EPZICOM- abacavir sulfate and lamivudine tablet, film coated 
ViiV Healthcare Company

----------

MEDICATION GUIDE

EPZICOM (ep' zih com)

(abacavir and lamivudine tablets)

What is the most important information I should know about EPZICOM?

EPZICOM can cause serious side effects, including:

Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with EPZICOM and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA‑B*5701. Your healthcare provider 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 EPZICOM, call your healthcare provider right away to find out if you should stop taking EPZICOM.

Symptom(s)

  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

 
A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times.
 
If you stop EPZICOM because of an allergic reaction, never take EPZICOM (abacavir and lamivudine) or any other abacavircontaining medicine (TRIUMEQ, TRIZIVIR, or ZIAGEN) again.
 
If you have an allergic reaction, dispose of any unused EPZICOM. Ask your pharmacist how to properly dispose of medicines.
If you take EPZICOM or any other abacavir‑containing medicine again after you have had an allergic reaction, within hours you may get lifethreatening symptoms that may include very low blood pressure or death.
If you stop EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your healthcare provider before taking it again. Taking EPZICOM again can cause a serious allergic or life‑threatening reaction, even if you never had an allergic reaction to it before.

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.

Worsening of hepatitis B virus (HBV) infection. If you have HBV infection and take EPZICOM, your HBV may get worse (flare-up) if you stop taking EPZICOM. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
Do not run out of EPZICOM. Refill your prescription or talk to your healthcare provider before your EPZICOM is all gone.
Do not stop EPZICOM without first talking to your healthcare provider.
If you stop taking EPZICOM, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat HBV. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking EPZICOM.
Resistant HBV. If you have human immunodeficiency virus-1 (HIV-1) and HBV, the HBV can change (mutate) during your treatment with EPZICOM and become harder to treat (resistant).
For more information about side effects, see “What are the possible side effects of EPZICOM?”

What is EPZICOM?

EPZICOM is a prescription medicine used with other HIV-1 medicines to treat HIV-1 infection.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

EPZICOM contains the prescription medicines abacavir and lamivudine.

EPZICOM should not be used in children weighing less than 55 pounds (25 kg).

Do not take EPZICOM if you:

have a certain type of gene variation called the HLA-B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with EPZICOM.
are allergic to abacavir, lamivudine, or any of the ingredients in EPZICOM. See the end of this Medication Guide for a complete list of ingredients in EPZICOM.
have certain liver problems.

Before you take 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.
have or have had liver problems, including hepatitis B or C virus infection.
have kidney problems.
have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
are pregnant or plan to become pregnant.
 
Pregnancy Registry. There is a pregnancy registry for women who take HIV-1 medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
are breastfeeding or plan to breastfeed. Do not breastfeed if you take EPZICOM.
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with EPZICOM. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with EPZICOM.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EPZICOM with other medicines.

How should I take EPZICOM?

Take EPZICOM exactly as your healthcare provider tells you to take it.
Do not change your dose or stop taking EPZICOM without talking with your healthcare provider.
If you miss a dose of EPZICOM, take it as soon as you remember. Do not take 2 doses at the same time or take more than your healthcare provider tells you to take.
Stay under the care of a healthcare provider during treatment with EPZICOM.
EPZICOM may be taken with or without food.
Tell your healthcare provider if your child has trouble swallowing EPZICOM tablets.
Do not run out of EPZICOM. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy
If you take too much EPZICOM, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of EPZICOM?

EPZICOM can cause serious side effects including:
See “What is the most important information I should know about EPZICOM?”
Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
feel very weak or tired
unusual (not normal) muscle pain
trouble breathing
stomach pain with nausea and vomiting
feel cold, especially in your arms and legs
feel dizzy or light-headed
have a fast or irregular heartbeat
Severe liver problems. In some cases, severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:
your skin or the white part of your eyes turns yellow (jaundice)
dark or “tea-colored” urine
light-colored stools (bowel movements)
loss of appetite for several days or longer
nausea
pain, aching, or tenderness on the right side of your stomach area

You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking EPZICOM.
Heart attack. Some HIV-1 medicines including EPZICOM may increase your risk of heart attack.

The most common side effects of EPZICOM include:

allergic reactions
trouble sleeping
depression
headache or migraine
tiredness or weakness
dizziness
nausea
diarrhea

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of EPZICOM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

How should I store EPZICOM?

Store EPZICOM at room temperature.

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 purposes other than those listed in a Medication Guide. 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. You can ask your healthcare provider or pharmacist for the information about EPZICOM that is written for health professionals.

What are the ingredients in EPZICOM?

Active ingredients: abacavir and lamivudine

Inactive ingredients: magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Tablet film coating contains: OPADRY orange YS-1-13065-A made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

 
  Manufactured for:
 
  ViiV Healthcare
 
  Research Triangle Park, NC 27709

EPZICOM, TRIUMEQ, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies.

The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to the ViiV Healthcare group of companies. The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

©2021 ViiV Healthcare group of companies or its licensor.

EPZ:15MG

For more information call 1-877-844-8872.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 02/2021

Revised: 12/2021
ViiV Healthcare Company