Results in Patients Undergoing Surgery
Five subjects receiving COAGADEX in clinical trials underwent 7 surgical procedures
- Three of the subjects were enrolled in TEN01
The other 2 subjects were enrolled in Study TEN03, a non-randomized, prospective study in subjects with mild to severe factor X deficiency (plasma concentration of factor X <20 IU/dL) undergoing planned surgery
- Both subjects in Study TEN03 had 2 separate surgical procedures
Investigator-Assessed Outcome of Surgery in Subjects Receiving COAGADEX
Subjects were given a loading dose before the procedure to raise factor X level to 70-90 IU/dL. Doses after surgery were given to maintain factor X level above 50 IU/dL.
Limitation of Use
Perioperative management of bleeding in major surgery in patients with severe hereditary factor X deficiency has not been studied
Safety of COAGADEX in surgical patients
- The most common AEs, each reported on 3 occasions, were constipation and dyspepsia; all other AEs were reported on ≤2 occasions. No AE was considered related to treatment with COAGADEX
- Two serious AEs were reported (tooth abscess predating surgical procedure; hospitalization due to bleeding following a complex procedure requiring intravenous anesthesia and intubation to extract 2 teeth). Neither serious AE was considered related to COAGADEX
- No thrombotic events or other evidence of thrombogenicity were reported
- All inhibitor results were negative
- No viral seroconversions were observed
COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.
Reference: Escobar M, Auerswald G, Austin S, et al. Haemophilia. 2016;22:713-720.