Protein C Concentrate
Class: Anticoagulants, Miscellaneous
Brands: Ceprotin
Introduction
Anticoagulant; a vitamin K-dependent serine protease precursor prepared from pooled human plasma.
Uses for Protein C Concentrate
Congenital Protein C Deficiency
Replacement therapy in patients with severe congenital protein C deficiency for prevention and treatment of venous thrombosis and purpura fulminans (designated an orphan drug by FDA for this use).
Protein C Concentrate Dosage and Administration
General
Dosage and duration of therapy is dependent on the severity of protein C deficiency, the plasma protein C concentration, and the patient’s age and clinical condition.
Individualize dosage based on measured protein C activity, expressed as a percentage of normal plasma protein C concentrations, and adjust according to the pharmacokinetic profile for each individual patient.
Determine plasma protein C concentrations before and during therapy using a chromogenic assay to measure protein C activity.
During acute thrombotic episodes, measure protein C activity immediately before administration until the patient is stabilized and continue monitoring afterward. The magnitude of increase in plasma protein C activity may be substantially reduced during acute episodes.
Monitor coagulation parameters; however, correlation between levels of protein C activity and coagulation parameters not yet established.
Administration
IV Administration
Administer by IV injection.
Initiate therapy under supervision of a clinician experienced in replacement therapy with coagulation factors/inhibitors and where monitoring of protein C activity is feasible.
Protein C (human) may be self-administered if clinician determines that the patient and/or caregiver is competent to safely administer the drug after appropriate training.
Reconstitution
Prior to reconstitution, allow lyophilized powder and manufacturer-supplied diluent to warm to room temperature.
Reconstitute lyophilized powder with diluent provided by manufacturer. Use strict aseptic technique since drug contains no preservative.
Reconstitute appropriate number of vials based on the indicated dosage. Vials contain approximately 500 or 1000 IU protein C (human); actual potency is labeled on each vial.
Reconstitute single-use vials of lyophilized powder by adding 5 or 10 mL of sterile water for injection to vial containing approximately 500 or 1000 units of protein C (human), respectively, using transfer needle provided by manufacturer; resulting solution contains approximately 100 units of protein C (human) per mL. Swirl vial gently until powder is completely dissolved.
Withdraw reconstituted solution from vial(s) using filter needle provided by manufacturer. Before administration, replace filter needle with a suitable needle or infusion set with winged adapter. Filter needle provided by manufacturer is intended to filter contents of a single vial.
Administer at room temperature within 3 hours of reconstit...
