Alphanate 500iu Vwf/hum Inj 1vl
It is used to treat or prevent bleeding in people with hemophilia.It is used to treat or prevent bleeding in people with von Willebrand disease.
Drug Class
Hemostatic agent
Pharmacologic Class
Coagulation factor; Plasma-derived
Pregnancy Category
Category C
FDA Approved
Sep 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alphanate is a medicine made from human plasma (the liquid part of blood). It contains two important proteins, Factor VIII and von Willebrand Factor, which are crucial for blood clotting. It is used to treat bleeding in people with Hemophilia A (a condition where the blood doesn't clot properly due to low Factor VIII) and von Willebrand Disease (a condition where the blood doesn't clot properly due to low or faulty von Willebrand Factor). By giving you these proteins, Alphanate helps your blood clot normally and stops or prevents bleeding.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions 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.
Prior to use, this medication must be mixed according to the instructions provided by your doctor. Avoid shaking the mixture. The solution should be used within 3 hours of preparation. Do not use the solution if it changes color. After mixing, you may notice a few flakes or particles. The filter used during the mixing process is designed to remove these particles from the solution. However, if the solution appears cloudy, is leaking, or still contains flakes or particles after filtration, do not use it.
After administering the injection, discard any remaining medication from the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Never reuse needles or other items. When 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
Store this medication at room temperature, avoiding freezing. Keep the medication in its original container, protected from light. Ensure all medications are stored in a secure location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To ensure safe and effective use, follow your doctor's instructions 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.
Prior to use, this medication must be mixed according to the instructions provided by your doctor. Avoid shaking the mixture. The solution should be used within 3 hours of preparation. Do not use the solution if it changes color. After mixing, you may notice a few flakes or particles. The filter used during the mixing process is designed to remove these particles from the solution. However, if the solution appears cloudy, is leaking, or still contains flakes or particles after filtration, do not use it.
After administering the injection, discard any remaining medication from the opened vial. Dispose of needles and other sharp objects in a designated needle/sharp disposal box. Never reuse needles or other items. When 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
Store this medication at room temperature, avoiding freezing. Keep the medication in its original container, protected from light. Ensure all medications are stored in a secure location, out of reach of children and pets.
Missed Dose Instructions
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid activities that carry a high risk of injury or bleeding (e.g., contact sports) unless approved by your doctor.
- Always carry your medication and identification indicating your bleeding disorder.
- Inform all healthcare providers (including dentists) about your condition and medication.
- Maintain good dental hygiene to prevent gum bleeding.
- Avoid aspirin and NSAIDs (e.g., ibuprofen, naproxen) unless specifically instructed by your doctor, as they can increase bleeding risk.
Available Forms & Alternatives
Available Strengths:
- Alphanate 250iu Vwf/hum Inj 1vl
- Alphanate 500iu Vwf/hum Inj 1 Vl
- Alphanate 1000iu Vwf/hum Inj, 10ml
- Alphanate 1500iu Vwf/hum Inj, 10ml
- Alphanate 2000iu Vwf Human Inj,10ml
- Alphanate 250iu Vwf/hum Inj 1vl
- Alphanate 500iu Vwf/hum Inj 1vl
- Alphanate 1000iu Vwf/hum Inj, 1vl
- Alphanate 1500iu Vwf/hum Inj, 1vl
- Alphanate Vwf Cmplx Human Inj, 1 Vl
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on factor levels, type and severity of bleeding, and surgical procedure. Dosing is calculated to achieve a desired increase in Factor VIII (FVIII) and/or von Willebrand Factor (VWF) activity.
Condition-Specific Dosing:
Hemophilia A (FVIII deficiency):
1 IU FVIII/kg body weight typically increases FVIII activity by approximately 2 IU/dL (2%). Initial dose for major bleeding/surgery: 40-50 IU FVIII/kg to achieve 80-100% FVIII activity. Maintenance doses and frequency depend on clinical response and FVIII levels.
von Willebrand Disease (VWD):
1 IU VWF:RCo/kg body weight typically increases VWF:RCo activity by approximately 2 IU/dL (2%). Initial dose for major bleeding/surgery: 50-80 IU VWF:RCo/kg to achieve 100% VWF:RCo activity. Subsequent doses and frequency depend on clinical response and VWF:RCo levels. For VWD, the FVIII content also contributes to hemostasis.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with severe bleeding disorders under specialist guidance. Dosing is weight-based and individualized.
Infant:
Dosing is weight-based and individualized, similar to adults, based on factor levels and clinical need.
Child:
Dosing is weight-based and individualized, similar to adults, based on factor levels and clinical need.
