"The European Medicines Agency (EMA) has updated information on the risk for body fat changes and lactic acidosis associated with antiretroviral medications for HIV infection.
HIV medicines will no longer require a warning regarding fa"...
(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.
|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 abacavir-containing medicine (TRIUMEQ®, TRIZIVIR® or ZIAGEN®) again.
- If you take EPZICOM 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 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.
- Build-up of acid in your
blood (lactic acidosis). Lactic acidosis can happen in some people who take EPZICOM.
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
- feel cold, especially in your arms and legs
- unusual (not normal) muscle pain
- feel dizzy or light-headed
- trouble breathing
- have a fast or irregular heartbeat
- stomach pain with nausea and vomiting
- Serious liver problems can happen in people who take EPZICOM. In some cases, these
serious 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)
- loss of appetite for several days or longer
- dark or “tea-colored” urine
- pain, aching, or tenderness on the right side of your stomach area
- light-colored stools (bowel movements)
You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking nucleoside analogue medicines for a long time.
- Worsening of hepatitis B
virus in people who have HIV-1 infection. If you have HIV-1 and hepatitis B virus (HBV) infection,
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. W orsening
liver disease can be serious and may lead to death
- 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.
- Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with EPZICOM and become harder to treat (resistant).
- Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with both HIV-1 and hepatitis C virus who are taking antiretroviral medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPZICOM and interferon with or without ribavirin tell your healthcare provider if you have any new symptoms.
What is EPZICOM?
EPZICOM is a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). EPZICOM contains 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR®).
EPZICOM should not be used in children weighing less than 55 pounds (25 kg).
When used with other antiretroviral medicines to treat HIV-1 infection, EPZICOM may help:
- reduce the amount of HIV-1 in your blood. This is called “viral load”.
- increase the number of CD4+ (T) cells in your blood, that help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
EPZICOM does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others.
- Do not share or re-use 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 safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
Who should not take EPZICOM?
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 or any of the ingredients in EPZICOM. See the end of this Medication Guide for a complete list of ingredients in EPZICOM.
- have liver problems.
What should I tell my healthcare provider before taking EPZICOM?
Before you take EPZICOM tell your healthcare provider 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.
- drink alcohol or take medicines that contain alcohol.
- are pregnant or plan to become
pregnant. Taking EPZICOM during pregnancy has not been associated with an
increased risk of birth defects. Talk to your healthcare provider if you are
pregnant or plan to become pregnant.
Pregnancy Registry. There is a pregnancy registry for women who take antiretroviral 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-thecounter medicines, vitamins, and herbal supplements.
Some medicines interact with EPZICOM. Keep a list of your medicines to show your healthcare provider and pharmacist. 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.
You should not take EPZICOM if you also take:
- abacavir (TRIUMEQ, TRIZIVIR or ZIAGEN)
- lamivudine (COMBIVIR®, DUTREBIS™, EPIVIR, EPIVIR-HBV®, TRIUMEQ, or TRIZIVIR)
- emtricitabine (EMTRIVA®, ATRIPLA®, COMPLERA®, STRIBILD®, or TRUVADA®)
Tell your healthcare provider if you take:
- any other medicine to treat HIV-1
- medicines to treat hepatitis viruses such as interferon or ribavirin
How should I take EPZICOM?
- Take EPZICOM exactly as your healthcare provider tells you.
- 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. If you are not sure about your dosing, call your healthcare provider.
- Stay under the care of a healthcare provider while taking 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. W hen 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?”
- 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.
- Changes in body fat can happen in people who take HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
- Heart attack (myocardial infarction). Some HIV-1 medicines including EPZICOM may increase your risk of heart attack.
The most common side effects of EPZICOM include:
- trouble sleeping
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. For more information, ask your healthcare provider or pharmacist. 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 59°F to 86°F (15°C 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 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.
If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about EPZICOM that is written for health professionals.
For more information go to www.EPZICOM.com or call 1-877-844-8872.
What are the ingredients in EPZICOM?
Active ingredients: abacavir sulfate 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.
(Front of card)
(abacavir and lamivudine) tablets
Patients taking EPZICOM may have a serious allergic reaction (hypersensitivity reaction) that can cause death. If you get a symptom from 2 or more of the following groups whiletaking EPZICOM, call your healthcare provider right away to find out if you should stop taking this medicine.
|Group 3||Nausea, vomiting, diarrhea, or abdominal (stomach area) pain|
|Group 4||Generally ill feeling, extreme tiredness, or achiness|
|Group 5||Shortness of breath, cough, or sore throat|
Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.
(Back of Card)
(abacavir and lamivudine) tablets
If you must stop treatment with EPZICOM because you have had an allergic reaction to abacavir, NEVER take EPZICOM or another abacavir-containing medicine (ZIAGEN®, TRIUMEQ®, or TRIZIVIR®) again. If you take EPZICOM or another 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.
Last reviewed on RxList: 10/23/2015
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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