Alphanate 1500iu 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
Antihemophilic Agent
Pharmacologic Class
Human Plasma-Derived Coagulation Factor VIII and von Willebrand Factor Complex
Pregnancy Category
Category C
FDA Approved
Aug 1992
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 blood clotting. People with Hemophilia A don't have enough Factor VIII, and people with von Willebrand Disease don't have enough von Willebrand Factor (and often also have low Factor VIII). Alphanate helps replace these missing proteins to stop or prevent bleeding.
How to Use This Medicine
Proper Use of This 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, but the filter used during preparation will remove these from the solution. However, if the solution appears cloudy, is leaking, or still contains flakes or particles after filtering, do not use it.
Administration and Disposal
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 or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep it in its original container, protected from light. Store all medications in a safe location, out of the reach of children and pets.
Missed 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 in case of a missed 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, but the filter used during preparation will remove these from the solution. However, if the solution appears cloudy, is leaking, or still contains flakes or particles after filtering, do not use it.
Administration and Disposal
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 or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, avoiding freezing. Keep it in its original container, protected from light. Store all medications in a safe location, out of the reach of children and pets.
Missed 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 in case of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Always carry identification indicating your bleeding disorder.
- Avoid activities that carry a high risk of injury.
- Avoid aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) unless specifically approved by your doctor, as they can interfere with blood clotting.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your prescribed dosing schedule carefully and do not miss doses.
- Learn how to self-administer the medication if instructed by your healthcare provider.
- Report any new or unusual bleeding, or signs of allergic reaction, immediately to your doctor.
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 of bleeding, and patient weight. Dosing is expressed in International Units (IU).
Condition-Specific Dosing:
Hemophilia A (Factor VIII Deficiency):
Dose (IU) = Body Weight (kg) x Desired FVIII Increase (% of normal) x 0.5 (IU/kg per % increase). For major hemorrhage/surgery, target FVIII activity 80-100% initially, then maintain >40-50%. For minor hemorrhage, target FVIII activity 30-60%. Administer intravenously.
von Willebrand Disease (VWD):
Dose (IU VWF:RCo) = Body Weight (kg) x Desired VWF:RCo Increase (% of normal) x 0.7 (IU/kg per % increase). For major hemorrhage/surgery, target VWF:RCo activity >60% and FVIII activity >50% initially, then maintain >30-50%. For minor hemorrhage, target VWF:RCo activity >30% and FVIII activity >30%. Administer intravenously.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with severe bleeding disorders under close monitoring and individualized dosing.
Infant:
Dosing is individualized based on weight, factor levels, and clinical need, similar to adult dosing principles.
Child:
Dosing is individualized based on weight, factor levels, and clinical need, similar to adult dosing principles.
Adolescent:
Dosing is individualized based on weight, factor levels, and clinical need, similar to adult dosing principles.
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
Alphanate is a purified, pasteurized, and nanofiltered plasma-derived concentrate of Factor VIII (FVIII) and von Willebrand Factor (VWF). In patients with Hemophilia A, it temporarily replaces the deficient endogenous FVIII, which is an essential cofactor in the intrinsic coagulation pathway, promoting hemostasis. In patients with von Willebrand Disease (VWD), it provides both VWF, which mediates platelet adhesion and aggregation at sites of vascular injury, and FVIII, which is stabilized and protected from degradation by VWF, thereby correcting the dual hemostatic defect.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (intravenous administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume (for both FVIII and VWF)
ProteinBinding:
Factor VIII circulates bound to von Willebrand Factor (VWF). VWF circulates as multimers.
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 8-12 hours; VWF:Ag: 19-35 hours
Clearance:
FVIII: 2.5-5.0 mL/hr/kg; VWF:RCo: 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolized and excreted via normal protein catabolism pathways
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Immediately after infusion
DurationOfAction:
Dependent on the half-life of FVIII and VWF, typically 8-24 hours for FVIII and longer for VWF components, requiring repeat dosing based on clinical need and factor levels.
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 upset stomach 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Upset stomach
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 about side effects, 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 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 upset stomach 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Upset stomach
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 about side effects, 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 allergic reaction: rash, hives, itching, flushing, swelling of the face/lips/tongue, difficulty breathing, wheezing, chest tightness, dizziness, faintness.
- Signs of thrombosis (blood clot): pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, or coughing up blood; sudden vision changes or severe headache.
- Signs of inhibitor development (if treatment becomes less effective): increased frequency or severity of bleeding episodes, bleeding that does not respond to usual doses of Alphanate.
- Fever, chills, headache, nausea, vomiting.
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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 other laboratory evaluations should be performed 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 potentially contain viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the risk of infection, 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 sufficient quantities 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 potentially contain viruses that can cause disease. Although the medication is thoroughly screened, tested, and treated to minimize the risk of infection, 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 sufficient quantities 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:
- While acute overdose is unlikely to cause severe symptoms beyond potential volume overload, very high or repeated doses, especially of VWF-containing products, can increase the risk of thrombotic events (blood clots).
- Symptoms of thrombosis (as listed above).
What to Do:
In case of suspected overdose or thrombotic symptoms, seek immediate medical attention. Call 911 or your local emergency number. For general overdose information, contact a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis confirmation (Hemophilia A or VWD type)
Rationale: To ensure appropriate therapy and guide dosing.
Timing: Prior to initiation of therapy
Baseline Factor VIII activity (for Hemophilia A and VWD)
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to first infusion
Baseline von Willebrand Factor ristocetin cofactor activity (VWF:RCo) and VWF antigen (VWF:Ag) (for VWD)
Rationale: To establish baseline deficiency and guide initial dosing for VWD.
