Kcentra 500unit Inj Kit
WARNING: People are treated with drugs to thin the blood when they have health problems that raise the chance of blood clots. This drug is used to undo the effects of those drugs. Very bad and sometimes deadly blood clots have happened after using this drug. Talk with your doctor if you have ever had a blood clot.Before you use this drug, tell your doctor if you have had a heart attack, a blood problem called disseminated intravascular coagulation (DIC), stroke, chest pain, or very bad blood vessel disease within the past 3 months. You will need to talk about the benefits and risks of using this drug. @ COMMON USES: It is used to undo the effects of certain blood thinners like warfarin.
Drug Class
Hemostatic Agent
Pharmacologic Class
Prothrombin Complex Concentrate
Pregnancy Category
Not available
FDA Approved
Apr 2013
DEA Schedule
Not Controlled
Overview
What is this medicine?
Kcentra is a medicine given by injection into a vein. It contains important proteins that help your blood clot. It's used when your blood is too thin, usually because of a blood thinner medication like warfarin, and you have serious bleeding or need urgent surgery. It helps your blood clot faster to stop bleeding.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a specified period.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
Lifestyle & Tips
- Report any new or worsening bleeding immediately to your healthcare provider.
- Be aware of symptoms of blood clots (e.g., chest pain, shortness of breath, swelling/pain in leg/arm, sudden weakness/numbness, severe headache). Seek immediate medical attention if these occur.
- Discuss with your doctor when it is safe to resume your blood thinner medication, if applicable.
- Follow all post-treatment instructions from your healthcare team.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Dose based on patient's INR and body weight. Administer as a single intravenous infusion. For INR 2 to <4: 25 units/kg. For INR 4 to <6: 35 units/kg. For INR ≥6: 50 units/kg. Maximum dose is 2500 units for 25 units/kg, 3500 units for 35 units/kg, and 5000 units for 50 units/kg.
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
acute_major_bleeding:
Administer as per standard dosing based on INR and body weight.
urgent_surgery_invasive_procedure:
Administer as per standard dosing based on INR and body weight.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
No specific recommendations; monitor closely for efficacy and adverse events.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Kcentra is a 4-factor prothrombin complex concentrate (4F-PCC) containing Vitamin K-dependent coagulation Factors II (prothrombin), VII (proconvertin), IX (Christmas factor), and X (Stuart-Prower factor), together with anticoagulant Proteins C and S. It works by rapidly increasing the plasma levels of these coagulation factors, thereby reversing the anticoagulant effect of Vitamin K antagonists (VKAs) and restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediately after infusion (functional activity)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Distributed within the plasma volume
ProteinBinding:
Not applicable (complex mixture of proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Factor II: 40-60 hours; Factor VII: 4-6 hours; Factor IX: 16-30 hours; Factor X: 25-40 hours
Clearance:
Not available (varies by factor)
ExcretionRoute:
Metabolic degradation
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within 10-30 minutes (INR correction)
PeakEffect:
Within 10-30 minutes (INR correction)
DurationOfAction:
Several hours (INR correction), depends on factor half-lives and continued VKA effect
Safety & Warnings
BLACK BOX WARNING
ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS: KCENTRA is associated with a risk of arterial and venous thromboembolic complications. Monitor patients receiving KCENTRA for signs and symptoms of thromboembolic events. KCENTRA was not studied in patients who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. KCENTRA may not be suitable in patients with a history of thromboembolic events or disseminated intravascular coagulation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Flushing
Rapid heartbeat
Anxiety
Severe dizziness or fainting
Rapid breathing
Painful urination
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Feeling extremely tired or weak
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Upset stomach or vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Flushing
Rapid heartbeat
Anxiety
Severe dizziness or fainting
Rapid breathing
Painful urination
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Feeling extremely tired or weak
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Upset stomach or vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of new or worsening bleeding (e.g., unusual bruising, nosebleeds, blood in urine or stool, prolonged bleeding from cuts)
- Signs of a blood clot (e.g., sudden chest pain, shortness of breath, pain or swelling in an arm or leg, sudden weakness or numbness on one side of your body, sudden severe headache, vision changes)
- Signs of an allergic reaction (e.g., hives, rash, itching, difficulty breathing, wheezing, swelling of your face, lips, tongue, or throat, dizziness)
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 allergic reaction you experienced, including any symptoms that occurred.
If you have ever had a low platelet count (thrombocytopenia) caused by heparin, a medication used to prevent blood clotting.
* If you have an IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), a type of antibody that plays a crucial role in your immune system.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have ever had a low platelet count (thrombocytopenia) caused by heparin, a medication used to prevent blood clotting.
* If you have an IgA deficiency, a condition where your body does not produce enough immunoglobulin A (IgA), a type of antibody that plays a crucial role in your immune system.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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. Be sure to discuss any concerns or questions you have with your doctor.
As this medication is derived from human plasma, a component of blood, there is a risk of transmitting viruses that can cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize the risk of infection. It is crucial to discuss this risk with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.
