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(asfotase alfa) Solution for Subcutaneous Administration


STRENSIQ is a formulation of asfotase alfa, which is a soluble glycoprotein composed of two identical polypeptide chains. Each chain contains 726 amino acids with a theoretical mass of 161 kDa. Each chain consists of the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP), the human immunoglobulin G1 Fc domain and a deca-aspartate peptide used as a bone targeting domain. The two polypeptide chains are covalently linked by two disulfide bonds.

STRENSIQ is a tissue nonspecific alkaline phosphatase produced by recombinant DNA technology in a Chinese hamster ovary cell line. TNSALP is a metallo-enzyme that catalyzes the hydrolysis of phosphomonoesters with release of inorganic phosphate and alcohol. Asfotase alfa has a specific activity of 620 to 1250 units/mg. One activity unit is defined as the amount of asfotase alfa required to form 1 μmol of p-nitrophenol from pNPP per minute at 37°C.

STRENSIQ (asfotase alfa) is a sterile, preservative-free, nonpyrogenic, clear, slightly opalescent or opalescent, colorless to slightly yellow, with few small translucent or white particles, aqueous solution for subcutaneous administration. STRENSIQ is supplied in glass single-use vials containing asfotase alfa; dibasic sodium phosphate, heptahydrate; monobasic sodium phosphate, monohydrate; and sodium chloride at a pH between 7.2 and 7.6. Table 5 describes the content of STRENSIQ vial presentations.

Table 5: Content of STRENSIQ Vial Presentations

Ingredient Quantity per Vial
Asfotase Alfa 18 mg/0.45 mL 28 mg/0.7 mL 40 mg/mL 80 mg/0.8 mL
Dibasic sodium phosphate, heptahydrate 2.48 mg 3.85 mg 5.5 mg 4.4 mg
Monobasic sodium phosphate, monohydrate 0.28 mg 0.43 mg 0.62 mg 0.5 mg
Sodium chloride 3.94 mg 6.13 mg 8.76 mg 7.01 mg

Last reviewed on RxList: 11/3/2016
This monograph has been modified to include the generic and brand name in many instances.

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