ABACAVIR tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Major Pharmaceuticals

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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: 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 U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. The rate of miscarri

Produktbesonderheiten:

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:                Cartons of 30 tablets (10 tablets per blister card x 3), NDC 0904-6874-04        

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

ABACAVIR- abacavir tablet, film coated
Major Pharmaceuticals
----------
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 abacav

Fachinformation

ABACAVIR- ABACAVIR TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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._
•
•
•
•
•
•
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 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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg scored (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
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)
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