Wilate Inj 1000iu, 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
Pharmacologic Class
Antihemophilic factor/von Willebrand factor complex (Human)
Pregnancy Category
Not available
FDA Approved
Dec 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Wilate is a medicine that helps your blood clot. It contains two important proteins, Factor VIII and von Willebrand Factor, which are missing or not working properly in people with hemophilia A or von Willebrand disease. By giving you these proteins, Wilate helps 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. If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication, and avoid shaking the vial. The mixed solution should be used within 4 hours. Check the solution for any changes in color or clarity; it should be colorless to faint yellow. Do not use the medication if the solution has changed color, is cloudy, leaking, or contains particles.
Disposal
After administering the injection, discard any remaining medication in 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 or concerns, consult your doctor or pharmacist.
Storage and Handling
Store this medication at room temperature or in the refrigerator. Do not freeze the medication. If stored at room temperature, record the date it was removed from the refrigerator. Discard any unused vials after 6 months or by the expiration date, whichever occurs first.
Missed Dose
If you miss a dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take 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.
Preparation and Administration
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. Do not heat the medication, and avoid shaking the vial. The mixed solution should be used within 4 hours. Check the solution for any changes in color or clarity; it should be colorless to faint yellow. Do not use the medication if the solution has changed color, is cloudy, leaking, or contains particles.
Disposal
After administering the injection, discard any remaining medication in 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 or concerns, consult your doctor or pharmacist.
Storage and Handling
Store this medication at room temperature or in the refrigerator. Do not freeze the medication. If stored at room temperature, record the date it was removed from the refrigerator. Discard any unused vials after 6 months or by the expiration date, whichever occurs first.
Missed Dose
If you miss a dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take 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 your medication and infusion supplies with you.
- Follow your doctor's instructions for dosing and administration carefully.
- Report any bleeding episodes, even minor ones, to your healthcare provider.
- Be aware of and report any signs of allergic reactions (e.g., hives, itching, swelling, difficulty breathing) or blood clots (e.g., chest pain, shortness of breath, leg pain/swelling).
- Avoid activities that carry a high risk of injury or bleeding.
- Consider wearing a medical alert bracelet or carrying an identification card indicating your condition and treatment.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on patient's FVIII and VWF:RCo levels, type of bleeding, and clinical response. For Hemophilia A: 20-50 IU FVIII/kg for on-demand treatment or prophylaxis. For von Willebrand Disease (VWD): 40-80 IU VWF:RCo/kg for on-demand treatment or surgical prophylaxis.
Dose Range:
20 - 80 mg
Condition-Specific Dosing:
Hemophilia A (on-demand):
20-40 IU FVIII/kg
Hemophilia A (prophylaxis):
20-50 IU FVIII/kg 2-3 times per week
VWD (on-demand):
40-80 IU VWF:RCo/kg
VWD (surgical prophylaxis):
40-80 IU VWF:RCo/kg pre-op, then 40-60 IU VWF:RCo/kg every 12-24 hours for 1-3 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is weight-based, similar to adult dosing per kg, individualized based on FVIII/VWF:RCo levels and clinical response.
Child:
Dosing is weight-based, similar to adult dosing per kg, individualized based on FVIII/VWF:RCo levels and clinical response.
Adolescent:
Dosing is weight-based, similar to adult dosing per kg, individualized based on FVIII/VWF:RCo levels and clinical response.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; not removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Wilate is a plasma-derived, highly purified concentrate of human coagulation Factor VIII (FVIII) and von Willebrand Factor (VWF). It replaces the deficient FVIII and VWF in patients with Hemophilia A and von Willebrand Disease (VWD), respectively. FVIII acts as a cofactor for activated Factor IX (FIXa) in the intrinsic coagulation pathway, leading to the activation of Factor X (FX) and subsequent thrombin generation. VWF mediates platelet adhesion to the subendothelium at sites of vascular injury and acts as a carrier protein for FVIII, protecting it from premature degradation and prolonging its half-life in circulation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Not applicable (intravenous administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Primarily confined to the plasma volume; Vd not typically reported for protein concentrates.
ProteinBinding:
VWF binds to FVIII, stabilizing it.
CnssPenetration:
No
Elimination:
HalfLife:
FVIII: 10-19 hours; VWF:RCo: 12-24 hours
Clearance:
Not specifically reported, but cleared via proteolytic degradation.
ExcretionRoute:
Metabolized and eliminated via endogenous protein degradation pathways.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon completion of infusion)
PeakEffect:
Immediate (upon completion of infusion)
DurationOfAction:
Dependent on half-life of FVIII and VWF, and clinical need (e.g., 12-24 hours for VWD, longer for FVIII prophylaxis)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek emergency medical attention:
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
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 do not go away, 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 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 immediately or seek emergency medical attention:
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
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 do not go away, 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 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:
- Hives or rash
- Itching
- Swelling of the face, lips, tongue, or throat
- Chest tightness or difficulty breathing
- Wheezing
- Dizziness or faintness
- Unusual bleeding or bruising
- Chest pain
- Shortness of breath
- Pain, swelling, or redness in an arm or leg (signs of a blood clot)
- Sudden weakness or numbness on one side of the body
- Vision changes or 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests and laboratory checks should be conducted as directed by your doctor to monitor your condition.
