Alphanate 1000iu 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
Coagulation Factor
Pharmacologic Class
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Pregnancy Category
Category C
FDA Approved
Aug 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 blood clotting. It is used to treat and prevent bleeding episodes in people with Hemophilia A (a bleeding disorder where the body doesn't make enough Factor VIII) and von Willebrand Disease (a bleeding disorder where the body doesn't make enough von Willebrand Factor or it doesn't work properly). It is given as an injection into a vein.
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.
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 it in its original container, protected from light. Ensure that all medications are stored 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 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.
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 it in its original container, protected from light. Ensure that all medications are stored 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 for guidance.
Lifestyle & Tips
- Always carry a medical alert identification (e.g., bracelet or card) stating your condition and treatment.
- Avoid medications that interfere with blood clotting, such as aspirin or NSAIDs (e.g., ibuprofen, naproxen), unless specifically approved by your doctor.
- Report any new or unusual bleeding, bruising, or signs of an allergic reaction (e.g., hives, itching, swelling, difficulty breathing) to your healthcare provider immediately.
- Follow your prescribed dosing schedule carefully, whether for on-demand treatment or prophylaxis.
- Store the medication as directed (refrigerated or at room temperature, depending on the specific product and preparation instructions) and do not use if expired or if the solution is cloudy or contains particles.
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, patient weight, and the severity/type of bleeding or surgical procedure. Dosing aims to achieve target FVIII and VWF:RCo levels.
Condition-Specific Dosing:
Hemophilia A (on-demand treatment):
Initial dose typically 20-50 IU FVIII/kg to achieve 40-100% FVIII activity. Subsequent doses and frequency based on clinical response and FVIII levels.
Von Willebrand Disease (VWD) (on-demand treatment):
Initial dose typically 40-80 IU VWF:RCo/kg (corresponding to 10-20 IU FVIII/kg) to achieve 80-100% VWF:RCo and FVIII activity. Subsequent doses and frequency based on clinical response and VWF:RCo/FVIII levels.
Surgical Prophylaxis (Hemophilia A):
Pre-operative dose to achieve 80-100% FVIII activity, followed by maintenance doses to keep FVIII >50% for 3-5 days, then >30% for 7-10 days.
Surgical Prophylaxis (VWD):
Pre-operative dose to achieve 80-100% VWF:RCo and FVIII activity, followed by maintenance doses to keep VWF:RCo >50% and FVIII >50% for 3-7 days.
Pediatric Dosing
Neonatal:
Not established, but used in neonates with hemophilia/VWD under specialist guidance, weight-based dosing similar to older children.
Infant:
Dosing is weight-based and individualized, similar principles to adults.
Child:
Dosing is weight-based and individualized, similar principles to adults.
Adolescent:
Dosing is weight-based and individualized, similar principles to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
Not removed by dialysis; no specific adjustment needed.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Alphanate provides exogenous Factor VIII (FVIII) and von Willebrand Factor (VWF), which are essential components of the coagulation cascade. FVIII is a cofactor for Factor IXa in the activation of Factor X, leading to thrombin generation and fibrin clot formation. VWF 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.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
End of infusion
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Primarily confined to the plasma volume (approximately 0.04-0.08 L/kg for FVIII)
ProteinBinding:
FVIII is bound to VWF in plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 10-20 hours; VWF:RCo: 8-12 hours
Clearance:
FVIII: 2.5-6.0 mL/hr/kg; VWF:RCo: 3.0-6.0 mL/hr/kg
ExcretionRoute:
Metabolized and excreted via normal protein catabolism pathways.
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon infusion)
PeakEffect:
End of infusion or shortly thereafter
DurationOfAction:
FVIII activity typically maintained for 8-24 hours; VWF activity for 12-24 hours or longer depending on baseline levels and dose.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 problems, drooping on one side of the face, or blurred vision
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Upset stomach
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 attention 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 problems, drooping on one side of the face, or blurred vision
If you experience any of the following symptoms, which may indicate a blood clot, seek medical help immediately:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Upset stomach
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 allergic reaction: hives, rash, itching, swelling of the face/lips/tongue/throat, difficulty breathing, wheezing, dizziness, fainting, chest tightness, rapid heartbeat.
- Signs of bleeding that is not controlled by treatment: persistent bleeding, new or worsening bruising, joint pain/swelling, blood in urine or stool, severe headache.
- Signs of blood clots (rare but serious): pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath; chest pain; sudden vision changes; slurred speech.
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 this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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 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 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.
As this medication is derived from human plasma, a component of blood, there is a potential 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 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 to make an informed decision.
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.
As this medication is derived from human plasma, a component of blood, there is a potential 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 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 to make an informed decision.
Overdose Information
Overdose Symptoms:
- While acute overdose symptoms are unlikely, 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 would involve close monitoring for signs of thrombosis and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII (FVIII) activity levels
Rationale: To establish baseline and guide initial dosing for Hemophilia A.
