EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Lupin Pharmaceuticals, Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 and 100 tablets with child-resistant closure as follows:   Store at 25  C (77  F); excursions permitted to 15º to 30 C (59  to 86  F) [See USP Controlled Room Temperature].  

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM COATED
Lupin Pharmaceuticals, 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 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 tablets are 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

Termékjellemzők

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
LUPIN 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 tablets
for HIV-1 PrEP (2.2)
06/2020
W