|PROTEIN C CONCENTRATE (HUMAN)
Classifications: anticoagulant; protein inhibitor ; Therapeutic: anticoagulant; thrombolytic; protein c replacement therapy
Pregnancy Category: C
500 unit, 1000 unit vials of lyophilized powder
Protein C is a critical element in a pathway that provides a natural mechanism for control of the coagulation system. The
pathway prevents excess procoagulant responses to activating stimuli.
Protein C is necessary to decrease thrombin generation and intravascular clot formation.
Treatment of patients with severe congenital protein C deficiency; protein C replacement therapy for the prevention and
treatment of venous thrombosis and purpura fulminans in children and adults.
Hypersensitivity to human protein C; concurrent administration with tissue plasminogen activator (tPA); hypernatremia; pregnancy
(category C); lactation.
Concurrent administration of anticoagulants; heparin induced thrombocytopenia (HIT); renal impairment; hepatic impairment;
Route & Dosage
|Acute Episodes of Venous Thrombosis and Purpura Fulminans and Short-Term Prophylaxis
Adult: IV Initial dose 100120 units/kg; then 6080 units/kg q6h x 3. Maintenance dose: 4560 units/kg
ADMINISTER: Direct/IV Infusion: ??Bring powder and supplied diluent to room temperature. Insert supplied double-ended transfer needle into diluent vial, then
invert and rapidly insert into protein C powder vial. (If vacuum does not draw diluent into vial, discard.) Remove transfer
needle and gently swirl to dissolve. ??Resulting solution concentration is 100 units/mL and it should be colorless to slightly yellowish, clear to slightly opalescent
and free from visible particles. ??Withdraw required dose with the supplied filter needle.
ADMINISTER: Direct/IV Infusion: Infuse at 2 mL/min. Direct/IV Infusion for Child >10 kg: Infuse at 0.2 mL/kg/min.
- Store at room temperature for no more than 3 h after reconstitution. Prior to reconstitution, protect from light.
Adverse Effects (≥1%)Body as a Whole:
Fever, hyperhidrosis, hypersensitivity reactions (rash, pruritits), restlessness. CNS:
Protein C concentrate can increase bleeding caused by alteplase, reteplase,
0.51 h. Half-Life:
Assessment & Drug Effects
- Monitor for and promptly report S&S of bleeding or hypersensitivity reactions (see Appendix F).
- Monitor vital signs including BP and temperature.
- Lab tests: Baseline and periodic protein C activity, protein C trough level with acute thrombotic events; platelet counts;
frequent serum sodium with renal function impairment.
Patient & Family Education
- Report immediately early signs of hypersensitivity reactions including hives, generalized itching, tightness in chest, wheezing,
- Report immediately any signs of bleeding including black tarry stools, pink/red-tinged urine, unusual bruising.