Koate 250unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor VIII
Pregnancy Category
Category C
FDA Approved
Jan 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Koate is a medicine that helps your blood clot. People with hemophilia A don't have enough of a special protein called Factor VIII, which is needed for blood to clot properly. Koate replaces this missing protein, helping to stop or prevent bleeding episodes. It is given as an injection into a vein.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all accompanying information and adhere to the provided guidelines. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Inspection
Prior to use, this medication must be mixed according to the instructions provided by your doctor. Use the mixed solution within 3 hours of preparation. Visually inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. After administering the dose, discard any remaining solution.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Never reuse needles or other items. Once the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
For specific storage instructions, refer to the product labeling or consult with your doctor or pharmacist.
Missed Dose
If you miss a dose of Hemofil M, contact your doctor to determine the best course of action.
To ensure safe and effective use, follow your doctor's instructions for taking this medication. Carefully read all accompanying information and adhere to the provided guidelines. This medication is administered via injection into a vein. If you are self-administering, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Inspection
Prior to use, this medication must be mixed according to the instructions provided by your doctor. Use the mixed solution within 3 hours of preparation. Visually inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. After administering the dose, discard any remaining solution.
Safe Disposal
Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Never reuse needles or other items. Once the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
For specific storage instructions, refer to the product labeling or consult with your doctor or pharmacist.
Missed Dose
If you miss a dose of Hemofil M, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Always carry your medication and medical identification (e.g., medical alert bracelet) indicating you have hemophilia.
- Avoid activities that carry a high risk of injury or bleeding.
- Avoid medications that interfere with clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Maintain good dental hygiene and inform your dentist about your hemophilia.
- Follow your doctor's instructions for regular infusions, even if you are not bleeding, to prevent future bleeds (prophylaxis).
- Report any new or unusual bleeding, joint pain, or signs of an allergic reaction immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on factor VIII deficiency, location and severity of bleeding, and patient's clinical condition. Typically 20-40 IU/kg for on-demand treatment of bleeding episodes.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
onDemandBleeding:
20-40 IU/kg IV, repeat every 8-12 hours as needed to achieve desired factor VIII level.
prophylaxis:
20-50 IU/kg IV 2-3 times per week.
surgeryMinor:
30-50 IU/kg IV pre-op, maintain factor VIII levels at 50-80% for 1-2 days.
surgeryMajor:
50 IU/kg IV pre-op, maintain factor VIII levels at 80-100% for 7-14 days.
Pediatric Dosing
Neonatal:
Dosing is individualized based on weight and clinical need, similar to older children/adults (e.g., 20-50 IU/kg).
Infant:
Dosing is individualized based on weight and clinical need, similar to older children/adults (e.g., 20-50 IU/kg).
Child:
Dosing is individualized based on weight and clinical need, similar to adults (e.g., 20-50 IU/kg).
Adolescent:
Dosing is individualized based on weight and clinical need, similar to adults (e.g., 20-50 IU/kg).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Human) is a purified plasma-derived preparation of coagulation Factor VIII. Factor VIII is an essential cofactor in the intrinsic pathway of blood coagulation. It forms a complex with activated Factor IX (FIXa) and calcium on a phospholipid surface, which then activates Factor X (FX) to Factor Xa (FXa). FXa, in turn, converts prothrombin to thrombin, leading to the formation of a stable fibrin clot. In patients with hemophilia A, Factor VIII is deficient or defective, leading to impaired clot formation. Administration of Antihemophilic Factor (Human) temporarily replaces the missing Factor VIII, restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.04-0.08 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
8-18 hours (mean 12 hours)
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolic degradation
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Immediate (at end of infusion)
DurationOfAction:
Dependent on half-life, typically 8-12 hours for significant hemostatic effect, up to 24 hours for some patients.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 certain infections (parvovirus B19, hepatitis A), including:
+ Fever or chills
+ Headache
+ Feeling very sleepy
+ Runny nose
+ Rash
+ Joint pain
+ Tiredness
+ Poor appetite
+ Upset stomach or vomiting
+ Diarrhea
+ Stomach pain
+ Yellow skin or eyes
Shortness of breath
Severe dizziness or fainting
Flushing
Feeling extremely tired or weak
Chest pain or pressure, or a rapid heartbeat
Abnormal burning, numbness, or tingling sensations
Restlessness
Blurred vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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 attention 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 certain infections (parvovirus B19, hepatitis A), including:
+ Fever or chills
+ Headache
+ Feeling very sleepy
+ Runny nose
+ Rash
+ Joint pain
+ Tiredness
+ Poor appetite
+ Upset stomach or vomiting
+ Diarrhea
+ Stomach pain
+ Yellow skin or eyes
Shortness of breath
Severe dizziness or fainting
Flushing
Feeling extremely tired or weak
Chest pain or pressure, or a rapid heartbeat
Abnormal burning, numbness, or tingling sensations
Restlessness
Blurred vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 an allergic reaction: hives, rash, itching, swelling of the face/lips/tongue, difficulty breathing, wheezing, chest tightness, dizziness.
- Signs of bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stool, severe headache, joint pain or swelling, muscle pain or swelling.
- Signs of inhibitor development: increased frequency or severity of bleeding, or if your usual dose of Koate is no longer effective.
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, any of 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 are allergic to mouse proteins, discuss this with your doctor, as it may be relevant to your treatment.
* Potential interactions with other medications or health conditions. To ensure safe treatment, tell your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems or conditions
It is crucial to verify that it is safe to take this medication with all 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, any of 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 are allergic to mouse proteins, discuss this with your doctor, as it may be relevant to your treatment.
