ABACAVIR tablet, film coated

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 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets are 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 MACDP as the

Product summary:

Abacavir tablets USP, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, coated tablet, debossed with ‘D’ and ‘88’ on either side of the score line on one side and plain with a score line on other side. They are packaged as follows:                Bottles of 60                                                     NDC 65862-073-60                Store at 20° to 25 °C (68° to 77 °F); excursions permitted to 15 ° to 30 °C (59 ° to 86 °F) [see USP Controlled Room Temperature ].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Abacavir Tablets USP
(a bak' a vir)
What is the most important information I should know about abacavir
tablets?
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 hours you may get life-threatening symptoms
that may include very 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

Summary of Product characteristics

ABACAVIR - ABACAVIR TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABACAVIR TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR
TABLETS.
ABACAVIR TABLETS, FOR ORAL USE
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 tablets, a nucleoside analogue human immunodeficiency virus
(HIV-1) reverse transcriptase
inhibitor, are indicated in combination with other antiretroviral
agents for the treatment of HIV-1 infection.
(1)
DOSAGE AND ADMINISTRATION
Before initiating abacavir, 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
Tablets: 300 mg scored (3)
CONTRAINDICATIONS
Presence of HLA-B*5701 allele. (4)
Prior hypersensitivity reaction to abacavir. (4)
Moderate