Pharmacokinetics

Mean pharmacokinetic (PK) parameters of COAGADEX following a single 25 IU/kg dose to subjects 12 years of age and older:

  • A mean half-life of 30.3 hours1
  • Mean incremental recovery 2.04 IU/dL per IU/kg1
  • No evidence of inhibitors to factor X

Runner

In clinical trials, the incremental recovery of COAGADEX was significantly lower in children than adults

  • A previous study in adults and children ≥12 years reported a mean incremental recovery of 2.04 IU/dL per IU/kg1
  • In a study of young children under 12 years of age, incremental recovery was significantly lower at each time point among subjects aged 0-5 years compared with subjects aged 6-11 years1

Incremental Recovery by Age Group1

Chart - Incremental Recovery by Age Group

  • The lower incremental recovery in children requires a higher dose adjustment factor for subjects 0 to 11 years of age. See the Dosing section.

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

Reference: 1. COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2018.

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.