Alphanate Vwf Cmplx Human Inj, 1 Vl
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
Jan 1970
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 and prevent bleeding in people with Hemophilia A (a condition where the body doesn't make enough Factor VIII) and von Willebrand Disease (a condition affecting von Willebrand Factor, which helps platelets stick together and protects Factor VIII). By replacing these missing proteins, Alphanate helps your blood clot properly.
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 provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
Before use, this medication must be mixed according to the instructions provided by your doctor. Do not shake the mixture. The solution should be used within 3 hours of preparation. If the solution changes color, 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, protected from light. Store all medications in a safe 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 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 provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Administration
Before use, this medication must be mixed according to the instructions provided by your doctor. Do not shake the mixture. The solution should be used within 3 hours of preparation. If the solution changes color, 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, protected from light. Store all medications in a safe 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 case of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Avoid activities that may increase the risk of bleeding or injury.
- Inform all healthcare providers (including dentists) that you are using this medication.
- Carry identification indicating your bleeding disorder.
- Follow your doctor's instructions for regular infusions, even if you are not currently bleeding, especially for prophylaxis.
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 patient's weight, severity of deficiency, and desired factor levels. Dosing for Hemophilia A and von Willebrand Disease (VWD) differs significantly.
Condition-Specific Dosing:
Hemophilia A (Factor VIII deficiency):
Initial dose: 20-40 IU FVIII/kg body weight, aiming for 40-80% FVIII activity. Subsequent doses and frequency (e.g., every 8-12 hours) depend on clinical response and FVIII levels. For prophylaxis, 25-50 IU FVIII/kg 2-3 times per week.
von Willebrand Disease (VWD):
Initial dose for major bleeding/surgery: 50-80 IU VWF:RCo/kg body weight, aiming for >60% VWF:RCo and >40% FVIII activity. Subsequent doses (e.g., 40-60 IU VWF:RCo/kg every 8-12 hours) depend on clinical response and factor levels. For minor bleeding/procedures: 30-50 IU VWF:RCo/kg.
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 adult dosing principles but adjusted for smaller body mass and potentially different pharmacokinetics.
Child:
Dosing is weight-based and individualized, similar to adult dosing principles.
Adolescent:
Dosing is weight-based and individualized, similar to adult dosing principles.
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 considerations for dose adjustment, as it is a large protein not significantly cleared by dialysis. Monitor factor levels as usual.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Alphanate contains both Factor VIII (FVIII) and von Willebrand Factor (VWF). FVIII is an essential cofactor for Factor IXa in the intrinsic coagulation pathway, accelerating the activation of Factor X to Factor Xa. 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. Administration of Alphanate temporarily replaces the deficient FVIII and/or VWF, restoring hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (immediate effect upon IV administration)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume (FVIII: 0.04-0.06 L/kg; VWF: 0.05-0.08 L/kg)
ProteinBinding:
FVIII is bound to VWF; VWF circulates freely and bound to FVIII.
CnssPenetration:
Limited (does not cross the blood-brain barrier)
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 8-14 hours (individual variability exists)
Clearance:
FVIII: 2.5-5.0 mL/hr/kg; VWF:RCo: 3.0-6.0 mL/hr/kg
ExcretionRoute:
Not applicable (catabolized into amino acids)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Within minutes of infusion completion
DurationOfAction:
Dependent on the half-life of FVIII and VWF, typically 8-24 hours for clinical effect, requiring repeat dosing for sustained hemostasis.
Safety & Warnings
BLACK BOX WARNING
Thrombosis may occur in patients receiving plasma-derived von Willebrand Factor and Factor VIII products, especially in the setting of known risk factors. Monitor for signs and symptoms of thrombosis.
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 notice 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), including:
+ 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 changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Mild stomach upset
Constipation
Dizziness, tiredness, or 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 notice 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), including:
+ 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 changes, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people taking this medication will not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Mild stomach upset
Constipation
Dizziness, tiredness, or 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 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 (thrombosis): pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, sudden vision changes, slurred speech, weakness on one side of the body. Seek immediate medical attention.
- Signs of continued bleeding: new or worsening bruising, prolonged bleeding from cuts, frequent nosebleeds, blood in urine or stool, severe headache, joint pain or swelling. Contact your doctor.
- Fever, chills, headache, nausea, vomiting (may be infusion-related reactions).
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 is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication 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 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 is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication 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 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 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 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 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 a traditional 'overdose' is unlikely, excessively high levels of Factor VIII and VWF can increase the risk of thrombotic events (blood clots).
- Symptoms of thrombosis as listed above.
