EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Treatment of HIV-1 Infection 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)]. 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) 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)]. 8.1 PregnancyPregnancy Exposure Registry There is a pregnancy exposure registry that monitors pr

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: 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]. Keep container tightly closed Dispense only in original container

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and
tenofovir
disoproxil fumarate tablet, film coated
DIRECT RX
----------
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 p

Summary of Product characteristics

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
DIRECT RX
----------
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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
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 with both
clinical and
laboratory follow-up for at least several months in individuals who
are infected with
HBV and discontinue emtricitabine and tenofovir disoproxil fumarate.
If
appropriate, anti-hepatitis B therapy may be warranted [see Warnings
and
Precautions (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 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-1
infection are present unless negative infection status is confirmed
[see Warnings
and Precautions (5.2)].
1.1 Treatment of HIV-1 Infection
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)].
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
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