Patient Medication Information: uses, side effects, how to take - Adynovate
What is ADYNOVATE used for?
- To prevent and control bleeding in patients with hemophilia A.
- To prevent or reduce the number of bleeding episodes when used regularly (prophylaxis).
- Perioperative management.
ADYNOVATE is not used to treat von Willebrand disease.
How does ADYNOVATE work?
ADYNOVATE is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. ADYNOVATE raises the level of Factor VIII in the blood, to support the treatment or prevention of bleeding. ADYNOVATE is the extended half-life Factor VIII built on ADVATE.
What are the ingredients in ADYNOVATE?
Medicinal ingredients
- PEGylated recombinant human FVIII
Non-medicinal ingredients
- Calcium Chloride x 2 H2O
- Glutathione
- Histidine
- Mannitol
- Polysorbate 80
- Sodium Chloride
- Trehalose dehydrate
- Tris(hydroxymethyl)-aminomethan
ADYNOVATE comes in the following dosage forms:
Lyophilized Powder for Intravenous Injection 250, 500, 750, 1000, 1500, 2000 or 3000 IU/vial. Each strength is supplied with 5 mL sterile Water for Injection (USP, Ph.Eur.) for reconstitution. 250, 500, 750, 1000 and 1500 IU/vial also available with 2 mL sterile Water for Injection (USP, Ph. Eur.) for reconstitution.
Do not use ADYNOVATE if:
- Are allergic to mice or hamster protein
- Are allergic to any ingredients in ADYNOVATE or ADVATE
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ADYNOVATE. Talk about any health conditions or problems you may have, including if you:
- Have or have had any medical problems.
- Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
- Have any allergies, including allergies to mice or hamster protein.
Are breastfeeding. It is not known if ADYNOVATE passes into your milk and if it
can harm your baby.
Are pregnant or planning to become pregnant. It is not known if ADYNOVATE may
harm your unborn baby.
- Have been told that you have inhibitors to Factor VIII.
Other warnings you should know about:
Your body may form inhibitors to Factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ADYNOVATE:
There are no known interactions of ADYNOVATE with other medications.
How to take ADYNOVATE:
ADYNOVATE is given directly into the bloodstream.
You may infuse ADYNOVATE at a hemophilia treatment center, at your healthcare provider’s office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia A learn to infuse their ADYNOVATE by themselves or with the help of a family member.
Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any ADYNOVATE left in the vial at the end of your infusion as directed by your healthcare professional.
You may have to have blood tests done after getting ADYNOVATE to be sure that your blood level of Factor VIII is high enough to clot your blood.
Call your healthcare provider right away if your bleeding does not stop after taking ADYNOVATE.
Administration
Preparation and Reconstitution
Reconstitution Concentration
| Vial Size | Volume of Diluent to be Added to Vial | Approximate Available Volume | Concentration per mL |
| 2 mL (250 IU) | 2 mL | 2 mL | 125 IU |
| 2 mL (500 IU) | 2 mL | 2 mL | 250 IU |
| 2 mL (750 IU) | 2 mL | 2 mL | 375 IU |
| 2 mL (1000 IU) | 2 mL | 2 mL | 500 IU |
| 2 mL (1500 IU) | 2 mL | 2 mL | 750 IU |
| 5 mL (250 IU) | 5 mL | 5 mL | 50 IU |
| 5 mL (500 IU) | 5 mL | 5 mL | 100 IU |
| 5 mL (750 IU) | 5 mL | 5 mL | 150 IU |
| 5 mL (1000 IU) | 5 mL | 5 mL | 200 IU |
| 5 mL (1500 IU) | 5 mL | 5 mL | 300 IU |
| 5 mL (2000 IU) | 5 mL | 5 mL | 400 IU |
| 5 mL (3000 IU) | 5 mL | 5 mL | 600 IU |
- 1. Use aseptic technique (clean and germ free) and a flat work surface during the reconstitution procedure.
- 2. Allow the vials of ADYNOVATE and diluent to reach room temperature before use.
- 3. Remove plastic caps from the ADYNOVATE and diluent vials.
- 4.
Cleanse rubber stoppers with an alcohol wipe and allow drying prior to use.
