TENOFOVIR DISOPROXIL FUMARATE tablet, coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Quinn Pharmaceuticals

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Tenofovir disoproxil fumarate 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 2 years of age and older weighing at least 35 kg. Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 35 kg. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate 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 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 Metropoli

Product samenvatting:

Tenofovir disoproxil fumarate tablets, 300 mg, are almond-shaped, blue, film-coated tablets containing 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil, and are debossed with “32” on one side. Each bottle contains 30 tablets and a desiccant (silica gel canister or sachet), and is closed with a child-resistant closure (NDC 69076-105-03). Store tenofovir disoproxil fumarate tablets at 25°C (77°F), excursions permitted to 15-30°C(59-86°F) (see USP Controlled Room Temperature). • Keep container tightly closed. • Dispense only in original container. • Do not use if seal over bottle opening is broken or missing.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET,
COATED
QUINN PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TENOFOVIR DISOPROXIL
FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR TENOFOVIR
DISOPROXIL FUMARATE TABLETS. 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 TENOFOVIR
DISOPROXIL FUMARATE. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN
HBV-INFECTED
PATIENTS WHO DISCONTINUE TENOFOVIR DISOPROXIL FUMARATE. IF
APPROPRIATE, RESUMPTION OF
ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. ( 5.1)
INDICATIONS AND USAGE
Tenofovir disoproxil fumarate 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 2 years of age and older weighing at least 35 kg. (
1.1)
for the treatment of chronic hepatitis B in adults and pediatric
patients 2 years and older weighing at
least 35 kg. ( 1.2)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating tenofovir disoproxil fumarate
test for hepatitis B virus infection and
HIV-1 infection. Prior to initiation and during use of tenofovir
disoproxil fumarate, 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 weighing at
least 35 kg: One tenofovir
disoproxil fumarate 300 mg tablet once daily taken orally without
regard to food. ( 2.2)
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