Alphanate 2000iu Vwf Human Inj,10ml
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
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Pregnancy Category
Category C
FDA Approved
Mar 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alphanate is a medicine made from human plasma that contains two important proteins: Factor VIII and von Willebrand Factor. These proteins are crucial for your blood to clot properly and stop bleeding. People with certain bleeding disorders, like Hemophilia A or von Willebrand Disease, don't have enough of these proteins or they don't work correctly. Alphanate helps to replace them, allowing your blood to form clots and stop bleeding.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
Before use, this medication must be mixed according to the instructions provided by your doctor. Do not shake the mixture. The medication should be used within 3 hours of preparation. Check the solution for any changes in color; if it has changed, do not use it. After mixing, you may notice a few flakes or particles. The filter used during preparation removes 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.
Disposal and Storage
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. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage Instructions
Store the medication at room temperature, avoiding freezing. Keep the medication in its original container, protected from light. Store all medications in a safe location, out of the reach of children and pets.
Missing a Dose
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 if you miss a dose, contact your doctor for guidance.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous injection. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparing the Medication
Before use, this medication must be mixed according to the instructions provided by your doctor. Do not shake the mixture. The medication should be used within 3 hours of preparation. Check the solution for any changes in color; if it has changed, do not use it. After mixing, you may notice a few flakes or particles. The filter used during preparation removes 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.
Disposal and Storage
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. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage Instructions
Store the medication at room temperature, avoiding freezing. Keep the medication in its original container, protected from light. Store all medications in a safe location, out of the reach of children and pets.
Missing a Dose
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 if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Always carry your medication and supplies with you, especially when traveling.
- Follow your doctor's instructions for dosing and administration precisely.
- Maintain a bleeding diary to track bleeding episodes and medication use.
- Avoid activities that carry a high risk of injury or bleeding.
- Inform all healthcare providers (including dentists) that you have a bleeding disorder and are using this medication.
- Wear a medical alert bracelet or carry an identification card indicating your condition.
- Avoid aspirin and NSAIDs (e.g., ibuprofen, naproxen) unless specifically approved 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 indication, severity of bleeding, and patient's baseline factor levels. Dosing is expressed in International Units (IU) of Factor VIII (FVIII) or von Willebrand Factor:Ristocetin Cofactor (VWF:RCo).
Condition-Specific Dosing:
Hemophilia A (on-demand treatment):
Initial dose typically 20-50 IU FVIII/kg, aiming for a target FVIII activity level (e.g., 80-100% for major bleeds). Subsequent doses and frequency depend on clinical response and FVIII half-life.
von Willebrand Disease (VWD) (on-demand treatment):
Initial dose typically 40-80 IU VWF:RCo/kg, aiming for target VWF:RCo and FVIII activity levels (e.g., VWF:RCo >60% and FVIII >40% for major bleeds). Subsequent doses and frequency depend on clinical response and VWF/FVIII half-lives. Dosing is often based on VWF:RCo units, with the FVIII content being co-administered.
Surgical Prophylaxis (Hemophilia A):
Pre-operative dose to achieve FVIII activity of 80-100%. Maintenance doses may be required post-operatively.
Surgical Prophylaxis (VWD):
Pre-operative dose to achieve VWF:RCo >60% and FVIII >40%. Maintenance doses may be required post-operatively.
Pediatric Dosing
Neonatal:
Not established, but used in neonates/infants with severe bleeding disorders under close monitoring. Dosing is weight-based, similar to adults.
Infant:
Dosing is weight-based, similar to adults, adjusted for clinical response and factor levels.
Child:
Dosing is weight-based, similar to adults, adjusted for clinical response and factor levels.
Adolescent:
Dosing is weight-based, similar to adults, adjusted for clinical response and factor levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Dialysis:
No specific dose adjustment required. Monitor for fluid overload and electrolyte balance.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required. Monitor for signs of thrombosis due to potential altered coagulation profile.
