Hemofil M 1700 Unit Inj
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent
Pharmacologic Class
Blood coagulation factor VIII
Pregnancy Category
Category C
FDA Approved
Mar 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hemofil M contains a natural protein called Factor VIII, which is missing or not working correctly in people with hemophilia A. When you infuse this medicine, it helps your blood clot properly, stopping or preventing 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 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. 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. Do not reuse needles or any other components. 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 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 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. 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. Do not reuse needles or any other components. 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 supplies, especially when traveling.
- Learn how to self-infuse the medication correctly, or ensure a caregiver is trained.
- Maintain a medical alert identification (e.g., bracelet or necklace) indicating you have hemophilia A.
- Avoid medications that interfere with clotting, such as aspirin and NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Practice good dental hygiene and inform your dentist about your hemophilia.
- Avoid activities with a high risk of injury, especially head injuries.
- Regularly monitor for signs of bleeding and seek prompt medical attention for any significant bleeding episode.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on factor VIII levels, type and severity of bleeding, and patient weight. Doses are expressed in International Units (IU). 1 IU/kg typically raises Factor VIII levels by approximately 2 IU/dL (2%).
Condition-Specific Dosing:
onDemandTreatment:
Minor hemorrhage (e.g., early hemarthrosis, epistaxis): 15-25 IU/kg every 8-12 hours. Major hemorrhage (e.g., severe hemarthrosis, intracranial hemorrhage): 30-50 IU/kg initially, then 20-30 IU/kg every 8-12 hours to maintain Factor VIII levels. Surgical prophylaxis: Pre-operative dose to achieve 80-100% Factor VIII activity, then maintain levels at 30-60% for 10-14 days.
routineProphylaxis:
25-50 IU/kg 2-3 times per week, or as determined by clinical response and Factor VIII levels.
Pediatric Dosing
Neonatal:
Not established for routine use; use in life-threatening bleeding only, with careful monitoring. Dosing similar to infants/children on a weight-adjusted basis.
Infant:
Dosing similar to adults on a weight-adjusted basis (IU/kg). Prophylaxis often initiated early.
Child:
Dosing similar to adults on a weight-adjusted basis (IU/kg). Prophylaxis often initiated early.
Adolescent:
Dosing similar to adults on a weight-adjusted basis (IU/kg).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; 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 protein in the intrinsic pathway of blood coagulation. In patients with hemophilia A, Factor VIII is deficient or defective, leading to impaired clot formation. Administration of Antihemophilic Factor (Human) temporarily replaces the missing Factor VIII, allowing for the formation of a stable fibrin clot and control of bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect after IV infusion)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.04-0.08 L/kg (similar to plasma volume)
ProteinBinding:
Binds non-covalently to von Willebrand factor (vWF) in plasma, which stabilizes Factor VIII and protects it from degradation.
CnssPenetration:
Limited
Elimination:
HalfLife:
8-12 hours (range 5-24 hours, highly variable among individuals)
Clearance:
Approximately 2-4 mL/hr/kg
ExcretionRoute:
Metabolic degradation; no specific excretion route.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of intravenous infusion)
PeakEffect:
Immediately after 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 patients.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 help right away:
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:
- Uncontrolled bleeding (e.g., prolonged nosebleeds, bleeding from gums, heavy menstrual bleeding)
- Joint pain, swelling, or warmth (signs of a joint bleed)
- Severe headache, vision changes, confusion, or weakness (signs of a head bleed)
- Blood in urine or stools
- Rash, hives, itching, swelling of the face or throat, difficulty breathing, or dizziness (signs of an allergic reaction)
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 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 prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems or conditions
It is crucial to verify that it is safe to take this medication with 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 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 prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems or conditions
It is crucial to verify that it is safe to take this medication with 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 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 possibility 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 possibility 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 an overdose is unlikely to cause acute toxicity, very high levels of Factor VIII could theoretically increase the risk of thrombotic events (blood clots), especially in patients with other risk factors.
- Symptoms of thrombosis could include chest pain, shortness of breath, swelling or pain in a limb.
What to Do:
If an overdose is suspected, contact your healthcare provider or emergency services immediately. Monitor for signs of thrombosis. In the US, call Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid)
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to first administration or when switching products.
Inhibitor (neutralizing antibody) screening
Rationale: To detect the presence of Factor VIII inhibitors, which can render treatment ineffective. Important for all patients, especially those with severe hemophilia A.
Timing: Prior to first administration and periodically thereafter.
Viral markers (e.g., HIV, HBV, HCV)
Rationale: Although plasma-derived products are highly purified and viral inactivated, monitoring for potential viral transmission is prudent, especially with older products or in specific patient populations.
