Hemofil M 1000 Unit Inj
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Blood Coagulation Factor; Factor VIII
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hemofil M is a medicine that replaces a missing protein in your blood called Factor VIII. People with hemophilia A don't have enough of this protein, which is needed for blood to clot properly. By giving you this medicine, it helps your blood clot and stops or prevents bleeding episodes.
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 prepared solution within 3 hours of mixing. 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 its color has changed. 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 box 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.
Missed Dose
If you miss a dose, contact your doctor promptly 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 prepared solution within 3 hours of mixing. 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 its color has changed. 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 box 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.
Missed Dose
If you miss a dose, contact your doctor promptly to determine the best course of action.
Lifestyle & Tips
- Always carry your medication and supplies, especially when traveling.
- Wear a medical alert bracelet or necklace indicating you have hemophilia A.
- Avoid activities that carry a high risk of injury or bleeding.
- Avoid medications that interfere with clotting, such as aspirin or NSAIDs (e.g., ibuprofen, naproxen), unless specifically advised by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your doctor's instructions for regular infusions, even if you feel well, to prevent bleeding episodes (prophylaxis).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII deficiency, location and extent of bleeding, and patient's clinical condition. Typically 20-50 IU/kg for on-demand treatment of bleeding episodes, administered intravenously. For prophylaxis, 20-40 IU/kg 2-3 times per week.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
onDemandBleeding:
20-50 IU/kg IV, repeat as needed to achieve desired Factor VIII level.
prophylaxis:
20-40 IU/kg IV 2-3 times per week.
surgery:
Pre-operative dose to achieve 80-100% Factor VIII activity, followed by maintenance doses to keep levels >30-50% for 1-2 weeks post-op.
Pediatric Dosing
Neonatal:
Not established (use with caution, often individualized based on bleeding and Factor VIII levels)
Infant:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg IV for bleeding, 20-40 IU/kg 2-3 times per week for prophylaxis).
Child:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg IV for bleeding, 20-40 IU/kg 2-3 times per week for prophylaxis).
Adolescent:
Dosing is weight-based, similar to adults (e.g., 20-50 IU/kg IV for bleeding, 20-40 IU/kg 2-3 times per week for prophylaxis).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; Factor VIII is a large protein 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 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. Administered Factor VIII binds to von Willebrand factor (vWF) in the circulation, which stabilizes and protects it from degradation. Activated Factor VIII (Factor VIIIa) then serves as a cofactor for Factor IXa, accelerating the conversion of Factor X to Factor Xa. Factor Xa, in turn, converts prothrombin to thrombin, which then converts fibrinogen to fibrin, forming a stable clot.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (peak activity achieved at the end of infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.04-0.08 L/kg
ProteinBinding:
Primarily binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
8-12 hours (range 7-19 hours, highly variable among individuals)
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolic degradation and excretion of metabolites.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on half-life, typically 8-12 hours, requiring repeat dosing for sustained effect.
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 immediately or seek emergency 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), 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 mild 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, contact your doctor for advice:
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 immediately or seek emergency 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), 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 mild 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, contact your doctor for advice:
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 bleeding: new or worsening joint pain/swelling, muscle pain, unusual bruising, prolonged bleeding from cuts, nosebleeds, blood in urine or stools, severe headache (may indicate brain bleed).
- Signs of allergic reaction: rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing, chest tightness, wheezing, dizziness, fainting.
- Signs of inhibitor development: your usual dose of Factor VIII is no longer stopping bleeding effectively.
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, 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, 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, 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 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 although it is thoroughly screened, tested, and treated to minimize the risk of viral transmission, there is still a potential risk of infection. Discuss this aspect with your doctor to understand the precautions taken and the residual risks involved.
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 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 although it is thoroughly screened, tested, and treated to minimize the risk of viral transmission, there is still a potential risk of infection. Discuss this aspect with your doctor to understand the precautions taken and the residual risks involved.
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 acute overdose is unlikely to cause severe toxicity due to the nature of the protein, very high levels could theoretically increase the risk of thrombotic events, though this is rare and not well-documented with Factor VIII concentrates.
- Symptoms might include headache, flushing, or mild allergic reactions.
What to Do:
In case of suspected overdose or unusual symptoms, seek immediate medical attention. Contact your doctor or emergency services. For general poison control, call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity level
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to first administration.
Bleeding history and severity
Rationale: To assess the clinical need and guide treatment strategy (on-demand vs. prophylaxis).
Timing: Prior to initiation of therapy.
Viral markers (e.g., HIV, Hepatitis B/C)
Rationale: For plasma-derived products, to monitor for potential viral transmission, though modern purification methods (like Hemofil M's monoclonal antibody purification) significantly reduce this risk.