What to Do:
If an overdose is suspected or factor levels are excessively high, discontinue infusion and monitor for signs of thrombosis. Management is supportive and may involve anticoagulation if a thrombotic event occurs. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII (FVIII:C) activity
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
Rationale: To determine baseline deficiency and guide initial dosing for VWD.
Timing: Prior to first infusion
von Willebrand Factor antigen (VWF:Ag)
Rationale: To determine baseline deficiency for VWD.
Timing: Prior to first infusion
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic status and monitor for bleeding complications.
Timing: Prior to first infusion
Viral markers (e.g., HIV, HCV, HBV)
Rationale: Although highly purified and viral inactivated, as a plasma-derived product, baseline screening is prudent.
Timing: Prior to first infusion (if not recently done)
Routine Monitoring
Factor VIII (FVIII:C) activity
Frequency: Before and after initial dose, then as clinically indicated (e.g., every 12-24 hours) to guide subsequent dosing.
Target: Dependent on indication (e.g., 40-100% for bleeding, >100% for surgery).
Action Threshold: Adjust dose or frequency to maintain desired levels.
von Willebrand Factor ristocetin cofactor (VWF:RCo) activity
Frequency: Before and after initial dose, then as clinically indicated (e.g., every 12-24 hours) to guide subsequent dosing.
Target: Dependent on indication (e.g., >60% for major bleeding/surgery).
Action Threshold: Adjust dose or frequency to maintain desired levels.
Clinical assessment for bleeding
Frequency: Continuously during treatment.
Target: Cessation of bleeding.
Action Threshold: Persistent bleeding requires re-evaluation of dosing or alternative strategies.
Signs and symptoms of hypersensitivity/anaphylaxis
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately, provide supportive care.
Signs and symptoms of thrombosis
Frequency: Regularly, especially in VWD patients or those with risk factors.
Target: Absence of symptoms.
Action Threshold: Investigate and manage suspected thrombotic events.
Symptom Monitoring
- Signs of bleeding (e.g., new bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stool, joint pain/swelling)
- Signs of allergic reaction (e.g., hives, rash, 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, sudden vision changes, slurred speech, weakness on one side of the body)
- Fever, chills, headache (may indicate infusion reaction or viral infection)
Special Patient Groups
Pregnancy
Alphanate is considered Category C. It should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Bleeding disorders can pose significant risks during pregnancy and delivery, and replacement therapy may be necessary.
Trimester-Specific Risks:
First Trimester:
No specific data on first-trimester risks. Use only if clearly indicated.
Second Trimester:
No specific data on second-trimester risks. Use only if clearly indicated.
Third Trimester:
May be used to manage bleeding complications during labor and delivery, or for prophylaxis in the peripartum period, under close medical supervision.
Lactation
Lactation risk is L3 (moderately safe). Human Factor VIII and VWF are endogenous proteins. While there is no specific data on excretion into human milk, it is unlikely to cause harm to the breastfed infant due to its large molecular size and protein nature, which would be digested in the infant's GI tract. Benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
Low risk of adverse effects to the infant.
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 adult dosing principles. Close monitoring of factor levels and clinical response is essential.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. However, elderly patients may have a higher incidence of cardiovascular disease and other comorbidities, which could increase the risk of thrombotic events. Monitor closely for signs of thrombosis.
Clinical Information
Clinical Pearls
- Alphanate contains both Factor VIII and von Willebrand Factor, making it suitable for both Hemophilia A and von Willebrand Disease, unlike some other FVIII products.
- Dosing is highly individualized and requires careful monitoring of factor levels (FVIII:C and VWF:RCo) to achieve desired hemostasis.
- Administer intravenously at a slow rate to minimize infusion-related reactions. Always follow reconstitution instructions carefully.
- Patients should be monitored for signs of hypersensitivity reactions, especially during the initial infusions.
- Due to the risk of thrombosis, particularly in VWD patients, monitor for signs and symptoms of blood clots, especially if high doses or prolonged treatment is required.
- Development of inhibitors (antibodies) to Factor VIII can occur in Hemophilia A patients, leading to treatment failure. Monitor for lack of clinical response.
- As a plasma-derived product, despite viral inactivation steps, patients should be informed of the theoretical risk of viral transmission, though this risk is extremely low with current manufacturing processes.
Alternative Therapies
- Recombinant Factor VIII (e.g., Advate, Eloctate, Jivi, Hemlibra - for Hemophilia A)
- Recombinant von Willebrand Factor (e.g., Vonvendi - for VWD)
- Desmopressin (DDAVP) (for mild to moderate VWD and mild Hemophilia A, by releasing endogenous VWF and FVIII)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid - as adjunctive therapy for bleeding)
Cost & Coverage
Average Cost:
Highly variable, typically thousands to tens of thousands of dollars per vial depending on potency (IU). 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'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.