Timing: Baseline and periodically as per clinical guidelines.
Routine Monitoring
Factor VIII activity levels
Frequency: During acute bleeding episodes (pre- and post-infusion), during surgery (to maintain target levels), and periodically during prophylaxis (trough levels).
Target: Varies based on clinical situation (e.g., 80-100% for major surgery, 30-50% for major bleeding, >1% for prophylaxis).
Action Threshold: If levels are not within target range, adjust dose or frequency. If levels are unexpectedly low, consider inhibitor development.
Clinical response (cessation of bleeding, resolution of symptoms)
Frequency: Continuously during acute bleeding episodes.
Target: Not applicable
Action Threshold: If bleeding persists or recurs, re-evaluate Factor VIII levels, consider inhibitor development, or adjust dosing.
Inhibitor (neutralizing antibody) screening
Frequency: Every 3-6 months for severe hemophilia A patients, annually for mild/moderate, or whenever there is a poor clinical response to Factor VIII replacement.
Target: Negative (<0.6 Bethesda Units/mL)
Action Threshold: If positive, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Signs and symptoms of allergic or hypersensitivity reactions
Frequency: During and immediately after infusion.
Target: Not applicable
Action Threshold: Stop infusion immediately, provide supportive care (antihistamines, corticosteroids, epinephrine).
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from minor cuts, blood in urine/stools, nosebleeds, headaches, vision changes)
- Signs of allergic reaction (e.g., hives, rash, itching, facial swelling, difficulty breathing, chest tightness, dizziness, faintness)
- Signs of inhibitor development (e.g., poor response to previously effective doses of Factor VIII, increased frequency or severity of bleeding episodes)
Special Patient Groups
Pregnancy
Use during pregnancy only if clearly needed. Hemophilia A is rare in women, but carriers may experience bleeding complications. Factor VIII levels naturally increase during pregnancy, but replacement therapy may be required for bleeding episodes or during delivery. Close monitoring of Factor VIII levels is essential.
Trimester-Specific Risks:
First Trimester:
No specific risks identified; use if clinically indicated.
Second Trimester:
No specific risks identified; use if clinically indicated.
Third Trimester:
Increased risk of bleeding during delivery. Factor VIII levels should be monitored and maintained at adequate levels (e.g., >50% for vaginal delivery, >80-100% for C-section) to prevent hemorrhage.
Lactation
It is not known whether Antihemophilic Factor (Human) is excreted in human milk. However, as a large protein, it is unlikely to be absorbed intact by the infant. The benefits of breastfeeding should be weighed against any potential risks. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk to the infant.
Pediatric Use
Antihemophilic Factor (Human) is a cornerstone of treatment for hemophilia A in pediatric patients, including infants and children. Dosing is weight-based (IU/kg). Prophylaxis is often initiated early in life to prevent joint damage and improve quality of life. Inhibitor development is a significant concern in this population, especially in severe hemophilia A.
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 increase the risk of complications. Monitor for potential thrombotic events if high doses are used in patients with pre-existing cardiovascular risk factors.
Clinical Information
Clinical Pearls
- Hemofil M is a plasma-derived Factor VIII product. While highly purified and viral inactivated, recombinant Factor VIII products are generally preferred for new patients due to theoretical viral transmission risks, though the risk with modern plasma-derived products is extremely low.
- Dosing is highly individualized; regular monitoring of Factor VIII levels and clinical response is crucial.
- Inhibitor development (neutralizing antibodies to Factor VIII) is the most serious complication of hemophilia A treatment, leading to treatment failure. Patients should be regularly screened for inhibitors.
- Patients should be educated on early recognition of bleeding episodes and prompt treatment to prevent long-term joint damage.
- Always reconstitute the product according to manufacturer instructions and administer via intravenous infusion. Do not mix with other medications or solutions.
Alternative Therapies
- Recombinant Antihemophilic Factor (Factor VIII) products (e.g., Advate, Eloctate, Adynovate, Xyntha, Kogenate FS, Recombinate, Afstyla, Jivi, Esperoct)
- Other plasma-derived Factor VIII products (e.g., Koate-DVI, Alphanate, Humate-P)
- 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 (e.g., Emicizumab - a bispecific antibody mimicking Factor VIIIa, for prophylaxis in patients with or without inhibitors)
- Desmopressin (DDAVP) for mild hemophilia A (increases endogenous Factor VIII release)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy for mucosal bleeding.
Cost & Coverage
Average Cost:
Highly variable, typically $1-$2 per IU. A 1700 IU vial could cost $1700-$3400 or more. per 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'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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.