Ceprotin 1000unit Inj, 1 Vial
It is used to treat or prevent blood clots and blood spots, bruising, and change in skin color in people with protein C deficiency.
Drug Class
Anticoagulant
Pharmacologic Class
Human plasma-derived protein; Antithrombotic agent
Pregnancy Category
Not available
FDA Approved
Jul 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ceprotin is a medicine made from human blood that helps your body prevent harmful blood clots. It replaces a natural protein called Protein C that some people don't have enough of, which can lead to serious clotting problems.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered into a vein over a period of time. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
Before use, this medication must be mixed according to the instructions provided by your doctor. Allow the medication to reach room temperature before mixing. Do not heat the medication. Gently mix the solution without shaking it. After mixing, do not refrigerate the solution. Use the medication within 3 hours of preparation.
Inspecting the Medication
Before administering the medication, inspect the solution for any signs of damage or contamination. Do not use the medication if the solution is cloudy, leaking, or contains particles. The medication should be colorless to faintly yellow. If the solution changes color, do not use it. Each vial is for single use only; discard any remaining medication after the dose is administered.
Disposing of Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at a temperature below freezing. If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered into a vein over a period of time. If you are self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
Before use, this medication must be mixed according to the instructions provided by your doctor. Allow the medication to reach room temperature before mixing. Do not heat the medication. Gently mix the solution without shaking it. After mixing, do not refrigerate the solution. Use the medication within 3 hours of preparation.
Inspecting the Medication
Before administering the medication, inspect the solution for any signs of damage or contamination. Do not use the medication if the solution is cloudy, leaking, or contains particles. The medication should be colorless to faintly yellow. If the solution changes color, do not use it. Each vial is for single use only; discard any remaining medication after the dose is administered.
Disposing of Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in a refrigerator at a temperature below freezing. If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Report any signs of bleeding (e.g., unusual bruising, nosebleeds, blood in urine/stools) or clotting (e.g., pain/swelling in legs, sudden shortness of breath) to your doctor immediately.
- Avoid activities that carry a high risk of injury or bleeding.
- Inform all healthcare providers, including dentists, that you are receiving Protein C Concentrate.
- Carry identification indicating your condition and treatment.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels.
Dose Range:
60 - 150 mg
Condition-Specific Dosing:
severe congenital Protein C deficiency:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels. Dosing frequency and duration depend on the clinical condition and Protein C activity levels.
Pediatric Dosing
Neonatal:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels. Dosing frequency and duration depend on the clinical condition and Protein C activity levels.
Infant:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels. Dosing frequency and duration depend on the clinical condition and Protein C activity levels.
Child:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels. Dosing frequency and duration depend on the clinical condition and Protein C activity levels.
Adolescent:
Initial dose: 100-150 IU/kg, followed by maintenance doses of 60-80 IU/kg every 6-12 hours, adjusted to maintain Protein C activity levels. Dosing frequency and duration depend on the clinical condition and Protein C activity levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Dialysis:
Not available. Use with caution and monitor Protein C activity.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Protein C is a vitamin K-dependent plasma protein that is synthesized in the liver. It is activated by thrombin in the presence of thrombomodulin on the endothelial cell surface. Activated Protein C (APC) is a serine protease that, in the presence of protein S and phospholipids, inactivates coagulation Factors Va and VIIIa, thereby inhibiting thrombin generation and promoting fibrinolysis. This mechanism helps to regulate blood coagulation and prevent excessive clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
Not applicable (is a protein itself)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6-10 hours (functional half-life)
Clearance:
Approximately 6.5 mL/kg/hr
ExcretionRoute:
Metabolites excreted renally
Unchanged:
Not applicable (protein is catabolized)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of administration)
PeakEffect:
Within 1-2 hours (peak plasma levels)
DurationOfAction:
Approximately 6-12 hours (based on half-life and clinical response)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that increase in size
+ Uncontrollable bleeding
Dizziness or fainting
Shortness of breath
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or persist, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact your doctor for medical advice or reach out to the FDA at 1-800-332-1088. You can also submit reports online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that increase in size
+ Uncontrollable bleeding
Dizziness or fainting
Shortness of breath
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or persist, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can contact your doctor for medical advice or reach out to the FDA at 1-800-332-1088. You can also submit reports online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual bleeding or bruising
- Nosebleeds that don't stop
- Blood in urine or stools (black, tarry stools or bright red blood)
- Severe headache or dizziness
- Sudden pain, swelling, or redness in an arm or leg
- Sudden shortness of breath or chest pain
- Signs of allergic reaction: rash, hives, itching, flushing, swelling of face/lips/tongue, difficulty breathing, wheezing, dizziness, feeling faint, chest tightness.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are allergic to heparin or mouse proteins, discuss this with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have.
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are allergic to heparin or mouse proteins, discuss this with your doctor.
To ensure safe treatment, tell your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have.
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. If you have any questions or concerns, be sure to discuss them with your doctor.
If you are following a low-sodium or sodium-free diet, consult with your doctor before taking this medication, as some products may contain sodium.
This medication contains small amounts of heparin, which can increase the risk of developing heparin-induced thrombocytopenia (HIT), a potentially life-threatening blood disorder. If you develop HIT, you may experience easier bleeding. It is crucial to discuss this risk with your doctor.
