Adynovate 3000unit Inj, 1 Vial
It is used to treat or prevent bleeding in people with hemophilia.
Drug Class
Antihemophilic agent
Pharmacologic Class
Coagulation factor; Recombinant Factor VIII, pegylated
Pregnancy Category
Not available
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, a condition where blood doesn't clot properly. It works by replacing a missing protein in the blood called Factor VIII, which is essential for clotting. This medicine has been modified to stay in the body longer, so it doesn't need to be given as often as some other Factor VIII products.
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.
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 cloudiness, leakage, or particles before use. If the solution has changed color, do not use it.
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 any other items. Once the disposal box is full, follow local regulations for its 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, but 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.
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 cloudiness, leakage, or particles before use. If the solution has changed color, do not use it.
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 any other items. Once the disposal box is full, follow local regulations for its 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, but do not freeze.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain a regular infusion schedule as prescribed by your doctor.
- Keep a detailed record of all infusions, including dose, date, and time.
- Report any bleeding episodes, even minor ones, to your healthcare provider.
- Avoid activities that carry a high risk of injury or bleeding.
- Wear medical identification (e.g., bracelet) indicating hemophilia A.
- Follow up with your healthcare team regularly for monitoring and management.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Individualized based on Factor VIII levels, bleeding severity, and patient weight. For on-demand treatment of bleeding episodes: 10-50 IU/kg. For routine prophylaxis: 40-50 IU/kg twice weekly or 40-50 IU/kg every 3-4 days.
Dose Range:
10 - 50 mg
Condition-Specific Dosing:
onDemandTreatment:
Initial dose 10-50 IU/kg depending on severity of hemorrhage. Subsequent doses and frequency based on clinical response and Factor VIII levels.
routineProphylaxis:
40-50 IU/kg twice weekly or 40-50 IU/kg every 3-4 days. Dosing interval may be extended up to 7 days based on individual patient response and Factor VIII levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing is similar to adults, individualized based on Factor VIII levels, bleeding severity, and patient weight. For routine prophylaxis: 40-50 IU/kg twice weekly or 40-50 IU/kg every 3-4 days.
Child:
Dosing is similar to adults, individualized based on Factor VIII levels, bleeding severity, and patient weight. For routine prophylaxis: 40-50 IU/kg twice weekly or 40-50 IU/kg every 3-4 days.
Adolescent:
Dosing is similar to adults, individualized based on Factor VIII levels, bleeding severity, and patient weight. For routine prophylaxis: 40-50 IU/kg twice weekly or 40-50 IU/kg every 3-4 days.
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; Factor VIII is a large protein and not removed by dialysis. 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.
Pharmacology
Mechanism of Action
Antihemophilic Factor (Recombinant [Pegylated]) is a recombinant DNA-derived, Factor VIII concentrate. It temporarily replaces the missing coagulation Factor VIII that is needed for effective hemostasis in patients with hemophilia A. The pegylation (covalent attachment of polyethylene glycol) extends the half-life of Factor VIII in circulation.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravenous administration)
Tmax:
Not applicable (IV administration, immediate effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
Binds to von Willebrand factor (vWF)
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life: Approximately 14.5 ± 3.0 hours (range 10.1 to 20.0 hours), which is longer than non-pegylated recombinant Factor VIII.
Clearance:
Approximately 3.4 ± 0.8 mL/hr/kg
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Immediate (upon intravenous administration)
PeakEffect:
Within minutes of administration (peak Factor VIII activity)
DurationOfAction:
Extended due to pegylation, allowing for less frequent dosing (e.g., twice weekly or every 3-4 days for prophylaxis).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
Chest pain
Dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 persist, contact your doctor for advice:
Headache
Upset stomach
Diarrhea
* Irritation at the injection site (if applicable)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
Chest pain
Dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 persist, contact your doctor for advice:
Headache
Upset stomach
Diarrhea
* Irritation at the injection site (if applicable)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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, faintness. Seek immediate medical attention.
- Signs of inhibitor development: increased frequency or severity of bleeding, or if your usual dose of Adynovate doesn't stop bleeding as expected. Report to your doctor.
- Signs of blood clots (rare): pain, swelling, warmth, redness in a limb; shortness of breath; chest pain. Seek immediate medical attention.
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 potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All of your health problems, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
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 potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
All of your health problems, as they may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
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, as this may indicate that your current dose 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 to discuss the potential benefits and risks of this medication to both you and your baby.
