Generic Name and Formulations:
Asfotase alfa 18mg/0.45mL, 28mg/0.7mL, 40mg/mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Alexion Pharmaceuticals, Inc.
Indications for STRENSIQ:
Treatment of perinatal/infantile- and juvenile-onset hypophosphatasia.
See full labeling. Give by SC inj in the abdomen, thigh, or deltoid; rotate inj sites. 6mg/kg per week given as 2mg/kg 3 times weekly or 1mg/kg 6 times weekly. Perinatal/infantile-onset: if ineffective, may increase dose up to 9mg/kg per week given as 3mg/kg 3 times weekly. <40kg: do not use 80mg/0.8mL vial.
Do not administer to areas that are reddened, inflamed, or swollen. Discontinue if severe hypersensitivity reaction occurs; monitor for reoccurrence if decision to re-administer. Perform ophthalmic exams and renal ultrasounds at baseline and periodically during treatment; monitor for ectopic calcifications and changes in vision or renal function. Pregnancy. Nursing mothers.
May cause erroneous results in lab assays that utilize alkaline phosphatase (ALP)-conjugated test system. Do not rely on serum ALP measurements for clinical decision making due to expected high levels.
Tissue nonspecific alkaline phosphatase.
Inj site reactions, lipodystrophy, ectopic calcifications, hypersensitivity reactions.
Single-use vials—1, 12
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