On-demand Trial Results: Safety

Hiker

Only 6 adverse reactions (3.4%) occurring in 2 patients were considered by the investigator to be possibly related to treatment with COAGADEX

  • Infusion-site erythema (2 mild events), back pain (1 mild event), and fatigue (1 mild event and 1 moderate event) in 1 patient
  • Infusion-site pain (1 mild event) in 1 patient

Six patients (37.5%) experienced a total of 13 serious adverse events (AEs)

  • No serious AEs were considered by investigators to be related to COAGADEX
  • One serious AE of death occurred due to pneumonia and nosocomial infection

Other safety results

  • No thrombotic events or clinical signs of thrombogenicity
  • No hypersensitivity reactions to factor X
  • No evidence of inhibitors to factor X
  • No viral seroconversions were observed

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. In clinical studies, the most common adverse reactions with COAGADEX were infusion site erythema, back pain, fatigue, and infusion site pain.

Reference: Austin S, Norton M, et al. Safety and efficacy of FACTOR X, a new high-purity factor X concentrate: a phase 3 study in patients with hereditary factor X deficiency. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18 2015.

Indications for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary factor X deficiency for:

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied.

Important Safety Information for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately and contact their physician.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.