Adolescent:
Dosing is weight-based and individualized, similar to adults, based on factor levels and clinical need.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Dialysis:
Not significantly removed by dialysis. No specific adjustment recommended, but monitor factor levels closely.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Alphanate is a plasma-derived concentrate containing both Factor VIII (FVIII) and von Willebrand Factor (VWF). In patients with Hemophilia A, it replaces the deficient endogenous FVIII, which is essential for the intrinsic coagulation pathway, acting as a cofactor for Factor IXa in the activation of Factor X. In patients with von Willebrand Disease (VWD), it replaces deficient or dysfunctional VWF, which mediates platelet adhesion to the subendothelium and serves as a carrier protein for FVIII, protecting it from proteolytic degradation and localizing it to the site of injury. The administration of Alphanate thus restores hemostasis by providing both the necessary FVIII activity and VWF function.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (intravenous administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume (for FVIII, ~0.04-0.06 L/kg; for VWF, similar to plasma volume)
ProteinBinding:
FVIII is tightly bound to VWF in plasma, which stabilizes FVIII and prolongs its half-life.
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 12-24 hours
Clearance:
FVIII: 2-5 mL/kg/hr; VWF:RCo: 2-4 mL/kg/hr (variable depending on patient and VWD type)
ExcretionRoute:
Not applicable (metabolized)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous infusion)
PeakEffect:
Within minutes to 1 hour post-infusion
DurationOfAction:
Dependent on the half-life of FVIII and VWF, typically 12-24 hours for a significant hemostatic effect, requiring repeat dosing.
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
Flushing
Severe dizziness or fainting
Abnormal burning, numbness, or tingling sensations
Stinging
Swelling
Severe stomach upset or vomiting
Restlessness
Dark urine or yellow skin and eyes
Rapid heartbeat
Blue discoloration of the mouth
Weakness on one side of the body
Trouble speaking or thinking
Balance problems
Drooping on one side of the face
Blurred vision
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color change, or pain in a leg or arm
+ Trouble speaking or swallowing
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:
Mild stomach upset
Constipation
Dizziness
Fatigue
Weakness
Headache
* Back pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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
Flushing
Severe dizziness or fainting
Abnormal burning, numbness, or tingling sensations
Stinging
Swelling
Severe stomach upset or vomiting
Restlessness
Dark urine or yellow skin and eyes
Rapid heartbeat
Blue discoloration of the mouth
Weakness on one side of the body
Trouble speaking or thinking
Balance problems
Drooping on one side of the face
Blurred vision
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color change, or pain in a leg or arm
+ Trouble speaking or swallowing
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:
Mild stomach upset
Constipation
Dizziness
Fatigue
Weakness
Headache
* Back pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to contact 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, flushing, swelling of the face/lips/tongue, difficulty breathing, wheezing, dizziness, feeling faint. Seek immediate medical attention.
- Signs of a blood clot: Pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, coughing up blood; sudden severe headache, vision changes, weakness or numbness on one side of the body. Seek immediate medical attention.
- Signs of continued or worsening bleeding: Persistent bleeding from cuts, nosebleeds, blood in urine or stools, unusual bruising, joint pain or swelling, severe headache.
- Fever or chills (may indicate an infusion reaction or infection).
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. 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. Regular blood tests and laboratory checks should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be a sign that your current dosage is not effective.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, discuss this with your doctor.
This medication is derived from human plasma, which may pose a risk of transmitting viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize this risk, it is crucial to discuss this with your doctor.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
If you experience unexplained bruising or bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be a sign that your current dosage is not effective.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, discuss this with your doctor.
This medication is derived from human plasma, which may pose a risk of transmitting viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize this risk, it is crucial to discuss this with your doctor.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While rare, very high doses could theoretically increase the risk of thrombotic events (blood clots).
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Management is supportive and may involve monitoring for signs of thrombosis. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Concomitant use may increase the risk of thrombosis, especially in patients with VWD type 2B. Use with caution and monitor closely.
Monitoring
Baseline Monitoring
Factor VIII (FVIII:C) activity levels
Rationale: To determine baseline deficiency and guide initial dosing for Hemophilia A.
Timing: Prior to first infusion.
von Willebrand Factor ristocetin cofactor (VWF:RCo) activity levels
Rationale: To determine baseline deficiency and guide initial dosing for von Willebrand Disease.
Timing: Prior to first infusion.
Complete Blood Count (CBC) with platelet count
Rationale: To assess overall hematologic status and identify other potential causes of bleeding.
Timing: Prior to first infusion and periodically as clinically indicated.
Viral markers (e.g., HIV, Hepatitis B, Hepatitis C)
Rationale: Although highly purified, plasma-derived products carry a theoretical risk of viral transmission. Baseline testing is important for patient monitoring.