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, as this may indicate that your current dose 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 to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported with Factor VIII products. Very high doses could theoretically increase the risk of thrombotic events, but this is rare.
What to Do:
In case of suspected overdose, contact your healthcare provider or emergency services. Management is supportive. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Monitoring
Baseline Monitoring
Factor VIII activity levels
Rationale: To determine baseline Factor VIII deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Inhibitor (neutralizing antibody) levels
Rationale: To detect the presence of Factor VIII inhibitors, which can render treatment ineffective. Patients with hemophilia A may develop inhibitors.
Timing: Prior to initiation of therapy and periodically thereafter.
Routine Monitoring
Factor VIII activity levels
Frequency: Periodically, especially during dose adjustments, before and after surgery, or if clinical response is inadequate.
Target: Target levels vary based on clinical situation (e.g., 80-120% for major surgery, 30-60% for minor bleeding).
Action Threshold: Adjust dose or frequency if levels are outside target range or if bleeding is not controlled.
Clinical response (cessation of bleeding, absence of new bleeding episodes)
Frequency: Continuously during treatment.
Target: Resolution of bleeding symptoms.
Action Threshold: If bleeding persists or recurs, consider increasing dose, shortening dosing interval, or checking for inhibitors.
Inhibitor (neutralizing antibody) levels
Frequency: Regularly (e.g., every 3-6 months) or if there is an unexpected lack of clinical response to treatment.
Target: Negative or low titer.
Action Threshold: If inhibitors develop or titers increase, consider alternative treatments (e.g., bypassing agents) or immune tolerance induction.
Signs of hypersensitivity/allergic reactions
Frequency: During and immediately after infusion.
Target: Absence of symptoms.
Action Threshold: Stop infusion immediately if symptoms occur and provide appropriate medical management.
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, tightness in chest, wheezing, dizziness, faintness)
- Signs of inhibitor development (e.g., increased frequency or severity of bleeding, poor response to Factor VIII treatment)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Adynovate in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Factor VIII is a normal component of human plasma, and replacement therapy is generally considered safe for the mother.
Trimester-Specific Risks:
First Trimester:
Risk unknown. Factor VIII is a large protein and unlikely to cross the placenta in significant amounts.
Second Trimester:
Risk unknown. Factor VIII is a large protein and unlikely to cross the placenta in significant amounts.
Third Trimester:
Risk unknown. Factor VIII is a large protein and unlikely to cross the placenta in significant amounts.
Lactation
It is not known whether Adynovate is excreted in human milk. Factor VIII is a large protein and unlikely to be excreted into breast milk in clinically significant amounts. The developmental and health benefits of breastfeeding should be considered 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.
Infant Risk:
Low risk. Large protein unlikely to be absorbed orally by the infant.
Pediatric Use
Adynovate is approved for use in pediatric patients, including neonates, infants, children, and adolescents with hemophilia A. Dosing is individualized based on weight, Factor VIII levels, and clinical response. Pharmacokinetic studies in pediatric patients show similar half-life to adults.
Geriatric Use
Clinical studies of Adynovate 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 based on age, but monitor Factor VIII levels and clinical response.
Clinical Information
Clinical Pearls
- Adynovate is a pegylated Factor VIII product, offering an extended half-life compared to standard recombinant Factor VIII, allowing for less frequent infusions for prophylaxis.
- Dosing is highly individualized; regular monitoring of Factor VIII activity levels is crucial to ensure adequate hemostasis and optimize prophylaxis.
- Patients should be educated on the signs of allergic reactions and inhibitor development, and instructed to seek immediate medical attention if these occur.
- Proper aseptic technique is critical during preparation and administration to prevent infection.
- Always check the expiration date and storage conditions before use. Do not freeze the diluent.
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)
- Bypassing agents (e.g., FEIBA, NovoSeven RT) for patients with inhibitors
- Emicizumab (Hemlibra) - a bispecific antibody that mimics Factor VIIIa, used for prophylaxis in patients with or without inhibitors.
Cost & Coverage
Average Cost:
Extremely high (e.g., tens of thousands to hundreds of thousands USD per year depending on dosing) per 3000 IU vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered by major medical and pharmacy benefit plans for hemophilia A)
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 overdose, including the medication taken, the amount, and the time it occurred.