ABACAVIR SULFATE 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:

Apotex Corp

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 a

Product summary:

Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows: Bottles of 60 tablets (NDC 60505-3583-6). Unit Dose packs of 60 tablets (NDC 60505-3583-0). Each pack contains 6 blister cards of 10 tablets each. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Apotex Corp
----------
MEDICATION GUIDE
Abacavir Tablets, USP
(A bak' a vir)
What is the most important information I should know about abacavir
tablets?
Abacavir can cause serious side effects, including:
•
Serious allergic reactions (hypersensitivity reaction) that can cause
death have happened with
abacavir 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 two 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 tablets or any other abacavir-
containing medicine (EPZICOM®, TRIUMEQ®, or TRIZIVIR®) again.
•
If you have an allergic reaction, dispose of any unused abacavir. 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, talk with your healthcare provider before taking it again.
Taking abacavir tablets 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
again, start taking it when you are around
medical help or people

Summary of Product characteristics

ABACAVIR SULFATE- ABACAVIR SULFATE TABLET, FILM COATED
APOTEX CORP
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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 TABLETS OR ANY OTHER
ABACAVIR-CONTAINING PRODUCT. (5.1)
RECENT MAJOR CHANGES
Boxed Warning 05/2018
Warnings and Precautions, Lactic Acidosis and Severe 05/2018
Hepatomegaly with Steatosis (5.2)
Warnings and Precautions, Fat Redistribution (previous 5.4) Removed
05/2018
Warnings and Precautions, Myocardial Infarction (5.4) 05/2018
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, 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 e