On-demand Trial Results: Safety

Hiker

Six adverse events (3.4%) occurring in 2 subjects were considered by the investigator to be possibly related to treatment with COAGADEX1,2

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

Six subjects (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. If symptoms occur, patients should discontinue use of the product immediately, contact their physician, and administer appropriate treatment.

Reference: 1. Austin S, Kavakli K, Norton M, et al. Haemophilia. 2016;22:419-425. 2. Austin S, Norton M, et al. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18, 2015.

Indications and Usage for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children with hereditary factor X deficiency for:

Limitation of Use

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

Contraindication for COAGADEX

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

Important Safety Information for COAGADEX

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

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.