EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

DirectRx

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)]. 8.1 Pregnancy Teratogenic Effects Pregnancy Exposure Registry: There is a pregnancy e

Produktbesonderheiten:

Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 and 100 tablets with child-resistant closure as follows: 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) tablets are white, capsule shaped, biconvex, film-coated, debossed with "LU" on one side and "Q31" on the other side. Bottles of 30 68180-287-06 Bottles of 100 68180-287-01 Store at 25 C (77 F); excursions permitted to 15º to 30 C (59 to 86 F) [See USP Controlled Room Temperature]. Keep container tightly closed Dispense only in original container

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and
tenofovir
disoproxil fumarate tablet, film coated
DirectRx
----------
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
tablets, your healthcare provider

Fachinformation

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
DIRECTRX
----------
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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)].
2.1 Testing Prior to Initiation of Emtricitabine and Tenofovir
Disoproxil Fumarate Tablets
for Treatment of HIV-1 Infection or for HIV-1 PrEP
Prior to or when initiating emtricitabine and tenofovir disoproxil
fumarate tablets, test
individuals for hepatitis B virus infection [see Warnings and
Precautions (5.1)].
Prior to initiation and during use of emtricitabine and tenofovir
disoproxil fumarate
tablets, on a clinically appropriate schedule, assess serum
creatinine, estimated
creatinine clearance, urine glucose and urine protein in all
individuals. In individuals with
chronic kidney disease, also assess serum phosphorus [see Warnings and
Precautions
(5.3)].
2.2 HIV-1 Screening for Individuals Receiving Emtricitabine and
Tenofovir Disoproxil
Fumarate Tablets for HIV-1 PrEP
Screen all individual for HIV-1 infection immediately prior to
initiating emtricitabine and
tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once
every 3 months
while taking emtricitabine and tenofovir disoproxil fumarate tablets,
and upon diagnosis
of any other sexually transmitted infections (STIs) [