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Moroctocog alfa information


Moroctocog alfa
Clinical data
Trade namesReFacto, ReFacto AF
AHFS/Drugs.comMonograph
Pregnancy
category
  • AU: B2[1]
Routes of
administration
Intravenous (IV)
ATC code
  • B02BD02 (WHO)
Legal status
Legal status
  • UK: POM (Prescription only)[2]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
  • 284036-24-4
DrugBank
  • DB13999
ChemSpider
  • none
UNII
  • 113E3Z3CJJ
KEGG
  • D08232
ChEMBL
  • ChEMBL2109137

Moroctocog alfa (trade name ReFacto in the EU) is a recombinant antihemophilic factor genetically engineered from Chinese hamster ovary (CHO) cell line. Chemically it is a glycoprotein.[3] It is manufactured by Genetics Institute, Inc. and used to control and prevent hemorrhagic bleeding and prophylaxis associated with surgery or to reduce the number of spontaneous bleeding episodes in patients with hemophilia A.[4] It is partially a recombinant coagulation factor VIII since it has an amino acid sequence which compares to the 90 + 80 kDa form of factor VIII (BDDrFVIII).[5] It also has posttranslational modifications which are similar to those of the plasma-derived molecule. It can not prevent hemorrhagic bleeding associated with von Willebrand's disease since it is not a von Willebrand factor.

The most common side effects include headache, cough, pain in the joints and fever.[6] People may also develop antibodies against factor VIII medicines such as moroctocog alfa.[6] These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control.[6] Uncommonly, people may also develop allergic reactions.[6]

People with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.[6] Moroctocog alfa works in the body in the same way as human factor VIII.[6] It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.[6]

The human coagulation factor VIII in moroctocog alfa is not extracted from human blood but is produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.[6]

  1. ^ a b "Antihemophilic factor Use During Pregnancy". Drugs.com. 20 January 2020. Retrieved 11 March 2020.
  2. ^ "ReFacto AF 250 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 17 October 2019. Retrieved 13 May 2020.
  3. ^ "ReFacto sAntihemophilic Factor, Recombinant" (PDF). Wyeth Pharmaceuticals Inc.
  4. ^ Frampton JE (September 2016). "Efmoroctocog Alfa: A Review in Haemophilia A". Drugs. 76 (13): 1281–1291. doi:10.1007/s40265-016-0622-z. PMID 27487799. S2CID 28322.
  5. ^ "ReFacto AF 2000 IU powder and solvent for solution for injection" (PDF). Wyeth Farma S.A. European Medicines Agency.
  6. ^ a b c d e f g h Cite error: The named reference ReFacto AF EPAR was invoked but never defined (see the help page).

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Moroctocog alfa (trade name ReFacto in the EU) is a recombinant antihemophilic factor genetically engineered from Chinese hamster ovary (CHO) cell line...

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