PROTEIN C CONCENTRATE (HUMAN)

PROTEIN C CONCENTRATE (HUMAN)
(pro'teen)
Ceprotin
Classifications: anticoagulant; protein inhibitor ;
Therapeutic: anticoagulant; thrombolytic; protein c replacement therapy
Pregnancy Category: C

Availability

500 unit, 1000 unit vials of lyophilized powder

Action

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.

Therapeutic Effect

Protein C is necessary to decrease thrombin generation and intravascular clot formation.

Uses

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.

Contraindications

Hypersensitivity to human protein C; concurrent administration with tissue plasminogen activator (tPA); hypernatremia; pregnancy (category C); lactation.

Cautious Use

Concurrent administration of anticoagulants; heparin induced thrombocytopenia (HIT); renal impairment; hepatic impairment; older adults.

Route & Dosage

Acute Episodes of Venous Thrombosis and Purpura Fulminans and Short-Term Prophylaxis
Adult: IV Initial dose 100–120 units/kg; then 60–80 units/kg q6h x 3. Maintenance dose: 45–60 units/kg q6–12h.

Administration

Intravenous

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: Lightheadedness. CV: Hemothorax, hypotension.

Interactions

Drug: Protein C concentrate can increase bleeding caused by alteplase, reteplase, or tenecteplase.

Pharmacokinetics

Peak: 0.5–1 h. Half-Life: 9.9 h.

Nursing Implications

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, difficulty breathing.
Report immediately any signs of bleeding including black tarry stools, pink/red-tinged urine, unusual bruising.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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