Dosing & Uses
Dosage Forms & 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%
Dosage Forms & 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
Adverse 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 & 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
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
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
