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Recombinant factor VIIa INN: Eptacog alfa
Clinical data
Trade names
Novoseven, Sevenfact, others
Other names
rFVIIa, Coagulation factor VIIa (recombinant), Coagulation factor VIIa (recombinant)-jncw
Biosimilars
Aryoseven
AHFS/Drugs.com
Monograph
License data
US DailyMed: Coagulation factor VIIa (recombinant)
Pregnancy category
AU: B1
Routes of administration
Intravenous injection
ATC code
B02BD08 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)
UK: POM (Prescription only)[1]
US: ℞-only[2][3]
EU: Rx-only[4][5]
In general: ℞ (Prescription only)
Identifiers
CAS Number
102786-61-8Y
DrugBank
DB00036
ChemSpider
none
UNII
AC71R787OV
KEGG
D00172
Recombinant factor VIIa (rfVIIa) is a form of blood factor VII that has been manufactured via recombinant technology.[4][5] It is administered via an injection into a vein.[6][4][5] It is used to treat bleeding episodes in people who have acquired haemophilia, among other indications.[7] There are several disimilar forms, and biosimilars for each. All forms are activated.
Biosimilar, produced through rabbit milk.[8] Approved in the EU in 2022.[5]
The most common side effects with Novoseven include venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), fever and reduced effectiveness of treatment.[4] The most common side effects with Cevenfacta include injection site discomfort and hematoma (a collection of blood under the skin) as well as injection-related reactions, an increase in body temperature, dizziness and headache.[5]
Novoseven was approved for medical use in the European Union in February 1996,[4] and in the United States in March 1999.[9]
^"NovoSeven 1 mg (50KIU) powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 21 November 2019. Archived from the original on 15 January 2021. Retrieved 1 April 2020.
^ abcCite error: The named reference NovoSeven RT FDA label was invoked but never defined (see the help page).
^Cite error: The named reference Sevenfact FDA label was invoked but never defined (see the help page).
^ abcde"NovoSeven EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 27 February 2023.
^ abcdeCite error: The named reference Cevenfacta EPAR was invoked but never defined (see the help page).
^Cite error: The named reference FDA NovoSeven RT was invoked but never defined (see the help page).
^ abCite error: The named reference NovoSeven FDA label was invoked but never defined (see the help page).
^Cite error: The named reference FDA Sevenfact PR was invoked but never defined (see the help page).
^Cite error: The named reference FDA NovoSeven was invoked but never defined (see the help page).
and 23 Related for: Recombinant factor VIIa information
RecombinantfactorVIIa (rfVIIa) is a form of blood factor VII that has been manufactured via recombinant technology. It is administered via an injection...
factor VII), which in turn activates factor IX and factor X. Using genetic recombination a recombinantfactorVIIa (eptacog alfa) (trade names include...
peptide, glycosylated and then cleaved by factor XIa (of the contact pathway) or factorVIIa (of the tissue factor pathway) to produce a two-chain form, where...
plasma (FFP), vitamin K, prothrombin complex concentrates, or recombinantfactorVIIa can be given to reverse the effect of warfarin. High doses of vitamin...
trauma. For severe bleeding, for example from bleeding disorders, recombinantfactorVIIa—a protein that assists blood clotting—may be appropriate. While...
recombinantfactorVIIa, and prothrombin complex concentrate (PCC) have been utilized with proven efficacy. Specifically with warfarin, four factor PCC...
trials to understand more about the potential benefits and risks. RecombinantfactorVIIa (rFVIIa) is not, as of 2012, supported by the evidence for most...
time (INR) every one to four weeks. Many other medications and dietary factors can interact with warfarin, either increasing or decreasing its effectiveness...
serine protease factorVIIa. The best known function of tissue factor is its role in blood coagulation. The complex of TF with factorVIIa catalyzes the...
of whether there is poor nutritional status. Administration of recombinantfactorVIIa has shown promise; however, this treatment approach requires further...
Comparative thrombotic event incidence after infusion of recombinantfactorVIIa versus factor VIII inhibitor bypass activity. J Thromb Haemost 2004; 2:1700-1708...
hemophilia A and rare coagulation disorders. Patterns of response to recombinantfactorVIIa. J Thromb Haemost. 2004;2:102-10. Karger R, Egbring R, Weippert-Kretschmer...
fresh frozen plasma are commonly used coagulation factor products. Recombinant activated human factor VII is increasingly popular in the treatment of major...
1980s. Lusher later conducted the first studies on the use of recombinantfactorVIIa in the treatment of bleeding episodes in patients with hemophilia...
activated factorVIIa (normally present in trace amounts in the blood), forming the extrinsic tenase complex. This complex further activates factor IX and...
between intensive and less intensive blood pressure control. Giving FactorVIIa within 4 hours limits the bleeding and formation of a hematoma. However...
promptly to prevent further complications. In the case of DIC, recombinant activated factorVIIa is quick way to address this issue. Serine proteinase inhibitor...
Factor II (thrombin) (IIa), and also the activated form of Factor VII (VIIa) from the tissue factor pathway (formerly known as the extrinsic pathway). The...
2008, the company sold its MAXY-VII candidate drug, a recombinant form of clotting factorVIIa, to Bayer HealthCare. 2009 saw the formation of a joint...
slow, tight-binding inhibitor of factor Xa with a Ki value of 0.3–0.6 nM but it also inhibits trypsin. Recombinant Antistasin can be produced by genetically...
of transfusions may be reduced if these patients are given recombinant human factorVIIa[medical citation needed] since the underlying cause are antibodies...
development and commercialization of three drug candidates, recombinant blood clotting factorsVIIa, VIII and IX, the latter of which is in clinical trials...