- 5. Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside (Figure A). Do not remove the device from the package.
- 6. Turn the package over. Press straight down to fully insert the clear plastic spike through the diluent vial stopper (Figure B).
- 7. Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C). Do not remove the blue cap from the BAXJECT II Hi-Flow device. Do not touch the exposed purple plastic spike.
- 8.
Turn the system over so that the diluent vial is on top. Quickly insert the purple plastic spike fully into the ADYNOVATE vial stopper by pushing straight down
(Figure D). The vacuum will draw the diluent into the ADYNOVATE vial.
- 9. Swirl gently until ADYNOVATE is completely dissolved. Do not refrigerate after reconstitution.
Administration
Visually inspect the reconstituted ADYNOVATE solution for particulate matter and discoloration prior to administration.
- The appearance of ADYNOVATE is clear and colorless.
- Do not use if particulate matter or discoloration is observed.
- Administer ADYNOVATE as soon as possible, but no later than 3 hours after reconstitution.
Administration Steps:
- 1.
Remove the blue cap from the BAXJECT II Hi-Flow device. Connect the syringe to the BAXJECT II Hi-Flow device (Figure E). Use of a Luer-lock syringe is recommended.
Do not inject air.
- 2. Turn the system upside down (ADYNOVATE vial now on top). Draw the factor concentrate into the syringe by pulling the plunger back slowly (Figure F).
- 3.
Disconnect the syringe; attach a suitable needle and inject intravenously as instructed under Administration by Bolus Infusion. If a patient is to receive more than one vial of ADYNOVATE, the contents of multiple vials may be drawn into the same syringe.
A BAXJECT II Hi-Flow device is required to reconstitute of each vial of ADYNOVATE and diluent needed.
- 4. Administer ADYNOVATE over a period of less than or equal to 5 minutes (maximum infusion rate 10 mL per min).
| Figure A | Figure B | Figure C |
|---|---|---|
 |  |  |
| Figure D | Figure E | Figure F |
 |  |  |
Usual dose:
Your ADYNOVATE regimen will be individualized to meet your needs. Your healthcare provider will tell you how much ADYNOVATE to use based on your individual weight, level of physical activity, the severity of your hemophilia A, and where you are bleeding. Your healthcare provider may adjust your dose or frequency to provide you with the levels of FVIII protection that you need.
Your healthcare provider may measure your individual pharmacokinetics to confirm or adjust your ADYNOVATE regimen.
Overdose:
The effects of higher than recommended doses of ADYNOVATE have not been characterized.
| If you think you, or a person you are caring for, have taken too much ADYNOVATE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
Talk to your doctor if you have missed a dose.
What are possible side effects from using ADYNOVATE?
These are not all the possible side effects you may have when taking ADYNOVATE. If you experience any side effects not listed here, tell your healthcare professional.
You can have an allergic reaction to ADYNOVATE.
Your healthcare provider may monitor you for an increase in some white blood cells (shown in a blood test).
Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting, redness of the eye, adverse reaction of the skin or an infusion reaction.
The common side effects of ADYNOVATE are headache, diarrhea, nausea, dizziness and rash. Tell your healthcare provider about any side effects that bother you or do not go away.
These are not all the possible side effects you may feel when taking ADYNOVATE. If you experience any side effects not listed here, contact your healthcare professional. Please also see 7 WARNINGS AND PRECAUTIONS.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Powder form (prior to reconstitution):
|
freeze.
|
Reconstituted (mixed) product:
- See Administration instructions above.
- Reconstitute ADYNOVATE with 2 mL or 5 mL Sterile Water for Injection. Use within 3 hours after reconstitution.
Do not use product:
- After the expiration date printed on the carton or vial.
- If powder stored at room temperature for more than 3 months.
- If reconstituted for more than 3 hours.
Keep out of reach and sight of children. Dispose of ADYNOVATE and administration components in accordance with local and provincial laws.
If you want more information about ADYNOVATE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.takeda.com/en-ca, or by calling 1-800-268-2772.
Last Revised: September 19, 2023
ADYNOVATE® is a registered trademark of Baxalta Incorporated.