Patient Medication Information: uses, side effects, how to take - Idelvion
What is IDELVION used for?
IDELVION is a medicine used to treat your Hemophilia B. Hemophilia B is a bleeding disorder passed down from your parents where your blood does not clot normally.
IDELVION can help reduce bleeding and prevent damage to your joints over time. Your healthcare professional may give you IDELVION regularly, or only when needed or before and after surgery or any procedure that might increase the risk of bleeding such as complicated tooth extraction, etc.
How does IDELVION work?
A protein (Factor IX) in your body is missing or does not work well. IDELVION gives a working copy of this protein to help your blood clot and to stop your bleeding. You may need regular injections of IDELVION to prevent or control your bleeding.
What are the ingredients in IDELVION?
Medicinal ingredients: Coagulation Factor IX, Albumin Fusion Protein.
Non-medicinal ingredients: Mannitol, Polysorbate 80, Sucrose, Tri-sodium citrate.
IDELVION comes in the following dosage forms:
IDELVION is available in 5 different strengths as a powder: 250 IU, 500 IU, 1000 IU, 2000 IU, or 3500 IU and supplied with Sterile Water for Injection (Diluent). After mixing with Sterile Water for Injection (reconstitution) the prepared solution will have final concentration as shown in the table below.
| Powder Strength | Sterile Water for Injection (Diluent) Volume | Final Concentration |
|---|---|---|
| 250 IU | 2.5 mL | 100 IU/mL |
| 500 IU | 2.5 mL | 200 IU/mL |
| 1000 IU | 2.5 mL | 400 IU/mL |
| 2000 IU | 5 mL | 400 IU/mL |
| 3500 IU | 5 mL | 700 IU/mL |
The package contains one single-use product vial of IDELVION, one vial of Sterile Water for Injection (Diluent), one Mix2Vial® filter transfer set and an inner carton. The inner carton contains one syringe and one infusion set.
Do not use IDELVION if:
- you are allergic to hamster proteins
- you are allergic to any ingredients in IDELVION
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IDELVION. Talk about any health conditions or problems you may have, including if you:
are pregnant or planning to become pregnant. It is not known if IDELVION may harm your unborn baby.
- are breast-feeding. It is not known if IDELVION passes into the milk and if it can harm your baby.
- had any allergic reactions in the past to this product or to any ingredient in this product.
Other warnings you should know about:
Allergic reactions may occur with IDELVION. Call your healthcare professional right away and stop treatment if you get a rash or hives, have itching, tightness of the chest or throat, difficulty breathing, feeling faint or dizzy (low blood pressure), or feeling sick (nausea).
- Your body’s immune system may prevent IDELVION from working properly by producing inhibitors to Factor IX. Tests are needed to see how much inhibitors you have and if they change over time. If you form inhibitors, your healthcare professional may tell you to stop taking the medicine altogether. If you need a central venous access device (CVAD for injection of IDELVION), the risk of complications including local infections, bacteria in the blood (bacteraemia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
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 IDELVION:
- no known drug interactions
How to take IDELVION:
IDELVION is given directly into the bloodstream (intravenous injection). IDELVION should be administered as directed by your healthcare professional. You or your caregiver should be trained by your healthcare professional on how to give IDELVION.
Home administration of IDELVION
Only give IDELIVON to yourself or your child after you have been taught how to give this product by your or your child’s healthcare professional.
Always follow the specific instructions given by your healthcare professional. The steps listed below are general guidelines for using IDELVION. If you are unsure of the instructions, call your healthcare professional before using IDELVION. Talk to your healthcare professional before traveling. Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container.
Preparing (Reconstitution)
- Prepare IDELVION using a sterile method (aseptic technique) with the Sterile Water for Injection (Diluent) provided in the kit.
- Only use IDELVION that is not expired (expiration date is shown on the vial label and carton).
- You should look at the mixture to make sure there are no visible particles and that the solution is clear or yellow. Do not use if the solution is another colour or if particulate matter is observed.
- IDELVION is for single use only should be used within 4 hours after Sterile Water for Injection (Diluent) is added (it contains no preservatives). Discard vials after use that still contains liquid.
- If a package is opened or damaged, do not use and please contact your healthcare professional.
Administration
- Do not mix IDELVION with other medicines.
- Administer by injecting into a vein (intravenous injection).
- Always work on a clean flat surface and wash your hands before performing the following procedures. Use aseptic technique when administering IDELVION.
- Administer IDELVION at room temperature.
- For injection of IDELVION, the provided administration sets (Mix2Vial® filter transfer sets) are recommended to be used because treatment failure can occur as a consequence of Factor IX adsorption to the material of some other injection equipment.
