EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated
Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Infovoldik
(PIL)
20-07-2020
Toote omadused
(SPC)
20-07-2020
Toimeaine:
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)
Saadav alates:
Amneal Pharmaceuticals NY LLC
Manustamisviis:
ORAL
Retsepti tüüp:
PRESCRIPTION DRUG
Näidustused:
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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate
Toote kokkuvõte:
Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 tablets with child-resistant closure as follows: They are available as follows: Bottles of 30: NDC 69238-1547-3 They are available as follows: Bottles of 30: NDC 69238-1549-3 They are available as follows: Bottles of 30: NDC 69238-1548-3 They are available as follows: Bottles of 30: NDC 69238-1527-3 Store at 20° to 25ºC (68° to 77ºF); excursions permitted between 15º to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature].
Volitamisolek:
Abbreviated New Drug Application
Infovoldik
FUMARATE TABLET, FILM COATED
Amneal Pharmaceuticals NY LLC
----------
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 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 chec
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Toote omadused
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- EMTRICITABINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS NY LLC
----------
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)
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 Tablets for
HIV-1 PrEP (2.2)
06/2020
Warnings and Precautions
Comprehensive Managemen
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