Hemofil M 500 Unit Inj
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor; Factor VIII
Pregnancy Category
Category C
FDA Approved
Jul 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hemofil M is a medicine that helps your blood clot. It contains a protein called Factor VIII, which is missing or not working properly in people with hemophilia A. By giving you this medicine, it helps stop bleeding episodes and can prevent them from happening.
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 guidelines provided. 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 Use
Prior to use, this medication must be mixed according to the instructions provided by your doctor. The mixed solution should be used within 3 hours of preparation. Inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the color has changed. After administering the dose, discard any remaining medication. Dispose of needles and other sharp objects in a designated needle/sharp disposal container. Do not reuse needles or any other components. Once the disposal box is full, follow local regulations for its proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For specific guidance on storing and disposing of Hemofil M, follow the instructions provided with the medication.
Missed Dose
If you miss a dose, contact your doctor immediately 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 guidelines provided. 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 Use
Prior to use, this medication must be mixed according to the instructions provided by your doctor. The mixed solution should be used within 3 hours of preparation. Inspect the solution for any signs of cloudiness, leakage, or particulate matter. Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the color has changed. After administering the dose, discard any remaining medication. Dispose of needles and other sharp objects in a designated needle/sharp disposal container. Do not reuse needles or any other components. Once the disposal box is full, follow local regulations for its proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
For specific guidance on storing and disposing of Hemofil M, follow the instructions provided with the medication.
Missed Dose
If you miss a dose, contact your doctor immediately to determine the best course of action.
Lifestyle & Tips
- Always carry your Factor VIII medication and supplies with you.
- Learn how to self-infuse if appropriate, or ensure a caregiver is trained.
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports).
- Maintain good dental hygiene to prevent gum bleeding.
- Inform all healthcare providers (including dentists) that you have hemophilia and are on Factor VIII therapy.
- Wear a medical alert bracelet or carry an identification card.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient's Factor VIII level, bleeding severity, and clinical response. Generally, 1 IU/kg of Factor VIII increases plasma Factor VIII activity by approximately 2 IU/dL (2%).
Condition-Specific Dosing:
onDemandTreatment:
Minor hemorrhage: 15-25 IU/kg (target FVIII activity 30-50%). Moderate hemorrhage: 25-50 IU/kg (target FVIII activity 50-100%). Major hemorrhage (life-threatening): 50 IU/kg initially, then 25-50 IU/kg every 8-12 hours (target FVIII activity 80-100%).
prophylaxis:
25-40 IU/kg 3 times per week, or 20-50 IU/kg every other day. Adjust frequency and dose based on individual response and bleeding episodes.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with severe hemophilia A. Dosing is weight-based and individualized.
Infant:
Dosing is weight-based and individualized, similar to adult dosing principles (1 IU/kg increases FVIII by ~2%).
Child:
Dosing is weight-based and individualized, similar to adult dosing principles (1 IU/kg increases FVIII by ~2%).
Adolescent:
Dosing is weight-based and individualized, similar to adult dosing principles (1 IU/kg increases FVIII by ~2%).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
Not removed by dialysis; no specific adjustment needed.
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 plasma-derived concentrate of Factor VIII, a crucial glycoprotein in 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:
Immediate (after completion of infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05-0.08 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-12 hours (range 5-24 hours), highly variable among individuals.
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Primarily through protein degradation pathways; not renally excreted as intact protein.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on the half-life of Factor VIII, typically 8-12 hours, requiring repeat dosing for sustained effect.
Confidence:
Medium
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 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 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, contact your doctor for advice:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
This is not an exhaustive list of possible 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 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 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, contact your doctor for advice:
Feeling nervous and excitable
Headache
Stomach pain
Upset stomach
This is not an exhaustive list of possible 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:
- Any new or unusual bleeding (e.g., prolonged nosebleeds, bleeding gums, blood in urine or stool)
- Joint pain, swelling, or warmth (signs of a joint bleed)
- Muscle pain or swelling
- Severe headache, vision changes, or confusion (signs of a head bleed)
- Severe abdominal pain
- Signs of an allergic reaction: rash, hives, itching, swelling of the face/lips/tongue, difficulty breathing, dizziness, chest tightness.
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.
If you are allergic to mouse proteins, discuss this with your doctor, as it may be relevant to your treatment.
To ensure safe use, tell your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking this medication with your existing medications and health conditions.
Stop or change the dose of any medication, including this one, to avoid potential interactions or complications.
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.
If you are allergic to mouse proteins, discuss this with your doctor, as it may be relevant to your treatment.
To ensure safe use, tell your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking this medication with your existing medications and health conditions.
Stop or change the dose of any medication, including this one, to avoid potential interactions or complications.
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 viral transmission, there is still a potential risk of infection. It is important to discuss this with your doctor.
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 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 viral transmission, there is still a potential risk of infection. It is important to discuss this with your doctor.
