Manufacturing Process

COAGADEX is manufactured from plasma obtained from healthy US donors who have passed viral screening tests

  • During the manufacturing process, COAGADEX undergoes 3 processing steps specifically designed to remove or inactivate viruses:
    1. Solvent/detergent treatment targeting enveloped viruses
    2. A virus filtration step designed to remove small viruses including non-enveloped viruses
    3. Terminal dry-heat treatment at 80°C for 72 hours in the final container to inactivate enveloped and non-enveloped viruses

    Viral Reduction in Pathogen Safety Studies

    *This 15 nm filtration step has also been tested by PCR using the human parvovirus B19 virus itself and confirmed to be effective, i.e. >5.9 log reduction.

    BVD, bovine viral diarrhea virus, model for hepatitis C virus (HCV); CPV, canine parvovirus, model for human parvovirus B19; HAV, hepatitis A virus; HIV, human immunodeficiency virus; HSV, herpes simplex virus; IBR, infectious bovine rhinotracheitis, bovine herpesvirus model for enveloped DNA viruses including hepatitis B; NA, not applicable, solvent detergent step is limited to the inactivation of enveloped viruses; NT, not tested; SIN, Sindbis virus, model for HCV; WNV, West Nile Virus.

  • Tests for prion protein reduction have reported an overall decrease of >9.2 log10: 2.5 log10 with metal chelate chromatography, >3.7 log10 with anion exchange chromatography, and 3.0 log10 for virus filtration

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Reference: COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 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 ‚Č•5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.