Koate 500 Unit 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
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Koate 500 Unit Inj is a medicine used to treat and prevent bleeding in people with Hemophilia A, a genetic bleeding disorder. It works by replacing a missing clotting protein in your blood called Factor VIII, which helps your blood clot properly.
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 intravenous injection. 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 prepared solution within 3 hours of mixing. 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 your doctor or pharmacist.
Storage and Disposal
For specific storage instructions, refer to the product labeling or consult your doctor or pharmacist. If you miss a dose of Hemofil M, contact your doctor for guidance on the appropriate 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 intravenous injection. 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 prepared solution within 3 hours of mixing. 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 your doctor or pharmacist.
Storage and Disposal
For specific storage instructions, refer to the product labeling or consult your doctor or pharmacist. If you miss a dose of Hemofil M, contact your doctor for guidance on the appropriate course of action.
Lifestyle & Tips
- Always carry your medication and emergency contact information.
- Follow your prescribed dosing schedule carefully, whether for on-demand treatment or prophylaxis.
- Learn how to self-infuse if recommended by your healthcare provider.
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) that you have Hemophilia A and are on Factor VIII replacement therapy.
- Wear a medical alert bracelet or carry an identification card.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on factor VIII levels, type and severity of bleeding, and patient's clinical condition. Dosing is calculated using the formula: Units required = Body weight (kg) Ã Desired factor VIII increase (% or IU/dL) Ã 0.5 (IU/kg per IU/dL).
Condition-Specific Dosing:
on-demand_treatment_minor_hemorrhage:
10-20 IU/kg to achieve 20-40% factor VIII activity, repeat every 12-24 hours as needed.
on-demand_treatment_moderate_hemorrhage:
15-30 IU/kg to achieve 30-60% factor VIII activity, repeat every 12-24 hours as needed.
on-demand_treatment_major_hemorrhage_or_surgery:
30-50 IU/kg to achieve 60-100% factor VIII activity, then maintain at 30-50% with repeat doses every 8-24 hours as needed. Initial dose may be higher (e.g., 50 IU/kg) for life-threatening bleeds.
prophylaxis:
25-50 IU/kg 2-3 times per week, or as determined by physician based on patient's response and bleeding history.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with Hemophilia A. Dosing is individualized based on weight and factor VIII levels, similar to adult dosing principles.
Infant:
Dosing is individualized based on weight and factor VIII levels, similar to adult dosing principles.
Child:
Dosing is individualized based on weight and factor VIII levels, similar to adult dosing principles.
Adolescent:
Dosing is individualized based on weight and factor VIII levels, similar to adult dosing principles.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required.
Dialysis:
No specific adjustment required; not significantly cleared by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Human) is a purified preparation of Factor VIII, a crucial component of the intrinsic coagulation pathway. In patients with Hemophilia A, Factor VIII is deficient or defective, leading to impaired hemostasis. Administration of Antihemophilic Factor (Human) temporarily replaces the missing Factor VIII, allowing for the formation of a stable fibrin clot and restoration of normal hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediately after infusion
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 40-50 mL/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Typically 8-12 hours (range 5-24 hours), varies among individuals and product types.
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolic degradation, not primarily excreted renally or hepatically as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life, typically 8-24 hours, requiring repeat dosing to maintain therapeutic levels.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
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 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
Signs of certain infections (parvovirus B19, hepatitis A), including:
+ Fever or chills
+ Headache
+ Feeling extremely 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 others that bother you or persist, contact your doctor:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 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
Signs of certain infections (parvovirus B19, hepatitis A), including:
+ Fever or chills
+ Headache
+ Feeling extremely 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 others that bother you or persist, contact your doctor:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 bleeding: new or worsening joint pain/swelling, muscle pain, unusual bruising, nosebleeds that won't stop, blood in urine or stool, prolonged bleeding from cuts or after dental work.
- Signs of allergic reaction: rash, hives, itching, flushing, swelling of the face/lips/tongue, difficulty breathing, wheezing, dizziness, feeling faint.
- Signs of inhibitor development: if your bleeding does not stop or recurs despite receiving your usual dose of Koate, or if you need much higher doses to control bleeding.
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 as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure that it is safe for you to take this medication in combination with your other medications and health conditions.
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 as a result of the allergy.
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, provide your doctor and pharmacist with a comprehensive list of all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug. This will help ensure that it is safe for you to take this medication in combination with your other medications and health conditions.
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 blood tests and other laboratory evaluations should be conducted as directed by your doctor to monitor your condition. If you find that the usual dose of this medication is not providing the expected relief, contact your doctor immediately.
This medication is derived from human plasma, a component of blood, and as such, it may potentially contain viruses that could cause disease. Although the medication undergoes rigorous screening, testing, and treatment to minimize the risk of infection transmission, it is crucial 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 vital to discuss the potential benefits and risks of this medication with your doctor, as this will help determine the best course of action for both you and your baby.
Regular blood tests and other laboratory evaluations should be conducted as directed by your doctor to monitor your condition. If you find that the usual dose of this medication is not providing the expected relief, contact your doctor immediately.
This medication is derived from human plasma, a component of blood, and as such, it may potentially contain viruses that could cause disease. Although the medication undergoes rigorous screening, testing, and treatment to minimize the risk of infection transmission, it is crucial 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 vital to discuss the potential benefits and risks of this medication with your doctor, as this will help determine the best course of action for both you and your baby.
