Dosing and uses of Ceprotin, Protein C Concentrate Human (protein C concentrate)
Adult dosage forms and strengths
lyophilized powder
- 500 International Units
- 1000 International Units
Protein C Deficiency
Indicated for prevention and treatment of venous thrombosis and purpura fulminans in patients with congenital Protein C deficiency
Acute episode or short term prophylaxis: Initial 100-120 IU/kg IV, THEN 60-80 International Units/kg IV q6hr for 3 doses; THEREAFTER 45-60 IU/kg IV BID/QId
Long-term prophylaxis: 45-60 IU/kg IV q12hr
Warfarin-Induced Skin Necrosis (Orphan)
Replacement therapy in congenital or acquired protein C deficiency for the prevention and treatment of warfarin-induced skin necrosis during oral anticoagulation
Orphan indication sponsor
- Immuno Clinical Research Corp; 750 Lexington Avenue, 19th Floor; New York, NY 10022
Other Information
Adjust to higher peak protein C activity levels during periods of increased thrombolytic risk caused by infection, trauma, and surgery
Maintain trough protein C activity levels >25%
Pediatric dosage forms and strengths
lyophilized powder
- 500 International Units
- 1000 International Units
Protein C Deficiency
Indicated for prevention and treatment of venous thrombosis & purpura fulminans in patients with congenital Protein C deficiency
Acute episode or short term prophylaxis: Initial 100-120 IU/kg IV, THEN 60-80 Units/kg IV q6hr for 3 doses; THEREAFTER 45-60 IU/kg IV BID/QId
Long-term prophylaxis: 45-60 IU/kg IV q12hr
Ceprotin, Protein C Concentrate Human (protein C concentrate) adverse (side) effects
Frequency not defined
Most common: hypersensitivity, allergic rxns, lightheadedness, itching, rash
Other: hemothorax, hypotension, hyperhydrosis, fever, restlessness, heparin-induced thrombocytopenia
Warnings
Cautions
contains traces of mouse proteins & heparin:- risk of allergic rxns
Made from human plasma: theoretical risk of transmitting blood-borne pathogens
Risk of bleeding w/ simultaneous administration of tPA &/or anticoagulants
Contains heparin: risk of heparin-induced thrombocytopenia; is suspected, check Plt count immediately & discontinue administration
Daily dose contains >200 mg sodium
Risk of shortened half-life in cases of acute thrombosis, purpura fulminans & skin necrosis
Risk of allergic rxns
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if distributed into breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Ceprotin, Protein C Concentrate Human (protein C concentrate)
Half-Life: 9.8 hr
Peak Plasma Time: 0.5 hr
Peak Plasma Concentration: 110 IU/dL
Vd: 0.74 L/kg
Mechanism of action
Precursor of vitamin K-dependent anticoagulant gylcoprotein (serine protease) synthesized in liver; converted by thrombin/thrombomodulin-complex on endothelial cell surface to activated Protein C (APC)
Administration
IV Preparation
Reconstitute aseptically, warm drug & diluent (SWI) vials to room temp, remove caps & cleanse stoppers w/ germicidal soln
Remove covering from one end of the double-ended transfer needle & insert needle through center of diluent vial stopper
Remove protective covering from other end of double-ended transfer needle; invert diluent vial over upright vial; then rapidly insert free end of needle through vial stopper
The vacuum in drug vial will draw in diluent
If there is no vacuum in vial, do not use, & contact Baxter Customer Service at 1-888-CEPROTIN (237-7684)
Disconnect the two vials by removing needle from vials; gently swirl vial to completely dissolve. Solution should appear colorless to slight yellowish & free from visible particles.
IV Administration
Administer within 3 hr after reconstitution
Attach filter needle to sterile, disposable syringe; admit air into syringe, insert needle into vial, inject air into vial & withdraw reconstituted Protein C Conc into syringe
Remove filter needle, attach a suitable needle or infusion set with winged adapter
Administer at max rate of 2 mL/min; for children <10 kg, NMT 0.2 mL/kg/min
Storage
Intact vials can be refrigerated at 2-8°C (36-46°F) for 3 yr
Protect unopened vials from light
Do not freeze
