Koate 1000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Blood Coagulation Factor
Pregnancy Category
Category C
FDA Approved
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine is a special protein called Factor VIII, which is missing or not working correctly in people with hemophilia A. It helps your blood clot properly to stop or prevent bleeding. It is given directly 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 administering 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 the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly to maintain cleanliness.
Preparation and Inspection
Prior to use, this medication requires mixing. Follow the specific mixing instructions provided by your doctor. The mixed solution should be used within 3 hours of preparation. Inspect the solution for any visible particles, cloudiness, or signs of leakage. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, discard the solution if it has changed color.
Disposal and Storage
After administering the dose, discard any remaining medication. Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Do not reuse needles or any other components. When 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 of Hemofil M
If you miss a dose, contact your doctor for guidance on the appropriate course of action.
To ensure safe and effective use, follow your doctor's instructions for administering 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 the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly to maintain cleanliness.
Preparation and Inspection
Prior to use, this medication requires mixing. Follow the specific mixing instructions provided by your doctor. The mixed solution should be used within 3 hours of preparation. Inspect the solution for any visible particles, cloudiness, or signs of leakage. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, discard the solution if it has changed color.
Disposal and Storage
After administering the dose, discard any remaining medication. Dispose of used needles and other sharp objects in a designated needle/sharp disposal container. Do not reuse needles or any other components. When 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 of Hemofil M
If you miss a dose, contact your doctor for guidance on the appropriate course of action.
Lifestyle & Tips
- Follow your doctor's instructions for dosing and frequency, especially for prophylactic treatment.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion.
- Learn how to recognize signs of bleeding and when to administer your medication.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear a medical alert bracelet or carry an identification card stating you have hemophilia.
- Maintain good dental hygiene to prevent gum bleeding.
- Discuss all medications, including over-the-counter drugs and supplements, with your doctor, as some can increase bleeding risk (e.g., aspirin, NSAIDs).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on Factor VIII levels, bleeding severity, and patient weight. Dosing is expressed in International Units (IU). For on-demand treatment of bleeding episodes, typical doses range from 10-50 IU/kg, administered intravenously. For prophylaxis, typical doses range from 25-50 IU/kg 2-3 times per week.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
minor_hemorrhage:
10-20 IU/kg to achieve 20-40% Factor VIII activity
moderate_hemorrhage:
15-30 IU/kg to achieve 30-60% Factor VIII activity
major_hemorrhage_or_surgery:
30-50 IU/kg to achieve 60-100% Factor VIII activity, followed by maintenance doses as needed
Pediatric Dosing
Neonatal:
Dosing is similar to adults on a per-kg basis, but careful monitoring is essential due to physiological differences. Not established for routine use in neonates without specific indication.
Infant:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical response.
Child:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical response.
Adolescent:
Dosing is similar to adults on a per-kg basis, individualized based on Factor VIII levels and clinical response.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Dialysis:
Not significantly cleared by dialysis; no specific dose adjustment required based on dialysis status alone, but clinical monitoring is always recommended.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Human) is a purified preparation of Factor VIII, a crucial glycoprotein in the intrinsic pathway of blood coagulation. In patients with hemophilia A, Factor VIII is deficient or defective, leading to impaired hemostasis. Administration of Antihemophilic Factor 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 IV infusion
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 prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Typically 8-12 hours (range 6-20 hours, highly variable among individuals)
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on half-life and initial dose, typically 8-12 hours for significant Factor VIII activity, but clinical effect can last longer depending on the target level and bleeding severity.
Safety & Warnings
Side Effects
Urgent 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 medical attention immediately:
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), such as:
+ 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 immediately:
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), such as:
+ 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, dizziness, chest tightness, feeling faint.
- Signs of inhibitor development (if you notice your usual dose is not stopping bleeding as effectively): increased frequency or severity of bleeding episodes, bleeding that is harder to control.
- Any new or unusual bleeding, especially severe or persistent 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, 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 the medications you are taking, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any health problems you have, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication, including this one, to ensure your safety and the effectiveness of your treatment.
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 the medications you are taking, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any health problems you have, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before starting, stopping, or changing the dose of any medication, including this one, to ensure your safety and the effectiveness of your treatment.
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 work and laboratory tests, as directed by your doctor, are crucial to monitor your condition. 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 viral transmission, there is still a potential risk of disease. Discuss this with your doctor to understand the precautions taken and the residual risks.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of 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 health and the health of your baby.
Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your condition. 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 viral transmission, there is still a potential risk of disease. Discuss this with your doctor to understand the precautions taken and the residual risks.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of 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 health and the health of your baby.
