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Strensiq Generic Name & Formulations
Legal Class
Rx
General Description
Asfotase alfa 18mg/0.45mL, 28mg/0.7mL, 40mg/mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tissue nonspecific alkaline phosphatase.
How Supplied
Single-use vials—1, 12
Manufacturer
Generic Availability
NO
Strensiq Indications
Indications
Treatment of perinatal/infantile- and juvenile-onset hypophosphatasia.
Strensiq Dosage and Administration
Adult
Not applicable.
Children
See full labeling. Give by SC inj in the abdomen, thigh, deltoid, or buttocks; 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.
Strensiq Contraindications
Not Applicable
Strensiq Boxed Warnings
Not Applicable
Strensiq Warnings/Precautions
Warnings/Precautions
Do not administer to areas that are reddened, inflamed, or swollen. Discontinue if severe hypersensitivity reaction occurs; monitor for reoccurrence if repeat treatment. Perform ophthalmic exams and renal ultrasounds at baseline and periodically during treatment. Monitor for ectopic calcifications and changes in vision or renal function. Possible immune-mediated clinical effects. Pregnancy. Nursing mothers.
Strensiq Pharmacokinetics
See Literature
Strensiq Interactions
Interactions
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.
Strensiq Adverse Reactions
Adverse Reactions
Inj site reactions, lipodystrophy, ectopic calcifications, hypersensitivity reactions.
Strensiq Clinical Trials
See Literature
Strensiq Note
Not Applicable
Strensiq Patient Counseling
See Literature
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