protein C concentrate (Rx)

Brand and Other Names:Ceprotin, Protein C Concentrate Human
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder

  • 500 International Units
  • 1000 International Units
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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
more...

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

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Adverse Effects

Frequency Not Defined

Most common: hypersensitivity, allergic rxns, lightheadedness, itching, rash

Other: hemothorax, hypotension, hyperhydrosis, fever, restlessness, heparin-induced thrombocytopenia

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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

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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.

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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)

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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

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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