TENOFOVIR DISPROXIL 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:

Macleods Pharmaceuticals 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 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 tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 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 populati

Product summary:

Tenofovir disoproxil fumarate tablets are available in bottles containing 30 tablets with child-resistant closure as follows: • 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil): tablets are blue coloured, oval shaped, biconvex, film coated tablets are debossed with 'CL 77' on one side and plain on the other side, and are available in unit of use bottles (containing a desiccant [silica gel sachet] and closed with a child-resistant closure) of:30 tablets (NDC 33342-096-07) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TENOFOVIR DISPROXIL FUMARATE - TENOFOVIR DISPROXIL FUMARATE TABLET
MACLEODS PHARMACEUTICALS 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 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 TABLETS. HEPATIC FUNCTION SHOULD BE MONITORED
CLOSELY IN HBV-
INFECTED PATIENTS WHO DISCONTINUE TENOFOVIR DISOPROXIL FUMARATE
TABLETS. 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
Tenofovir disoproxil fumarate tablets are 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 10 kg. (1.1)
• for the treatment of chronic hepatitis B in adults and pediatric
patients 2 years and older weighing at
least 10 kg.(1.2)
DOSAGE AND ADMINISTRATION
• Testing: Prior to or when initiating tenofovir disoproxil fumarate
tablets test for hepatitis B virus infection
and HIV-1 infection. Prior to initiation and during use of tenofovir
disoproxil fumarate tablets, on a clinically
appropriate schedule, assess serum creatinine, estimated creatinine
clearance, urine glucose, and urine
protein in all patient