ABACAVIR tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Camber Pharmaceuticals, Inc.

INN (Nome Internazionale):

ABACAVIR SULFATE

Composizione:

ABACAVIR 300 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablet 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 major birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR

Dettagli prodotto:

Abacavir tablets, USP containing abacavir sulfate, USP equivalent to 300 mg abacavir are yellow colored, biconvex, capsule shaped, film coated tablets debossed with 'H' on one side and '139' on other side separating 13 & 9 with score line. They are packaged as follows: Bottles of 60 tablets (NDC 31722-557-60) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Abacavir Tablets, USP
(ah-BAH-kah-veer)What is the most important information I should know
about abacavir tablets?
Abacavir can cause serious side effects, including:
•Serious allergic reaction (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 tablets 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, 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
tablets again, start taking it when you a

Scheda tecnica

ABACAVIR - ABACAVIR TABLET
CAMBER PHARMACEUTICALS, INC.
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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 USP, 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 TABLETS. (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 TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A PRIOR
HYPERSENSITIVITY REACTION TO ABACAVIR AND IN
HLA-B*5701-POSITIVE PATIENTS. (4)
• DISCONTINUE ABACAVIR TABLETS AS SOON AS A HYPERSENSITIVITY
REACTION IS SUSPECTED. REGARDLESS OF HLA-
B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR TABLETS IF
HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN
WHEN OTHER DIAGNOSES ARE POSSIBLE. (5.1)
• FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART
ABACAVIR TABLET 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 tablet, 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