Esperoct 500unit Inj 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic Agent
Pharmacologic Class
Coagulation Factor VIII (Recombinant, Pegylated)
Pregnancy Category
Not available
FDA Approved
Feb 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Esperoct is a medicine used to treat and prevent bleeding in people with hemophilia A. Hemophilia A is a genetic bleeding disorder where the blood does not clot properly because of a missing or low amount of a protein called Factor VIII. Esperoct replaces this missing protein, helping your blood to clot and stop bleeding.
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 injection into a vein. 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.
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. You can warm it to room temperature by holding the vial in your hands until it feels as warm as your body temperature.
Before use, this medication must be mixed according to the instructions provided by your doctor. Avoid shaking the vial. After mixing, use the medication within 4 hours if stored at room temperature. If necessary, the mixture can be stored in the refrigerator for up to 24 hours. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Also, do not use the medication if the solution has changed color.
After using the medication, discard any remaining balance 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 Disposal
Store unopened vials of this medication in the refrigerator. Do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an injection into a vein. 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.
If the medication has been stored in the refrigerator, allow it to reach room temperature before mixing. Do not heat the medication. You can warm it to room temperature by holding the vial in your hands until it feels as warm as your body temperature.
Before use, this medication must be mixed according to the instructions provided by your doctor. Avoid shaking the vial. After mixing, use the medication within 4 hours if stored at room temperature. If necessary, the mixture can be stored in the refrigerator for up to 24 hours. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Also, do not use the medication if the solution has changed color.
After using the medication, discard any remaining balance 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 Disposal
Store unopened vials of this medication in the refrigerator. Do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Follow your prescribed dosing schedule carefully, even if you feel well.
- Learn how to self-infuse if recommended by your healthcare provider.
- Keep a detailed record of all infusions, including date, time, dose, and reason for infusion (prophylaxis or bleed treatment).
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical identification (e.g., bracelet) indicating you have hemophilia A.
- Discuss any planned surgeries or dental procedures with your healthcare team in advance.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Prophylaxis: 50 units/kg intravenously every 4 days or 60 units/kg intravenously twice weekly. On-demand treatment: 20-50 units/kg intravenously depending on bleed severity.
Dose Range:
20 - 60 mg
Condition-Specific Dosing:
prophylaxis:
50 units/kg IV every 4 days or 60 units/kg IV twice weekly
on_demand_minor_bleed:
20-30 units/kg IV
on_demand_moderate_bleed:
30-40 units/kg IV
on_demand_major_bleed:
40-50 units/kg IV
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing based on weight and clinical response, similar to older children and adults. Prophylaxis: 50 units/kg IV every 4 days or 60 units/kg IV twice weekly.
Child:
Dosing based on weight and clinical response, similar to adults. Prophylaxis: 50 units/kg IV every 4 days or 60 units/kg IV twice weekly.
Adolescent:
Dosing based on weight and clinical response, similar to adults. Prophylaxis: 50 units/kg IV every 4 days or 60 units/kg IV twice weekly.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific recommendations; monitor Factor VIII levels and clinical response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Confidence:
High
Pharmacology
Mechanism of Action
Turoctocog alfa pegol is a recombinant coagulation Factor VIII (FVIII) that temporarily replaces the missing coagulation FVIII needed for effective hemostasis in patients with hemophilia A. FVIII is an essential cofactor for activated Factor IX (FIXa) in the activation of Factor X (FX) to Factor Xa (FXa). FXa, in turn, converts prothrombin into thrombin, which then converts fibrinogen into fibrin, leading to clot formation. Pegylation extends the half-life of the molecule.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (intravenous administration)
FoodEffect:
Not applicable (intravenous administration)
Distribution:
Vd:
Approximately 0.05 L/kg (similar to plasma volume)
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 19 hours (terminal half-life)
Clearance:
Approximately 2.6 mL/hr/kg
ExcretionRoute:
Primarily via the reticuloendothelial system after proteolytic degradation.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Within minutes of administration
DurationOfAction:
Extended due to pegylation, allowing for less frequent dosing (up to 4 days for prophylaxis).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, including:
+ 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
Chest pain
Dizziness or fainting
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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, including:
+ 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
Chest pain
Dizziness or fainting
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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other 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: rash, hives, itching, facial swelling, tightness in the chest, wheezing, dizziness, feeling faint. Seek immediate medical attention.
- Signs of inhibitor development: increased bleeding, bleeding that does not stop with your usual dose of Esperoct, or needing more frequent doses.
- Signs of blood clots (rare): pain, swelling, warmth, or redness in an arm or leg; sudden shortness of breath; chest pain.
