Wilate Inj, 500iu, 1 Vial
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; Coagulation Factor
Pharmacologic Class
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Pregnancy Category
Category C
FDA Approved
Dec 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Wilate is a medicine made from human plasma that contains two important proteins: Factor VIII and von Willebrand Factor. These proteins are crucial for blood clotting. People with certain bleeding disorders, like hemophilia A or von Willebrand disease, don't have enough of these proteins or they don't work properly. Wilate helps replace these missing proteins to stop or prevent bleeding.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via injection into a vein. If you are responsible for self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
Before use, this medication must be mixed according to the instructions provided by your doctor. If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Avoid heating the medication. Do not shake the vial. The mixed solution should be used within 4 hours of preparation. The solution is colorless to faintly yellow; do not use it if the color changes or if it appears cloudy, is leaking, or contains particles.
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 any other components. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Expiration
Store this medication at room temperature or in the refrigerator, but do not freeze it. If stored at room temperature, note the date it was removed from the refrigerator. Unused vials stored at room temperature should be discarded after 6 months or by the expiration date, whichever occurs first.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at once or extra doses to compensate for the missed dose. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
To ensure safe and effective use, follow your doctor's instructions carefully. Read all accompanying information and adhere to the guidelines provided. This medication is administered via injection into a vein. If you are responsible for self-administering the injection, your doctor or nurse will provide personalized instruction on the proper technique. Before and after handling the medication, wash your hands thoroughly.
Preparation and Handling
Before use, this medication must be mixed according to the instructions provided by your doctor. If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Avoid heating the medication. Do not shake the vial. The mixed solution should be used within 4 hours of preparation. The solution is colorless to faintly yellow; do not use it if the color changes or if it appears cloudy, is leaking, or contains particles.
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 any other components. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Expiration
Store this medication at room temperature or in the refrigerator, but do not freeze it. If stored at room temperature, note the date it was removed from the refrigerator. Unused vials stored at room temperature should be discarded after 6 months or by the expiration date, whichever occurs first.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at once or extra doses to compensate for the missed dose. If you are unsure about what to do in the event of a missed dose, contact your doctor for guidance.
Lifestyle & Tips
- Always carry your medication and supplies, especially when traveling.
- Wear a medical alert bracelet or carry an identification card stating your condition and medication.
- Avoid activities that carry a high risk of injury or bleeding.
- Consult your healthcare provider before taking any new medications, especially over-the-counter drugs like aspirin or NSAIDs (e.g., ibuprofen, naproxen), as they can interfere with blood clotting.
- Maintain good dental hygiene to prevent gum bleeding.
- Follow your prescribed dosing schedule carefully, whether for on-demand treatment or prophylaxis.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient's weight, type and severity of bleeding, and target factor levels. For VWD: Initial dose typically 40-80 IU VWF:RCo/kg. For Hemophilia A: Initial dose typically 20-50 IU FVIII/kg.
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
vonWillebrandDisease_onDemand:
Initial dose 40-80 IU VWF:RCo/kg, subsequent doses as needed to maintain VWF:RCo levels. Administer every 8-24 hours.
vonWillebrandDisease_perioperative:
Pre-operative dose 40-60 IU VWF:RCo/kg, 1-2 hours prior to surgery. Post-operative doses as needed to maintain VWF:RCo levels for 3-7 days.
hemophiliaA_onDemand:
Initial dose 20-50 IU FVIII/kg, subsequent doses as needed to achieve target FVIII levels. Administer every 8-12 hours.
hemophiliaA_prophylaxis:
20-40 IU FVIII/kg 2-3 times per week.
Pediatric Dosing
Neonatal:
Not established, use with extreme caution and expert consultation.
Infant:
Dosing is weight-based, similar to adults (IU/kg), but requires careful monitoring of factor levels and clinical response. Consult specialized guidelines.
Child:
Dosing is weight-based, similar to adults (IU/kg), but requires careful monitoring of factor levels and clinical response. Consult specialized guidelines.
Adolescent:
Dosing is weight-based, similar to adults (IU/kg), typically follows adult guidelines.
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; not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required.
