Protein C Concentrate (Human)
Pronouncation: PRO-teen KAN-sen-trateClass: Thrombolytic agent
Trade Names:
Ceprotin
- Powder for injection, lyophilized 500 units
- Powder for injection, lyophilized 1,000 units
Pharmacology
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Exerts antithrombotic effect by inactivation of the activated forms of factors V and VIII, which leads to a decrease in thrombin formation.
Pharmacokinetics
Absorption
C max and AUC increase linearly with dose between 40 and 80 units/kg.
Elimination
Median t ½ is 9.8 h (range, 4.9 to 14.7 h).
Indications and Usage
Prevention and treatment of venous thrombosis and purpura fulminans in patients with severe congenital protein C deficiency; congenital protein C replacement therapy for children and adults.
Contraindications
None.
Dosage and Administration
Acute Episode/Short-Term ProphylaxisAdults
IV Start with 100 to 120 units/kg. Subsequent 3 doses consist of 60 to 80 units/kg given every 6 h. Maintenance dose 45 to 60 units/kg every 6 or 12 h. Adjust the dose to maintain a target peak protein C activity of 100%. After resolution of the acute episode, continue the same dose to maintain trough protein C activity level above 25%. These dosing guidelines are also recommended for neonates and children.
Long-Term ProphylaxisAdults
IV 45 to 60 units/kg every 12 h. These dosing guidelines are also recommended for neonates and children.
General Advice
- In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists, a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent. In the initial phase of treatment, activity of protein C is more rapidly suppressed than that of the procoagulant factors. Therefore, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained. Patients with severe congenital protein C deficiency are at greater risk of warfarin-induced skin necrosis. During initiation of oral anticoagulant therapy, start with a low dose of anticoagulant and adjust dose incrementally, rather than starting with a standard loading dose.
- Administer at room temperature not more than 3 h after reconstitution.
- Administer at a max rate of 2 mL/min except for children with body weight less than 10 kg (22 lb), where the injection rate should not exceed 0.2 mL/kg/min.
Storage/Stability
Store refrigerated at 36° to 46°F. Do not freeze. Protect from light. Use reconstituted solution within 3 h of reconstitution.
Drug Interactions
AnticoagulantsRisk of bleeding episodes may be increased.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Hypotension (postmarketing).
CNS
Light-headedness, restlessness (postmarketing).
Hypersensitivity
Hypersensitivity/allergic reactions, including itching and rash.
Miscellaneous
Fever, hemothorax, hyperhidrosis (postmarketing).
Precautions
MonitorMeasurement of protein C activity using a chromogenic assay is recommended for determination of plasma level of protein C before and during treatment. Protein C concentrate t ½ may be shortened in certain clinical conditions (eg, acute thrombosis, purpura fulminans, skin necrosis). In case of an acute thrombotic event, perform protein C activity measurements immediately prior to the next injection until the patient is stabilized. After patient is stabilized, continue monitoring protein C levels to maintain the trough protein C above 25%. Monitor coagulation parameters during acute phase of the disease. Monitor patients with renal function impairment for sodium overload. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Neonatal and children were included in retrospective and prospective trials evaluating safety and efficacy.
Hypersensitivity
Because product may contain traces of mouse protein and/or heparin, allergic reactions to these substances cannot be ruled out.
Bleeding episodes
May occur.
Heparin-induced thrombocytopenia
May occur because product contains trace amounts of heparin.
Infections
Because protein C concentrate is prepared from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.
Low-sodium diet
Quantity of sodium in product exceeds 200 mg.
Overdosage
Symptoms
No symptoms have been reported.
Patient Information
- Inform patients about the early signs of hypersensitivity reactions, including anaphylaxis, generalized urticaria, hives, hypotension, tightness in chest, and wheezing. If symptoms occur, patients should immediately discontinue the infusion and inform health care provider as soon as possible.
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