EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Exelan Pharmaceuticals, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 35 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 for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)] . Emtricitabine and tenofovir disoproxil fumarate 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 fumarate during

Ապրանքի ամփոփագիր:

The blue coloured, capsule-shaped, biconvex 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 "C209" on one side and plain on other side, and are available in unit of use bottles (containing a dessicant [silica gel] and closed with a CRC closure) of: Store at 20° to 25°C (68° to 77 °F) (see USP Controlled Room Temperature).

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM COATED
Exelan Pharmaceuticals, Inc.
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MEDICATION GUIDE
Emtricitabine (em tri sit' uh bean) and Tenofovir disoproxil fumarate
(te noe' fo veer) Tablets 200/300mg
Read this Medication Guide before you start taking emtricitabine and
tenofovir disoproxil fumarate 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 is
Emtricitabine and tenofovir disoproxil
fumarate tablet?" 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, 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. If
you have HBV infection and take emtricitabine and tenofovir disoproxil
fumarate, your HBV may
get worse (flare-up) if you stop taking emtricitabine and tenofovir
disoproxil fumarate. 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
tablets are all gone.
•
Do not stop taking Emtricitabine and tenofovir disoproxil 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 health often a

Ապրանքի հատկությունները

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
EXELAN PHARMACEUTICALS, 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
for HIV-1 PrEP (2.2) 06/2020
Warnings