Epzicom contains a combination of abacavir and lamivudine. Abacavir and lamivudine are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Epzicom is a combination medicine used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS).

Epzicom is not a cure for HIV or AIDS.

Epzicom can cause severe or fatal side effects. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not take Epzicom if you have liver disease, or if you have ever tested positive for a gene variation called HLA-B*5701. Do not take this medicine if you have ever had an allergic reaction to any medicine that contains abacavir or lamivudine.

Stop taking Epzicom and call your doctor at once if you have signs of an allergic reaction to Epzicom: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you've ever had hepatitis B, it may become active or get worse after you stop using Epzicom. You may need frequent liver function tests for several months.

Before taking this medicine

You should not use Epzicom if you are allergic to abacavir or lamivudine, or:

• if you have liver disease;

• if you have ever tested positive for a gene variation called HLA-B*5701; or

• if you have ever had an allergic reaction to any medicine that contains abacavir or lamivudine (Combivir, Epivir, Triumeq, Trizivir, Ziagen).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

To make sure Epzicom is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);

• kidney disease;

• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or

• if you drink alcohol.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Epzicom should not be given to a child who weighs less than 55 pounds.

Take Epzicom exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Epzicom may be taken with or without food. Tell the doctor if a child taking this medicine has trouble swallowing the tablet.

Epzicom comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Epzicom. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose of Epzicom for HIV Infection:

1 tablet orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose of Epzicom for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-Recommended as part of alternative regimens (NNRTI-based, protease inhibitor-based, or triple NRTI) for nonoccupational postexposure prophylaxis of HIV infection
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose of Epzicom for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose of Epzicom for HIV Infection:

At least 25 kg: 1 tablet orally once a day

Comments:
-Use of the individual components is recommended for patients less than 25 kg; the manufacturer product information for Epzicom should be consulted.
-Before prescribing this drug, the ability to swallow tablets should be assessed.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

You should not use Epzicom if you are allergic to abacavir or lamivudine, or:

• if you have liver disease;

• if you have ever tested positive for a gene variation called HLA-B*5701; or

• if you have ever had an allergic reaction to any medicine that contains abacavir or lamivudine (Combivir, Epivir, Triumeq, Trizivir, Ziagen).

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

To make sure Epzicom is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);

• kidney disease;

• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or

• if you drink alcohol.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Epzicom should not be given to a child who weighs less than 55 pounds.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.

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

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;

• Group 2 - rash;

• Group 3 - nausea, vomiting, diarrhea, stomach pain;

• Group 4 - general ill feeling, extreme tiredness, body aches;

• Group 5 - shortness of breath, cough, sore throat.

Once you have an allergic reaction to abacavir, you must never use it again. If you stop taking this medicine for any reason, talk to your doctor before you start taking it again.

Also call your doctor at once if you have:

• other signs of allergic reaction - hives, swelling in your face or throat, trouble breathing;

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, fast/slow or irregular heartbeats, dizziness, feeling cold, feeling very weak or tired; or

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Abacavir and lamivudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Epzicom side effects include:

• allergic reaction;

• depression, trouble sleeping;

• feeling weak or tired;

• headache, dizziness, migraine;

• nausea, diarrhea; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with abacavir and lamivudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.