Overdose Information
Overdose Symptoms:
- While overdose is rare and generally not life-threatening, excessively high Factor VIII levels could theoretically increase the risk of thrombosis (blood clots), though this is not commonly reported with Factor VIII replacement therapy.
What to Do:
If an overdose is suspected, contact your healthcare provider or emergency services immediately. Management is generally supportive, and Factor VIII levels may be monitored. 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 administration and periodically thereafter.
Inhibitor (neutralizing antibody) screen (Bethesda assay)
Rationale: To detect pre-existing inhibitors that could render treatment ineffective.
Timing: Prior to first administration and periodically thereafter, especially if treatment response is suboptimal.
Complete Blood Count (CBC)
Rationale: To assess overall hematologic status and monitor for potential bleeding complications.
Timing: Prior to treatment, especially in acute bleeding episodes.
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after initial dose to confirm target levels, then as clinically indicated (e.g., daily during acute bleeding, periodically during prophylaxis).
Target: Dependent on clinical situation (e.g., 20-40% for minor bleeds, 80-100% for major bleeds/surgery).
Action Threshold: If levels are below target, adjust dose or frequency. If levels are unexpectedly low, consider inhibitor development.
Inhibitor (neutralizing antibody) assay
Frequency: Every 3-6 months, or more frequently if there is a poor clinical response to Factor VIII replacement.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If >0.6 BU/mL, consider high-titer inhibitor and adjust treatment strategy (e.g., immune tolerance induction, bypassing agents).
Clinical response (cessation of bleeding, resolution of symptoms)
Frequency: Continuously during treatment.
Target: Resolution of bleeding, pain, swelling.
Action Threshold: Persistent or recurrent bleeding indicates inadequate dosing or inhibitor development.
Signs of allergic reaction (e.g., urticaria, angioedema, dyspnea, hypotension)
Frequency: During and immediately after infusion.
Target: Absence of allergic symptoms.
Action Threshold: Stop infusion immediately, administer appropriate supportive care (e.g., antihistamines, epinephrine).
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, dizziness, chest tightness)
- Fever, chills, headache (may indicate infusion reaction or infection)
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered. Factor VIII levels naturally increase during pregnancy, but women with hemophilia A may still require Factor VIII replacement, especially around delivery, to prevent excessive bleeding. The decision should be made by a physician experienced in hemophilia management.
Trimester-Specific Risks:
First Trimester:
No specific risks identified beyond general pregnancy considerations. Factor VIII is a human protein.
Second Trimester:
No specific risks identified.
Third Trimester:
Increased risk of bleeding during labor and delivery for women with hemophilia A. Factor VIII replacement may be necessary to maintain adequate hemostasis.
Lactation
Antihemophilic Factor (Human) is a natural component of human plasma and is not expected to be harmful to a breastfed infant. It is generally considered compatible with breastfeeding.
Infant Risk:
Low risk. Factor VIII is a large protein and is unlikely to be absorbed systemically by the infant in significant amounts via breast milk.
Pediatric Use
Antihemophilic Factor is a cornerstone of treatment for pediatric patients with hemophilia A, including prophylaxis. Dosing is weight-based and individualized. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs).
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. However, age-related comorbidities and potential for cardiovascular disease should be considered, as high Factor VIII levels could theoretically increase thrombotic risk, though this is rare with replacement therapy.
Clinical Information
Clinical Pearls
- Factor VIII products are dosed in International Units (IU). Ensure accurate calculation based on patient weight and desired Factor VIII activity level.
- Always reconstitute Factor VIII products according to manufacturer's instructions, using the provided diluent and administration sets.
- Infuse slowly to minimize the risk of infusion-related reactions.
- Monitor for inhibitor development, especially in previously untreated patients (PUPs) or those with a history of inhibitors, as this can significantly impact treatment effectiveness.
- Educate patients and caregivers on home infusion techniques, proper storage, and recognition of bleeding episodes and adverse reactions.
- Maintain a comprehensive treatment log for all infusions.
- Consider genetic counseling for women who are carriers of hemophilia A.
Alternative Therapies
- Recombinant Factor VIII products (e.g., Advate, Eloctate, Xyntha)
- Bypassing agents (e.g., activated prothrombin complex concentrate [aPCC], recombinant Factor VIIa) for patients with inhibitors
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in patients with or without inhibitors
- Gene therapy (e.g., Roctavian) - emerging treatment for severe hemophilia A
Cost & Coverage
Average Cost:
Highly variable, often thousands of dollars per dose depending on unit strength and quantity. per 1000 IU vial
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical benefit for hemophilia treatment)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.