SOFOSBUVIR AND VELPATASVIR- velpatasvir and sofosbuvir tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VELPATASVIR (UNII: KCU0C7RS7Z) (VELPATASVIR - UNII:KCU0C7RS7Z), SOFOSBUVIR (UNII: WJ6CA3ZU8B) (SOFOSBUVIR - UNII:WJ6CA3ZU8B)

Available from:

Asegua Therapeutics LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2, 2.3, 2.4) and Clinical Studies (14)] : - without cirrhosis or with compensated cirrhosis - with decompensated cirrhosis for use in combination with ribavirin. Sofosbuvir and velpatasvir and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see Dosage and Administration (2.2, 2.3, 2.4)]. Risk Summary If sofosbuvir and velpatasvir is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Refer to the ribavirin prescribing information for more information on ribavirin-associated risks of use during pregnancy. No adequate human data are available to establish wheth

Product summary:

Each sofosbuvir and velpatasvir tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir, is pink, diamond-shaped, film-coated, debossed with "ASE" on one side and "9761" on the other. Each carton contains 28 tablets (2 blister cards each containing 14 tablets) (NDC 72626-2701-1). Store below 30 °C (86 ºF).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

SOFOSBUVIR AND VELPATASVIR- VELPATASVIR AND SOFOSBUVIR TABLET, FILM
COATED
ASEGUA THERAPEUTICS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOFOSBUVIR AND
VELPATASVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SOFOSBUVIR AND VELPATASVIR TABLETS.
SOFOSBUVIR AND VELPATASVIR TABLETS, FOR ORAL USE, 400 MG/100 MG
(AUTHORIZED GENERIC OF
EPCLUSA )
INITIAL U.S. APPROVAL: 2016
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED
WITH
HCV AND HBV
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATITIS B VIRUS (HBV) REACTIVATION HAS BEEN REPORTED, IN SOME CASES
RESULTING IN
FULMINANT HEPATITIS, HEPATIC FAILURE, AND DEATH. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1)
06/2021
Dosage and Administration
Recommended Treatment Regimen and Duration in Patients 3 Years of Age
and
Older (2.2)
06/2021
Recommended Dosage in Pediatric Patients 3 Years of Age and Older
(2.4)
06/2021
Preparation and Administration of Sofosbuvir and Velpatasvir (EPCLUSA)
Oral
Pellets (2.5)
06/2021
INDICATIONS AND USAGE
Sofosbuvir and velpatasvir is a fixed-dose combination of sofosbuvir,
a hepatitis C virus (HCV) nucleotide
analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A
inhibitor, and is indicated for the
treatment of adults and pediatric patients 3 years of age and older
with chronic HCV genotype 1, 2, 3, 4, 5,
or 6 infection (1):
without cirrhosis or with compensated cirrhosis
with decompensated cirrhosis for use in combination with ribavirin.
DOSAGE AND ADMINISTRATION
Testing prior to the initiation of therapy: Test all patients for HBV
infection by measuring HBsAg and
anti-HBc. (2.1)
See recommended treatment regimen and duration in patients 3 years of
age and older with
genotypes 1, 2, 3, 4, 5, or 6 HCV in table below: (2.2)
PATIENT POPULATION
REGIMEN AND DURATION
*
Treatment-naïve and treatment-experienced ,
without cirrhosis and with compensated cirrhosis
(Child-Pugh A)
Sofosbuvir and velpat