Timing: Baseline and periodically as per clinical guidelines.
Routine Monitoring
Factor VIII activity level
Frequency: Before and after initial dose, then as clinically indicated to ensure therapeutic levels are achieved and maintained, especially during acute bleeding or surgery.
Target: Varies based on indication (e.g., 80-100% for major surgery, 30-50% for minor bleeding, >1% for prophylaxis).
Action Threshold: Levels below target may require increased dose or frequency; unexpectedly low levels may indicate inhibitor development.
Clinical response (cessation of bleeding)
Frequency: Continuously during acute bleeding episodes.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding may indicate inadequate dosing, inhibitor development, or other underlying issues.
Signs of inhibitor development (e.g., lack of response to Factor VIII)
Frequency: Periodically, especially in previously untreated patients (PUPs) or those with a history of inhibitors. Bethesda assay for inhibitor titers.
Target: Inhibitor titer <0.6 Bethesda Units (BU).
Action Threshold: Inhibitor titer >0.6 BU requires alternative treatment strategies (e.g., bypassing agents, immune tolerance induction).
Signs of allergic or hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Absence of rash, urticaria, dyspnea, hypotension.
Action Threshold: Presence of symptoms requires immediate cessation of infusion and appropriate medical management.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, muscle pain, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, fainting)
- Fever, chills, headache (may indicate infusion reaction or, historically, viral transmission)
Special Patient Groups
Pregnancy
Use in pregnant women should be considered only if clearly indicated. Hemophilia A is an X-linked disorder, so female carriers may have lower Factor VIII levels and be at risk for bleeding complications during pregnancy and delivery. Factor VIII levels should be monitored, and replacement therapy administered as needed to maintain adequate hemostasis.
Trimester-Specific Risks:
First Trimester:
No specific risks identified, but Factor VIII levels may fluctuate.
Second Trimester:
No specific risks identified.
Third Trimester:
Increased risk of bleeding during delivery if Factor VIII levels are low. Close monitoring and Factor VIII replacement are crucial.
Lactation
It is not known whether Antihemophilic Factor (Human) is excreted in human milk. However, Factor VIII is a large protein and is unlikely to pass into breast milk in significant amounts. The benefits of breastfeeding should be weighed against any potential risks. Generally considered compatible with breastfeeding when clinically indicated.
Infant Risk:
Low risk to the infant.
Pediatric Use
Antihemophilic Factor (Human) is a cornerstone of treatment for hemophilia A in pediatric patients, including neonates and infants. Dosing is weight-based, and prophylaxis is often initiated early in life to prevent joint damage. Inhibitor development is a significant concern in this population, especially in previously untreated patients (PUPs), requiring close monitoring.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, geriatric patients may have age-related comorbidities (e.g., cardiovascular disease) that could influence treatment decisions or increase the risk of complications. Monitor for fluid overload in patients with cardiac compromise.
Clinical Information
Clinical Pearls
- Inhibitor development (antibodies against Factor VIII) is the most serious complication of Factor VIII replacement therapy, occurring in approximately 25-30% of severe hemophilia A patients, especially in previously untreated patients (PUPs).
- The 'M' in Hemofil M refers to monoclonal antibody purification, which was a significant advancement in reducing viral transmission risks compared to earlier plasma-derived products.
- Dosing is highly individualized and often guided by pharmacokinetic parameters (e.g., half-life) and Factor VIII activity levels.
- Patients should be educated on self-administration techniques and the importance of prompt treatment of bleeding episodes.
- Prophylaxis (regular infusions to prevent bleeding) is the standard of care for severe hemophilia A to prevent long-term joint damage (arthropathy).
Alternative Therapies
- Other plasma-derived Factor VIII concentrates (e.g., Humate-P, Alphanate)
- Recombinant Factor VIII concentrates (e.g., Advate, Eloctate, Adynovate, Kogenate FS, Xyntha, Nuwiq, Jivi, Afstyla)
- Bypassing agents for patients with inhibitors (e.g., Activated Prothrombin Complex Concentrate (aPCC) - FEIBA, Recombinant Factor VIIa - NovoSeven RT)
- Non-factor replacement therapies (e.g., Emicizumab (Hemlibra) - a bispecific antibody mimicking Factor VIIIa, approved for prophylaxis in patients with and without inhibitors)
- Desmopressin (DDAVP) - for mild to moderate hemophilia A, by increasing endogenous Factor VIII and vWF release.
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) - adjunct therapy for mucosal bleeding.
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per dose depending on unitage and brand) per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical insurance and government programs like Medicaid/Medicare Part B)
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.