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ABACAVIR solution


  1. Patient Information
  2. Abacavir Can Cause Serious Side Effects, Including:
  3. Call Your Healthcare Provider Right Away If You Get Any Of The Following Symptoms That Could Be Signs Of Lactic Acidosis:
  4. Call Your Healthcare Provider Right Away If You Have Any Of The Following Signs Of Liver Problems:
  5. Abacavir Oral Solution 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).the Safety And Effectiveness Of Abacavir Has Not Been Established In Children Under 3 Months Of Age.when Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Oral Solution May Help:
  6. 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.are Allergic To Abacavir Or Any Of The Ingredients In Abacavir Oral Solution. Before You Take Abacavir Oral Solution, Tell Your Healthcare Providers If You:
  7. Tell Your Healthcare Provider If You Take:
  8. Medicines Are Sometimes Prescribed For Purposes Other Than Those Listed In A Medication Guide. Do Not Use Abacavir For A Condition For Which It Was Not Prescribed. Do Not Give Abacavir 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 That Is Written For Healthcare Professionals.what Are The Ingredients In Abacavir Oral Solution?
  9. Manufactured For:

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 oral solution, 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[see Warnings 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 oral solution.
that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir is not immediately discontinued.
to not restart abacavir oral solution 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 oral solution to avoid restarting abacavir.
that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir oral solution is stopped right away.
that if they have interrupted abacavir oral solution 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 oral solution 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 oral solution if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity[see Boxed 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 oral solution is started[see Warnings 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.[see Warnings 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[see Use 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[see Use in Specific Populations (8.2)].
Missed Dose
Instruct patients that if they miss a dose of abacavir oral solution, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose[see Dosage and Administration (2)].
Availability of Medication Guide
Instruct patients to read the Medication Guide before starting abacavir oral solution 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.
The other brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse the Hetero Labs Limited or its products.

Abacavir Can Cause Serious Side Effects, Including: 


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



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 oral solution because of an allergic reaction, never take abacavir oral solution or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, and TRIZIVIR) again.
If you have an allergic reaction, dispose of any unused abacavir oral solution. Ask your pharmacist how to properly dispose of medicines.
If you take abacavir oral solution 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 oral solution for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking abacavir oral solution 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 abacavir oral solution 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 abacavir oral solution. 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 problemscan happen in people who take abacavir. 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.

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) loss of appetite for several days or longer

Abacavir Oral Solution 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).the Safety And Effectiveness Of Abacavir Has Not Been Established In Children Under 3 Months Of Age.when Used With Other Antiretroviral Medicines To Treat Hiv-1 Infection, Abacavir Oral Solution 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 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.

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.are Allergic To Abacavir Or Any Of The Ingredients In Abacavir Oral Solution. Before You Take Abacavir Oral Solution, Tell Your Healthcare Providers 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.
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.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.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 with other medicines.

Tell Your Healthcare Provider If You Take: 


any other medicine to treat HIV-1
methadone
How should I take abacavir oral solution?
Take abacavir oral solution exactly as your healthcare provider tells you.

Do not change your dose or stop taking abacavir oral solution without talking with your healthcare provider. If you miss a dose of abacavir oral solution, 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.
Abacavir oral solution may be taken with or without food.
For children aged 3 months and older, your healthcare provider will prescribe a dose of abacavir oral solution based on your child s body weight.
Do not run out of abacavir. 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 oral solution, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of abacavir oral solution?
Abacavir can cause serious side effects including:

Store abacavir oral solution at room temperature, between 20 to 25 C (68 to 77 F).
Do not freeze abacavir oral solution. You may store abacavir oral solution in a refrigerator.
Keep abacavir oral solution and all medicines out of the reach of children.
General information for safe and effective use of abacavir

Medicines Are Sometimes Prescribed For Purposes Other Than Those Listed In A Medication Guide. Do Not Use Abacavir For A Condition For Which It Was Not Prescribed. Do Not Give Abacavir 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 That Is Written For Healthcare Professionals.what Are The Ingredients In Abacavir Oral Solution? 


Active ingredient: abacavir sulfate USP
Inactive ingredients: anhydrous citric acid, methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), noncrystallizing sorbitol solution, strawberry and banana flavors and water.

All brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited.

Manufactured For: 



AbacavirOSaddress2

Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854


Manufactured by:
HETERO LABS LIMITED
22-110, I.D.A., Jeedimetla,
Hyderabad 500 055, India.


This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 08/2017



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