Pharmacology
Mechanism of Action
Alphanate contains both Factor VIII (FVIII) and von Willebrand Factor (VWF). FVIII is an essential cofactor in the intrinsic coagulation pathway, accelerating the activation of Factor X by Factor IXa. In Hemophilia A, FVIII deficiency leads to impaired clot formation. VWF is a multimeric plasma protein that mediates platelet adhesion to the subendothelium at sites of vascular injury and serves as a carrier protein for FVIII, protecting it from proteolytic degradation and localizing it to the site of injury. In von Willebrand Disease (VWD), deficiency or dysfunction of VWF leads to impaired platelet plug formation and reduced FVIII levels. Administration of Alphanate temporarily replaces the deficient FVIII and VWF, restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediate (peak activity achieved at the end of infusion)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately plasma volume (distributed within the intravascular compartment)
ProteinBinding:
FVIII is bound to VWF; VWF circulates as multimers.
CnssPenetration:
No
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 12-24 hours
Clearance:
Variable, dependent on individual patient factors and baseline levels.
ExcretionRoute:
Metabolized proteins are excreted via normal physiological pathways.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on the half-lives of FVIII and VWF, typically 12-24 hours for a significant hemostatic effect, requiring repeat dosing for sustained activity.
Safety & Warnings
Side Effects
Serious 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
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 changes, drooping on one side of the face, or 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
Most people do not experience serious side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Mild stomach upset
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. 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
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 changes, drooping on one side of the face, or 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
Most people do not experience serious side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Mild stomach upset
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: Hives, rash, itching, swelling of the face/lips/tongue, difficulty breathing, wheezing, dizziness, feeling faint, rapid heartbeat.
- Signs of a blood clot: Pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath, chest pain, coughing up blood.
- Persistent or worsening bleeding despite treatment.
- Fever, chills, headache, nausea, vomiting, tingling sensation.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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. You will need to bring enough medication to last throughout your trip.
If you are 65 years or older, exercise caution when using this medication, 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. You will need to bring enough medication to last throughout your trip.
If you are 65 years or older, exercise caution when using this medication, 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:
- Signs of hypercoagulability or thrombosis (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke)
- Disseminated intravascular coagulation (DIC) in rare, extreme cases
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. Management is supportive and may include discontinuation of the product, close monitoring for thrombotic events, and initiation of anticoagulant therapy if indicated. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Moderate Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Concurrent use may increase the risk of thrombosis, especially in patients with VWD undergoing surgery or with other thrombotic risk factors. Use with caution and monitor closely.
Monitoring
Baseline Monitoring
Diagnosis confirmation (Hemophilia A or VWD type)
Rationale: To ensure appropriate indication and guide dosing.
Timing: Prior to initiation of therapy
Baseline FVIII activity level
Rationale: To assess severity of Hemophilia A and guide initial dosing.
Timing: Prior to initiation of therapy
Baseline VWF:RCo activity, VWF:Ag, FVIII activity (for VWD)
Rationale: To assess VWD type and severity, and guide initial dosing.
Timing: Prior to initiation of therapy
CBC with platelet count
Rationale: To assess overall hematologic status and identify other potential bleeding issues.
Timing: Prior to initiation of therapy
aPTT (activated partial thromboplastin time)
Rationale: To assess intrinsic pathway coagulation, which is prolonged in FVIII deficiency.
Timing: Prior to initiation of therapy
Screening for FVIII inhibitors (Bethesda assay)
Rationale: To detect pre-existing inhibitors that would render FVIII replacement ineffective.
Timing: Prior to initiation of therapy, especially in Hemophilia A patients
Routine Monitoring
FVIII activity level
Frequency: Before and after initial dose, then as clinically indicated (e.g., daily during acute bleeding/surgery, or less frequently for prophylaxis)
Target: Dependent on indication (e.g., 80-100% for major bleeds, 40-60% for moderate bleeds, >1% for prophylaxis)
Action Threshold: Adjust dose or frequency if target levels are not achieved or sustained.
VWF:RCo activity level (for VWD)
Frequency: Before and after initial dose, then as clinically indicated (e.g., daily during acute bleeding/surgery)
Target: Dependent on indication (e.g., >60% for major bleeds/surgery)
Action Threshold: Adjust dose or frequency if target levels are not achieved or sustained.
Clinical assessment for bleeding cessation
Frequency: Continuously during acute bleeding episodes
Target: Cessation of bleeding
Action Threshold: If bleeding persists or recurs, re-evaluate dosing, consider inhibitor development, or other causes of bleeding.