Pharmacology
Mechanism of Action
Wilate is a plasma-derived, high-purity, double virus-inactivated concentrate of human von Willebrand Factor (VWF) and coagulation Factor VIII (FVIII). It replaces the deficient or defective VWF and FVIII in patients with von Willebrand disease (VWD) and hemophilia A, respectively. VWF mediates platelet adhesion and aggregation and serves as a carrier protein for FVIII, protecting it from premature degradation and localizing it to the site of injury. FVIII is an essential cofactor in the intrinsic coagulation pathway, promoting the conversion of Factor X to Factor Xa, which ultimately leads to fibrin clot formation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (after IV infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.04-0.06 L/kg for FVIII; 0.03-0.05 L/kg for VWF:RCo
ProteinBinding:
FVIII binds to VWF; VWF circulates as multimers
CnssPenetration:
Limited
Elimination:
HalfLife:
FVIII: 12-18 hours; VWF:RCo: 10-24 hours
Clearance:
FVIII: 2.5-4.5 mL/hr/kg; VWF:RCo: 2.5-5.0 mL/hr/kg
ExcretionRoute:
Metabolites excreted via renal and fecal routes
Unchanged:
Not applicable (protein catabolism)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (upon completion of infusion)
DurationOfAction:
Dependent on half-life of FVIII and VWF, typically 8-24 hours for clinical effect, longer for sustained factor levels.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of certain infections (parvovirus B19, hepatitis A), such as:
+ Fever or chills
+ Headache
+ Feeling very sleepy
+ Runny nose
+ Rash
+ Joint pain
+ Tiredness
+ Poor appetite
+ Upset stomach or vomiting
+ Diarrhea
+ Stomach pain
+ Yellow skin or eyes
Flushing
Severe dizziness or fainting
Abnormal burning, numbness, or tingling sensations
Stinging
Swelling
Severe 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 serious side effects, and some may only have mild symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Mild stomach upset
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of certain infections (parvovirus B19, hepatitis A), such as:
+ Fever or chills
+ Headache
+ Feeling very sleepy
+ Runny nose
+ Rash
+ Joint pain
+ Tiredness
+ Poor appetite
+ Upset stomach or vomiting
+ Diarrhea
+ Stomach pain
+ Yellow skin or eyes
Flushing
Severe dizziness or fainting
Abnormal burning, numbness, or tingling sensations
Stinging
Swelling
Severe 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 serious side effects, and some may only have mild symptoms. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Mild stomach upset
Constipation
Dizziness, tiredness, or weakness
Headache
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, dizziness, chest tightness, difficulty breathing.
- Signs of a blood clot: pain, swelling, warmth, or redness in an arm or leg; sudden chest pain, shortness of breath, coughing up blood.
- Signs of continued bleeding: persistent bleeding from a cut, nosebleeds that won't stop, unusual bruising, blood in urine or stools, severe headache, joint pain or swelling.
- Fever, chills, fatigue (may indicate viral transmission, though highly unlikely with modern purification methods).
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) medications, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken in conjunction with all your other 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) medications, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, it is vital to verify that this medication can be taken in conjunction with all your other 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 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 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 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 acute overdose is unlikely to cause severe symptoms, very high levels of FVIII and VWF could theoretically increase the risk of thrombotic events (blood clots).
- Symptoms of thrombosis (e.g., chest pain, shortness of breath, pain/swelling in a limb).
What to Do:
In case of suspected overdose or adverse reaction, discontinue infusion immediately and seek emergency medical attention. Call 911 or your local emergency number. For general overdose information, call a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis confirmation (VWD type, Hemophilia A severity)
Rationale: To ensure appropriate indication and guide dosing.
Timing: Prior to initiation of therapy.
Baseline FVIII activity and VWF:RCo levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor screening (FVIII inhibitors, VWF inhibitors)
Rationale: To detect pre-existing inhibitors that may affect treatment efficacy.
Timing: Prior to initiation of therapy.
Blood type (ABO)
Rationale: To assess risk of isohemagglutinin-mediated hemolysis, especially with large or frequent doses in patients with A, B, or AB blood groups.
Timing: Prior to initiation of therapy.
