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ABACAVIR AND LAMIVUDINE tablet, film coated


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

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 lamivudine 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 and lamivudine. 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 and lamivudine.
  • that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir and lamivudine is not immediately discontinued.
  • to not restart abacavir and lamivudine 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 and lamivudine to avoid restarting abacavir.
  • that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir and lamivudine is stopped right away.
  • that if they have interrupted abacavir and lamivudine 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 and lamivudine or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others.

Patients with Hepatitis B or C Co-infection


Advise patients co-infected with HIV-1 and HBV that worsening of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their physician[seeWarnings and Precautions (5.2)].


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 and lamivudine if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity[seeWarnings and Precautions (5.3)].

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 and lamivudine is started[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 and lamivudine 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 and lamivudine, 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 lamivudine 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.

What Is The Most Important Information I Should Know About Abacavir And Lamivudine Tablets? 

Abacavir and lamivudine tablets

Can Cause Serious Side Effects, Including: 


  • Serious allergic reactions (hypersensitivity reaction)that can cause death have happened with abacavir and lamivudine 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.

Ifyou get a symptom from 2 or more of the following groups while taking abacavir and lamivudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir and lamivudine 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 and lamivudine tablets because of an allergic reaction, never take abacavir and lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ, TRIZIVIR,or ZIAGEN) again.


  • If you have an allergic reaction, dispose of any unused abacavir and lamivudine tablets. Ask your pharmacist how to properly dispose of medicines.
  • If you take abacavir and lamivudine 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 and lamivudine tablets for any other reason, even for a few days, and you are not allergic to abacavir and lamivudine tablets, talk with your healthcare provider before taking them again. Taking abacavir and lamivudine 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 and lamivudine tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one.


  • 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 abacavir and lamivudine tablets. A '' flare-up'' is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death

  • Do not run out of abacavir and lamivudine tablets. Refill your prescription or talk to your healthcare provider before your abacavir and lamivudine tablets is all gone.
  • Do not stop abacavir and lamivudine tablets without first talking to your healthcare provider.
  • If you stop taking abacavir and lamivudine tablets, 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 abacavir and lamivudine tablets and become harder to treat (resistant).

What Are Abacavir And Lamivudine Tablets? 


Abacavir and lamivudine 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). Abacavir and lamivudine tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).


Abacavir and lamivudine tablets should not be used in children weighing less than 55 pounds (25 kg).

When Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir And Lamivudine Tablets May Help: 


1. reduce the amount of HIV-1 in your blood. This is called viral load .

2. 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 and lamivudine 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 And Lamivudine Tablets 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 and lamivudine tablets.
  • are allergic to abacavir or any of the ingredients in abacavir and lamivudine tablets.

Before You Take Abacavir And Lamivudine 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 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. 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 and lamivudine 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 and lamivudine 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 and lamivudine 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 and lamivudine tablets with other medicines.

Tell Your Healthcare Provider If You Take: 

  • any other medicine to treat HIV-1
  • medicines to treat hepatitis viruses such as interferon or ribavirin
  • methadone

How Should I Take Abacavir And Lamivudine Tablets? 


  • Take abacavir and lamivudine tablets exactly as your healthcare provider tells you.
  • Do not change your dose or stop taking abacavir and lamivudine tablets without talking with your healthcare provider. If you miss a dose of abacavir and lamivudine 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 and lamivudine tablets.
  • Abacavir and lamivudine tablets may be taken with or without food.
  • Tell your healthcare provider if your child has trouble swallowing abacavir and lamivudine tablets.
  • Do not run out of abacavir and lamivudine tablets. 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 abacavir and lamivudine, call your healthcare provider or go to the nearest hospital emergency room right away.

Abacavir And Lamivudine Tablets Can Cause Serious Side Effects Including: 


    • Build-upof acid in your blood (lactic acidosis).Lactic acidosis can happen in some people who take abacavir and lamivudine 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
      • 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

    • Seriousliverproblemscan happen in people who take abacavir and lamivudine 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).

    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
      • nausea
      • light-colored stools (bowel movements)
      • 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 abacavir and lamivudine tablets.

    • Heart attack (myocardial infarction).Some HIV-1 medicines including abacavir and lamivudine tablets may increase your risk of heart attack.

    The Most Common Side Effects Of Abacavir And Lamivudine Tablets Include: 

    • trouble sleeping
    • nausea
    • depression
    • diarrhea
    • headache
    • rash
    • tiredness
    • fever
    • dizziness

    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 abacavir and lamivudine tablets. 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 abacavir and lamivudine

    Tablets? 


    Active ingredients: abacavir sulfate and lamivudine


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


    Tablet film coating contains: Opadry Orange YS-1-13065-A that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.


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


    EPIVIR, 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 Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.


    Distributed by:
    Aurobindo Pharma USA, Inc.
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 038, India

    Revised: 07/2019



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