TENOFOVIR DISOPROXIL FUMARATE- tenofovir disoproxil fumarate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, 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 tablets are 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. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection: - Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA® , COMPLERA® , DESCOVY® , GENVOYA® , ODEFSEY® , STRIBILD® , TRUVADA® , or VEMLIDY® [see Warnings and Precautions (5.4) ]. Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HBV infection: - The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced w

Product summary:

Tenofovir disoproxil fumarate tablets are available as follows: 300 mg – light-blue to blue, modified capsule-shaped, film-coated tablets, debossed with “TV” on one side of the tablet and “7104” on the other side, in unit of use bottles of 30 (containing a desiccant and closed with a child-resistant closure) (NDC 0093-7104-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TENOFOVIR DISOPROXIL FUMARATE- TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
TEVA PHARMACEUTICALS USA, 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: 2001
WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS 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 THESE PATIENTS. IF APPROPRIATE, RESUMPTION OF
ANTI-HEPATITIS B THERAPY MAY BE
WARRANTED. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1.1) 04/2017
Boxed Warning, Lactic Acidosis/Severe Hepatomegaly With Steatosis
Removed 04/2017
Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly With
Steatosis (5.3) 04/2017
Warnings and Precautions, Coadministration With Other Products (5.4)
04/2017
Warnings and Precautions, Fat Redistribution Removed 04/2017
INDICATIONS AND USAGE
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1
reverse transcriptase inhibitor and an HBV reverse
transcriptase inhibitor. (1)
Tenofovir disoproxil fumarate tablets are 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. (1)
Tenofovir disoproxil fumarate tablets are indicated for the treatment
of chronic hepatitis B in adults and pediatric
patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Recommended dose for the treatment of HIV-1 or chronic hepatitis B 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. (2.1)
Recommended dose for the treatment of HIV-1 in ped