EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and tenofovir disoproxil fumarate tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Disponível em:

Camber Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14)] .  Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.2)] . Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.2)]

Resumo do produto:

The white to off-white, capsule shaped, film coated tablets contain 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil), are debossed with ‘H’ on one side and with ‘124’ on the other side, and are available in unit of use bottles [containing a dessicant (silica gel sachet) and closed with a child-resistant closure] of: • 30 tablets (NDC 31722-560-30) Store at 20° to 25°C (68° to 77°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.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE - EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLETS.
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B AND RISK OF
DRUG
RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
FOR
HIV-1 PRE-EXPOSURE PROPHYLAXIS (PREP) IN UNDIAGNOSED EARLY HIV-1
INFECTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• SEVERE ACUTE EXACERBATIONS OF HEPATITIS B (HBV) HAVE BEEN REPORTED
IN HBV-INFECTED
INDIVIDUALS WHO HAVE DISCONTINUED EMTRICITABINE AND TENOFOVIR
DISOPROXIL FUMARATE.
HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN THESE INDIVIDUALS WHO
DISCONTINUE
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE. IF APPROPRIATE,
ANTI-HEPATITIS B
THERAPY MAY BE WARRANTED. ( 5.1)
• EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE USED FOR HIV-1
PREP MUST ONLY BE
PRESCRIBED TO INDIVIDUALS CONFIRMED TO BE HIV-NEGATIVE IMMEDIATELY
PRIOR TO INITIATING
AND AT LEAST EVERY 3 MONTHS DURING USE. DRUG-RESISTANT HIV-1 VARIANTS
HAVE BEEN
IDENTIFIED WITH THE USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL
FUMARATE FOR HIV-1
PREP FOLLOWING UNDETECTED ACUTE HIV-1 INFECTION. DO NOT INITIATE
EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE FOR HIV-1 PREP IF SIGNS OR SYMPTOMS OF
ACUTE HIV
INFECTION ARE PRESENT UNLESS NEGATIVE INFECTION STATUS IS CONFIRMED. (
5.2)
RECENT MAJOR CHANGES
Indications and Usage
HIV-1 Pre-Exposure Prophylaxis (PrEP) (
1.2) 06/2020
Dosage and Administration
HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir
Disoproxil Fumarate Tablets for HIV-1
PrEP ( 2.2) 06/2020
Warnings and Precautions
Comprehens