ABACAVIR tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Abacavir tablets USP 300 mg, 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 sulfate 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 miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown. In animal reproduction studies, oral administration of abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (AUC) at the recommended clinical daily dose. However, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (AUC) at the recommended clinical dose (see Data) . Data Human Data: Based on prospective reports to the APR of exposures to abacavir during pregnancy resulting in live births (including over 1,300 exposed in the first trimester and over 1,300 exposed in second/third trimester), there was no difference between the overall risk of birth defects for abacavir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of defects in live births was 3.2% (95% CI: 2.3% to 4.3%) following first trimester exposure to abacavir-containing regimens and 2.9% (95% CI: 2.1% to 4.0%) following second/third trimester exposure to abacavir-containing regimens. Abacavir has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see Clinical Pharmacology ( 12.3)] . Animal Data: Abacavir was administered orally to pregnant rats (at 100, 300, and 1,000 mg per kg per day) and rabbits (at 125, 350, or 700 mg per kg per day) during organogenesis (on Gestation Days 6 through 17 and 6 through 20, respectively). Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) or developmental toxicity (decreased fetal body weight and crown-rump length) were observed in rats at doses up to 1,000 mg per kg per day, resulting in exposures approximately 35 times the human exposure (AUC) at the recommended daily dose. No developmental effects were observed in rats at 100 mg per kg per day, resulting in exposures (AUC) 3.5 times the human exposure at the recommended daily dose. In a fertility and early embryo-fetal development study conducted in rats (at 60, 160, or 500 mg per kg per day), embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) or toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at doses up to 500 mg per kg per day. No developmental effects were observed in rats at 60 mg per kg per day, resulting in exposures (AUC) approximately 4 times the human exposure at the recommended daily dose. Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. In pregnant rabbits, no developmental toxicities and no increases in fetal malformations occurred at up to the highest dose evaluated, resulting in exposures (AUC) approximately 9 times the human exposure at the recommended dose. Risk Summary The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Abacavir is present in human milk. There is no information on the effects of abacavir on the breastfed infant or the effects of the drug on milk production. Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving abacavir tablets. The safety and effectiveness of abacavir sulfate have been established in pediatric patients aged 3 months and older. Use of abacavir sulfate is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir sulfate in adults and pediatric subjects [see Dosage and Administration ( 2.3), Adverse Reactions ( 6.2), Clinical Pharmacology ( 12.3), Clinical Studies ( 14.2)] . Clinical trials of abacavir sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of abacavir sulfate in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. A dose reduction is required for patients with mild hepatic impairment (Child-Pugh Class A) [see Dosage and Administration ( 2.4)] . The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate or severe hepatic impairment; therefore, abacavir sulfate is contraindicated in these patients [see Contraindications ( 4), Clinical Pharmacology ( 12.3)] .

Produktsammanfattning:

Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are yellow colored, capsule shaped, biconvex, film coated tablets, having scoreline on both sides with "5" and "14" debossed on either side of scoreline on one side. They are packaged as follows: NDC: 70518-1274-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

REMEDYREPACK INC.
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MEDICATION GUIDE
Abacavir (a-BAK-a-vir) Tablets
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
tablet 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 abacavirtablets, call your
healthcare provider right away to find out if you should stop taking
abacavir tablets.
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 tablets, 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 are
around medical help or people who can call a healthcare provider if
you need one.
What is abacavir tablets?
Abacavir tablet is a prescription HIV-1 (Human Immunodeficiency Virus
type 1) medicine used with
other antiret

Produktens egenskaper

ABACAVIR- ABACAVIR TABLET, FILM COATED
REMEDYREPACK 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, 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
OCCURREDWITH ABACAVIR
SULFATE. ( 5.1)
HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (
5.1)
PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGHER RISK OF
EXPERIENCING A
HYPERSENSITIVITY REACTION TO ABACAVIR. ( 5.1)
ABACAVIR TABLETIS 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 TABLETS OR
ANY OTHER ABACAVIR-CONTAINING PRODUCT. ( 5.1)
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 tablets, 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 hyperse