EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Active ingredient:

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

Available from:

A-S Medication Solutions

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 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 ta

Product summary:

Product: 50090-6494 NDC: 50090-6494-1 30 TABLET, FILM COATED in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

                                FUMARATE TABLET, FILM COATED
A-S Medication Solutions
----------
MEDICATION GUIDE
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 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 are all gone.
•
Do not stop taking emtricitabine and tenofovir disoproxil fumarate
tablets without
first talking to your healthcare provider.
•
If you taking emtricitabine and tenofovir disoproxil fumarate tablets,
your healthcare
provider will need to check your health ofte
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE - EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
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.
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
USE 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 for HIV-1 PrEP (2.2) 06/2020
Warnings and Precautions
Comprehensi
                                
                                Read the complete document
                                
                            

Search alerts related to this product