Asfotase alfa

Asfotase alfa
Clinical data
Trade namesStrensiq
Other namesALXN-1215
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Subcutaneous injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability46–98%
Elimination half-life~5 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC7108H11008N1968O2206S56
Molar mass161125.18 g·mol−1

Asfotase alfa, sold under the brand name Strensiq, is a medication used in the treatment of people with perinatal/infantile- and juvenile-onset hypophosphatasia.[5][6][7][8][9][10][11]

The most common side effects include injection site reactions, hypersensitivity reactions (such as difficulty breathing, nausea, dizziness and fever), lipodystrophy (a loss of fat tissue resulting in an indentation in the skin or a thickening of fat tissue resulting in a lump under the skin) at the injection site, and ectopic calcifications of the eyes and kidney.[7][6]

The enzyme tissue non-specific alkaline phosphatase (ALP) plays a key role in creating and maintaining healthy bones, and managing calcium and phosphate in the body. People with hypophosphatasia cannot make enough working ALP, which leads to weak bones. Asfotase alfa is a version of the human ALP enzyme and serves as a replacement, thereby increasing levels of working ALP.[6]

  1. ^ "Asfotase alfa (Strensiq) Use During Pregnancy". Drugs.com. 15 July 2019. Retrieved 10 May 2020.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  3. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  4. ^ "Strensiq - Summary of Product Characteristics (SmPC)". (emc). 21 January 2020. Retrieved 10 May 2020.
  5. ^ "Strensiq- asfotase alfa solution". DailyMed. 7 February 2018. Retrieved 10 May 2020.
  6. ^ a b c Cite error: The named reference Strensiq EPAR was invoked but never defined (see the help page).
  7. ^ a b "FDA approves new treatment for rare metabolic disorder". U.S. Food and Drug Administration (FDA) (Press release). 24 October 2015. Archived from the original on 24 October 2015. Retrieved 11 May 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ U.S. Patent 7,763,712.
  9. ^ Scott LJ (February 2016). "Asfotase Alfa: A Review in Paediatric-Onset Hypophosphatasia". Drugs. 76 (2): 255–62. doi:10.1007/s40265-015-0535-2. PMID 26744272. S2CID 23910180.
  10. ^ Hofmann C, Seefried L, Jakob F (May 2016). "Asfotase alfa: enzyme replacement for the treatment of bone disease in hypophosphatasia". Drugs of Today. 52 (5). Barcelona, Spain: 271–85. doi:10.1358/dot.2016.52.5.2482878. PMID 27376160.
  11. ^ Bowden SA, Foster BL (2018). "Profile of asfotase alfa in the treatment of hypophosphatasia: design, development, and place in therapy". Drug Design, Development and Therapy. 12: 3147–3161. doi:10.2147/DDDT.S154922. PMC 6161731. PMID 30288020.