Novoseven Rt (coagulation factor VIIa (recombinant))

Factor VII Intravenous Vial (EA)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Factor VIIa (recombinant) is a biosynthetic preparation of blood coagulation factor VIIa prepared using recombinant DNA technology.

Factor VIIa (recombinant) is a sterile, lyophilized powder containing biosynthetic blood coagulation factor VIIa prepared using recombinant DNA technology. Factor VIIa (recombinant) is structurally similar to endogenous human factor VIIa and promotes hemostasis through activation of the extrinsic blood coagulation pathway. Factor VIIa is a cofactor in the activation of factor X (Stuart-Prower factor) to factor Xa and factor IX (Christmas factor) to IXa.

Following injury to the vessel wall, tissue factor (TF) is exposed to circulating blood; factor VIIa forms complexes with TF on TF-bearing cells, where these complexes activate factor X to factor Xa and factor IX to factor IXa. Factor Xa, in the presence of activated factor V (labile factor), negatively charged phospholipids, and calcium, converts prothrombin to thrombin and subsequently fibrinogen is converted to fibrin to form a hemostatic plug that provides local hemostasis. This process may also occur on the surface of activated platelets.

Factor VIIa (recombinant) produces hemostasis in the absence of factor VIII or factor IX by binding to activated platelets and directly activating factor X to generate thrombin independently of TF. Administration of factor VIIa (recombinant) increases circulating concentrations of factor VIIa approximately 1000-fold higher than physiologic levels.

Factor VIIa (recombinant) is used for the treatment and prevention of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor (factor VIII) deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively. The drug also is used for the treatment and prevention of hemorrhagic episodes in patients with acquired hemophilia (i.e., those with acquired inhibitors to factor VIII or IX). In addition, factor VIIa (recombinant) is used for the treatment and prevention of hemorrhagic episodes in patients with congenital factor VII deficiency.

Generic name: coagulation factor VIIa (recombinant)
Pronunciation: (factor VIIA,ree-KOM-bin-unt)
Drug class: Factor VII
Therapeutic class: Hematological Agents

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Novoseven Rt:

  • Acquired Coagulation Factor Inhibitor Disorder
  • Bleeding Episode In Glanzmann's Thrombasthenia
  • Bleeding Episode In Hemophilia A
  • Bleeding Episode In Hemophilia B
  • Bleeding Prevention In Hemophilia
  • Hereditary Factor Vii Deficiency Disease
  • Prevention Of Surgery-Induced Bleeding In Glanzmann's Thrombasthenia

Also known as: Bleeding Episode In Glanzmann's Disease, Bleeding Episode In Glanzmann's Syndrome, Bleeding Episode In Glanzmann-Naegeli Disorder, Bleeding Episode In Gt, Bleeding In Glanzmann's Thrombasthenia, Bleeding Prophylaxis In Hemophilia, Congenital Factor Vii Deficiency, Hemorrhage Prophylaxis In Hemophilia, Hemorrhaging In Glanzmann's Thrombasthenia, Hemorrhaging In Hemophilia A, Hemorrhaging In Hemophilia B, Hereditary Factor Vii Deficiency Syndrome, Hereditary Hypoproconvertinemia, Prevent Surgery-Induced Bleeding In Glanzmann's Disease, Prevent Surgical Hemorrhage In Glanzmann Thrombasthenia, Prevention Of Peri-Operative Hemorrhage In Glanzmann's Disease, Prevention Of Peri-Operative Hemorrhage In Glanzmann's Thrombasthenia, Prevention Of Peri-Operative Hemorrhage In Glanzmann-Naegeli Disorder, Prevention Of Peri-Operative Hemorrhage In Gt, Prevention Of Surgery-Induced Bleeding In Glanzmann-Naegeli Disorder, Prevention Of Surgery-Induced Bleeding In Gt, Surgical Bleed Prophylaxis In Glanzmann's Thrombasthenia.

Dosing

No dosing information is available for this tab.

Drug interactions

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Contraindications

The manufacturer states that there are no known contraindications to the use of factor VIIa (recombinant).

Adverse reactions

The most common adverse effects reported in clinical trials in patients receiving factor VIIa (recombinant) include fever, hemorrhage, hypertension, hypotension, injection site reaction, arthralgia, headache, nausea, vomiting, pain, edema, and rash.

Precautions

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ICD codes

CodeTypeDescription
Acquired coagulation factor inhibitor disorder
D68.31ICD10CMHemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors
D68.311ICD10CMAcquired hemophilia
D68.312ICD10CMAntiphospholipid antibody with hemorrhagic disorder
D68.318ICD10CMOther hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitors
Bleeding episode in glanzmann's thrombasthenia
D69.1ICD10CMQualitative platelet defects
Bleeding episode in hemophilia A
D66ICD10CMHereditary factor VIII deficiency
Z14.02ICD10CMSymptomatic hemophilia A carrier
Bleeding episode in hemophilia B
D67ICD10CMHereditary factor IX deficiency
Bleeding prevention in hemophilia
D66ICD10CMHereditary factor VIII deficiency
D67ICD10CMHereditary factor IX deficiency
D68.311ICD10CMAcquired hemophilia
Z14.02ICD10CMSymptomatic hemophilia A carrier
Hereditary factor VII deficiency disease
D68.2ICD10CMHereditary deficiency of other clotting factors
Prevention of surgery-induced bleeding in glanzmann's thrombasthenia
D69.1ICD10CMQualitative platelet defects

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data