Routine Monitoring
FVIII activity and VWF:RCo levels
Frequency: During acute bleeding episodes or perioperative management: frequently (e.g., every 6-24 hours) to ensure target levels are achieved and maintained. For prophylaxis: periodically to confirm trough levels.
Target: VWD: VWF:RCo >50 IU/dL for minor bleeds, >80-100 IU/dL for major bleeds/surgery. Hemophilia A: FVIII >30-50 IU/dL for minor bleeds, >80-100 IU/dL for major bleeds/surgery.
Action Threshold: Levels below target range indicate need for additional dosing or dose adjustment.
Clinical response (cessation of bleeding, wound healing)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: Persistent or recurrent bleeding indicates inadequate treatment or inhibitor development.
Inhibitor screening (FVIII inhibitors, VWF inhibitors)
Frequency: Periodically (e.g., every 3-6 months or if treatment efficacy decreases).
Target: Negative for inhibitors.
Action Threshold: Positive inhibitor screen requires specialized management.
Signs and symptoms of thrombosis
Frequency: Regularly, especially in patients with risk factors or receiving high doses.
Target: Absence of thrombotic events.
Action Threshold: Presence of thrombotic symptoms requires immediate medical evaluation and management.
Symptom Monitoring
- Signs of allergic reaction (hives, rash, itching, swelling, dizziness, chest tightness, difficulty breathing)
- Signs of bleeding (new or worsening bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools, joint pain/swelling)
- Signs of thrombosis (pain, swelling, redness in a limb; sudden chest pain, shortness of breath)
- Headache
- Nausea
- Paresthesia
Special Patient Groups
Pregnancy
Wilate is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Management of VWD and Hemophilia A during pregnancy and delivery is complex and requires close collaboration between hematologists and obstetricians. Factor levels often increase naturally during pregnancy, but may still require monitoring and factor replacement, especially around delivery.
Trimester-Specific Risks:
First Trimester:
No specific data on first-trimester risks. Use only if clearly needed.
Second Trimester:
No specific data on second-trimester risks. Monitor factor levels.
Third Trimester:
Increased risk of bleeding during delivery. Close monitoring of factor levels and appropriate factor replacement are crucial to prevent postpartum hemorrhage.
Lactation
It is unknown whether Wilate is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Wilate is administered to a nursing woman. The decision to breastfeed should consider the potential benefits of breastfeeding for the infant and the potential benefits of therapy for the mother.
Infant Risk:
Low risk, as it is a human protein that would likely be digested if ingested by the infant. However, specific data are lacking.
Pediatric Use
Wilate is approved for use in pediatric patients. Dosing is weight-based (IU/kg) and adjusted based on clinical response and factor levels. Pediatric patients, especially infants, may have different pharmacokinetic profiles and require careful monitoring.
Geriatric Use
Clinical studies of Wilate 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, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Wilate contains both FVIII and VWF in a physiologically balanced 1:1 ratio, making it suitable for both Hemophilia A and VWD.
- Always reconstitute Wilate according to package insert instructions, using the provided diluent and transfer device. Do not shake the vial.
- Administer intravenously at a rate comfortable for the patient, typically 2-4 mL/minute. Do not exceed 10 mL/minute.
- Monitor for signs of allergic reactions, especially during the initial infusions. Have epinephrine and other supportive measures readily available.
- Regular monitoring of FVIII and VWF:RCo levels is crucial to ensure adequate hemostasis and prevent over-treatment, which could increase thrombosis risk.
- Patients should be educated on self-administration techniques, proper storage, and recognition of adverse effects.
- Inhibitor development is a potential complication, especially in severe Hemophilia A patients. Monitor for decreased efficacy of treatment.
Alternative Therapies
- Recombinant Factor VIII (for Hemophilia A, e.g., Advate, Eloctate, Hemlibra)
- Recombinant von Willebrand Factor (for VWD, e.g., Vonvendi)
- Desmopressin (DDAVP) (for mild VWD and mild Hemophilia A, if responsive)
- Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid) (adjunctive therapy for bleeding episodes)
Cost & Coverage
Average Cost:
Highly variable per IU
Insurance Coverage:
Specialty tier, often requires prior authorization and is covered under medical benefit for specific diagnoses.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about 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.