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Sebelipase alfa information


Sebelipase alfa
Clinical data
Trade namesKanuma
AHFS/Drugs.comMonograph
License data
  • US DailyMed: Sebelipase_alfa
Pregnancy
category
  • AU: B1[1]
Routes of
administration
Intravenous infusion
ATC code
  • A16AB14 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[2][3]
  • CA: ℞-only[4]
  • UK: POM (Prescription only)
  • US: ℞-only[5]
  • EU: Rx-only[6]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life0.1 hours
Identifiers
DrugBank
  • DB11563
ChemSpider
  • none
KEGG
  • D10377

Sebelipase alfa, sold under the brand name Kanuma, is a recombinant form of the enzyme lysosomal acid lipase (LAL) that is used as a medication for the treatment of lysosomal acid lipase deficiency (LAL-D).[6][7] It is administered via intraveneous infusion.[5] It was approved for medical use in the European Union and in the United States in 2015.[8][6][5][7]

  1. ^ "Sebelipase alfa (Kanuma) Use During Pregnancy". Drugs.com. 14 June 2019. Retrieved 4 May 2020.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 9 April 2023.
  3. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 31 March 2024.
  4. ^ "Genetic disorders". Health Canada. 9 May 2018. Retrieved 13 April 2024.
  5. ^ a b c "Kanuma- sebelipase alfa injection, solution, concentrate". DailyMed. 18 December 2018. Retrieved 4 May 2020.
  6. ^ a b c "Kanuma EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 4 May 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ a b "Kanuma (Sebelipase alfa)". U.S. Food and Drug Administration (FDA). 6 January 2016. Retrieved 4 May 2020.
  8. ^ Cite error: The named reference nhs1 was invoked but never defined (see the help page).

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