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.
If you are allergic to hamsters, discuss this with your doctor, as it may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, tell your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or adverse effects.
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.
If you are allergic to hamsters, discuss this with your doctor, as it may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, tell your doctor and pharmacist about:
+ All prescription and over-the-counter (OTC) medications you are taking
+ Any natural products or vitamins you are using
+ Existing health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or adverse effects.
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 other laboratory assessments 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. These symptoms may indicate that your current dosage is not effective.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Regular blood tests and other laboratory assessments 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. These symptoms may indicate that your current dosage is not effective.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication for the duration of your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- While rare, very high Factor VIII levels could theoretically increase the risk of thrombotic events (blood clots).
- Symptoms might include unusual bruising, bleeding, or signs of thrombosis (e.g., chest pain, shortness of breath, swelling/pain in a limb).
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services immediately. Call 1-800-222-1222 (Poison Control). Management would involve close monitoring of Factor VIII levels and clinical signs, and supportive care.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) screening (Bethesda assay)
Rationale: To detect pre-existing inhibitors which can render treatment ineffective.
Timing: Prior to initiation of therapy.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially when adjusting dose, during surgery, or if clinical response is inadequate.
Target: Dependent on clinical situation (e.g., >1% for prophylaxis, higher for bleeding episodes/surgery).
Action Threshold: If levels are unexpectedly low or clinical response is poor, investigate for inhibitors or other issues.
Inhibitor (neutralizing antibody) screening
Frequency: Regularly (e.g., every 3-6 months, or more frequently in high-risk patients like previously untreated patients (PUPs) or if clinical response is poor).
Target: Negative (<0.6 Bethesda Units/mL).
Action Threshold: Positive inhibitor titer requires alternative treatment strategies.
Clinical response (bleeding episodes)
Frequency: Continuously
Target: Reduction or cessation of bleeding.
Action Threshold: Persistent or recurrent bleeding may indicate inadequate dosing, inhibitor development, or other complications.
Symptom Monitoring
- Signs of allergic or hypersensitivity reactions (e.g., rash, hives, itching, facial swelling, tightness in chest, wheezing, dizziness, faintness)
- Signs of inhibitor development (e.g., increased bleeding, lack of response to treatment)
- Signs of thrombotic events (rare, but possible with high FVIII levels or in patients with risk factors)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Esperoct in pregnant women. Animal reproduction studies have not shown evidence of fetal harm. Esperoct should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific data, theoretical risk considered low for a protein product.
Second Trimester:
No specific data, theoretical risk considered low for a protein product.
Third Trimester:
No specific data, theoretical risk considered low for a protein product.
Lactation
It is unknown whether Esperoct is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Esperoct is administered to a nursing woman. However, as a large protein, absorption by the infant is unlikely.
Infant Risk:
Low risk (L3 - no human data, but unlikely to be harmful due to large molecular size and poor oral absorption).
Pediatric Use
Esperoct is approved for use in pediatric patients of all ages. Dosing is weight-based and similar to adults. Close monitoring of Factor VIII levels and inhibitor development is crucial, especially in previously untreated patients (PUPs) who are at higher risk for inhibitor formation.
Geriatric Use
Clinical studies of Esperoct did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustment is recommended for elderly patients, but dosing should be individualized based on Factor VIII levels and clinical response.
Clinical Information
Clinical Pearls
- Esperoct is a pegylated Factor VIII product, offering an extended half-life compared to conventional Factor VIII products, allowing for less frequent prophylactic infusions (e.g., every 4 days or twice weekly).
- Always reconstitute Esperoct according to the manufacturer's instructions, using the provided diluent and administration set.
- Monitor for the development of Factor VIII inhibitors, especially in previously untreated patients (PUPs) or if there is a lack of clinical response to treatment.
- Patients should be educated on the signs and symptoms of allergic reactions and inhibitor development.
- This product does not contain von Willebrand factor, so it is not indicated for von Willebrand disease.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Adynovate, Jivi, Nuwiq, Xyntha)
- Non-Factor VIII replacement therapies for hemophilia A (e.g., Emicizumab [Hemlibra])
- Bypassing agents for patients with inhibitors (e.g., FEIBA, NovoSeven RT)
- Desmopressin (DDAVP) for mild hemophilia A (not for severe hemophilia A or patients with inhibitors)
- Antifibrinolytics (e.g., tranexamic acid, aminocaproic acid) as adjunctive therapy
Cost & Coverage
Average Cost:
Highly variable, typically several thousand to tens of thousands of dollars per vial depending on unit strength and quantity. per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.