Alphanate 1000iu Vwf/hum 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
Antihemorrhagic
Pharmacologic Class
Blood Coagulation Factors, Plasma-Derived
Pregnancy Category
Category C
FDA Approved
Jun 1986
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. It is used to treat bleeding episodes or prevent bleeding during surgery in people with Hemophilia A (a condition where the blood doesn't clot properly due to a lack of Factor VIII) and von Willebrand Disease (a condition affecting blood clotting due to a problem with von Willebrand Factor). It helps your blood clot normally.
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. 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 this medication at room temperature, avoiding freezing. Keep the medication in its original container to protect it from light. Store all medications in a safe location, out of the 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 case of a missed dose, contact your doctor.
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 this medication at room temperature, avoiding freezing. Keep the medication in its original container to protect it from light. Store all medications in a safe location, out of the 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 case of a missed dose, contact your doctor.
Lifestyle & Tips
- Always carry your medication and infusion supplies with you.
- Maintain a medical alert identification (e.g., bracelet or necklace) indicating your condition and treatment.
- Avoid activities that carry a high risk of injury or bleeding.
- Regularly consult with your hematologist and healthcare team.
- Learn proper infusion techniques if administering at home.
- Keep a detailed log of infusions, doses, and any bleeding episodes.
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 FVIII and VWF:RCo activity levels, type of bleeding/surgery, and patient weight. Dosing is calculated in International Units (IU).
Condition-Specific Dosing:
Hemophilia A (FVIII deficiency):
Initial dose for major hemorrhage: 50-100 IU FVIII/kg to achieve 100% FVIII activity. Subsequent doses 25-50 IU FVIII/kg every 8-12 hours to maintain FVIII activity. For minor hemorrhage: 15-25 IU FVIII/kg. For prophylaxis: 25-40 IU FVIII/kg 2-3 times per week.
Von Willebrand Disease (VWD):
Initial dose for major hemorrhage/surgery: 50-80 IU VWF:RCo/kg. Subsequent doses 40-60 IU VWF:RCo/kg every 12-24 hours as needed to maintain VWF:RCo activity. For minor hemorrhage: 40-50 IU VWF:RCo/kg. Dosing aims to achieve target VWF:RCo and FVIII:C levels.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Dosing is weight-based, similar to adults, but requires careful monitoring due to developmental differences in pharmacokinetics and coagulation systems. Consult specialist.
Child:
Dosing is weight-based, similar to adults. For Hemophilia A: 1 IU FVIII/kg typically raises FVIII activity by ~2 IU/dL. For VWD: 1 IU VWF:RCo/kg typically raises VWF:RCo activity by ~2 IU/dL. Individualized based on clinical response and laboratory values.
Adolescent:
Dosing is weight-based, similar to adults. Individualized based on clinical response and laboratory values.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific considerations; 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 contains both Factor VIII (FVIII) and von Willebrand Factor (VWF). In Hemophilia A, FVIII is deficient, leading to impaired coagulation. Exogenous FVIII replaces the missing factor, enabling normal hemostasis. In von Willebrand Disease (VWD), VWF is deficient or dysfunctional, impairing platelet adhesion and aggregation, and also leading to secondary FVIII deficiency (as VWF stabilizes FVIII). Exogenous VWF corrects the primary VWF defect and stabilizes endogenous or co-administered FVIII, restoring normal hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume (FVIII and VWF primarily remain in the intravascular space)
ProteinBinding:
FVIII is highly bound to VWF in plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 12-24 hours
Clearance:
Variable, depends on individual patient factors and baseline levels.
ExcretionRoute:
Not applicable (metabolized proteins)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Within minutes of infusion completion
DurationOfAction:
FVIII activity: 8-24 hours; VWF activity: 12-24 hours (can be longer for VWF due to stabilization of endogenous FVIII)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 or 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, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people experience few or no side effects when taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Upset stomach
Constipation
Dizziness
Fatigue
Weakness
Headache
* Back pain
Reporting Side Effects
This is not an exhaustive list of possible 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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 or 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, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people experience few or no side effects when taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Upset stomach
Constipation
Dizziness
Fatigue
Weakness
Headache
* Back pain
Reporting Side Effects
This is not an exhaustive list of possible 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 an allergic reaction: hives, rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing, wheezing, dizziness, fainting, chest tightness.
- Signs of a blood clot: pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath; chest pain.
- Signs of inhibitor development (if treatment becomes less effective): increased frequency or severity of bleeding episodes, bleeding that does not respond to usual doses.
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.
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
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 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.
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
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 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. Regular blood tests and laboratory checks 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 dose 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 is a component of blood. Although it is screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease. Consult with your doctor to discuss this risk.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication. It is crucial to have enough medication to last throughout your trip.
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 dose 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 is a component of blood. Although it is screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease. Consult with your doctor to discuss this risk.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication. It is crucial to have enough medication to last throughout your trip.
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 overdose is unlikely to cause severe harm, very high levels of FVIII and VWF 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
Monitoring
Baseline Monitoring
Baseline FVIII:C activity
Rationale: To determine the severity of Hemophilia A and guide initial dosing.