If you experience unexplained bruising, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication 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 to assess the potential risks.
This medication is derived from human plasma, which may pose a 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 your doctor to ensure you have an adequate supply of this medication. It is also important to discuss any travel plans with your doctor to receive guidance on managing your condition while away.
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, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
If you experience unexplained bruising, bleeding, or if bleeding does not stop after taking this medication, contact your doctor immediately. This could be an indication 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 to assess the potential risks.
This medication is derived from human plasma, which may pose a 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 your doctor to ensure you have an adequate supply of this medication. It is also important to discuss any travel plans with your doctor to receive guidance on managing your condition while away.
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, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Increased risk of thrombotic events (blood clots)
- Elevated FVIII and VWF levels beyond therapeutic range
What to Do:
In case of suspected overdose, seek immediate medical attention. Management is supportive and may include monitoring for signs of thrombosis. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis confirmation (FVIII activity, VWF:RCo, VWF:Ag, FVIII binding to VWF)
Rationale: To confirm Hemophilia A or von Willebrand Disease and guide initial dosing.
Timing: Prior to initiation of therapy
Viral markers (e.g., HIV, HBV, HCV)
Rationale: Although highly purified, plasma-derived products carry a theoretical risk of viral transmission. Baseline status is important.
Timing: Prior to initiation of therapy
Routine Monitoring
FVIII activity levels
Frequency: Prior to and periodically during treatment, especially for surgical procedures or severe bleeding episodes.
Target: Target levels vary based on indication (e.g., 80-100% for major surgery, 30-50% for minor bleeding).
Action Threshold: Adjust dose if levels are not within target range or if bleeding is not controlled.
VWF:RCo levels
Frequency: Prior to and periodically during treatment, especially for VWD patients.
Target: Target levels vary based on indication (e.g., >50% for minor bleeding, >80% for major surgery).
Action Threshold: Adjust dose if levels are not within target range or if bleeding is not controlled.
Development of FVIII inhibitors (neutralizing antibodies)
Frequency: Periodically, especially in Hemophilia A patients, or if expected FVIII levels are not achieved or bleeding is not controlled.
Target: Negative (no inhibitors)
Action Threshold: If inhibitors develop, consider alternative treatments or immune tolerance induction.
Signs/symptoms of thrombosis
Frequency: Regularly, especially in patients with risk factors for thrombosis.
Target: Absence of thrombotic events
Action Threshold: Discontinue treatment and manage thrombosis if symptoms occur.
Symptom Monitoring
- Signs of allergic or hypersensitivity reactions (e.g., hives, rash, flushing, swelling, chest tightness, dyspnea, wheezing, hypotension)
- Signs of thrombosis (e.g., chest pain, shortness of breath, pain/swelling in a limb, neurological changes)
- Effectiveness in controlling bleeding episodes
Special Patient Groups
Pregnancy
Limited data on Wilate use in pregnant women. Animal reproduction studies have not been conducted. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Hemostatic management during pregnancy and delivery should be individualized.
Trimester-Specific Risks:
First Trimester:
Risk unknown; use only if clearly indicated.
Second Trimester:
Risk unknown; use only if clearly indicated.
Third Trimester:
Risk unknown; use only if clearly indicated. Close monitoring of FVIII and VWF levels is crucial during labor and delivery.
Lactation
It is unknown whether Wilate is excreted in human milk. Endogenous FVIII and VWF are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Wilate and any potential adverse effects on the breastfed infant from Wilate or from the underlying maternal condition. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk; large protein unlikely to be absorbed intact by the infant.
Pediatric Use
Wilate is approved for use in pediatric patients. Dosing is weight-based and individualized based on FVIII and VWF:RCo levels and clinical response. Safety and efficacy profiles are generally similar to adults.
Geriatric Use
No specific dose adjustment is required for elderly 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
- Wilate is a plasma-derived product containing both FVIII and VWF, making it suitable for both Hemophilia A and von Willebrand Disease.
- The FVIII and VWF components are present in a physiological 2:1 ratio, which is beneficial for VWD patients as it provides both the FVIII and VWF needed for hemostasis.
- Dosing must be individualized based on the patient's specific FVIII and VWF:RCo levels, the type and severity of bleeding, and the patient's clinical response.
- Regular monitoring of FVIII activity and VWF:RCo levels is crucial to ensure adequate therapeutic levels and prevent over- or under-dosing.
- Patients should be monitored for the development of FVIII inhibitors, especially those with Hemophilia A, as this can lead to treatment failure.
- While highly purified, plasma-derived products carry a theoretical risk of viral transmission, though modern manufacturing processes significantly reduce this risk.
- Patients with risk factors for thrombosis (e.g., history of DVT, obesity, prolonged immobilization) should be closely monitored for thrombotic events, especially with higher doses or prolonged use.
Alternative Therapies
- Recombinant Factor VIII (for Hemophilia A, e.g., Advate, Eloctate, Hemlibra)
- Desmopressin (DDAVP) (for mild to moderate von Willebrand Disease and mild Hemophilia A)
- Antifibrinolytic agents (e.g., tranexamic acid, aminocaproic acid) (adjunctive therapy for bleeding)
- Cryoprecipitate (contains FVIII and VWF, but less purified and standardized)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of USD per vial depending on strength and quantity. per 1000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for approved indications)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor 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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.