Signs and symptoms of allergic/anaphylactic reactions
Frequency: During and immediately after infusion
Target: Absence of symptoms (e.g., urticaria, angioedema, dyspnea, hypotension)
Action Threshold: Stop infusion immediately, provide supportive care (antihistamines, epinephrine, corticosteroids).
Signs and symptoms of thrombosis/thromboembolism
Frequency: Regularly, especially with high doses or prolonged use, or in patients with risk factors
Target: Absence of symptoms (e.g., pain, swelling, redness, shortness of breath, chest pain)
Action Threshold: Investigate immediately, consider dose reduction or discontinuation, initiate anticoagulation if indicated.
FVIII inhibitor development (Bethesda assay)
Frequency: Regularly in Hemophilia A patients (e.g., every 3-6 months or if treatment efficacy decreases)
Target: <0.6 Bethesda Units (BU)
Action Threshold: If inhibitors develop, consider alternative treatments (e.g., bypassing agents).
Symptom Monitoring
- Bleeding (e.g., joint bleeds, muscle bleeds, mucosal bleeding, excessive bruising)
- Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, wheezing, dizziness, fainting)
- Signs of thrombosis (e.g., pain, swelling, warmth, redness in a limb; sudden shortness of breath, chest pain, rapid heart rate, cough)
- Headache
- Fever
- Chills
- Nausea
- Vomiting
- Tingling sensation
Special Patient Groups
Pregnancy
Alphanate is a Category C drug. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment of bleeding disorders during pregnancy is crucial for maternal and fetal well-being.
Trimester-Specific Risks:
First Trimester:
No specific data on increased risk of congenital anomalies. Use only if clearly needed.
Second Trimester:
No specific data on increased risk. Use only if clearly needed.
Third Trimester:
May be used to manage bleeding complications during labor and delivery. Monitor FVIII and VWF levels closely.
Lactation
It is not known whether Alphanate is excreted in human milk. However, due to its large molecular weight, it is unlikely to pass into breast milk in significant amounts or be orally absorbed by the infant. The benefits of breastfeeding should be weighed against the potential risks. Generally considered compatible with breastfeeding, but caution is advised.
Infant Risk:
Low risk of harm to the infant due to poor oral bioavailability of large protein molecules.
Pediatric Use
Alphanate is indicated for use in pediatric patients with Hemophilia A and VWD. Dosing is weight-based and individualized, similar to adults. Safety and efficacy have been demonstrated in pediatric populations. Close monitoring of factor levels and clinical response is essential.
Geriatric Use
Clinical studies 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. Monitor for age-related comorbidities and increased risk of thrombosis.
Clinical Information
Clinical Pearls
- Alphanate contains both FVIII and VWF, making it suitable for both Hemophilia A and VWD, unlike single-factor products.
- Dosing for VWD should primarily be based on VWF:RCo units, with the FVIII component being a co-administered benefit.
- For VWD, the FVIII component of Alphanate may have a prolonged half-life due to the stabilizing effect of the co-administered VWF, potentially allowing for less frequent dosing than with FVIII-only products.
- Always reconstitute the product according to manufacturer's instructions and administer via intravenous infusion.
- Monitor for inhibitor development in Hemophilia A patients, especially those with severe disease or during initial exposure.
- Be vigilant for signs of thrombosis, particularly in VWD patients receiving high or repeated doses, or those with other thrombotic risk factors (e.g., surgery, immobility, use of antifibrinolytics).
- Ensure patients and caregivers are trained on proper home infusion techniques and recognition of adverse reactions.
Alternative Therapies
- Recombinant Factor VIII (for Hemophilia A, e.g., Advate, Eloctate, Jivi, Hemlibra - emicizumab)
- Recombinant von Willebrand Factor (for VWD, e.g., Vonvendi)
- Desmopressin (DDAVP) (for mild Hemophilia A and Type 1 VWD)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) (adjunctive therapy for bleeding control)
- Cryoprecipitate (contains FVIII, VWF, fibrinogen, fibronectin - older therapy, higher pathogen risk)
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of USD per dose depending on strength and quantity. For example, a 2000 IU vial could range from $2,000 to $5,000+. per vial (e.g., 2000 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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.