As this medication is derived from human plasma, there is a risk of transmitting viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize this risk, it is essential to discuss this possibility with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
If you are following a low-sodium or sodium-free diet, consult with your doctor before taking this medication, as some products may contain sodium.
This medication contains small amounts of heparin, which can increase the risk of developing heparin-induced thrombocytopenia (HIT), a potentially life-threatening blood disorder. If you develop HIT, you may experience easier bleeding. It is crucial to discuss this risk with your doctor.
As this medication is derived from human plasma, there is a risk of transmitting viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize this risk, it is essential to discuss this possibility with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Increased risk of bleeding (e.g., excessive bruising, prolonged bleeding from minor cuts, spontaneous bleeding)
What to Do:
In case of suspected overdose, seek immediate medical attention. Contact your doctor or emergency services. For general poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): May counteract the pro-fibrinolytic effect of Protein C, potentially increasing the risk of thrombosis. Concomitant use should be avoided unless clinically necessary and with close monitoring.
Moderate Interactions
- Other anticoagulants (e.g., heparin, warfarin, direct oral anticoagulants): Concomitant use may increase the risk of bleeding. Close clinical and laboratory monitoring (e.g., PT, aPTT, anti-Xa levels) is recommended.
Confidence Interactions
Monitoring
Baseline Monitoring
Protein C activity levels
Rationale: To confirm diagnosis of severe congenital Protein C deficiency and establish baseline for therapeutic monitoring.
Timing: Prior to initiation of therapy
Coagulation parameters (PT, aPTT, fibrinogen)
Rationale: To assess baseline coagulation status and identify any pre-existing coagulopathies.
Timing: Prior to initiation of therapy
Clinical assessment for bleeding or thrombotic events
Rationale: To establish baseline clinical status.
Timing: Prior to initiation of therapy
Routine Monitoring
Protein C activity levels
Frequency: Prior to each infusion, or as clinically indicated to maintain target levels (e.g., 25-100% of normal)
Target: Typically 25-100% of normal, or as determined by treating physician based on clinical response
Action Threshold: Adjust dose if levels are outside target range or if clinical response is inadequate/excessive.
Clinical assessment for signs of bleeding or thrombosis
Frequency: Daily or with each infusion, and as needed
Target: Absence of new or worsening bleeding/thrombosis
Action Threshold: Investigate and manage any new bleeding or thrombotic events; consider dose adjustment or discontinuation.
Vital signs (blood pressure, heart rate, temperature)
Frequency: During and after infusion, then as clinically indicated
Target: Stable
Action Threshold: Monitor for signs of allergic reaction or infusion-related adverse events.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, hematuria, melena, hematemesis, prolonged bleeding from minor cuts)
- Signs of thrombosis (e.g., pain, swelling, redness, warmth in an extremity; sudden shortness of breath, chest pain, vision changes, slurred speech)
- Signs of allergic reaction (e.g., rash, hives, itching, flushing, swelling of face/lips/tongue, difficulty breathing, dizziness, lightheadedness, chest tightness)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Ceprotin in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus. The decision to use should be made on a case-by-case basis by a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Not specifically studied; theoretical risk of viral transmission from plasma-derived product.
Second Trimester:
Not specifically studied; theoretical risk of viral transmission from plasma-derived product.
Third Trimester:
Not specifically studied; theoretical risk of viral transmission from plasma-derived product.
Lactation
It is not known whether Protein C Concentrate is excreted in human milk. Caution should be exercised when Ceprotin is administered to a nursing mother. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ceprotin and any potential adverse effects on the breastfed infant from Ceprotin or from the underlying maternal condition.
Infant Risk:
Risk unknown; theoretical risk of viral transmission from plasma-derived product. Monitor breastfed infant for any adverse effects.
Pediatric Use
Ceprotin is indicated for pediatric patients with severe congenital Protein C deficiency. Dosing is weight-based and similar to adult dosing. Safety and efficacy have been established in this population.
Geriatric Use
Clinical studies of Ceprotin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Ceprotin is a highly specialized product for a rare genetic disorder; ensure accurate diagnosis of severe congenital Protein C deficiency before initiation.
- Administer intravenously at a slow rate (e.g., 1-2 mL/minute) to minimize the risk of infusion-related reactions.
- Monitor Protein C activity levels closely to guide dosing and ensure therapeutic efficacy, especially during acute thrombotic episodes or surgical procedures.
- Be vigilant for signs of bleeding, particularly when co-administered with other anticoagulants.
- Patients should be educated on the signs and symptoms of both bleeding and thrombosis, and when to seek immediate medical attention.
- As a plasma-derived product, there is a theoretical risk of viral transmission, although the manufacturing process includes steps to reduce this risk.
Alternative Therapies
- Fresh Frozen Plasma (FFP): Can provide Protein C, but carries higher risks of volume overload, allergic reactions, and viral transmission, and Protein C concentration is variable.
- Other anticoagulants (e.g., heparin, warfarin): Used for general thrombotic conditions, but do not replace Protein C in deficiency states; may be used adjunctively but require careful monitoring.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered for approved indications)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider for personalized advice. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken.