[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.

[9][7] Novoseven RT is indicated for the treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital factor VII deficiency, and Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets and for the treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.

[6][2] Sevenfact [coagulation factor VIIa (recombinant)-jncw] is approved for use in the United States and is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents twelve years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).

[11] There is a significant risk of arterial thrombosis with its use and thus, other than in those with factor VII deficiency or acquired hemophilia, it should only be given in clinical trials.

[11] Recombinant human factor VII, while initially looking promising in intracerebral hemorrhage, failed to show benefit following further study and is no longer recommended.

[8] The recombinant DNA (rDNA) construct in the genetically engineered rabbits used for the production of Sevenfact was approved by the FDA's Center for Veterinary Medicine.

[8] The safety and efficacy of coagulation factor VIIa (recombinant)-jncw were determined using data from a clinical study that evaluated 27 patients with hemophilia A or B with inhibitors, which included treatment of 465 mild or moderate, and three severe bleeding episodes.

[8] Another study evaluated the safety and pharmacokinetics of three escalating doses of coagulation factor VIIa (recombinant)-jncw in 15 subjects with severe hemophilia A or B with or without inhibitors.

[5] Recombinant factor VIIa was used routinely in severely wounded American troops during the Iraq War, credited with saving many lives but also resulting in a high number of deep venous thromboses and pulmonary emboli, as well as unexpected strokes, heart attacks, and deaths.