Alphanate 1500iu 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
Antihemophilic Agent; Hemostatic Agent
Pharmacologic Class
Coagulation Factor Replacement; Plasma-derived Factor VIII/von Willebrand Factor Complex
Pregnancy Category
Not formally assigned (Biologic), generally considered low risk when clinically indicated.
FDA Approved
Aug 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 essential for your blood to clot properly. If you have Hemophilia A or von Willebrand Disease, your body doesn't make enough of these proteins, or they don't work correctly. Alphanate replaces these missing proteins, helping your blood clot to stop or prevent bleeding episodes.
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.
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. 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
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
Store this medication at room temperature, avoiding freezing. Keep it 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
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.
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. 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
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
Store this medication at room temperature, avoiding freezing. Keep it 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
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 medical identification (e.g., bracelet, card) stating your condition and treatment.
- Avoid activities that carry a high risk of injury or bleeding.
- Maintain good dental hygiene to prevent gum bleeding.
- Discuss all medications, including over-the-counter drugs and supplements, with your healthcare provider, especially those that affect blood clotting (e.g., aspirin, NSAIDs).
- Learn proper self-administration techniques if you are infusing at home.
- Store the medication as directed (refrigerated, do not freeze) and reconstitute immediately before use.
Available Forms & Alternatives
Available Strengths:
- Alphanate 250iu Vwf/hum Inj 1vl
- Alphanate 500iu Vwf/hum Inj 1 Vl
- Alphanate 1000iu Vwf/hum Inj, 10ml
- Alphanate 1500iu Vwf/hum Inj, 10ml
- Alphanate 2000iu Vwf Human Inj,10ml
- Alphanate 250iu Vwf/hum Inj 1vl
- Alphanate 500iu Vwf/hum Inj 1vl
- Alphanate 1000iu Vwf/hum Inj, 1vl
- Alphanate 1500iu Vwf/hum Inj, 1vl
- Alphanate Vwf Cmplx Human Inj, 1 Vl
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication (Hemophilia A or VWD type), baseline factor levels, target factor levels, and patient weight. Dosing is in International Units (IU) per kilogram (kg).
Condition-Specific Dosing:
Hemophilia A (on-demand treatment):
Target FVIII activity levels: Minor bleeds (e.g., 20-40 IU/dL), Moderate bleeds (e.g., 40-60 IU/dL), Major bleeds/Surgery (e.g., 80-100 IU/dL). Dose calculation: IU = (Desired FVIII increase in IU/dL) x (Body weight in kg) / 2. (Approx. 1 IU/kg raises FVIII by 2 IU/dL). Administer every 8-24 hours as needed.
von Willebrand Disease (VWD) - Type 1, 2A, 2B, 2M, 3:
Initial dose typically 40-80 IU VWF:RCo/kg. Subsequent doses and frequency depend on patient response, VWF:RCo and FVIII levels, and type of bleeding/procedure. Target VWF:RCo and FVIII levels vary by clinical situation (e.g., 50-100 IU/dL for surgery). Administer every 12-24 hours as needed.
Hemophilia A (prophylaxis):
Individualized, typically 25-50 IU/kg 2-3 times per week.
Pediatric Dosing
Neonatal:
Dosing is weight-based and individualized, similar to adults, under close medical supervision.
Infant:
Dosing is weight-based and individualized, similar to adults, under close medical supervision.
Child:
Dosing is weight-based and individualized, similar to adults.
Adolescent:
Dosing is weight-based and individualized, similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required.
Dialysis:
No specific considerations for dose adjustment; not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required.
Pharmacology
Mechanism of Action
Alphanate is a plasma-derived concentrate containing both Factor VIII (FVIII) and von Willebrand Factor (VWF). It replaces the deficient or defective FVIII and VWF in patients with Hemophilia A and von Willebrand Disease, respectively. FVIII is an essential cofactor in the intrinsic coagulation pathway, promoting the conversion of Factor X to Xa. VWF acts as a carrier protein for FVIII, protecting it from proteolytic degradation and localizing it to the site of injury. VWF also mediates platelet adhesion to the subendothelium and platelet aggregation, crucial steps in primary hemostasis.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Immediately at the end of infusion
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately plasma volume (e.g., 0.04-0.06 L/kg for FVIII)
ProteinBinding:
Factor VIII circulates bound to von Willebrand Factor (VWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 10-18 hours; VWF:RCo: 8-14 hours (values can vary based on individual patient and VWD type)
Clearance:
Varies by individual and factor component (e.g., FVIII clearance approx. 2-5 mL/hr/kg)
ExcretionRoute:
Catabolism and cellular uptake
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (at the end of infusion)
DurationOfAction:
Dependent on the half-life of FVIII and VWF, typically 12-24 hours for FVIII activity, longer for VWF effects due to its role in platelet function.
Safety & Warnings
Side Effects
Urgent 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
Blurred vision
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color change, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Mild stomach upset
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.
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
Blurred vision
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color change, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Mild stomach upset
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 bleeding: unusual bruising, prolonged bleeding from minor cuts, nosebleeds that won't stop, blood in urine or stools, severe headache, sudden joint pain or swelling, muscle pain or swelling.
- Signs of allergic reaction: hives, rash, itching, flushing, swelling of the face, lips, tongue, or throat, difficulty breathing, wheezing, chest tightness, dizziness, feeling faint.
- 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.
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 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, including this one.
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 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, including this one.
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, as directed by your doctor, are crucial 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 your doctor to ensure you have an adequate supply of this medication for use during 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 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 your doctor to ensure you have an adequate supply of this medication for use during 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 to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While a conventional overdose is unlikely, excessively high levels of Factor VIII and VWF could theoretically increase the risk of thrombotic events (blood clots).