Timing: Prior to first infusion.
Routine Monitoring
Factor VIII (FVIII:C) activity levels
Frequency: Immediately post-infusion, then periodically (e.g., every 12-24 hours) to guide subsequent dosing, especially during major bleeding or surgery.
Target: Dependent on clinical situation (e.g., 80-100% for major surgery, 30-50% for minor bleeding).
Action Threshold: Adjust dose or frequency if levels are below target or clinical response is inadequate.
von Willebrand Factor ristocetin cofactor (VWF:RCo) activity levels
Frequency: Immediately post-infusion, then periodically (e.g., every 12-24 hours) to guide subsequent dosing, especially during major bleeding or surgery.
Target: Dependent on clinical situation (e.g., 100% for major surgery, 50% for minor bleeding).
Action Threshold: Adjust dose or frequency if levels are below target or clinical response is inadequate.
Clinical assessment of bleeding
Frequency: Continuously during acute bleeding episodes, then daily or as needed.
Target: Cessation or significant reduction of bleeding.
Action Threshold: If bleeding persists or worsens, re-evaluate dosing, consider inhibitor development, or investigate other causes.
Signs and symptoms of allergic/anaphylactic reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately, provide supportive care (e.g., antihistamines, epinephrine).
Signs and symptoms of thrombosis
Frequency: Periodically, especially in patients with risk factors or receiving high doses.
Target: Absence of symptoms (e.g., pain, swelling, redness, shortness of breath).
Action Threshold: Investigate immediately, consider discontinuing or reducing dose, initiate anticoagulation if indicated.
Development of FVIII inhibitors (antibodies)
Frequency: Periodically, especially in Hemophilia A patients (e.g., annually or if treatment efficacy decreases).
Target: Negative or low titer.
Action Threshold: If inhibitors develop, consider alternative treatments (e.g., bypassing agents).
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, prolonged bleeding from cuts, nosebleeds, blood in urine/stools, joint pain/swelling)
- Signs of allergic reaction (e.g., rash, hives, itching, flushing, swelling of face/lips/tongue, difficulty breathing, wheezing, dizziness, faintness)
- Signs of thrombosis (e.g., pain, swelling, warmth, redness in a limb; sudden chest pain, shortness of breath, coughing up blood; sudden severe headache, vision changes, weakness/numbness on one side of body)
- Fever, chills (may indicate infusion reaction or infection)
Special Patient Groups
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether Alphanate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Alphanate should be given to a pregnant woman only if clearly needed and the potential benefits outweigh the potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risks unknown; use only if clearly indicated.
Second Trimester:
Potential risks unknown; use only if clearly indicated.
Third Trimester:
Potential risks unknown; use only if clearly indicated.
Lactation
It is not known whether Alphanate is excreted in human milk. The decision to discontinue breastfeeding or discontinue the drug should be made taking into account the importance of the drug to the mother and the potential risks to the infant. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low to moderate risk. Proteins are generally digested in the infant's gut, but theoretical risks of viral transmission (though highly mitigated) or immune reactions exist.
Pediatric Use
Alphanate is indicated for use in pediatric patients with Hemophilia A and von Willebrand Disease. Dosing is weight-based and individualized, similar to adults, based on factor levels and clinical response. Safety and efficacy have been demonstrated in pediatric populations.
Geriatric Use
Clinical studies of Alphanate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. However, dosing is primarily based on factor levels and clinical need, not age.
Clinical Information
Clinical Pearls
- Alphanate contains both FVIII and VWF, making it suitable for both Hemophilia A and von Willebrand Disease, unlike some other factor concentrates that contain only FVIII.
- Dosing is highly individualized and requires laboratory monitoring of FVIII:C and VWF:RCo levels to ensure adequate hemostasis.
- Administer intravenously at a rate comfortable for the patient, typically 2-10 mL/minute. Do not exceed 10 mL/minute.
- Always reconstitute the lyophilized powder with the provided sterile water for injection immediately before use.
- Patients should be educated on the signs and symptoms of allergic reactions and thrombosis, and instructed to seek immediate medical attention if these occur.
- The risk of viral transmission, while extremely low due to modern purification and viral inactivation/removal processes, should still be discussed with patients.
- Consider the potential for inhibitor development in Hemophilia A patients, especially those with severe disease, and monitor for decreased treatment efficacy.
Alternative Therapies
- For Hemophilia A: Recombinant Factor VIII concentrates (e.g., Advate, Eloctate, Hemlibra - emicizumab, a bypassing agent)
- For von Willebrand Disease: Desmopressin (DDAVP) for mild VWD Type 1, other VWF-containing concentrates, antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid).
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on strength and quantity. per 500 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by medical benefit)
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.