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ABACAVIR- abacavir sulfate tablet, film coated


  1. Abacavir Tablets Can Cause Serious Side Effects, Including:
  2. Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms That Could Be Signs Of Lactic Acidosis:
  3. Call Your Healthcare Provider Right Away If You Have Any Of The Following Signs Of Liver Problems:
  4. What Are Abacavir Tablets?
  5. When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Tablets May Help:
  6. Do Not Take Abacavir Tablet If You:
  7. Are Allergic To Abacavir Or Any Of The Ingredients In Abacavir Tablets. Before You Take Abacavir Tablets, Tell Your Healthcare Provider If You:
  8. Tell Your Healthcare Provider If You Take:
  9. How Should I Take Abacavir Tablets?
  10. Abacavir Tablets Can Cause Serious Side Effects Including:
  11. What Are The Ingredients In Abacavir Tablets?
  12. Patient Information
  13. Inform Patients:

Abacavir Tablets Can Cause Serious Side Effects, Including: 

  • Serious allergic reactions (hypersensitivity reaction)that can cause death have happened with abacavir tablets 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 abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets.

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 abacavir tablets because of an allergic reaction, never take abacavir or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again.

  • If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines.
  • If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction,within hoursyou may getlife-threatening symptomsthat may includevery low blood pressure or death.
  • If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir tablets, talk with your healthcare provider before taking them again. Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to them before.

If your healthcare provider tells you that you can take abacavir tablets again, start taking them 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 abacavir tablets. 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
  • Serious liver problemscan happen in people who take abacavir tablets. 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) when you take abacavir tablets.
  • Call Your Healthcare Provider Right Away If You Have Any Of The Following Signs 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, very overweight (obese), or have been taking nucleoside analogue medicines for a long time.

    What Are Abacavir Tablets? 


    Abacavir tablets are 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).

    The safety and effectiveness of abacavir tablets has not been established in children under 3 months of age.

    When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Tablets 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).

    Abacavir tablets do not cure HIV-1 infection or AIDS.You must keep taking HIV-1 medicines to control HIV- 1 infection and decrease HIV-related illnesses.

    Do Not Take Abacavir Tablet 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 abacavir tablets.

    Are Allergic To Abacavir Or Any Of The Ingredients In Abacavir Tablets. Before You Take Abacavir Tablets, 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 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. 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 abacavir tablets.
    • 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 abacavir tablets.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 abacavir tablets.Do not start taking a new medicine without telling your healthcare provider.Your healthcare provider can tell you if it is safe to take abacavir tablets with other medicines.

    Tell Your Healthcare Provider If You Take: 

    • any other medicine to treat HIV-1
    • methadone

    How Should I Take Abacavir Tablets? 

    • Take abacavir tablets exactly as your healthcare provider tells you.
    • Do not change your dose or stop taking abacavir tablets without talking with your healthcare provider. If you miss a dose of abacavir tablets, 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 abacavir tablets.
    • Abacavir tablets may be taken with or without food.
    • For children aged 3 months and older, your healthcare provider will prescribe a dose of abacavir tablets based on your child s body weight.
    • Tell your healthcare provider if you or your child has trouble swallowing tablets. Abacavir comes as a tablet or as a liquid (oral solution).
    • Do not run out of abacavir tablets. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run out, get more from your healthcare provider or pharmacy.
    • If you take too much abacavir tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

    Abacavir Tablets Can Cause Serious Side Effects Including: 

    • Store abacavir tablets at room temperature, between 20 to 25 C (68 to 77 F).

    Keep abacavir tablets and all medicines out of the reach of children.

    General information for safe and effective use of abacavir tablets
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets for a condition for which it was not prescribed. Do not give abacavir tablets 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 abacavir tablets that is written for health professionals.

    For more information call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

  • What Are The Ingredients In Abacavir Tablets? 


    Active ingredient: abacavir
    Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose, iron oxide yellow, polysorbate 80, titanium dioxide, and triacetin.

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

    The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited. The markers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8202121/0817OS

    Patient Information 

    Advise the patient to read the FDA-approved patient labeling (Medication Guide).

    Hypersensitivity Reactions

    Inform Patients: 

    • that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir, and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir. The complete text of the Medication Guide is reprinted at the end of this document.
    • to carry the Warning Card with them.
    • how to identify a hypersensitivity reaction[seeWarnings and Precautions (5.1),Medication Guide].
    • that if they develop symptoms consistent with a hypersensitivity reaction they should call their healthcare provider right away to determine if they should stop taking abacavir.
    • that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir is not immediately discontinued.
    • to not restart abacavir or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
    • that if they have a hypersensitivity reaction, they should dispose of any unused abacavir to avoid restarting abacavir.
    • that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir is stopped right away.
    • that if they have interrupted abacavir for reasons other than symptoms of hypersensitivity (for example, those who have an interruption in drug supply), a serious or fatal hypersensitivity reaction may occur with reintroduction of abacavir.
    • to not restart abacavir or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others.

    Lactic Acidosis/Hepatomegaly with Steatosis
    Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking abacavir if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity[seeBoxed Warning,Warnings and Precautions (5.2)].

    Immune Reconstitution Syndrome
    Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when abacavir is started[seeWarnings and Precautions (5.3)].

    Redistribution/Accumulation of Body Fat
    Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time[seeWarnings and Precautions (5.4)].

    Pregnancy Registry
    Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy[seeUse in Specific Populations (8.1)].

    Lactation
    Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk[seeUse in Specific Populations (8.2)].

    Missed Dose
    Instruct patients that if they miss a dose of abacavir, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose[seeDosage and Administration (2)].

    Availability of Medication Guide
    Instruct patients to read the Medication Guide before starting abacavir and to re-read it each time the prescription is renewed. Instruct patients to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.



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