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:

Laurus Labs Limited

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-exper

Product summary:

Tenofovir disoproxil fumarate tablets 300 mg are supplied as blue colored, oval shaped, film-coated, and debossed with “LA16” on one side and plain on the other, containing 300 mg of tenofovir DF, which is equivalent to 245 mg of tenofovir disoproxil. These are packaged as follows: Bottle of 30                               NDC 42385-901-03 Bottle of 500                            NDC 42385-901-50 Store Tenofovir disoproxil fumarate tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C  (59° to 86°F) [see USP Controlled Room Temperature]. Keep the bottle tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TENOFOVIR DISOPROXIL FUMARATE - TENOFOVIR DISOPROXIL FUMARATE TABLET,
FILM COATED
LAURUS LABS LIMITED
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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 is a nucleotide analog HIV-1 reverse
transcriptase inhibitor and an HBV reverse
transcriptase inhibitor.
• 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