* Potential interactions with other medications or health conditions. To ensure safe treatment, tell your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems or conditions
It is crucial to verify that it is safe to take this medication with all 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. If you have a known allergy to latex, be sure to discuss this with your doctor.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you find that the usual dose of this medication is not effective, contact your doctor immediately.
This medication is derived from human plasma, a component of blood, and although it is thoroughly screened, tested, and treated to minimize the risk of transmitting infectious diseases, there is still a possibility of virus transmission. It is important to discuss this aspect with your doctor.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision regarding your treatment and the well-being of your baby.
Regular monitoring of your blood work and other laboratory tests is crucial, as directed by your doctor. If you find that the usual dose of this medication is not effective, contact your doctor immediately.
This medication is derived from human plasma, a component of blood, and although it is thoroughly screened, tested, and treated to minimize the risk of transmitting infectious diseases, there is still a possibility of virus transmission. It is important to discuss this aspect with your doctor.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor, as this will help you make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- While overdose is rare, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), though this is not commonly reported with therapeutic doses.
- Symptoms of thrombosis could include chest pain, shortness of breath, pain/swelling in a limb, sudden weakness or numbness.
What to Do:
In case of suspected overdose or unusual symptoms, seek immediate medical attention. Call 911 or your local emergency number. For general poison control, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Rationale: To detect the presence of Factor VIII inhibitors, which can render treatment ineffective.
Timing: Prior to initiation of therapy and periodically thereafter.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: During treatment for bleeding episodes (e.g., daily or every 12-24 hours), or periodically during prophylaxis (e.g., weekly to monthly).
Target: Target levels vary based on clinical situation (e.g., 30-50% for minor bleeding, 80-100% for major surgery).
Action Threshold: Adjust dose or frequency if levels are below target or if bleeding persists.
Inhibitor (neutralizing antibody) levels
Frequency: Periodically (e.g., every 3-6 months) or if treatment efficacy decreases or bleeding becomes difficult to control.
Target: Undetectable or low titer (<0.6 Bethesda Units/mL).
Action Threshold: If inhibitors develop or increase, consider immune tolerance induction (ITI) or bypassing agents.
Signs and symptoms of bleeding or thrombosis
Frequency: Continuously during treatment.
Target: Absence of bleeding or signs of thrombosis.
Action Threshold: Investigate new bleeding or thrombotic events; adjust therapy as needed.
Signs and symptoms of allergic/hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Absence of allergic symptoms.
Action Threshold: Stop infusion immediately and manage symptoms.
Symptom Monitoring
- Bleeding episodes (joint bleeds, muscle bleeds, mucosal bleeds)
- Pain or swelling in joints/muscles
- Headache, stiff neck, vomiting (suggestive of intracranial hemorrhage)
- Hives, rash, itching
- Wheezing, difficulty breathing, chest tightness
- Dizziness, lightheadedness
- Swelling of face, lips, tongue
- Fever, chills
Special Patient Groups
Pregnancy
Use only if clearly needed. Factor VIII levels naturally increase during pregnancy, but women with severe hemophilia A may still require treatment. Consult with a hematologist and obstetrician.
Trimester-Specific Risks:
First Trimester:
No specific increased risk of congenital malformations reported.
Second Trimester:
Generally considered safe if clinically indicated.
Third Trimester:
Factor VIII levels should be monitored, especially near delivery, to manage bleeding risk for both mother and fetus.
Lactation
Factor VIII is a natural component of human plasma and is unlikely to be harmful to a breastfed infant. Use is generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
L3 - Moderate risk. While unlikely to cause harm, monitor infant for any unusual symptoms.
Pediatric Use
Dosing is weight-based and similar to adults. Children, especially those with severe hemophilia, are at higher risk for inhibitor development, requiring close monitoring. Prophylaxis is common in pediatric patients.
Geriatric Use
No specific dose adjustment is typically required based on age alone. However, older patients may have comorbidities (e.g., cardiovascular disease) that could influence the risk-benefit profile, particularly regarding potential thrombotic events, though this is rare with Factor VIII replacement.
Clinical Information
Clinical Pearls
- Koate-DVI is a plasma-derived Factor VIII product, meaning it is made from human plasma. While screened and treated for viral safety, patients should be informed of the theoretical risk of pathogen transmission.
- Always reconstitute the lyophilized powder with the provided diluent and administer intravenously. Do not shake the vial vigorously.
- Infusion rate should be slow, typically 2-3 mL/minute, or as tolerated. Rapid infusion can lead to adverse reactions.
- Patients should be educated on self-administration techniques for home use, including aseptic technique.
- The development of Factor VIII inhibitors is a major complication of hemophilia A treatment. Regular monitoring is crucial.
- For patients undergoing surgery, close collaboration between the hematologist and surgeon is essential to ensure adequate Factor VIII levels are maintained pre-, intra-, and post-operatively.
Alternative Therapies
- Recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Afstyla, Nuwiq, Esperoct)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate [aPCC], recombinant Factor VIIa [rFVIIa])
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in patients with or without inhibitors.
- Desmopressin (DDAVP) - for mild hemophilia A and von Willebrand disease, not for severe hemophilia A.
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) - adjunct therapy to stabilize clots.
Cost & Coverage
Average Cost:
Highly variable, typically several dollars per IU (e.g., $1-$2 per IU) per IU
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical benefit)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. 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 medication taken, the amount, and the time it occurred.