Hemofil M 250 Unit Inj
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
Mar 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Antihemophilic Factor (Human) is a medicine used to help your blood clot. If you have hemophilia A, your body doesn't make enough of a protein called Factor VIII, which is essential for stopping bleeding. This medicine replaces that missing protein, helping your blood clot normally and preventing or treating 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 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 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.
Disposal and Storage
After administering the dose, discard any remaining solution. Properly dispose of used needles and sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other components. When the disposal box is full, follow local regulations for its safe disposal. If you have any questions or concerns, consult 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 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 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.
Disposal and Storage
After administering the dose, discard any remaining solution. Properly dispose of used needles and sharp objects in a designated needle/sharp disposal box. Do not reuse needles or any other components. When the disposal box is full, follow local regulations for its safe disposal. If you have any questions or concerns, consult 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
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports) unless approved by your doctor.
- Avoid medications that can interfere with blood clotting, such as aspirin, ibuprofen, naproxen, or other NSAIDs, unless specifically instructed by your doctor.
- Maintain good dental hygiene to prevent gum bleeding.
- Carry your medication and identification indicating your hemophilia status at all times.
- Follow your doctor's instructions for regular infusions, especially if on prophylaxis, to prevent bleeding episodes.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Dosing is individualized based on the severity of Factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Generally, 1 International Unit (IU) of Factor VIII per kg body weight increases the plasma Factor VIII activity by approximately 2 IU/dL (2% of normal activity).
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
on-demand treatment of bleeding episodes:
Minor hemorrhage (e.g., early hemarthrosis, epistaxis): 20-40 IU/kg to achieve 40-80% FVIII activity. Major hemorrhage (e.g., intracranial, gastrointestinal, life-threatening): 40-50 IU/kg initially to achieve 80-100% FVIII activity, followed by maintenance doses.
surgical prophylaxis:
Minor surgery: 30-50 IU/kg pre-op to achieve 60-100% FVIII activity. Major surgery: 50 IU/kg pre-op to achieve 80-100% FVIII activity, followed by maintenance doses to maintain levels for several days.
routine prophylaxis:
20-40 IU/kg 2-3 times per week, or as determined by physician based on patient response.
Pediatric Dosing
Neonatal:
Dosing is weight-based, similar to adults, but careful monitoring is essential due to potential differences in pharmacokinetics in neonates. Not established for routine use in neonates without specific indication.
Infant:
Dosing is weight-based, similar to adults. Prophylaxis may be initiated early in life to prevent joint damage.
Child:
Dosing is weight-based, similar to adults. Prophylaxis is common.
Adolescent:
Dosing is weight-based, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
Not significantly removed by dialysis. No specific adjustment needed, but monitor clinical response.
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 component of the intrinsic coagulation pathway. In patients with hemophilia A (Factor VIII deficiency), administration of Antihemophilic Factor (Human) temporarily increases the plasma levels of Factor VIII, thereby correcting the coagulation defect and allowing for effective hemostasis. Factor VIII acts as a cofactor for Factor IXa, accelerating the activation of Factor X to Factor Xa, which in turn leads to the generation of thrombin and the formation of a stable fibrin 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 - 0.06 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
8-12 hours (can vary significantly between individuals and specific products, ranging from 6 to 20 hours)
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated, not directly excreted unchanged.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on half-life and initial dose; typically 8-12 hours for significant hemostatic effect, but can extend up to 24 hours for some products/patients.
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 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 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 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 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:
- Signs of an allergic reaction: rash, hives, itching, swelling (especially of the face, lips, or tongue), difficulty breathing, chest tightness, dizziness, or fainting. Seek immediate medical attention.
- Signs of bleeding: unusual bruising, prolonged bleeding from cuts, nosebleeds that won't stop, blood in urine or stools, severe headache, joint pain or swelling (indicating a joint bleed).
- Signs that the medicine is not working: continued bleeding despite infusion, or more frequent/severe bleeding episodes than usual (may indicate inhibitor development).
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.
* Potential interactions with other medications or health conditions. To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Natural products and vitamins you are using
+ Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust 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.
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 prescription and over-the-counter (OTC) medications you are taking
+ Natural products and vitamins you are using
+ Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust 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 latex allergy, be sure to discuss this with your doctor.
Regular blood work and laboratory tests are crucial while taking this drug. Follow your doctor's instructions for scheduling these tests to ensure your health is monitored properly.
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 as such, there is a risk of transmitting viruses that could cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the 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 to make an informed decision regarding your health and the health of your baby.
Regular blood work and laboratory tests are crucial while taking this drug. Follow your doctor's instructions for scheduling these tests to ensure your health is monitored properly.
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 as such, there is a risk of transmitting viruses that could cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the 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 to make an informed decision regarding your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- While acute overdose is unlikely to cause severe toxicity, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), especially in patients with other risk factors.
