Adynovate 2000unit 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
Category C
FDA Approved
Nov 2015
DEA Schedule
Not Controlled
Overview
What is this medicine?
Adynovate is a medicine used to treat and prevent bleeding in people with hemophilia A. It works by replacing a missing protein in the blood called Factor VIII, which is needed for blood to clot properly. This version of Factor VIII has been modified to stay in the body longer, meaning fewer injections are needed.
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, do not refrigerate the medication. Use the medication within 3 hours of preparation. Check the solution for any visible particles, cloudiness, or leakage, and do not use it if you notice any of these issues. Also, do not use the medication if the solution has changed color. Dispose of any unused portion of the opened vial after use.
Disposal of Needles and Sharps
Dispose of used 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 of This Medication
Store unopened vials in the refrigerator, but do not freeze. 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, do not refrigerate the medication. Use the medication within 3 hours of preparation. Check the solution for any visible particles, cloudiness, or leakage, and do not use it if you notice any of these issues. Also, do not use the medication if the solution has changed color. Dispose of any unused portion of the opened vial after use.
Disposal of Needles and Sharps
Dispose of used 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 of This Medication
Store unopened vials in the refrigerator, but do not freeze. If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain a regular treatment schedule as prescribed by your doctor.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical alert identification indicating hemophilia A.
- Report any new or unusual bleeding episodes to your healthcare provider immediately.
- Learn proper self-administration techniques if applicable.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII levels, type of bleeding, and patient's clinical condition. For on-demand treatment of bleeding episodes: 20-40 IU/kg. For routine prophylaxis: 40-50 IU/kg twice weekly.
Dose Range:
20 - 50 mg
Condition-Specific Dosing:
onDemandBleeding:
20-40 IU/kg IV
routineProphylaxis:
40-50 IU/kg IV twice weekly
surgicalProphylaxis:
Pre-operative dose to achieve target FVIII level, then maintenance doses as needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing individualized based on Factor VIII levels and clinical response. Generally similar weight-based dosing as older children.
Child:
Dosing individualized based on Factor VIII levels and clinical response. For routine prophylaxis: 40-50 IU/kg IV twice weekly. For on-demand treatment: 20-40 IU/kg IV.
Adolescent:
Dosing individualized based on Factor VIII levels and clinical response. For routine prophylaxis: 40-50 IU/kg IV twice weekly. For on-demand treatment: 20-40 IU/kg IV.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment needed; monitor Factor VIII levels as clinically indicated.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant [Pegylated]) is a recombinant DNA-derived, Factor VIII concentrate. It temporarily replaces the deficient coagulation Factor VIII that is needed for effective hemostasis in patients with hemophilia A. The pegylation extends its half-life in circulation.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.05-0.07 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 14.5-19 hours (extended due to pegylation)
Clearance:
Approximately 2.5-3.5 mL/hr/kg
ExcretionRoute:
Primarily via proteolytic degradation; no specific excretion route
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate
PeakEffect:
Within minutes of administration
DurationOfAction:
Extended due to pegylation, allowing for less frequent dosing (e.g., twice weekly prophylaxis). Duration of hemostatic effect depends on baseline FVIII levels, dose, and bleeding severity.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor or seek medical attention immediately. Although rare, some people may have serious and potentially life-threatening reactions to this medication. Be aware of the following signs and symptoms:
Allergic reactions, which may include:
+ 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 have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Headache
Upset stomach
Diarrhea
* 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. Your doctor can provide medical advice on managing side effects.
If you experience any of the following severe side effects, contact your doctor or seek medical attention immediately. Although rare, some people may have serious and potentially life-threatening reactions to this medication. Be aware of the following signs and symptoms:
Allergic reactions, which may include:
+ 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 have mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Headache
Upset stomach
Diarrhea
* 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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness, fainting.
- Signs of inhibitor development: increased bleeding, bleeding that doesn't respond to treatment, or requiring higher doses to control bleeding.
- Signs of thrombosis (rare): pain, swelling, warmth, or redness in a limb; sudden chest pain; shortness of breath; sudden vision changes.
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.
If you have an allergy to hamster or mouse protein, as this may be relevant to your treatment.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all of your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Avoid starting, stopping, or changing 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.
If you have an allergy to hamster or mouse protein, as this may be relevant to your treatment.