What to Do:
If you suspect you have received too much medication or experience any unusual symptoms, contact your healthcare provider immediately or call emergency services (e.g., 911 in the US). For general poison control, call 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid): Concomitant use may increase the risk of thrombosis, especially in patients with von Willebrand Disease. Monitor closely.
Monitoring
Baseline Monitoring
Factor VIII (FVIII) activity levels
Rationale: To establish baseline for Hemophilia A and to guide dosing.
Timing: Prior to initiation of therapy.
von Willebrand Factor ristocetin cofactor (VWF:RCo) activity, VWF antigen (VWF:Ag), and FVIII activity levels
Rationale: To establish baseline for von Willebrand Disease and to guide dosing.
Timing: Prior to initiation of therapy.
FVIII inhibitor screen (Bethesda assay)
Rationale: To detect pre-existing FVIII inhibitors in Hemophilia A patients, which can affect treatment efficacy.
Timing: Prior to initiation of therapy, especially in previously untreated patients or those with poor response.
Viral markers (e.g., HIV, HBV, HCV, parvovirus B19)
Rationale: Although highly purified, it is a plasma-derived product. Baseline testing is standard for blood product recipients.
Timing: Prior to initiation of therapy.
Routine Monitoring
FVIII activity levels (Hemophilia A)
Frequency: During treatment of bleeding episodes or surgery, to ensure adequate hemostatic levels. Periodically for prophylaxis.
Target: Dependent on clinical situation (e.g., 80-100 IU/dL for major surgery).
Action Threshold: If levels are below target, consider additional dosing or investigate for inhibitors.
VWF:RCo and FVIII activity levels (VWD)
Frequency: During treatment of bleeding episodes or surgery, to ensure adequate hemostatic levels.
Target: Dependent on clinical situation (e.g., 50-100 IU/dL for surgery).
Action Threshold: If levels are below target, consider additional dosing.
FVIII inhibitor screen
Frequency: Periodically (e.g., every 3-6 months or annually) in Hemophilia A patients, or if there is a diminished clinical response to treatment.
Target: Negative
Action Threshold: Positive inhibitor titer requires specialized management.
Signs and symptoms of allergic/anaphylactic reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms
Action Threshold: Stop infusion immediately and manage symptoms if they occur.
Signs and symptoms of thrombosis (especially in VWD)
Frequency: During and after treatment, particularly with high doses or concomitant antifibrinolytics.
Target: Absence of symptoms
Action Threshold: Investigate immediately if symptoms of thrombosis (e.g., pain, swelling, redness in limb) occur.
Symptom Monitoring
- Signs of bleeding (e.g., new or worsening bruising, prolonged bleeding from cuts, nosebleeds, joint pain/swelling, blood in urine/stools)
- Signs of allergic reaction (e.g., hives, rash, itching, flushing, swelling of face/lips/tongue, difficulty breathing, wheezing, chest tightness, 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)
Special Patient Groups
Pregnancy
Alphanate is generally considered safe and often necessary for pregnant women with Hemophilia A or von Willebrand Disease to manage bleeding risks during pregnancy, labor, and delivery. The decision to use should be based on a careful assessment of the individual's clinical need and the potential risks versus benefits.
Trimester-Specific Risks:
First Trimester:
No specific increased risks identified beyond the general need to manage the underlying bleeding disorder.
Second Trimester:
No specific increased risks identified beyond the general need to manage the underlying bleeding disorder.
Third Trimester:
Crucial for managing bleeding risks during labor and delivery, especially for women with severe VWD or Hemophilia A carriers at risk of bleeding.
Lactation
Alphanate is considered compatible with breastfeeding. Factor VIII and VWF are large proteins and are not expected to be excreted into breast milk in significant amounts that would pose a risk to the nursing infant.
Infant Risk:
Low
Pediatric Use
Alphanate is safe and effective in pediatric patients. Dosing is weight-based and individualized, similar to adults. Close monitoring of factor levels and inhibitor development is crucial, especially in young children with Hemophilia A.
Geriatric Use
No specific dose adjustments are generally required for geriatric patients. However, older patients may have age-related comorbidities (e.g., cardiovascular disease) that could increase the risk of thrombosis, especially with high doses or concomitant antifibrinolytics. Monitor closely for signs of thrombosis.
Clinical Information
Clinical Pearls
- Dosing is highly individualized; regular monitoring of FVIII and VWF:RCo levels is essential to ensure adequate hemostasis and prevent over-treatment.
- Patients with Hemophilia A should be monitored for the development of FVIII inhibitors, especially if they experience a diminished response to treatment.
- For von Willebrand Disease, ensure that both VWF:RCo and FVIII activity levels are adequately maintained, as both are crucial for hemostasis.
- Administer slowly via intravenous infusion as directed; rapid infusion can lead to adverse reactions.
- Reconstitute the lyophilized powder immediately before use with the provided diluent and administer within 3 hours of reconstitution.
- Store the unreconstituted product refrigerated (2-8°C / 36-46°F) and do not freeze. Protect from light.
- Educate patients and caregivers on recognizing signs of bleeding, allergic reactions, and potential thrombotic events.
Alternative Therapies
- For Hemophilia A: Recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Adynovate, Nuwiq, Xyntha), Emicizumab (Hemlibra - for prophylaxis), bypassing agents (e.g., FEIBA, Novoseven RT) for inhibitor patients.
- For von Willebrand Disease: Desmopressin (DDAVP - for Type 1 VWD, mild/moderate), other VWF-containing products (e.g., Wilate, Vonvendi - recombinant VWF).
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on IU content. AWP for 1500 IU vial can range from $1,500 - $3,000+. per vial (e.g., 1500 IU)
Insurance Coverage:
Specialty tier, often requires prior authorization and is covered under medical benefit 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 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 ensure you receive the best possible care.