EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Golden State Medical Supply, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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

Prehľad produktov:

The white colored, 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), tablets engraved TE on one side and plain on the other side., and are available in unit of use bottles (75CC), containing a dessicant [silica gel canister or sachet] and closed with a child-resistant closure/screw cap of:

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

FUMARATE TABLET
Golden State Medical Supply, Inc.
----------
MEDICATION GUIDE
Medication Guide
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
(em tri SIT uh bean and te NOE' fo veer dye soe PROX il FYOU mar ate)
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 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 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 Tablet 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 health often and do blood

Súhrn charakteristických

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS.
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 200 MG/300 MG,
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 Teno