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:

Pharmasource Meds, LLC

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 for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.2)] . Preg

Product summary:

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) are white to off-white-colored, capsule-shaped, film-coated tablets, debossed with "1367" on one side and plain on other side and are supplied as follows: NDC 82982-068-03 in bottles of 3 tablets with child-resistant closure Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FUMARATE TABLET, FILM COATED
Pharmasource Meds, LLC
----------
Medication Guide
Emtricitabine (em" trye sye' ta been) and Tenofovir Disoproxil
Fumarate (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 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 fumarate
tablets, your
healthcare provider will need to check your health often and do blood
te

Summary of Product characteristics

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
PHARMASOURCE MEDS, LLC
----------
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, 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)
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
W