ABACAVIR- abacavir sulfate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)

Available from:

Aurobindo Pharma Limited

INN (International Name):

ABACAVIR SULFATE

Composition:

ABACAVIR 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir oral solution, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir oral solution is contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)] . - with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1)]. - with moderate or severe hepatic impairment [see Use in Specific Populations (8.6)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACD

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ABACAVIR - ABACAVIR SULFATE SOLUTION
Aurobindo Pharma Limited
----------
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 be

Summary of Product characteristics

ABACAVIR - ABACAVIR SULFATE SOLUTION
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR ORAL
SOLUTION.
ABACAVIR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1998
WARNING: HYPERSENSITIVITY REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED
WITH ABACAVIR. (5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1)
PATIENTS WHO CARRY THE HLA-B 5701 ALLELE ARE AT A HIGHER RISK OF
EXPERIENCING A HYPERSENSITIVITY
REACTION TO ABACAVIR. (5.1)
ABACAVIR IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY
REACTION TO ABACAVIR AND IN HLA-
B*5701-POSITIVE PATIENTS. (4)
DISCONTINUE ABACAVIR AS SOON AS A HYPERSENSITIVITY REACTION IS
SUSPECTED. REGARDLESS OF HLA-B 5701
STATUS, PERMANENTLY DISCONTINUE ABACAVIR IF HYPERSENSITIVITY CANNOT BE
RULED OUT, EVEN WHEN OTHER
DIAGNOSES ARE POSSIBLE. (5.1)
FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
ABACAVIR OR ANY OTHER ABACAVIR-
CONTAINING PRODUCT. (5.1)
INDICATIONS AND USAGE
Abacavir, a nucleoside analogue human immunodeficiency virus (HIV-1)
reverse transcriptase inhibitor, is indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
Before initiating abacavir oral solution, screen for the HLA-B*5701
allele. (2.1)
Adults: 600 mg daily, administered as either 300 mg twice daily or 600
mg once daily. (2.2)
Pediatric Patients Aged 3 Months and Older: Administered either once
or twice daily. Dose should be calculated on
body weight (kg) and should not exceed 600 mg daily. (2.3)
Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg
twice daily. (2.4)
DOSAGE FORMS AND STRENGTHS
Oral Solution: 20 mg per mL (3)
CONTRAINDICATIONS
Presence of HLA-B*5701 allele. (4)
Prior hypersensitivity reaction to abacavir.