- Care should be taken that no blood enters the syringe, as a clot may form.
- Record your or your child’s name and batch number of the product after taking or giving the medicine. This is to have a link between you or your child and the batch of the product.
The procedures provided in the table below are general guidelines for the preparation and reconstitution of IDELVION.
| Follow the steps below and use aseptic techniques to administer IDELVION. | |||||
| A | PREPARATION | ||||
Prepare the vials/Mix2Vial® and infusion supplies. Ensure that the Sterile Water for Injection (Diluent) and IDELVION vials are at room temperature. Prepare syringes, infusion sets and other supplies for the administration. | |||||
| B | RECONSTITUTION: follow these steps to reconstitute IDELVION | ||||
| 1 | Clean Stoppers: Remove the flip caps from both vials (IDELVION and diluent). Wipe the rubber stoppers with an antiseptic and allow the rubber stopper to dry. | ||||
| 2 | Open the Mix2Vial® package by peeling away the lid. To maintain sterility, leave the Mix2Vial® set in its clear outer package. |  | |||
| 3 | Prepare Diluent Vial: Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® keeping it in the package. Push the plastic spike at the blue end of the Mix2Vial® set firmly through the centre of the diluent vial stopper. |  | |||
| 4 | Remove the Mix2Vial® packaging: While holding the diluent vial, carefully remove the outer package from the Mix2Vial® set. Make sure that you pull off only the package, not the Mix2Vial® set. |  | |||
| 5 | Transfer Diluent into IDELVION Vial: Place the IDELVION vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® set attached to it and push the plastic spike of the clear end of the Mix2Vial® end firmly through the stopper of the IDELVION vial. The diluent will transfer into the IDELVION vial automatically. |  | |||
| 6 | Dissolve IDELVION: With the diluent and IDELVION vial still attached to the Mix2Vial® set, gently swirl the IDELVION vial to ensure the product is fully dissolved. Do not shake the vial. |  | |
| 7 | Unscrew empty diluent (Blue) vial: With one hand, grip the clear end of the Mix2Vial® set and with the other hand grip the blue end of the Mix2Vial® set and unscrew the set into two pieces. |  | |
| 8 | Load the syringe: Draw air into an empty, sterile syringe. Use the syringe provided with the product. With the IDELVION vial upright, screw the syringe to the Mix2Vial® set. Inject air into the product vial. While keeping the syringe plunger pressed, invert the IDELVION vial and draw the solution into the syringe by pulling the plunger back slowly. |  | |
| 9 | Prepare the administration set equipped with microbore tubing: Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial® set. Attach the syringe to the provided infusion set or another suitable administration set. |  | |
| 10 | After reconstitution, administration should begin promptly or within 3 hours. | ||
| 11 | Use a separate, unused Mix2Vial® transfer set for each product vial. | ||
| C | ADMINISTRATION | ||
Administer IDELVION using sterile (aseptic) techniques:
| |||
|
Usual dose:
Your healthcare professional will tell you how much IDELVION to use based on your weight, the severity of your Hemophilia B, and where you are bleeding. You may have to have blood tests done after getting IDELVION to be sure that your blood level of Factor IX is high enough to clot your blood. Call your healthcare professional right away if your bleeding does not stop after taking IDELVION.
Overdose:
No symptoms of overdose with IDELVION have been reported.
| If you think you, or a person you are caring for, have taken too much IDELVION, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
Talk to your healthcare professional if you miss a dose.
What are possible side effects from using IDELVION?
Common side effects of IDELVION are headache and dizziness. Other possible side effects include rash, eczema, and allergic reactions.
Your body can make antibodies, called inhibitors, against Factor IX, which may stop IDELVION from working properly. Your healthcare professional may need to test your blood for inhibitors from time to time.
These are not all the possible side effects you may have when taking IDELVION. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| The following side effects could mean you are having an allergic reaction: | |||
| √ | √ | |
| √ | √ | |
| √ | √ | |
| √ | √ | |
| √ | √ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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. |
We recommend that CSL Behring Canada be copied when reporting suspected side effects, at the following address:
AdverseReporting@CSLBehring.com
Storage:
- Store at +2 °C to +25° C. Do not freeze.
- IDELVION is stable for the period indicated by the expiration date printed on the outer carton and vial label. Store vial in original carton to protect from light.
Product after reconstitution: the product administration should begin promptly or within 3 hours.
Keep out of reach and sight of children.
If you want more information about IDELVION:
- 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 Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.cslbehring.ca, or by calling 1-866-773-7721.