Prescription Drug Information: Abacavir (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Abacavir Oral Solution USP: It is a clear to opalescent, yellowish, strawberry-banana-flavored liquid. Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir. It is packaged in opaque bottles with child-resistant closure. This product does not require reconstitution.

Bottles of 240 mL NDC 65862-089-24

Store at 20 ° to 25 °C (68° to 77 °F). [see USP Controlled Room Temperature ]. DO NOT FREEZE. May be refrigerated.

17 PATIENT COUNSELING 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 [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.
  • 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 [see 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 [see Warnings and Precautions (5.3)].

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, 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 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.

MEDICATION GUIDE

Abacavir Oral Solution USP
(a bak’ a vir)

What is the most important information I should know about abacavir oral solution?
Abacavir oral solution can cause serious side effects, including:

  • Serious allergic reactions (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 or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or 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 hours you may get life-threatening symptoms that may include very 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 oral solution, 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.

What is abacavir oral solution?

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 oral solution 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 oral solution 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.

Who should not take abacavir oral solution?

Do not take abacavir oral solution 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 oral solution.
  • are allergic to abacavir or any of the ingredients in abacavir oral solution. See the end of this Medication Guide for a complete list of ingredients in abacavir oral solution.
  • have liver problems.

What should I tell my healthcare provider before taking abacavir oral solution?

Before you take abacavir oral solution, 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 oral solution.
  • 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 oral solution. 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 oral solution. 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 oral solution 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 oral solution.
  • 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.
  • 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 oral solution. 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 oral solution can cause serious side effects including:
  • See “What is the most important information I should know about abacavir oral solution?”
  • 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
    • 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 problems can happen in people who take abacavir oral solution. 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 oral solution. 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 or very overweight (obese).
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when your 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 oral solution.
  • Heart attack (myocardial infarction). Some HIV-1 medicines including abacavir oral solution may increase your risk of heart attack.

The most common side effects of abacavir oral solution in adults include:

  • nausea
  • headache
  • generally not feeling well
  • tiredness
  • vomiting
  • bad dreams or sleep problems

The most common side effects of abacavir oral solution in children include:

  • fever and chills
  • nausea
  • vomiting
  • rash
  • ear, nose, or throat infections

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 oral solution. 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 oral solution?

  • 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 oral solution

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir oral solution for a condition for which it was not prescribed. Do not give abacavir oral solution 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 oral solution 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 oral solution?

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

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:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 06/2018

(Front of Card)

WARNING CARD

Abacavir Oral Solution USP

Patients taking abacavir oral solution 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 while taking abacavir oral solution, call your healthcare provider right away to find out if you should stop taking this medicine.

Symptom(s)
Group 1 Fever
Group 2 Rash
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)

WARNING CARD

Abacavir Oral Solution USP

If you must stop treatment with abacavir oral solution because you have had an allergic reaction to abacavir, NEVER take abacavir oral solution or another abacavir-containing medicine (EPZICOM® , TRIUMEQ ® , or 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 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.

Please read the Medication Guide for additional information on abacavir oral solution.

EPZICOM ® , TRIUMEQ ® , and TRIZIVIR ® are registered trademarks of the ViiV Healthcare group of companies.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 06/2018

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