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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:125513Orig1s000
OTHER REVIEW(S)PMR/PMC Development Template
This template should be completed by the PMR/PMC Development Coordinator and
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Who needs strensiq asfotatse alfa?
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Strensiq asfotatse alfa is typically prescribed to individuals diagnosed with hypophosphatasia (HPP), a rare genetic disorder that affects bone mineralization.
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It is used for the treatment of patients with perinatal, infantile, and juvenile-onset HPP, as well as those with childhood or adult-onset HPP who have evidence of ongoing bone remodeling.
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A qualified healthcare professional can determine if Strensiq asfotatse alfa is appropriate for a specific individual based on their medical history, symptoms, and diagnostic test results.
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What is strensiq asfotatse alfa?
Strensiq (asfotase alfa) is a medication used for the treatment of perinatal, infantile, and juvenile-onset hypophosphatasia (HPP).
Who is required to file strensiq asfotatse alfa?
Healthcare professionals and providers are required to file strensiq (asfotase alfa) usage information.
How to fill out strensiq asfotatse alfa?
Strensiq (asfotase alfa) usage and dosing information must be accurately documented and reported according to regulatory guidelines.
What is the purpose of strensiq asfotatse alfa?
The purpose of strensiq (asfotase alfa) is to help improve bone mineralization and prevent complications associated with HPP.
What information must be reported on strensiq asfotatse alfa?
Information such as patient details, dosage regimen, treatment duration, and any adverse reactions must be reported on strensiq (asfotase alfa).
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