Substance / Medication

Asfotase alfa

Overview

Active Ingredient
asfotase alfa
RxNorm CUI
1720259

Indications

® STRENSIQis indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Labeler: Alexion Pharmaceuticals, Inc.Updated: 2025-12-12T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Warnings and Precautions (5.1) [see] Initiate

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

1 trials linked to this intervention

1
Total Trials
0
Recruiting
1
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Efficacy and safety of asfotase alfa in patients with hypophosphatasia: A systematic review.
Shirinezhad Amirhossein, Esmaeili Sina, Azarboo Alireza et al. · Bone · 2024
PMID: 39089608Meta-Analysis
Ectopic Ocular Surface Calcification in Patients With Hypophosphatasia Treated With Asfotase Alfa.
Gospe Sidney M, Santiago-Turla Cecilia, DeArmey Stephanie M et al. · Cornea · 2019
PMID: 30969260RCT
Effects of asfotase alfa in adults with pediatric-onset hypophosphatasia over 24 months of treatment.
Seefried Lothar, Genest Franca, Petryk Anna et al. · Bone · 2023
PMID: 37481150Observational
Bone turnover and mineral metabolism in adult patients with hypophosphatasia treated with asfotase alfa.
Seefried L, Rak D, Petryk A et al. · Osteoporos Int · 2021
PMID: 34215909ObservationalFull text (PMC)
Effects of asfotase alfa on fracture healing of adult patient with hypophosphatasia and literature review.
Wang Songqi, Sun Lei, Hu Jing et al. · Orphanet J Rare Dis · 2025
PMID: 40189581Case ReportFull text (PMC)
Safety and efficacy of long term asfotase alfa treatment in childhood hypophosphatasia.
d'Angelo Debora Mariarita, Lauriola Federico, Silvestrini Luisa et al. · Ital J Pediatr · 2025
PMID: 40114282Case ReportFull text (PMC)
Case Report: Suboptimal response to standard-dose asfotase alfa in perinatal hypophosphatasia indicates a need for individualized dosing.
Petković Ramadža Danijela, Žigman Tamara, Čavka Mislav et al. · Front Endocrinol (Lausanne) · 2025
PMID: 40607219Case ReportFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Asfotase alfa (substance)
SNOMED CT
715255009
UMLS CUI
C3490795
RxNorm CUI
1720259
Labeler
Alexion Pharmaceuticals, Inc.

Clinical Data

This intervention maps to 2 entities in the Healos knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
1
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.