TENOFOVIR DISOPROXIL FUMARATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

TENOFOVIR DISOPROXIL FUMARATE

Composition:

TENOFOVIR DISOPROXIL FUMARATE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 10 kg. Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older Pediatric use information is approved for Gilead Sciences, Inc.'s VIREAD® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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

Product summary:

Tenofovir Disoproxil Fumarate Tablets 300 mg are white circular film-coated convex tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, engraved TDF on one side and plain on other side and are available in a 40 cc/ 50 cc HDPE container containing a desiccant (silica gel sachet) and closed with child-resistant screw cap. NDC: 70518-1002-00 NDC: 70518-1002-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 4 in 1 BLISTER PACK 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 the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET
REMEDYREPACK INC.
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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 DATE: 2001
WARNINGS: 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)
RECENT MAJOR CHANGES
Indications and Usage, Chronic Hepatitis B (1.2) 12/2018
Dosage and Administration (2.1, 2.2, 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
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse
transcriptase inhibitor and an HBV
reverse transcriptase inhibitor and is indicated: (1)
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 10 kg.
(1.1)
for the treatment of chronic hepatitis B in adults and pediatric
patients 12 years and older. (1.2)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating Tenofovir disoproxil fumarates
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)
R