Frequently asked questions about EPZICOM

EPZICOM is a prescription medicine used to treat HIV infection. EPZICOM includes two medicines: abacavir sulfate (ZIAGEN^®) and lamivudine, or 3TC (EPIVIR^®). Both of these medicines are called nucleoside analogue reverse transcriptase inhibitors (NRTIs). When used together in combination with other antiviral agents, they help lower the amount of HIV in your blood. This helps to keep your immune system as healthy as possible so that it can help fight infection.

Different combinations of medicines are used to treat HIV infection. You and your healthcare provider should discuss which combination of medicines is best for you.

• EPZICOM does not cure HIV infection or AIDS. We do not know if EPZICOM will help you live longer or have fewer of the medical problems that people get with HIV or AIDS. It is very important that you see your healthcare provider regularly while you are taking EPZICOM
• EPZICOM does not lower the risk of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles

Do not take EPZICOM if you:

• have ever had a serious allergic reaction (a hypersensitivity reaction) to EPZICOM or any other medicine that has abacavir as one of its ingredients (TRIZIVIR^® and ZIAGEN^®)
• have a liver that does not function properly
• are less than 18 years of age

Before starting EPZICOM, tell your healthcare provider about all of your medical conditions, 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. We do not know if EPZICOM will harm your unborn child. You and your healthcare provider will need to decide if EPZICOM is right for you. If you use EPZICOM while you are pregnant, talk to your healthcare provider about how you can be on the Antiviral Pregnancy Registry for EPZICOM
• are breastfeeding. Some of the ingredients in EPZICOM can 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 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 healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines:

• methadone
• HIVID^® (zalcitabine, ddC)
• EPIVIR or EPIVIR-HBV^® (lamivudine, 3TC), ZIAGEN (abacavir sulfate), COMBIVIR^® (lamivudine and zidovudine), or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine).

• Take EPZICOM by mouth exactly as your healthcare provider prescribes it. The usual dose is one tablet once a day. Do not skip doses
• You can take EPZICOM with or without food
• If you miss a dose of EPZICOM, take the missed dose right away. Then, take the next dose at the usual time
• Do not let your EPZICOM run out
• Starting EPZICOM again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If you run out of EPZICOM even for a few days, you must ask your healthcare provider if you can start EPZICOM again. If your healthcare provider tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a healthcare provider if you need one
• If you stop your anti-HIV drugs, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat
• If you take too much EPZICOM, call your healthcare provider or poison control center right away

• Do not take EPIVIR (lamivudine, 3TC), COMBIVIR (lamivudine and zidovudine), ZIAGEN (abacavir sulfate), or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) while taking EPZICOM. Some of these medicines are already in EPZICOM
• Do not take zalcitabine (HIVID, ddC) while taking EPZICOM

Avoid doing things that can spread HIV infection, as EPZICOM does not stop you from passing the HIV infection to others.

• Do not share needles or other injection equipment
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood
• Do not breastfeed. EPZICOM can be passed to babies in breast milk and could harm the baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk

EPZICOM can cause the following serious side effects:

• Serious allergic reaction that can cause death
• Lactic acidosis with liver enlargement (hepatomegaly) that can cause death
• Worsening of hepatitis B infection in patients who stop taking EPZICOM
• Changes in immune system. When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor
• Changes in body fat. These changes have happened in patients taking antiretroviral medicines like EPZICOM. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known

Some HIV medicines, including EPZICOM, may increase your risk of heart attack. 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, tell your healthcare provider.

The most common side effects with EPZICOM are trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of these side effects did not cause people to stop taking EPZICOM.

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

• Store EPZICOM at room temperature between 59° to 86°F (15° to 30°C)
• Keep EPZICOM and all medicines out of the reach of children

General information for safe and effective use of EPZICOM
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use EPZICOM for a condition for which it was not prescribed. Do not give EPZICOM to other people, even if they have the same symptoms that you have. It may harm them.

This is a summary of the most important information about EPZICOM. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information that is written for healthcare professionals, or call 1-888-825-5249.

Active ingredients: abacavir sulfate and lamivudine

Inactive ingredients: Each film-coated EPZICOM Tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY^® orange YS-1-13065-A) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

HIVID (zalcitabine) is a registered trademark of Roche Pharmaceuticals.
Opadry is a registered trademark of BPSI Holdings LLC.

As with all medicines, you may experience side effects while taking EPZICOM. The most common include:

• Trouble sleeping
• Depression
• Headache
• Tiredness
• Dizziness
• Nausea
• Diarrhea
• Rash
• Fever
• Stomach pain
• Abnormal dreams
• Anxiety

You can find more information about side effects in Is EPZICOM an Option for You?. Also, if you experience any side effects while taking EPZICOM, please contact your doctor.

However, before you start taking EPZICOM, your doctor will do a blood test to prescreen you for an allergic reaction to abacavir. The blood test will check if you have the HLA-B*5701 genetic variation. Patients who test negative for HLA-B*5701 may develop an allergic reaction to EPZICOM; however this occurs significantly less frequently than in patients who test positive for HLA-B*5701.

Our ViiV Patient Savings Card, depending upon your eligibility (restrictions apply), may be able to help you save on our prescription medicines, like EPZICOM. Learn more information about the ViiV Patient Savings Card.

If you have questions about ViiV Healthcare savings offers or any of the other patient assistance programs, please call us toll-free at 1-877-ViiV-USA (1-877-844-8872). Trained staff members are available weekdays from 8 a.m. to 8 p.m. Eastern time to take your call.