Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Asfotase alfa
Drug ID BADD_D00174
Description Asfotase alfa is a first-in-class bone-targeted enzyme replacement therapy designed to address the underlying cause of hypophosphatasia (HPP)—deficient alkaline phosphatase (ALP). Hypophosphatasia is almost always fatal when severe skeletal disease is obvious at birth. By replacing deficient ALP, treatment with Asfotase Alfa aims to improve the elevated enzyme substrate levels and improve the body's ability to mineralize bone, thereby preventing serious skeletal and systemic patient morbidity and premature death. Asfotase alfa was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on July 3, 2015, then approved by the European Medicine Agency (EMA) on August 28, 2015, and was approved by the U.S. Food and Drug Administration (FDA) on October 23, 2015. Asfotase Alfa is marketed under the brand name Strensiq® by Alexion Pharmaceuticals, Inc. The annual average price of Asfotase Alfa treatment is $285,000.
Indications and Usage Indicated for the treatment of patients with perinatal/infantile and juvenile onset hypophosphatasia (HPP).
Marketing Status Prescription
ATC Code A16AB13
DrugBank ID DB09105
KEGG ID D10595
MeSH ID C570710
PubChem ID Not Available
TTD Drug ID D05XSJ
NDC Product Code 25682-013; 25682-016; 25682-019; 25682-010
Synonyms asfotase alfa | ENB-0040 | Strensiq
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1174277-80-5
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Calcinosis08.03.04.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Chronic hepatitis11.07.01.009; 09.01.07.021--Not Available
Erythema23.03.06.001--Not Available
Flushing23.06.05.003; 08.01.03.025; 24.03.01.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypocalcaemia14.04.01.004--
Injection site atrophy12.07.03.022; 08.02.03.022--Not Available
Injection site haematoma12.07.03.004; 08.02.03.004; 24.07.01.009--Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Injection site hypertrophy12.07.03.026; 08.02.03.026--Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site mass12.07.03.010; 08.02.03.009--Not Available
Injection site rash12.07.03.032; 23.03.13.010; 08.02.03.032--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injection site urticaria12.07.03.029; 10.01.06.003; 08.02.03.029; 23.04.02.003--Not Available
Injection site warmth12.07.03.036; 08.02.03.036--Not Available
Irritability19.04.02.013; 08.01.03.011--
Macule23.03.03.037--Not Available
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Pain08.01.08.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Skin discolouration23.03.03.005--Not Available
Skin hypopigmentation23.05.02.003--
Swelling08.01.03.015--Not Available
Tenderness08.01.08.005--Not Available
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