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 treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- While overdose is rare and generally not associated with severe adverse effects, very high levels of Factor VIII could theoretically increase the risk of thrombosis (blood clots), though this is not commonly observed in clinical practice.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 1-800-222-1222 for poison control. Management would be supportive and focused on monitoring for thrombotic events, though specific antidotes are not available or typically needed.
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) screening (Bethesda assay)
Rationale: To detect the presence of Factor VIII inhibitors, which can render treatment ineffective. More common in severe hemophilia A.
Timing: Prior to initiation of therapy and periodically thereafter.
Hepatitis B/C, HIV serology (for plasma-derived products)
Rationale: Although highly purified and viral inactivated, historical risk and ongoing monitoring for blood-borne pathogens.
Timing: Prior to initiation and periodically as clinically indicated.
Routine Monitoring
Factor VIII activity levels
Frequency: During acute bleeding episodes (to ensure adequate hemostasis) and periodically during prophylaxis (to confirm trough levels).
Target: Varies based on indication (e.g., 80-100% for major bleed, 1-5% for prophylaxis trough).
Action Threshold: If levels are not within target range or bleeding persists, adjust dose or frequency, or investigate for inhibitors.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Frequency: Every 3-6 months, or more frequently in high-risk patients (e.g., newly treated patients, those with severe hemophilia) or if treatment efficacy decreases.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor titer is âĨ0.6 BU/mL, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Clinical assessment of bleeding episodes
Frequency: Continuously by patient/caregiver, and during clinic visits.
Target: Absence or reduction of bleeding episodes.
Action Threshold: Increased frequency or severity of bleeding may indicate inadequate dosing, inhibitor development, or other complications.
Symptom Monitoring
- Increased frequency or severity of bleeding episodes (e.g., joint bleeds, muscle bleeds, nosebleeds, gastrointestinal bleeds)
- Lack of expected response to Factor VIII treatment
- Signs of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, shortness of breath, chest tightness)
- Fever, chills, headache (may indicate infusion reaction)
Special Patient Groups
Pregnancy
Use during pregnancy should be carefully considered and managed by a hematologist. Factor VIII does not cross the placenta in significant amounts. Treatment is generally continued as needed to prevent bleeding complications in the mother, especially during labor and delivery. The potential benefits must outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified.
Second Trimester:
No specific increased risk identified.
Third Trimester:
Increased risk of bleeding for the mother during labor and delivery; Factor VIII levels should be monitored and maintained at adequate levels.
Lactation
Factor VIII is a large protein and is not expected to be excreted into breast milk in significant amounts. It is generally considered compatible with breastfeeding. Consult with a healthcare provider.
Infant Risk:
Low risk to the infant.
Pediatric Use
Antihemophilic Factor (Human) is a cornerstone of treatment for pediatric patients with hemophilia A, including neonates and infants. Dosing is weight-based and individualized. Regular monitoring for inhibitor development is crucial, especially in young children and those with severe hemophilia.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. Dosing should be based on Factor VIII levels and clinical response, similar to younger adults. Age-related comorbidities and polypharmacy should be considered, though drug interactions with Factor VIII are minimal.
Clinical Information
Clinical Pearls
- Hemofil M is a plasma-derived Factor VIII concentrate. While highly purified and viral inactivated, patients should be informed about the theoretical risks associated with plasma-derived products.
- Dosing is highly individualized; regular monitoring of Factor VIII activity levels is essential to ensure therapeutic efficacy and prevent under- or over-dosing.
- The most significant complication of Factor VIII replacement therapy is the development of neutralizing antibodies (inhibitors), which can render the treatment ineffective. Patients should be regularly screened for inhibitors, especially if they experience a decreased response to treatment.
- Proper storage (refrigeration, but can be stored at room temperature for a limited time) and reconstitution techniques are critical for maintaining product integrity and efficacy.
- Patients and caregivers should be thoroughly educated on self-administration techniques, recognition of bleeding episodes, and signs of allergic reactions.
- For patients undergoing surgery or invasive procedures, Factor VIII levels must be adequately maintained to prevent excessive bleeding.
Alternative Therapies
- Recombinant Antihemophilic Factor (Factor VIII) products (e.g., Advate, Eloctate, Jivi, Nuwiq, Xyntha)
- Other plasma-derived Antihemophilic Factor (Factor VIII) products (e.g., Koate-DVI, Alphanate, Humate-P)
- Bypassing agents (for patients with inhibitors): Activated Prothrombin Complex Concentrate (aPCC, e.g., Feiba), Recombinant Factor VIIa (rFVIIa, e.g., NovoSeven RT)
- Non-factor replacement therapies: Emicizumab (Hemlibra - a bispecific antibody mimicking FVIIIa cofactor function)
- Gene therapy (e.g., Roctavian - for severe hemophilia A, recently approved)
- Desmopressin (DDAVP - for mild hemophilia A or von Willebrand disease, not for severe hemophilia A)
Cost & Coverage
Average Cost:
Extremely high, often thousands to tens of thousands of USD per dose depending on units and patient weight. per 500 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical plans due to medical necessity for hemophilia).
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's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.