Ceprotin, Protein C Concentrate Human (protein C concentrate) dosing, indications, interactions, adverse effects, and more

Sections

Sections protein C concentrate
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

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

Frequency Not Defined

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

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

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)

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

No images available for this drug.

Patient Handout

PROTEIN C CONCENTRATE (HUMAN) - INJECTION

COMMON BRAND NAME(S): Ceprotin

USES: Protein C is a natural substance in your body that helps to decrease clotting in the blood vessels. This medication is used to prevent and treat blood clots (such as venous thrombosis, purpura fulminans) in people who are born with a severe lack of protein C.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using protein C concentrate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor. Dosage is based on your medical condition, age, weight, protein C level, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: Lightheadedness may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: easy or unusual bruising/bleeding, signs of infection (such as fever, chills), signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, yellowing eyes/skin, severe stomach/abdominal pain).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, chest pain, shortness of breath, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using protein C concentrate, tell your doctor or pharmacist if you are allergic to it; or to heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, low platelet counts after heparin treatment.This medication contains sodium. Consult your doctor or pharmacist if you are on a salt-restricted diet or if you have a condition that could be worsened by an increase in salt intake (such as heart failure, high blood pressure).Before having surgery, tell your doctor that you are using this medication.This medication is made from human blood. Even though the blood is carefully tested and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (including virus infections such as hepatitis). Consult your doctor or pharmacist for more information, and ask whether you should get vaccinations before receiving this medication.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anti-platelet medications (including clopidogrel, NSAIDs such as aspirin/ibuprofen), "blood thinners" (such as enoxaparin, heparin, warfarin), clot-dissolving drugs (including thrombolytics such as alteplase).If your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Lab and/or medical tests (such as protein C activity/levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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