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:

Redpharm Drug, 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)] .  Pre

Product summary:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, containing 200 mg FTC and 300 mg TDF, are white to off-white, modified capsule shaped, film-coated tablets, debossed with ‘I’ on one side and ‘37’ on the other side.            Bottles of 30                             NDC 65862-354-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR
DISOPROXIL FUMARATE TABLET, FILM COATED
Redpharm Drug, Inc.
----------
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 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 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 f

Summary of Product characteristics

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
REDPHARM DRUG, 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
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 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)
INDICATIONS AND USAGE
HIV-1 Treatment ( 1.1)
Emtricitabine and tenofovir disoproxil fumarate tablets are a two-drug
combination of emtricitabine (FTC)
and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog
reverse transcriptase inhibitors, and
is indicated:
in combination with other antir