Difference between revisions of "Factor VIIa, recombinant (NovoSeven RT)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Recombinant factor VIIa; complexes with tissue factor and can activate coagulation factors X to Xa and IX to IXa, which results in conversion of prothrombin to thrombin, and fibrinogen to fibrin to form a fibrin clot. There is still uncertainty about the precise mechanism, and activation of factor X on platelet surfaces may also play an important role. Clinical applications include use for patients with inhibitors to factors VIII and IX, as can be the case in hemophilia A and hemophilia B.<ref name="insert">[http://www.novo-pi.com/novosevenrt.pdf Factor VIIa, recombinant (NovoSeven RT) package insert]</ref><ref>[[Media:Factorviia.pdf | Factor VIIa, recombinant (NovoSeven RT) package insert (locally hosted backup)]]</ref><ref>[http://www.novosevenrt.com NovoSeven RT manufacturer's website]</ref> | + | Class/mechanism: Recombinant factor VIIa; complexes with tissue factor and can activate coagulation factors X to Xa and IX to IXa, which results in conversion of prothrombin to thrombin, and fibrinogen to fibrin to form a fibrin clot. There is still uncertainty about the precise mechanism, and activation of factor X on platelet surfaces may also play an important role. Clinical applications include use for patients with inhibitors to factors VIII and IX, as can be the case in hemophilia A and hemophilia B. The NovoSeven RT formulation contains sucrose and L-Methionine which "allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years."<ref name="insert">[http://www.novo-pi.com/novosevenrt.pdf Factor VIIa, recombinant (NovoSeven RT) package insert]</ref><ref>[[Media:Factorviia.pdf | Factor VIIa, recombinant (NovoSeven RT) package insert (locally hosted backup)]]</ref><ref>[http://www.novosevenrt.com NovoSeven RT manufacturer's website]</ref><ref>[http://www.fda.gov/newsevents/newsroom/pressannouncements/2008/ucm116894.htm 5/9/2008 FDA approval announcement for NovoSeven RT (fda.gov)]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
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==Patient drug information== | ==Patient drug information== | ||
| − | *Brief patient counseling information can be found | + | *Brief patient counseling information can be found in [http://www.novo-pi.com/novosevenrt.pdf the Factor VIIa, recombinant (NovoSeven RT) package insert]<ref name="insert"></ref> |
*[http://www.uptodate.com/contents/recombinant-human-factor-viia-patient-drug-information Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/recombinant-human-factor-viia-patient-drug-information Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/recombinant-human-factor-viia-patient-drug-information Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/recombinant-human-factor-viia-patient-drug-information Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)]</ref> | ||
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| + | ==History of changes in FDA indication== | ||
| + | *3/25/1999: [http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm056916.htm Initial FDA approval] "for use in the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX." | ||
| + | *5/9/2008: [http://www.fda.gov/newsevents/newsroom/pressannouncements/2008/ucm116894.htm FDA approval of NovoSeven RT formulation] for "treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX; the treatment of bleeding and the prevention of surgical bleeding in patients with congenital Factor VII deficiency; and the prevention of surgical bleeding in patients with acquired hemophilia." | ||
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| + | ==Also known as== | ||
| + | AryoSeven, coagulation factor VIIa, eptacog alfa (activated), factor 7a, NovoSeven, Novo-Seven, or NovoSeven room temperature stable. | ||
==References== | ==References== | ||
Revision as of 06:58, 19 September 2014
General information
Class/mechanism: Recombinant factor VIIa; complexes with tissue factor and can activate coagulation factors X to Xa and IX to IXa, which results in conversion of prothrombin to thrombin, and fibrinogen to fibrin to form a fibrin clot. There is still uncertainty about the precise mechanism, and activation of factor X on platelet surfaces may also play an important role. Clinical applications include use for patients with inhibitors to factors VIII and IX, as can be the case in hemophilia A and hemophilia B. The NovoSeven RT formulation contains sucrose and L-Methionine which "allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years."[1][2][3][4]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Patient drug information
- Brief patient counseling information can be found in the Factor VIIa, recombinant (NovoSeven RT) package insert[1]
- Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 3/25/1999: Initial FDA approval "for use in the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX."
- 5/9/2008: FDA approval of NovoSeven RT formulation for "treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX; the treatment of bleeding and the prevention of surgical bleeding in patients with congenital Factor VII deficiency; and the prevention of surgical bleeding in patients with acquired hemophilia."
Also known as
AryoSeven, coagulation factor VIIa, eptacog alfa (activated), factor 7a, NovoSeven, Novo-Seven, or NovoSeven room temperature stable.
References
- ↑ 1.0 1.1 1.2 Factor VIIa, recombinant (NovoSeven RT) package insert
- ↑ Factor VIIa, recombinant (NovoSeven RT) package insert (locally hosted backup)
- ↑ NovoSeven RT manufacturer's website
- ↑ 5/9/2008 FDA approval announcement for NovoSeven RT (fda.gov)
- ↑ Factor VIIa, recombinant (NovoSeven RT) patient drug information (UpToDate)