"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
Therapeutic administration of Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) , 60 mg/kg weekly, has been demonstrated to be well tolerated. In clinical studies, six reactions were observed with 517 infusions of Prolastin (alpha) , or 1.16%. None of the reactions was severe.18 The adverse reactions reported included delayed fever (maximum temperature rise was 38.9°C, resolving spontaneously over 24 hours) occurring up to 12 hours following treatment (0.77%), light-headedness (0.19%), and dizziness (0.19%).18 Mild transient leukocytosis and dilutional anemia several hours after infusion have also been noted.18 Since market entry, occasional reports of other flu-like symptoms, allergic-like reactions, chills, dyspnea, rash, tachycardia, and, rarely, hypotension have also been received. Rare cases of transient increase in blood pressure or hypertension and chest pain have also been reported.
Read the Prolastin (alpha) Side Effects Center for a complete guide to possible side effects
No information provided.
18. Data on file.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/10/2016
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