Timing: Prior to first infusion
Bleeding history and severity
Rationale: To assess clinical need and guide treatment strategy.
Timing: Prior to initiation of therapy
Inhibitor screening (Factor VIII inhibitors)
Rationale: To detect pre-existing inhibitors that may affect treatment efficacy.
Timing: Prior to first infusion, especially in previously treated patients
Routine Monitoring
Factor VIII activity levels
Frequency: Before and after initial infusion, then as clinically indicated (e.g., before subsequent infusions, during surgery, or for prolonged bleeding episodes)
Target: Dependent on clinical situation (e.g., 80-100% for major surgery, 30-60% for minor bleeding)
Action Threshold: Adjust dose or frequency if levels are below target or if bleeding persists.
von Willebrand Factor ristocetin cofactor activity (VWF:RCo) and VWF antigen (VWF:Ag)
Frequency: Before and after initial infusion, then as clinically indicated (e.g., before subsequent infusions, during surgery, or for prolonged bleeding episodes)
Target: Dependent on clinical situation (e.g., >60% for major surgery, >30% for minor bleeding)
Action Threshold: Adjust dose or frequency if levels are below target or if bleeding persists.
Clinical response (cessation of bleeding)
Frequency: Continuously during treatment
Target: Resolution of bleeding symptoms
Action Threshold: If bleeding persists despite adequate factor levels, investigate for inhibitors or other causes.
Inhibitor screening (Factor VIII inhibitors)
Frequency: Regularly (e.g., every 3-6 months or annually) or if expected FVIII levels are not achieved or bleeding is not controlled.
Target: Negative
Action Threshold: If inhibitors are detected, adjust treatment strategy (e.g., higher doses, bypassing agents).
Signs and symptoms of allergic/hypersensitivity reactions
Frequency: During and immediately after infusion
Target: Absence of symptoms
Action Threshold: Stop infusion immediately and provide supportive care if symptoms occur.
Signs and symptoms of thrombosis (especially with high or repeated doses)
Frequency: Regularly, especially in patients with risk factors
Target: Absence of symptoms
Action Threshold: Investigate and manage thrombosis if suspected.
Symptom Monitoring
- Bleeding (e.g., joint bleeds, muscle bleeds, epistaxis, menorrhagia, gastrointestinal bleeding)
- Signs of allergic reaction (e.g., rash, hives, itching, flushing, swelling of face/lips/tongue, dyspnea, wheezing, chest tightness, dizziness, faintness)
- Signs of thrombosis (e.g., pain, swelling, redness in a limb; sudden chest pain, shortness of breath; sudden vision changes)
- Fever
- Chills
- Headache
Special Patient Groups
Pregnancy
Alphanate is a Category C medication. 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. Factor VIII and VWF levels can increase during pregnancy, so monitoring of factor levels is important.
Trimester-Specific Risks:
First Trimester:
Risk unknown; use only if clearly needed.
Second Trimester:
Risk unknown; use only if clearly needed.
Third Trimester:
Risk unknown; use only if clearly needed. Close monitoring of factor levels is crucial as levels may fluctuate.
Lactation
It is not known whether Alphanate is excreted in human milk. Caution should be exercised when Alphanate is administered to a nursing mother. The decision to breastfeed should consider the potential benefits of breastfeeding for the infant and the potential benefits of therapy for the mother.
Infant Risk:
Risk level L3 (Moderately Safe - No controlled studies in lactating women; potential for adverse effects on the infant or milk production is possible but unlikely. Weigh risk vs. benefit.)
Pediatric Use
Alphanate is indicated for use in pediatric patients with Hemophilia A and VWD. Dosing is individualized based on weight, factor levels, and clinical need, similar to adult dosing principles. Safety and efficacy have been established 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. No specific dose adjustment is typically required based on age alone, but monitoring for thrombotic risk may be more critical.
Clinical Information
Clinical Pearls
- Alphanate contains both Factor VIII and von Willebrand Factor, making it suitable for both Hemophilia A and von Willebrand Disease, particularly Type 3 VWD or severe Type 1/2 VWD where FVIII replacement is also needed.
- Dosing is highly individualized and requires careful monitoring of Factor VIII and VWF:RCo levels to achieve desired hemostasis.
- Patients should be monitored for the development of Factor VIII inhibitors, especially in previously untreated patients (PUPs) or those with severe Hemophilia A.
- Thrombotic events are a potential risk, especially with high or repeated doses, or in patients with pre-existing risk factors for thrombosis. Consider prophylactic anticoagulation in high-risk surgical patients.
- Administer intravenously at a rate comfortable for the patient, typically 2-10 mL/minute. Do not exceed 10 mL/minute.
- Ensure proper storage (refrigerated, but can be stored at room temperature for a limited time) and reconstitution according to manufacturer's instructions.
- Patients should be educated on recognizing and reporting signs of allergic reactions immediately.
Alternative Therapies
- Recombinant Factor VIII (for Hemophilia A, e.g., Advate, Eloctate, Hemlibra (emicizumab) as prophylaxis)
- Desmopressin (DDAVP) (for mild Hemophilia A and Type 1 VWD, by releasing endogenous FVIII and VWF)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) (adjunctive therapy for bleeding control)
- Cryoprecipitate (contains FVIII, VWF, fibrinogen, fibronectin; less purified, higher infectious risk)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on IU strength. per 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 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 details about the medication taken, the amount, and the time it happened.