TRUVADA- emtricitabine and tenofovir disoproxil fumarate tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

INN (Διεθνής Όνομα):

EMTRICITABINE

Σύνθεση:

EMTRICITABINE 200 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

TRUVADA is 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)] . TRUVADA is 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 TRUVADA for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)] . TRUVADA 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 TRUVADA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of TRUVADA during pregnancy from observational s

Περίληψη προϊόντος:

Product: 50090-0870 NDC: 50090-0870-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-0870-2 5 TABLET, FILM COATED in a BOTTLE NDC: 50090-0870-3 3 TABLET, FILM COATED in a BOTTLE

Καθεστώς αδειοδότησης:

New Drug Application

Φύλλο οδηγιών χρήσης

A-S Medication Solutions
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: June 2020
Medication Guide
TRUVADA® (tru-VAH-dah)
(emtricitabine and tenofovir disoproxil fumarate)
tablets
Read this Medication Guide before you start taking TRUVADA 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 TRUVADA may be used. See
the section "What is TRUVADA?" for detailed information about how
TRUVADA may be used.
What is the most important information I should know about TRUVADA?
TRUVADA 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 TRUVADA. If you have HBV
infection and take
TRUVADA, your HBV may get worse (flare-up) if you stop taking TRUVADA.
A "flare-up" is
when your HBV infection suddenly returns in a worse way than before.
•
Do not run out of TRUVADA. Refill your prescription or talk to your
healthcare provider
before your TRUVADA is all gone.
•
Do not stop taking TRUVADA without first talking to your healthcare
provider.
•
If you stop taking TRUVADA, your healthcare provider will need to
check your health often
and do blood tests regularly for several months to check your HBV
infection, or give you a
medicine to treat hepatitis B. Tell your healthcare provider about any
new or unusual
symptoms you may have after you stop taking TRUVADA.
For more information about side effects, see the section "What are the
possible side effects of TRUVADA?".
Other important information for people who take TRUVADA to help reduce
their risk of getting human
immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure
prophylaxis or "PrEP":
Before taking TRUVADA to reduce your risk of getting HIV-1:
•
You must be HIV-1 neg

Αρχείο Π.Χ.Π.

TRUVADA- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM
COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRUVADA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRUVADA.
TRUVADA (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 TRUVADA 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 TRUVADA. HEPATIC FUNCTION SHOULD BE
MONITORED
CLOSELY IN THESE INDIVIDUALS WHO DISCONTINUE TRUVADA. IF APPROPRIATE
ANTI-HEPATITIS B
THERAPY MAY BE WARRANTED. (5.1)
TRUVADA 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 TRUVADA FOR
HIV-1 PREP FOLLOWING UNDETECTED ACUTE HIV-1 INFECTION. DO NOT INITIATE
TRUVADA 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 TRUVADA for HIV-1 PrEP (2.2)
06/2020
Warnings and Precautions
Comprehensive Management to Reduce the Risk of Sexually Transmitted
Infections,
Including HIV-1, and Development of HIV-1 Resistance When TRUVADA Is
Used for
HIV-1 PrEP (5.2)
06/2020
Immune Reconstitution Syndrome (5.4)
06/2020
INDICATIONS AND USAGE
HIV-1 Treatment (1.1)
TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir
disoproxil fumarate (TDF), both
HIV-1 nucleoside analog reverse transcriptase inhibitors, and is
in