As this medication is derived from human plasma, a component of blood, there is a risk of transmitting viruses that can cause disease. However, the medication undergoes rigorous screening, testing, and treatment to minimize the risk of infection. It is crucial to discuss this risk with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive clotting (thrombosis)
- Signs of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, vision problems)
- Signs of heart attack (e.g., chest pain, shortness of breath, discomfort in other areas of the upper body)
- Signs of deep vein thrombosis/pulmonary embolism (e.g., leg pain/swelling, shortness of breath, chest pain)
What to Do:
There is no specific antidote for Kcentra overdose. Management is supportive and may include anticoagulation if severe thrombosis occurs. Call 911 or your local emergency number immediately. For general poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Patients with known anaphylactic or severe systemic reaction to Kcentra components
- Patients with disseminated intravascular coagulation (DIC)
- Patients with heparin-induced thrombocytopenia (HIT) due to trace amounts of heparin in the product
Monitoring
Baseline Monitoring
INR (International Normalized Ratio)
Rationale: To determine initial dosing and assess baseline coagulation status.
Timing: Prior to Kcentra administration
Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT)
Rationale: To assess overall coagulation status.
Timing: Prior to Kcentra administration
Complete Blood Count (CBC) including platelets and hemoglobin
Rationale: To assess baseline hematologic status and severity of bleeding.
Timing: Prior to Kcentra administration
Vital Signs (heart rate, blood pressure, respiratory rate, temperature)
Rationale: To establish baseline physiological status and monitor for acute reactions.
Timing: Prior to Kcentra administration
Routine Monitoring
INR (International Normalized Ratio)
Frequency: Within 30 minutes of Kcentra administration, then as clinically indicated
Target: INR < 1.5 (for VKA reversal)
Action Threshold: If INR remains elevated, consider additional measures or repeat dosing if clinically appropriate and within maximum dose guidelines.
Signs and Symptoms of Thromboembolic Events
Frequency: Continuously during and after infusion, for several days post-treatment
Target: Absence of new or worsening signs/symptoms
Action Threshold: If signs/symptoms develop (e.g., chest pain, dyspnea, limb swelling, neurological deficits), immediately evaluate and manage appropriately.
Signs and Symptoms of Allergic/Hypersensitivity Reactions
Frequency: During and immediately after infusion
Target: Absence of allergic symptoms
Action Threshold: If symptoms develop (e.g., hives, rash, pruritus, dyspnea, anaphylaxis), stop infusion and provide supportive care.
Vital Signs
Frequency: During and immediately after infusion, then as clinically indicated
Target: Stable
Action Threshold: Significant changes may indicate adverse reaction or clinical deterioration.
Symptom Monitoring
- Signs of new or worsening bleeding (e.g., hematoma expansion, persistent oozing, blood in urine/stool)
- Signs of arterial thrombosis (e.g., chest pain, shortness of breath, sudden weakness/numbness, slurred speech, vision changes)
- Signs of venous thrombosis (e.g., swelling, pain, redness in an extremity)
- Signs of allergic reaction (e.g., hives, rash, itching, difficulty breathing, wheezing, swelling of face/throat, dizziness)
Special Patient Groups
Pregnancy
Kcentra is a human plasma-derived product. There are no adequate and well-controlled studies of Kcentra in pregnant women. It should be used during pregnancy only if clearly needed. The risk of thromboembolism is increased in pregnant women, and treatment with Kcentra may further increase this risk.
Trimester-Specific Risks:
First Trimester:
Risk of thrombosis may be increased.
Second Trimester:
Risk of thrombosis may be increased.
Third Trimester:
Risk of thrombosis may be increased, especially in the peripartum period.
Lactation
It is not known whether Kcentra is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kcentra is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Kcentra and any potential adverse effects on the breastfed infant from Kcentra or from the underlying maternal condition.
Infant Risk:
Unknown; potential for adverse effects on the breastfed infant is not established.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Kcentra is not indicated for use in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Elderly patients may have a higher baseline risk of thromboembolic events.
Clinical Information
Clinical Pearls
- Kcentra provides rapid (within 10-30 minutes) and effective reversal of VKA-induced anticoagulation, making it suitable for acute major bleeding or urgent procedures.
- The primary serious adverse event is thromboembolism. Careful patient selection, weighing the benefits of VKA reversal against the thrombotic risk, is crucial.
- Kcentra contains trace amounts of heparin. It is contraindicated in patients with a history of heparin-induced thrombocytopenia (HIT).
- While Kcentra rapidly corrects INR, it does not address the ongoing effect of the VKA. Concurrent administration of Vitamin K is often recommended to provide sustained VKA reversal.
- Dosing is weight-based and INR-dependent; accurate patient weight and INR are essential for appropriate dosing.
- Kcentra does not contain Factor VIII or von Willebrand Factor (vWF) and is not indicated for hemophilia A or von Willebrand disease.
Alternative Therapies
- Fresh Frozen Plasma (FFP) - slower onset, larger volume required, higher risk of volume overload and allergic reactions.
- Recombinant Factor VIIa (rFVIIa) - not indicated for general VKA reversal, typically used for specific bleeding disorders or off-label for refractory bleeding.
- Vitamin K - slower onset (hours to days), suitable for non-urgent VKA reversal.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per dose per 500 unit vial
Insurance Coverage:
Specialty drug, typically covered under medical benefit (Part B for Medicare) or hospital formulary for inpatient use.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.