Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP)
Read this carefully before you start taking IDELVION. This
leaflet is a summary and will not tell you everything about this drug. Talk to
your healthcare professional about your medical condition and treatment and ask
if there is any new information about IDELVION.
ABOUT THIS MEDICATION
What is IDELVION used for?
IDELVION, Coagulation Factor IX (Recombinant), Albumin
Fusion Protein is a medicine used to replace clotting factor (Factor IX) that
is missing in people with hemophilia B (also called congenital Factor IX
deficiency or Christmas disease). Hemophilia B is an inherited bleeding
disorder that prevents blood from clotting normally.
IDELVION can reduce the number of bleeding episodes when
used regularly (prophylaxis) and reduce the risk of joint damage due to
bleeding. IDELVION is used to prevent and control bleeding in all patients with
hemophilia B. Your healthcare provider may give you IDELVION when you have
How does IDELVION work?
IDELVION is injectable clotting (coagulation) Factor IX
made using recombinant technology. Factor IX is involved in blood clotting.
Lack of this factor means that blood does not clot as quickly as it should so
there is an increased tendency to bleed. IDELVION works by replacing factor IX
in haemophilia B patients to enable their blood to clot.
What are the ingredients in IDELVION?
Medicinal ingredients: Coagulation Factor IX
(Recombinant), Albumin (recombinant) Fusion Protein.
Non-medicinal ingredients: Mannitol, Polysorbate 80,
Sucrose, Tri-sodium citrate.
IDELVION comes in the following dosage forms:
IDELVION is a preservative free, sterile, non-pyrogenic,
lyophilized powder to be reconstituted with Sterile Water for Injection (SWFI)
for intravenous injection. IDELVION comes in 4 different dosage strengths: 250
IU, 500 IU, 1000 IU, or 2000 IU and must be reconstituted with the respective
supplied volume of SWFI (diluent) listed in the table below before it is
|Lyophilized Product Format
||Diluent Volume for Reconstitution
||Concentration of product once reconstituted
The IDELVION package consists of 2 boxes.
The “Product box” contains one single-use IDELVION
vial and one vial of Sterile Water for Injection (Diluent).
The “Device box” contains one Mix2Vial® filter
transfer set, one syringe, one infusion set and a plaster (non-sterile).
WARNINGS AND PRECAUTIONS
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.
- you are breast-feeding. It is not known if IDELVION
passes into the milk and if it can harm your baby.
- you had any allergic reactions in the past.
Allergic reactions may occur with IDELVION. Call your
healthcare provider right away and stop treatment if you get a rash or hives,
itching, tightness of the chest or throat, difficulty breathing,
light-headedness, dizziness, nausea, or a decrease in blood pressure.
Your body may form inhibitors to Factor IX. An inhibitor
is a part of the body's defense system. If you form inhibitors, it may stop
IDELVION from working properly. Your healthcare provider may need to test your
blood for inhibitors from time to time.
INTERACTIONS WITH THIS MEDICATION
Tell your healthcare professional about all the medicines
you take, including any drugs, vitamins, minerals, natural supplements or
PROPER USE OF THIS MEDICATION
How to take IDELVION:
IDELVION is given directly into the bloodstream. IDELVION
should be administered as directed by your healthcare provider. You should be
trained on how to do intravenous injections by your healthcare provider. Many
people with hemophilia B learn to inject their IDELVION by themselves or with
the help of a family member.
For intravenous use after reconstitution only.
Home administration of IDELVION
Do not attempt to self-administer unless you have been
taught how by your healthcare provider.
Always follow the specific instructions given by your
healthcare provider. The steps listed below are general guidelines for using
IDELVION. If you are unsure of the instructions, call your healthcare provider
before using IDELVION. Talk to your healthcare provider before traveling. Dispose
of all unused solution, empty vial(s), and other used medical supplies in an
appropriate medical waste container.
- Do not mix IDELVION with other medicinal products.
- Administer by intravenous injection.
- Always work on a clean flat surface and wash your hands
before performing the following procedures. Use aseptic technique when
- Administer IDELVION at room temperature.
- For injection of IDELVION, the provided administration
sets are recommended to be used because treatment failure can occur as a
consequence of factor IX adsorption to the internal surface of some injection
- As with any coagulation product, care should be taken
that no blood should enter the syringe, as there is the possibility of fibrin
- Record the name and batch number of the product after
administration to maintain a link between the patient and the batch of the
- Reconstitute IDELVION using aseptic technique with
diluent provided in the kit.
- Do not use IDELVION beyond the expiration date on the
vial label and carton.
- Visually inspect the reconstituted solution for
particulate matter and discoloration prior to administration. The solution
should be a yellow to colorless clear liquid and free from visible particles.
Do not use if discoloration or particulate matter is observed
- IDELVION is for single use only. Contains no
preservatives. Discard partially used vials.
- If a package is opened or damaged, do not use and please
contact your healthcare provider.
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
Prepare the vials/Mix2Vial® and administration supplies.
Ensure that the diluent and IDELVION vials are at room
Prepare syringes, infusion sets and other supplies for
B. RECONSTITUTION: follow these steps to reconstitute
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 center 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 product 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
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
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. Administer IDELVION using aseptic technique:
- Thoroughly wash and dry hands.
- Locate vein.
- Clean the injection site using an antiseptic skin
preparation. Allow each site to dry before proceeding.
- Insert the needle into the vein.
- Check for proper placement of the needle.
- Inject IDELVION into the vein using a slow intravenous
Your healthcare provider 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 provider right away if your bleeding does not stop after
No symptoms of overdose with IDELVION have been reported.
If you think you have taken too much IDELVION, contact
your healthcare professional, hospital emergency department or regional Poison
Control Centre immediately, even if there are no symptoms.
Talk to your healthcare provider if you miss a dose.
HOW TO STORE IT
- Store at +2 °C to +25° C. Do not freeze.
- The shelf life of IDELVION is up to 24 months for 250 IU
and 500 IU or 36 months for 1000 IU and 2000 IU. Do not use beyond the
expiration date on the IDELVION carton and vial labels.
- Store vial in original carton to protect from light.
Product after reconstitution: the product
administration should begin promptly or within 3 hours.
Side Effects, How Often They Happen And What To Do
What are possible side effects from using IDELVION?
A common side effect of IDELVION is headache. Other
possible side effects include rash, dizziness, and infusion related reactions.
These are not all the possible side effects you may feel
when taking IDELVION. If you experience any side effects not listed here, contact
your healthcare professional. Please also see section WARNINGS AND
|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:
|- Difficult breathing
|- Chest tightness
|- Swelling of the face, rash or hives
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 Suspected Side Effects
You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance Program by one of the
following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program, Health Canada, Postal Locator
0701E, Ottawa, Ontario. K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and
the adverse reaction reporting guidelines are available on the MedEffect™
Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to
the management of side effects, contact your health professional.
The Canada Vigilance Program does not provide medical
*We recommend that CSL Behring Canada be copied when
reporting suspected side effects, at the following address: [email protected], or be informed by pager. Pager Number: 1-613-783-1892
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; the manufacturer's (CSL Behring Canada,
Inc.) website at http://www.cslbehring.ca, or by calling CSL Behring Canada,
Inc. at 1-613-783-1892.