Timing: Prior to first dose or initiation of therapy.
Baseline VWF:RCo activity
Rationale: To determine the severity and type of VWD and guide initial dosing.
Timing: Prior to first dose or initiation of therapy.
Baseline FVIII inhibitor screen (Bethesda assay)
Rationale: To detect pre-existing FVIII inhibitors, which can render treatment ineffective.
Timing: Prior to first dose, especially in previously untreated patients or those with a history of poor response.
Viral marker testing (e.g., HIV, HBV, HCV)
Rationale: Although highly purified, plasma-derived products carry a theoretical risk of viral transmission. Baseline testing is important for patient monitoring.
Timing: Prior to initiation of long-term therapy.
Routine Monitoring
FVIII:C activity levels
Frequency: Before and after initial dose, then as clinically indicated (e.g., before subsequent doses, during major bleeding/surgery).
Target: Depends on indication (e.g., 80-100% for major bleeding, 30-50% for minor, 1-5% for prophylaxis trough).
Action Threshold: Adjust dose or frequency if levels are below target or clinical response is inadequate.
VWF:RCo activity levels
Frequency: Before and after initial dose, then as clinically indicated (e.g., before subsequent doses, during major bleeding/surgery).
Target: Depends on indication (e.g., >50% for major bleeding/surgery, >30% for minor).
Action Threshold: Adjust dose or frequency if levels are below target or clinical response is inadequate.
Clinical response (cessation of bleeding, wound healing)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: If bleeding persists or recurs, investigate for inhibitor development or inadequate dosing.
FVIII inhibitor testing (Bethesda assay)
Frequency: Regularly (e.g., every 3-6 months or annually) in Hemophilia A patients, or if there is a lack of clinical response to treatment.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitor titer is significant, consider alternative treatments (e.g., bypassing agents).
Signs of allergic/anaphylactic reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately, provide supportive care.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, hematuria, melena, joint pain/swelling)
- Signs of allergic reaction (e.g., rash, urticaria, pruritus, dyspnea, wheezing, chest tightness, facial swelling, hypotension)
- Signs of thrombosis (e.g., pain, swelling, redness in a limb, shortness of breath, chest pain)
- Headache, fever, chills, nausea, vomiting (infusion-related reactions)
Special Patient Groups
Pregnancy
Use during pregnancy only if clearly needed. Animal reproduction studies have not been conducted. Human data are limited. The decision to use should weigh the potential benefits against the potential risks to the fetus. Hemostatic management is critical during pregnancy and delivery for women with bleeding disorders.
Trimester-Specific Risks:
First Trimester:
Risk unknown, but generally considered low for protein products. Benefits of preventing hemorrhage likely outweigh theoretical risks.
Second Trimester:
Risk unknown, but generally considered low for protein products. Benefits of preventing hemorrhage likely outweigh theoretical risks.
Third Trimester:
Risk unknown, but generally considered low for protein products. Benefits of preventing hemorrhage during delivery likely outweigh theoretical risks.
Lactation
It is not known whether Alphanate is excreted in human milk. However, as a large protein, it is unlikely to be transferred into breast milk in significant amounts or to be orally absorbed by the infant. Use with caution. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Alphanate is widely used and effective in pediatric patients with Hemophilia A and VWD. Dosing is weight-based and individualized. Close monitoring of FVIII and VWF activity levels is crucial. Inhibitor development is a significant concern in previously untreated Hemophilia A children.
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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. No specific dose adjustments are typically required based solely on age, but comorbidities and increased risk of thrombosis should be considered.
Clinical Information
Clinical Pearls
- Alphanate contains both FVIII and VWF, making it suitable for both Hemophilia A and VWD, particularly VWD types that also require FVIII replacement.
- Dosing is highly individualized and requires careful laboratory monitoring (FVIII:C and VWF:RCo activity) to ensure adequate hemostasis and avoid over-treatment.
- Patients should be educated on the signs of allergic reactions and inhibitor development, and how to manage them.
- For VWD, the VWF component is crucial for primary hemostasis (platelet plug formation) and for stabilizing endogenous FVIII. The FVIII component directly addresses the FVIII deficiency.
- Administer intravenously after reconstitution. Do not mix with other medicinal products.
- Patients should be monitored for signs of thrombosis, especially those with risk factors or receiving high doses.
- Viral safety is high due to purification processes and viral inactivation/removal steps, but patients should still be informed of the theoretical risk of transmission of infectious agents.
Alternative Therapies
- Recombinant Factor VIII (for Hemophilia A, e.g., Advate, Eloctate, Jivi, Hemlibra (emicizumab) - non-factor replacement)
- Recombinant von Willebrand Factor (for VWD, e.g., Vonvendi)
- Other plasma-derived Factor VIII concentrates (for Hemophilia A, e.g., Hemofil M, Koate-DVI)
- Desmopressin (DDAVP) (for mild Hemophilia A and certain types of VWD, stimulates release of endogenous FVIII and VWF)
- Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid) (adjunctive therapy for bleeding control)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per 1000 IU vial. per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for approved indications)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.