can cause a serious or life-threatening reaction, even if you never had an allergic reaction to it before. If your doctor tells you that you can take this medication again, start taking it when you are around medical help or people who can call a doctor if you need one.

• Blood problems. Retrovir, one of the medicines in abacavir/lamivudine/zidovudine, can cause serious blood cell problems. These include reduced numbers of white blood cells (neutropenia) and extremely reduced numbers of red blood cells (anemia). These blood cell problems are especially likely to happen in patients with advanced human immunodeficiency virus (HIV) disease or AIDS. Your doctor should be checking your blood cell counts regularly while you are taking this medication. This is especially important if you have advanced HIV or AIDS. This is to make sure that any blood cell problems are found quickly.
• Lactic Acidosis. Some HIV medicines, including this medication, can cause a rare but serious condition called lactic acidosis with liver enlargement (hepatomegaly). Nausea and tiredness that don't get better may be symptoms of lactic acidosis. In some cases this condition can cause death. Women, overweight people, and people who have taken HIV medicines like abacavir/lamivudine/zidovudine for a long time have a higher chance of getting lactic acidosis and liver enlargement. Lactic acidosis is a medical emergency and must be treated in the hospital.
• Worsening of hepatitis B virus (HBV) infection. Patients with HBV infection who take abacavir/lamivudine/zidovudine and then stop it, may get flare-ups of their hepatitis. Flare-up is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping this medication. You may need to take anti-HBV medicines.
• Muscle weakness (myopathy). Retrovir, one of the medicines in abacavir/lamivudine/zidovudine, can cause muscle weakness. This can be a serious problem.
• Use with interferon- and ribavirin-based regimens. Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking abacavir/lamivudine/zidovudine as well as interferon with or without ribavirin and you experience side effects, be sure to tell your doctor.

This medication can have other serious side effects. Be sure to read the section below entitled "Side Effects" section.

Do not take abacavir/lamivudine/zidovudine if you:

• have ever had a serious allergic reaction (a hypersensitivity reaction) to abacavir/lamivudine/zidovudine or any other medicine that has abacavir as an ingredient such as Ziagen and Epzicom
• have a liver that does not function properly
• are an adolescent who weighs less than 90 pounds

Before starting this medication, tell your doctor about all your medical problems, including if you:

• have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
• are pregnant or planning to become pregnant. It is not known if this medication will harm your unborn child. You and your doctor will need to decide if abacavir/lamivudine/zidovudine is right for you. If you use abacavir/lamivudine/zidovudine while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry for this medication.
• are breastfeeding. Some of the ingredients in abacavir/lamivudine/zidovudine be passed to your baby in your breast milk. It is not known if they could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk.
• have liver problems including hepatitis B virus infection.
• have kidney problems.
• have low blood cell counts (bone marrow problem). Ask your doctor if you are not sure.
• have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine.

The recommended oral dose of abacavir/lamivudine/zidovudine for adults and adolescents is 1 tablet twice daily. Use is not recommended in adolescents who weigh less than 40 kg because it is a fixed-dose tablet.