VIREAD ACCESS- tenofovir disoproxil fumarate tablet, coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Verfügbar ab:

Gilead Sciences, Inc

INN (Internationale Bezeichnung):

TENOFOVIR DISOPROXIL FUMARATE

Zusammensetzung:

TENOFOVIR DISOPROXIL FUMARATE 300 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

VIREAD™ is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older. VIREAD is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VIREAD during pregnancy. Healthcare providers are encouraged to register patients on the worldwide Antiretroviral Pregnancy Register (APR) at www.apregistry.com/. Risk Summary Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data). The rate of miscarriage for individual drugs is

Produktbesonderheiten:

VIREAD tablets, 300 mg, are almond-shaped, white, film-coated tablets containing 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with "GILEAD" and "4331" on one side. VIREAD tablets are available in bottles of 30 tablets or 7 tablets. Each bottle also contains a desiccant (silica gel canister or sachet) and is closed with a child-resistant closure. Store below 30 °C (86 °F). Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.

Berechtigungsstatus:

Export only

Fachinformation

VIREAD ACCESS- TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED
GILEAD SCIENCES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIREAD SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIREAD.
GILEAD ACCESS PROGRAM
VIREAD™ (TENOFOVIR DISOPROXIL FUMARATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B VIRUS (HBV) HAVE BEEN
REPORTED IN HBV-
INFECTED PATIENTS WHO HAVE DISCONTINUED ANTI-HEPATITIS B THERAPY,
INCLUDING VIREAD.
HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN HBV-INFECTED PATIENTS,
WHO
DISCONTINUE VIREAD. IF APPROPRIATE, RESUMPTION OF ANTI-HEPATITIS B
THERAPY MAY BE
WARRANTED. (5.1)
RECENT MAJOR CHANGES
Indications and Usage Chronic Hepatitis B (1.2)
12/2018
Dosage and Administration (2.1, 2.2, 2.3, 2.4)
12/2018
Warnings and Precautions, (5.1, 5.2, 5.5, 5.7)
12/2018
Early Virologic Failure
_Removed_ 12//2018
INDICATIONS AND USAGE
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor
and an HBV reverse transcriptase
inhibitor and is indicated:
in combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and
pediatric patients 12 years of age and older. (1.1)
for the treatment of chronic hepatitis B in adults and pediatric
patients 12 years of age and older. (1.2)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating VIREAD test for hepatitis B virus
infection and HIV-1 infection. Prior to
initiation and during use of VIREAD, on a clinically appropriate
schedule, assess serum creatinine,
estimated creatinine clearance, urine glucose, and urine protein in
all patients. In patients with chronic
kidney disease, also assess serum phosphorous. (2.1)
Recommended tablet dosage in adults and pediatric patients 12 years of
age and older (35 kg or
more): 300 mg once daily taken orally without regard to food. (2.2)
Reco