Overdose Information
Overdose Symptoms:
- While overdose is rare and generally not associated with severe acute toxicity, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots), especially in patients with other risk factors.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is supportive and may involve monitoring for signs of thrombosis. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to first infusion and periodically thereafter.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status and identify any underlying issues.
Timing: Prior to initiation of therapy.
Coagulation parameters (PT, aPTT)
Rationale: To assess overall coagulation status, though aPTT may not directly correlate with Factor VIII levels in all cases.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing Factor VIII inhibitors, which can render treatment ineffective.
Timing: Prior to first infusion and periodically thereafter.
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after initial dose, then as needed to guide subsequent dosing and ensure therapeutic levels are maintained, especially during acute bleeding or surgery.
Target: Varies based on indication (e.g., 20-40% for minor bleeds, 60-100% for major bleeds/surgery).
Action Threshold: If levels are below target, increase dose or frequency; if levels are higher than expected, consider inhibitor development or altered pharmacokinetics.
Clinical assessment for bleeding/thrombosis
Frequency: Continuously during acute bleeding episodes; regularly during prophylaxis.
Target: Cessation of bleeding, absence of new bleeding episodes.
Action Threshold: Persistent or new bleeding requires re-evaluation of dosing and potential inhibitor testing. Signs of thrombosis require immediate medical attention.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Frequency: Every 3-6 months for the first few years of treatment, then annually or whenever there is a poor clinical response to Factor VIII.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: Detection of inhibitors (âĨ0.6 BU/mL) requires specialized management strategies (e.g., bypassing agents, immune tolerance induction).
Signs of allergic/anaphylactic reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Dyspnea, rash, urticaria, hypotension, tachycardia require immediate cessation of infusion and supportive care.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, nosebleeds, blood in urine/stool, prolonged bleeding from cuts)
- Signs of allergic reaction (e.g., rash, hives, itching, flushing, swelling of face/lips/tongue, difficulty breathing, wheezing, dizziness, fainting)
- Signs of inhibitor development (e.g., poor response to previously effective doses of Factor VIII, persistent or recurrent bleeding despite adequate dosing)
- Signs of thrombosis (rare, but possible with high doses or in patients with risk factors: pain, swelling, redness in a limb, shortness of breath, chest pain)
Special Patient Groups
Pregnancy
Koate is classified as Pregnancy Category C. Animal reproduction studies have not been conducted. It should be given to a pregnant woman only if clearly needed. Hemophilia A is an X-linked disorder, so female carriers may have lower Factor VIII levels and may require Factor VIII replacement during pregnancy and delivery to prevent bleeding complications.
Trimester-Specific Risks:
First Trimester:
No specific data on first-trimester risks; use only if clearly indicated.
Second Trimester:
No specific data on second-trimester risks; use only if clearly indicated.
Third Trimester:
Factor VIII levels may rise naturally in the third trimester in some carriers, but monitoring is crucial. Replacement therapy may be needed to ensure adequate hemostasis during labor and delivery, especially for carriers with low baseline Factor VIII levels.
Lactation
It is not known whether Antihemophilic Factor (Human) is excreted in human milk. Caution should be exercised when administering to a nursing mother. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Not available
Pediatric Use
Koate is indicated for use in pediatric patients with Hemophilia A. Dosing is individualized based on weight, Factor VIII levels, and clinical response, similar to adult dosing. Pediatric patients, especially previously untreated patients (PUPs), have a higher risk of developing Factor VIII inhibitors.
Geriatric Use
Clinical studies of Koate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on Factor VIII levels and clinical response. No specific dose adjustments are generally required based solely on age, but age-related comorbidities and polypharmacy should be considered.
Clinical Information
Clinical Pearls
- Always reconstitute Koate according to package insert instructions, using the provided diluent and administration set. Do not shake the vial vigorously.
- Administer intravenously at a rate comfortable for the patient, typically 2-10 mL/minute. Do not exceed 10 mL/minute.
- Monitor for signs of allergic reactions during and immediately after infusion. Have epinephrine and antihistamines readily available.
- The most significant complication of Factor VIII replacement therapy is the development of inhibitors (neutralizing antibodies) to Factor VIII, which can render treatment ineffective. Monitor Factor VIII levels and clinical response closely, and test for inhibitors if response is suboptimal.
- Patients should be educated on the signs of bleeding, allergic reactions, and inhibitor development, and instructed to seek immediate medical attention if these occur.
- Koate is derived from human plasma. While screened and treated to reduce viral transmission risk, the theoretical risk of transmitting infectious agents cannot be completely eliminated.
Alternative Therapies
- Other plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Recombinant Factor VIII products (e.g., Advate, Eloctate, Kogenate FS, Novoeight, Recombinate, Xyntha)
- Bypassing agents for patients with inhibitors (e.g., activated prothrombin complex concentrate [aPCC] like FEIBA, recombinant Factor VIIa [rFVIIa] like NovoSeven RT)
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in patients with or without inhibitors.
- Gene therapy (e.g., Roctavian) - emerging therapy for long-term Factor VIII expression.
Cost & Coverage
Average Cost:
Highly variable, typically several dollars per IU. A 500 IU vial can range from $500 to $1500+. per IU
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans due to medical necessity for Hemophilia A).
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.