VIREAD- tenofovir disoproxil fumarate tablet, coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Saatavilla:

Avera McKennan Hospital

INN (Kansainvälinen yleisnimi):

TENOFOVIR DISOPROXIL FUMARATE

Koostumus:

TENOFOVIR DISOPROXIL FUMARATE 300 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection: - VIREAD should not be used in combination with ATRIPLA® , COMPLERA® , STRIBILD® , or TRUVADA® [See Warnings and Precautions (5.4)] . VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection: - The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (14.2)]. - VIREAD was evalua

Tuoteyhteenveto:

VIREAD tablets, 300 mg, are almond-shaped, light blue, film-coated tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with "GILEAD" and "4331" on one side and with "300" on the other side. Each bottle contains 30 tablets, a desiccant (silica gel canister or sachet), and closed with a child-resistant closure. (NDC 61958-0401-1) NDC 69189-0401-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital Oral Powder VIREAD oral powder consists of white, coated granules containing 40 mg of tenofovir disoproxil fumarate, which is equivalent to 33 mg of tenofovir disoproxil, per gram of powder and is available in multi-use bottles containing 60 grams of oral powder, closed with a child-resistant closure, and co-packaged with a dosing scoop. (NDC 61958-0403-1) Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature). Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

VIREAD- TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED
AVERA MCKENNAN HOSPITAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIREAD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIREAD.
VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLETS, FOR ORAL USE
VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND POST
TREATMENT EXACERBATION OF HEPATITIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN REPORTED WITH
THE USE OF NUCLEOSIDE ANALOGS, INCLUDING VIREAD. (5.1)
SEVERE ACUTE EXACERBATIONS OF HEPATITIS HAVE BEEN REPORTED IN
HBV-INFECTED PATIENTS WHO HAVE
DISCONTINUED ANTI-HEPATITIS B THERAPY, INCLUDING VIREAD. HEPATIC
FUNCTION SHOULD BE MONITORED
CLOSELY IN THESE PATIENTS. IF APPROPRIATE, RESUMPTION OF
ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (5.2)
INDICATIONS AND USAGE
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor
and an HBV reverse transcriptase inhibitor.
VIREAD is indicated in combination with other antiretroviral agents
for the treatment of HIV-1 infection in adults and
pediatric patients 2 years of age and older. (1)
VIREAD is indicated for the treatment of chronic hepatitis B in adults
and pediatric patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Recommended dose for the treatment of HIV-1 or chronic hepatitis B in
adults and pediatric patients 12 years of age
and older (35 kg or more): 300 mg once daily taken orally without
regard to food. (2.1)
Recommended dose for the treatment of HIV-1 in pediatric patients (2
to less than 12 years of age):
Tablets: for pediatric patients weighing greater than or equal to 17
kg who can swallow an intact tablet, one VIREAD
tablet (150, 200, 250 or 300 mg based on body weight) once daily taken
orally without regard to food. (2.2)
Oral powder: 8 mg/kg VIREAD or