エプタコグアルファ
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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2014/06/05 08:43:11」(JST)
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| Clinical data |
| Trade names |
NovoSeven, AryoSeven |
| AHFS/Drugs.com |
Multum Consumer Information |
| Pregnancy cat. |
C (US) |
| Legal status |
℞-only (US) |
| Routes |
Intravenous injection |
| Identifiers |
| ATC code |
B02BD05 |
| Chemical data |
| Formula |
? |
Recombinant factor VIIa (rFVIIa) is a form of blood factor VII that has been manufactured via recombinant technology. The most commonly used rFVIIa is eptacog alfa (INN, trade names NovoSeven and AryoSeven).
Contents
- 1 Medical use
- 2 Mechanism of action
- 3 Manufacture
- 4 Route of administration
- 5 References
- 6 External links
Medical use
rFVIIa is not, as of 2012, supported by the evidence for most cases of major bleeding.[1] There is a significant risk of arterial thrombosis with its use and thus other than in those with factor VII deficiency should only be given in clinical trials.[1] Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.[2][3]
In people with hemophilia type A and B who have a deficiency of factors VIII and IX, these two factors are administered for controlling bleeding or as prophylaxis medication before starting surgeries. However, in some cases they subsequently develop neutralizing antibodies (NAb) against the drug. These NAbs increase over time and inhibit the action of (coagulation) in the persons body. rFVIIa, which is activated form factor VII, bypasses factors VIII and IX and causes coagulation of blood without the need for factors VIII and IX. This is important for some patients to shift to proper blood factors according to their level of NAbs. Other indications include use for patients with acquired hemophilia, people born with a deficiency of factor VII, and people with Glanzmann's thrombasthenia.
Another possible use is for partial reversal of new oral anticoagulants such as dabigatran, rivaroxaban, or apixaban.[4]
Mechanism of action
This treatment results in activation of the extrinsic pathway of blood coagulation.
Manufacture
rFVIIa is a glycoprotein which is produced by recombinant DNA technology. AryoSeven is formulated totally similar[clarification needed] to the original drug with the name of NovoSeven. The product is the first biosimilar or biogeneric of the above mentioned drug. This biomedicine is produced in baby hamster kidney cells (BHK) and has similar characteristics and functions with the native blood factor VII.
Route of administration
rFVIIa is normally administered intravenously (IV) under physician supervision.
References
- ^ a b Simpson, E; Lin, Y; Stanworth, S; Birchall, J; Doree, C; Hyde, C (Mar 14, 2012). "Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia.". Cochrane database of systematic reviews (Online) 3: CD005011. doi:10.1002/14651858.CD005011.pub4. PMID 22419303.
- ^ Mayer S, Brun N, Begtrup K, Broderick J, Davis S, Diringer M, Skolnick B, Steiner T (2005). "Recombinant activated factor VII for acute intracerebral hemorrhage". N. Engl. J. Med. 352 (8): 777–85. doi:10.1056/NEJMoa042991. PMID 15728810.
- ^ Mayer SA, Brun NC, Begtrup K, et al. (May 2008). "Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage". N. Engl. J. Med. 358 (20): 2127–37. doi:10.1056/NEJMoa0707534. PMID 18480205.
- ^ Throm Haemost 2012; 108:625
External links
- AryoGen website
- AryoSeven
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Antihemorrhagics (B02)
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Hemostatics
(coagulation) |
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Systemic
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Vitamin K
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- Phytomenadione (K1)
- Menadione (K3)
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Coagulation
factors
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- intrinsic: IX/Nonacog alfa
- VIII/Moroctocog alfa/Turoctocog alfa
- extrinsic: VII/Eptacog alfa
- common: X
- II/Thrombin
- I/Fibrinogen
- combinations: Prothrombin complex concentrate (II, VII, IX, X, protein C and S)
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Other
systemic
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- Etamsylate
- Carbazochrome
- Batroxobin
- thrombopoietin receptor agonist (Romiplostim
- Eltrombopag)
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Local
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- Absorbable gelatin sponge
- Oxidized cellulose
- Tetragalacturonic acid hydroxymethylester
- Thrombin
- Collagen
- Calcium alginate
- Epinephrine/Adrenalone
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| Antifibrinolytics |
- amino acids (Aminocaproic acid
- Tranexamic acid
- Aminomethylbenzoic acid)
serpins (Aprotinin
- Alfa1 antitrypsin
- C1-inhibitor
- Camostat)
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cell/phys (coag, heme, immu, gran), csfs
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rbmg/mogr/tumr/hist, sysi/epon, btst
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drug (B1/2/3+5+6), btst, trns
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UpToDate Contents
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English Journal
- Enhanced Pharmacokinetics of Factor VIIa as a Monomeric Fc Fusion.
- Salas J1, Liu T2, Lu Q2, Kulman JD2, Ashworth T2, Kistanova E2, Moore N2, Pierce GF2, Jiang H2, Peters R2.
- Thrombosis research.Thromb Res.2015 May;135(5):970-6. doi: 10.1016/j.thromres.2014.12.018. Epub 2015 Jan 3.
- Recombinant Factor VIIa (rFVIIa) is utilized for on-demand treatment of bleeding episodes in hemophilia patients with neutralizing antibodies (inhibitors) against Factor VIII or Factor IX, but a short half-life in the circulation (~2.5hrs) limits its use in a prophylactic setting. Recombinant FVIIa
- PMID 25721936
- Transfusion interventions in critical bleeding requiring massive transfusion: a systematic review.
- McQuilten ZK1, Crighton G2, Engelbrecht S2, Gotmaker R3, Brunskill SJ4, Murphy MF4, Wood EM2.
- Transfusion medicine reviews.Transfus Med Rev.2015 Apr;29(2):127-37. doi: 10.1016/j.tmrv.2015.01.001. Epub 2015 Feb 7.
- Critical bleeding (CB) requiring massive transfusion (MT) can occur in a variety of clinical contexts and is associated with substantial mortality and morbidity. In 2011, the Australian National Blood Authority (NBA) published patient blood management guidelines for CB and MT, which found limited hi
- PMID 25716645
- Monitoring bypassing agent therapy - a prospective crossover study comparing thromboelastometry and thrombin generation assay.
- Tran HT1, Sørensen B, Bjørnsen S, Pripp AH, Tjønnfjord GE, Andre Holme P.
- Haemophilia : the official journal of the World Federation of Hemophilia.Haemophilia.2015 Mar;21(2):275-83. doi: 10.1111/hae.12570. Epub 2014 Dec 18.
- The aim of this study was to evaluate the capability of thromboelastometry (ROTEM) and thrombin generation assay (TGA) to monitor the treatment response of bypassing agent (BPA) therapy and to study whether one method is superior to another. In a prospective crossover study haemophilia A patients wi
- PMID 25521720
Related Links
- NovoSeven is a powder and solvent that are made up into a solution for injection. It contains the active substance eptacog alfa. Two formulations of NovoSeven are available: the original formulation requires refrigeration and the newer ...
- Define Eptacog alfa. Eptacog alfa synonyms, Eptacog alfa pronunciation, Eptacog alfa translation, English dictionary definition of Eptacog alfa. Noun 1. factor VII - a coagulation factor formed in the kidney under the influence of ...
Related Pictures
★リンクテーブル★
[★]
- 英
- eptacog alfa
- 商
- ノボセブン
- 関
- 血液凝固因子、第VII因子
[★]
- 関
- alpha