EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Emtricitabine and tenofovir disoproxil fumarate tablets are 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 tablets are 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 is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)] . Pregnancy  Exposure  Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

Product summary:

Emtricitabine and tenofovir disoproxil fumarate tablets are available as follows: 200 mg of emtricitabine and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil) - white to off-white, film-coated, modified capsule-shaped tablets, debossed with "TV" on one side of the tablet and with "C75" on the other side. Available in unit of use bottles of 30 (containing a desiccant [silica gel canister] and closed with a child-resistant closure), NDC 0093-7704-56. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FUMARATE TABLET, FILM COATED
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Emtricitabine and Tenofovir Disoproxil Fumarate
(em" trye sye′ ta been and ten of′ oh vir dye" soe prox′ il
fue′ ma rate) Tablets
Read this Medication Guide before you start taking emtricitabine and
tenofovir disoproxil fumarate
tablets and each time you get a refill. There may be new information.
This information does not take the
place of talking to your healthcare provider about your medical
condition or your treatment.
This Medication Guide provides information about two different ways
that emtricitabine and tenofovir
disoproxil fumarate tablets may be used. See the section “What are
emtricitabine and tenofovir disoproxil
fumarate tablets?” for detailed information about how emtricitabine
and tenofovir disoproxil fumarate
tablets may be used.
What is the most important information I should know about
emtricitabine and tenofovir disoproxil
fumarate tablets?
Emtricitabine and tenofovir disoproxil fumarate tablets can cause
serious side effects, including:
•
Worsening of hepatitis B virus infection (HBV). Your healthcare
provider will test you for HBV
before start or when you start treatment with emtricitabine and
tenofovir disoproxil fumarate
tablets. If you have HBV infection and take emtricitabine and
tenofovir disoproxil fumarate
tablets, your HBV may get worse (flare-up) if you stop taking
emtricitabine and tenofovir
disoproxil fumarate tablets. A “flare-up” is when your HBV
infection suddenly returns in a worse
way than before.
•
Do not run out of emtricitabine and tenofovir disoproxil fumarate
tablets. Refill your prescription
or talk to your healthcare provider before your emtricitabine and
tenofovir disoproxil fumarate
tablets is all gone.
•
Do not stop taking emtricitabine and tenofovir disoproxil fumarate
tablets without first talking to
your healthcare provider.
•
If you stop taking emtricitabine and tenofovir disoproxil fumarate
tablets, your healthcare provider
will need to check your hea

Summary of Product characteristics

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
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 TABLETS 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
TABLETS. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY IN THESE
INDIVIDUALS WHO
DISCONTINUE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS.
IF APPROPRIATE,
ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (5.1)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 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
TABLETS FOR HIV-1 PREP FOLLOWING UNDETECTED ACUTE HIV-1 INFECTION. DO
NOT INITIATE
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS 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) 06/202