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.
Tissue nonspecific alkaline phosphatase.
Inj site reactions, lipodystrophy, ectopic calcifications, hypersensitivity reactions.
Single-use vials—1, 12