Timing: Prior to first infusion.
von Willebrand Factor (VWF:RCo) activity levels
Rationale: To establish baseline and guide initial dosing for von Willebrand Disease.
Timing: Prior to first infusion.
FVIII inhibitor screen (Bethesda assay)
Rationale: To detect pre-existing FVIII inhibitors, which can render treatment ineffective.
Timing: Prior to first infusion, especially in Hemophilia A patients.
Viral markers (HIV, HBV, HCV, Parvovirus B19)
Rationale: Although highly purified, plasma-derived products carry a theoretical risk of viral transmission. Baseline status is important for monitoring.
Timing: Prior to first infusion.
Routine Monitoring
FVIII and/or VWF:RCo activity levels
Frequency: Before and after initial dose, then as clinically indicated (e.g., daily during acute bleeding/surgery, or less frequently for prophylaxis).
Target: Depends on indication (e.g., >50% for moderate bleeding, >80-100% for severe bleeding/surgery).
Action Threshold: Adjust dose or frequency if levels are below target or clinical response is inadequate.
Clinical response (cessation of bleeding, resolution of symptoms)
Frequency: Continuously during treatment.
Target: Resolution of bleeding episode or prevention of bleeding.
Action Threshold: If bleeding persists or recurs, re-evaluate dosing, consider inhibitor development, or other causes.
Signs and symptoms of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion, and for several hours post-infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately if symptoms occur; manage symptomatically (antihistamines, corticosteroids, epinephrine).
FVIII inhibitor screen (Bethesda assay)
Frequency: Periodically (e.g., every 3-6 months or annually) in Hemophilia A patients, or if clinical response to treatment is suboptimal.
Target: <0.6 Bethesda Units (BU)/mL
Action Threshold: If inhibitors develop, consider alternative treatments or immune tolerance induction.
Signs and symptoms of thrombosis
Frequency: Monitor, especially in VWD patients receiving high doses or with other thrombotic risk factors.
Target: Absence of symptoms.
Action Threshold: Investigate and manage suspected thrombotic events immediately.
Symptom Monitoring
- Signs of bleeding (e.g., bruising, petechiae, epistaxis, hematuria, melena, joint pain/swelling)
- Signs of hypersensitivity/allergic reaction (e.g., hives, rash, itching, facial swelling, throat tightness, dyspnea, wheezing, dizziness, hypotension, chest tightness)
- Signs of thrombosis (e.g., pain, swelling, redness in a limb, shortness of breath, chest pain, sudden vision changes, slurred speech)
Special Patient Groups
Pregnancy
Category C. Animal reproduction studies have not been conducted. It is not known whether Alphanate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Alphanate should be given to a pregnant woman only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Potential risks unknown; use only if clearly indicated.
Second Trimester:
Potential risks unknown; use only if clearly indicated.
Third Trimester:
Potential risks unknown; use only if clearly indicated.
Lactation
L3 (Moderately Safe). It is not known whether Alphanate is excreted in human milk. As a large protein, it is unlikely to be secreted in significant amounts into breast milk or to be absorbed orally by the infant. Use with caution, weighing benefits to mother and potential risks to infant.
Infant Risk:
Low risk of adverse effects to the infant due to large molecular size and poor oral bioavailability.
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 patients. Clinical experience supports its use in this population.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on FVIII/VWF levels and clinical response, similar to younger adults. No specific dose adjustments are generally required based on age alone.
Clinical Information
Clinical Pearls
- Dosing of Alphanate is highly individualized and requires careful laboratory monitoring of FVIII and VWF:RCo activity levels to ensure therapeutic efficacy and minimize risks.
- Patients with Hemophilia A, particularly previously untreated patients (PUPs), are at risk for developing FVIII inhibitors (antibodies) which can render treatment ineffective. Regular inhibitor screening is crucial.
- While effective for VWD, high doses or prolonged use of FVIII/VWF products in VWD patients, especially those with other thrombotic risk factors, may increase the risk of thrombosis. Monitor for signs of clotting.
- Administer slowly (e.g., 1-2 mL/min) to minimize the risk of infusion-related reactions, which can include flushing, headache, nausea, and hypersensitivity.
- Alphanate contains both FVIII and VWF, making it suitable for both Hemophilia A and VWD. For VWD, it provides the necessary VWF for platelet adhesion and also stabilizes endogenous FVIII.
Alternative Therapies
- Recombinant Factor VIII products (for Hemophilia A, e.g., Advate, Eloctate, Hemlibra)
- Recombinant von Willebrand Factor products (for VWD, e.g., Vonvendi)
- Desmopressin (DDAVP) (for mild Hemophilia A and Type 1 VWD)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy for bleeding control.
Cost & Coverage
Average Cost:
Very high, varies significantly by strength and supplier per IU
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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.