What to Do:
In case of suspected overdose, contact your healthcare provider or poison control center immediately (1-800-222-1222). Management is supportive and may involve monitoring for signs of thrombosis.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine the baseline deficiency and guide initial dosing.
Timing: Prior to first administration and periodically.
Bleeding history and severity
Rationale: To assess the patient's specific needs and tailor treatment strategy.
Timing: At diagnosis and ongoing.
Viral markers (e.g., HIV, Hepatitis B/C)
Rationale: For plasma-derived products, to assess potential exposure risk, though modern products are highly purified and viral inactivated.
Timing: Prior to initiation and periodically as per guidelines.
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after initial dose, then as needed to ensure therapeutic levels, especially during acute bleeding or surgery. For prophylaxis, periodically to confirm trough levels.
Target: Varies by indication (e.g., 40-80% for minor bleeds, 80-100% for major bleeds/surgery).
Action Threshold: If levels are below target or clinical response is inadequate, adjust dose or frequency.
Clinical response (cessation of bleeding, resolution of symptoms)
Frequency: Continuously during acute bleeding episodes.
Target: Resolution of bleeding, pain reduction, improved mobility.
Action Threshold: Persistent bleeding or lack of improvement indicates need for dose adjustment or investigation of inhibitor development.
Development of Factor VIII inhibitors (neutralizing antibodies)
Frequency: Regularly, especially in previously untreated patients (PUPs) or those with inadequate response to treatment. Annually for patients on prophylaxis.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: Inhibitor levels âĨ0.6 BU/mL (or higher, depending on clinical context) require alternative treatment strategies.
Signs of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion.
Target: Absence of rash, urticaria, pruritus, dyspnea, chest tightness, hypotension.
Action Threshold: Any signs require immediate cessation of infusion and appropriate medical management.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, blood in urine/stools, severe headache, nosebleeds)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, chest tightness, dizziness, fainting)
- Signs of inhibitor development (e.g., lack of expected response to Factor VIII treatment, increased bleeding frequency or severity)
Special Patient Groups
Pregnancy
Antihemophilic Factor (Human) is generally considered safe and necessary for pregnant women with hemophilia A to manage bleeding complications during pregnancy, labor, and delivery. The decision to use should be based on clinical need and a risk-benefit assessment.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified beyond the general risks of hemophilia A.
Second Trimester:
No specific increased risk identified.
Third Trimester:
Crucial for managing bleeding risks during delivery. Factor VIII levels should be monitored closely and maintained at adequate levels, especially during labor and postpartum.
Lactation
Antihemophilic Factor (Human) is a large protein and is unlikely to be excreted into breast milk in significant amounts or absorbed orally by the infant. It is generally considered compatible with breastfeeding when clinically indicated for the mother.
Infant Risk:
Low risk to the breastfed infant.
Pediatric Use
Antihemophilic Factor (Human) is a cornerstone of treatment for pediatric patients with hemophilia A, including routine prophylaxis to prevent joint damage. Dosing is weight-based. Close monitoring for inhibitor development is crucial, especially in previously untreated patients (PUPs).
Geriatric Use
No specific dose adjustments are typically required based on age alone. However, geriatric patients may have comorbidities (e.g., cardiovascular disease, renal impairment) that could influence treatment decisions or require closer monitoring for potential complications, such as thrombotic events, although the risk is generally low with Factor VIII replacement.
Clinical Information
Clinical Pearls
- Always confirm the specific Factor VIII product (plasma-derived vs. recombinant, standard half-life vs. extended half-life) as pharmacokinetic profiles and dosing frequencies can differ.
- For on-demand treatment, administer as early as possible after a bleed begins to minimize joint damage and pain.
- Inhibitor development is a major complication, particularly in severe hemophilia A. Monitor for lack of clinical response to Factor VIII and test for inhibitors if suspected.
- Proper storage and reconstitution are critical. Follow manufacturer's instructions precisely.
- Patients should be educated on self-administration techniques, signs of bleeding, and adverse reactions, and encouraged to maintain a treatment log.
Alternative Therapies
- Other Antihemophilic Factor (Human) products (recombinant Factor VIII, other plasma-derived Factor VIII products)
- Extended half-life Factor VIII products (e.g., Eloctate, Adynovate, Jivi, Afstyla)
- Bypassing agents (for patients with Factor VIII 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 Factor VIIIa, used for prophylaxis.
- Gene therapy (e.g., Roctavian - valoctocogene roxaparvovec) for severe hemophilia A.
- Desmopressin (DDAVP) for mild hemophilia A (increases endogenous FVIII release).
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of dollars per dose depending on strength and brand. per vial (e.g., 250 IU, 500 IU, 1000 IU)
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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. If you have any questions or concerns about this medication, don't 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 information about the medication taken, the amount, and the time it happened.