STRENSIQ- asfotase alfa solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ASFOTASE ALFA (UNII: Z633861EIM) (ASFOTASE ALFA - UNII:Z633861EIM)

Beschikbaar vanaf:

Alexion Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

ASFOTASE ALFA

Samenstelling:

ASFOTASE ALFA 18 mg in 0.45 mL

Toedieningsweg:

SUBCUTANEOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). None. Risk Summary There are no available data on STRENSIQ use in pregnant women to inform a drug associated risk. In animal reproduction studies, asfotase alfa administered intravenously to pregnant rats and rabbits during the period of organogenesis showed no evidence of fetotoxicity, embryolethality or teratogenicity at doses causing plasma exposures up to 21 and 24 times, respectively, the exposure at the recommended human dose (see Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Asfotase alfa administered during the period of organogenesis to rats (from gestation Day 6 to Day 19 post-partum) and rabbits (on gestation days 7 to 19) at intravenous doses up to 50 mg/kg/day, approximately 21 and 24 times the human AUC of 65486 ng.h/mL

Product samenvatting:

STRENSIQ is supplied as a sterile, nonpyrogenic, preservative-free, clear, slightly opalescent or opalescent, colorless to slightly yellow aqueous solution; a few small translucent or white particles may be present. The product is available as single-dose vials in a carton of one (1) or twelve (12) vials at the following strengths: STRENSIQ vials must be stored in the original carton until the time of use under refrigerated conditions at 2°C to 8°C (36°F to 46°F) and protected from light. Once removed from refrigeration, STRENSIQ should be administered within 3 hours. Do not use beyond the expiration date stamped on the carton. DO NOT FREEZE OR SHAKE. Vials are for one time use only. Discard any unused product.

Autorisatie-status:

Biologic Licensing Application

Productkenmerken

STRENSIQ- ASFOTASE ALFA SOLUTION
ALEXION PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRENSIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STRENSIQ.
STRENSIQ (ASFOTASE ALFA) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Dosing and Administration (2.3, 2.4)
6/2020
Warnings and Precautions (5.4)
6/2020
INDICATIONS AND USAGE
STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for
the treatment of patients with
perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). (1)
DOSAGE AND ADMINISTRATION
Perinatal/Infantile-Onset HPP (2.1)
Recommended dosage regimen is 2 mg/kg administered subcutaneously
three times per week, or 1
mg/kg administered six times per week. Injection site reactions may
limit the tolerability of the six times
per week regimen.
The dose may be increased to 3 mg/kg three times per week for
insufficient efficacy.
Juvenile-Onset HPP (2.2)
Recommended dosage regimen is 2 mg/kg administered subcutaneously
three times per week, or 1
mg/kg administered six times per week. Injection site reactions may
limit the tolerability of the six times
per week regimen.
Preparation and Weight-Based Dosing (2.3):
_Caution:_ Do not use the 80 mg/0.8 mL vial in pediatric patients
weighing less than 40 kg because the
systemic asfotase alfa exposure achieved with the 80 mg/0.8 mL vial
(higher concentration) is lower
than that achieved with the other strength vials (lower
concentration). A lower exposure may not be
adequate for this subgroup of patients.
See full prescribing information for tables of weight-based dosing by
treatment regimen.
Administration (2.4):
For subcutaneous injection only.
Rotate injection sites. Do not administer to areas that are reddened,
inflamed or swollen.
DOSAGE FORMS AND STRENGTHS
Injection: 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL, or 80 mg/0.8 mL
solution in single-dose vials. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
H