Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ASFOTASE ALFA (UNII: Z633861EIM) (ASFOTASE ALFA - UNII:Z633861EIM)
Alexion Pharmaceuticals, Inc.
ASFOTASE ALFA
ASFOTASE ALFA 18 mg in 0.45 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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
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.
Biologic Licensing Application
STRENSIQ- ASFOTASE ALFA SOLUTION ALEXION PHARMACEUTICALS, INC. ---------- 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 Aqra d-dokument sħiħ