Any other medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
All of your health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to:
Discuss all of your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
Avoid starting, stopping, or changing 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 other laboratory evaluations should be performed 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 dose is not effective, and your doctor may need to adjust your treatment.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, and your doctor will help you make an informed decision.
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 dose is not effective, and your doctor may need to adjust your treatment.
Before traveling, consult with your doctor to ensure you have an adequate supply of this medication to last throughout your trip.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby, and your doctor will help you make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose are known for Factor VIII products other than potential for thrombotic events if extremely high levels are maintained, which is rare in hemophilia A patients.
What to Do:
In case of suspected overdose, contact a healthcare professional or poison control center immediately. Management is supportive and based on clinical presentation. Monitor for signs of thrombosis. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy
Inhibitor (neutralizing antibody) screen
Rationale: To detect pre-existing inhibitors to Factor VIII, which can impact efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Factor VIII activity levels
Frequency: Regularly, especially during dose adjustments, before and after surgery, or if bleeding is not controlled.
Target: Depends on clinical situation (e.g., >1% for prophylaxis, higher for bleeding/surgery).
Action Threshold: If levels are not therapeutic or bleeding persists, adjust dose or investigate for inhibitors.
Inhibitor (neutralizing antibody) screen
Frequency: Regularly (e.g., every 3-6 months, or more frequently in high-risk patients like previously untreated patients [PUPs]), or if expected clinical response is not achieved.
Target: Negative
Action Threshold: If inhibitors develop, consider alternative treatments or immune tolerance induction.
Signs and symptoms of allergic reactions
Frequency: During and after each infusion
Target: Absence of symptoms
Action Threshold: Stop infusion immediately if symptoms occur; manage symptomatically.
Symptom Monitoring
- Signs of bleeding (e.g., joint pain/swelling, bruising, prolonged bleeding from cuts, nosebleeds, blood in urine/stools)
- Signs of allergic reaction (e.g., rash, hives, itching, facial swelling, shortness of breath, chest tightness, dizziness)
- Signs of thrombosis (rare, but possible with high FVIII levels or predisposing factors)
Special Patient Groups
Pregnancy
Use only if clearly needed. Factor VIII does not cross the placenta in significant amounts. Hemophilia A in pregnant women is rare, but treatment may be necessary to manage bleeding complications during pregnancy and delivery. Monitor Factor VIII levels closely.
Trimester-Specific Risks:
First Trimester:
No specific risks identified beyond general pregnancy considerations.
Second Trimester:
No specific risks identified.
Third Trimester:
May be used to manage bleeding risk during labor and delivery; monitor Factor VIII levels.
Lactation
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Adynovate and any potential adverse effects on the breastfed infant from Adynovate or from the underlying maternal condition. Factor VIII is a large protein and is unlikely to be excreted into breast milk in significant amounts or absorbed orally by the infant.
Infant Risk:
Low risk
Pediatric Use
Adynovate is approved for use in pediatric patients, including neonates, infants, children, and adolescents. Dosing is individualized based on weight and Factor VIII levels. Safety and efficacy have been demonstrated in pediatric clinical trials.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dosing should be individualized based on Factor VIII levels and clinical response, similar to younger adults. No specific dose adjustment is generally required based on age alone.
Clinical Information
Clinical Pearls
- Adynovate is a pegylated Factor VIII product, offering an extended half-life compared to conventional Factor VIII products, allowing for less frequent prophylactic dosing (e.g., twice weekly).
- Proper reconstitution and administration technique are crucial. Ensure the product is at room temperature before reconstitution.
- Patients should be educated on the signs and symptoms of allergic reactions and inhibitor development.
- Regular monitoring of Factor VIII activity levels is essential to ensure therapeutic efficacy and guide dosing, especially during periods of increased bleeding or surgery.
- Patients should carry medical identification indicating their hemophilia A and treatment regimen.
Alternative Therapies
- Other recombinant Factor VIII products (e.g., Advate, Eloctate, Jivi, Nuwiq, Recombinate, Xyntha)
- Plasma-derived Factor VIII products (e.g., Humate-P, Alphanate)
- Emicizumab (Hemlibra) - a bispecific antibody mimicking Factor VIIIa, for patients with or without inhibitors
- Gene therapy for hemophilia A (e.g., Roctavian)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors
Cost & Coverage
Average Cost:
Extremely high (e.g., thousands to tens of thousands of USD per vial depending on unit strength) 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 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.