Idefirix

Package leaflet: Information for the user

Idefirix 11 mg powder for concentrate for solution for infusion

imlifidase
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

1. What Idefirix is and what it is used for
2. What you need to know before you are given Idefirix
3. How to use Idefirix
4. Possible side effects
5. How to store Idefirix
6. Contents of the pack and other information

1. What Idefirix is and what it is used for

Idefirix contains the active substance imlifidase, which belongs to a group of medicines called immunosuppressants. It is given before kidney transplantation to prevent the immune system (the body's defences) from rejecting the donated kidney.
Idefirix works by breaking down a type of antibody in the body called immunoglobulin G (IgG), which is involved in destroying foreign or harmful substances.
Imlifidase is a protein derived from a bacterium called Streptococcus pyogenes.

2. What you need to know before you are given Idefirix

Do not receive Idefirix

• if you are allergic to imlifidase or to any of the other ingredients of this medicine (listed in section 6);
• if you have a severe infection;
• if you have a blood disorder called thrombotic thrombocytopenic purpura (TTP), which causes blood clots to form in small blood vessels throughout the body.

Warnings and precautions
Infusion reactions
Idefirix contains a protein that may cause allergic reactions in some people. You will be given medicines to reduce the risk of an allergic reaction. If you experience any symptoms of an allergic reaction during the infusion (“drip”), such as severe rash, shortness of breath, feeling hot or flushed, it may be necessary to slow down or stop the infusion. Once these symptoms have disappeared or improved, the infusion may continue.
Infections
IgG antibodies are important for protection against infections. Since Idefirix breaks down IgG, you will be given antibiotics to reduce the risk of infections.
Antibody-mediated rejection (AMR)
Your body will produce new IgG antibodies, which may attack the transplanted kidney. Your doctor will closely monitor you and give you medicines to reduce the risk of rejection.
Children and adolescents
Do not administer this medicine to children or adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Idefirix
Tell your doctor if you are using, have recently used, or might use any other medicines.
Idefirix may affect the way some medicines work, and it may therefore be necessary to adjust the dose of these medicines.
Since Idefirix breaks down IgG, medicines based on IgG may not work if given at the same time. This applies to the following medicines:

• basiliximab (used to prevent rejection of kidney transplants),
• rituximab (used to treat certain cancers such as non-Hodgkin's lymphoma and chronic lymphocytic leukemia, and inflammatory diseases such as rheumatoid arthritis),
• alemtuzumab (used to treat a form of multiple sclerosis),
• adalimumab (used to treat inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn's disease and ulcerative colitis),
• denosumab (used to treat osteoporosis),
• belatacept (used to prevent rejection of kidney transplants),
• etanercept (used to treat inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis),
• rabbit anti-thymocyte globulin (rATG) (used to prevent rejection of kidney transplants),
• intravenous immunoglobulin (IVIg) (used to increase very low levels of immunoglobulins in the blood or to treat inflammatory diseases such as Guillain-Barré syndrome, Kawasaki disease and chronic inflammatory demyelinating polyneuropathy).

Pregnancy and breastfeeding
Idefirix is not recommended during pregnancy.
If you suspect you are pregnant, consult your doctor.
It is not known whether Idefirix passes into breast milk. You must not breastfeed while being treated with Idefirix.
Idefirix contains sodium and polysorbate 80
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This medicine contains 0.5 mg of polysorbate 80 in each mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Idefirix

Idefirix will be prescribed by a physician experienced in kidney transplantation and must be used in a
hospital setting. The medicine will be administered by intravenous infusion over approximately 15 minutes.
A healthcare professional will calculate the correct dose for you based on your body weight. Usually, a single dose of Idefirix is given, but your doctor may decide to administer a second dose before transplantation.
Information for healthcare professionals on dose calculation, preparation, and infusion of Idefirix is provided at the end of this leaflet.
If you are given more Idefirix than you should have
You will be closely monitored during and after the infusion. Healthcare professionals will check for the occurrence of any adverse reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you notice any of the following side effects:

• signs of infection, such as fever, chills, cough, feeling weak or generally unwell (very common: may affect more than 1 in 10 people);
• signs of an infusion reaction, such as severe rash, shortness of breath, feeling hot or flushed (common: may affect up to 1 in 10 people);
• muscle pain or fatigue (symptoms of myalgia) (common: may affect up to 1 in 10 people).

Other side effects include:
common (may affect up to 1 in 10 people):

• infections: lung infection (pneumonia), blood infections (sepsis), abdominal infection, upper respiratory tract infection, adenovirus infection, parvovirus infection, urinary tract infection, influenza, wound infection, post-operative wound infection, catheter site infection;
• transplant rejection (the IgG antibodies may attempt to reject the donor kidney, and you may feel widespread discomfort);
• high or low blood pressure (a symptom of low blood pressure may be dizziness, and a symptom of high blood pressure may be headache);
• reduced number of red blood cells (anaemia);
• dizziness upon changing body position, for example when standing up;
• headache;
• rupture of a blood vessel in the eye;
• decreased vision;
• increased heart rate;
• pain at the infusion site;
• increased liver enzymes (observed in blood tests).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Idefirix

Keep this medicine out of the sight and reach of children. Idefirix is stored in the hospital pharmacy.
Do not use this medicine after the expiry date which is stated on the vial label after “EXP” and on the carton after “Scad.” or “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2-8 °C). Do not freeze. Keep in the original packaging to protect from light.
Chemical and physical in-use stability after reconstitution and dilution has been demonstrated for 24 hours at a temperature of 2-8 °C, including 4 hours at 25 °C within this 24-hour period.
Do not use this medicine if you notice the presence of particulate matter or discoloration after reconstitution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Idefirix contains

• The active substance is imlifidase. Each vial contains 11 mg of imlifidase. After reconstitution, each mL of concentrate contains 10 mg of imlifidase.
• The other ingredients are: mannitol, polysorbate 80, trometamol, edetate disodium dihydrate, and hydrochloric acid (for pH adjustment). See section 2 “Idefirix contains sodium and polysorbate 80”.

Description of the appearance of Idefirix and contents of the pack

• Idefirix is supplied in a glass vial containing a lyophilized powder for concentrate for solution for infusion (powder for concentrate). The powder is a white, agglomerated lyophilisate.
• Packs contain 1 or 2 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder
Hansa Biopharma AB
P.O. Box 785
220 07 Lund
Sweden

Manufacturer
Biotechnologines farmacijos centras Biotechpharma UAB
Mokslininkų g. 4
LT-08412 Vilnius
Lithuania
Propharma Group The Netherlands B.V.
Schipholweg 59
2316 ZL, Leiden
The Netherlands

This medicinal product has been granted a marketing authorization under “conditional approval”. This means that
additional data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually, and this
package leaflet will be updated if necessary.

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Reconstitution of the powder
Add 1.2 mL of sterile water for injection to the Idefirix vial, taking care to
direct the stream against the glass wall and not onto the powder.
Gently swirl the vial for at least 30 seconds to ensure complete dissolution of the
powder. Do not shake, to minimize the risk of foam formation. At this point, the vial contains imlifidase 10 mg/mL, and up to 1.1 mL of solution can be withdrawn.
The reconstituted solution should be clear to slightly opalescent and colorless or slightly yellow. Do not use if discoloration or particulate matter is observed. It is recommended to immediately transfer the reconstituted solution from the vial into the infusion bag.

Preparation of the infusion solution
Slowly add the appropriate amount of reconstituted imlifidase solution to an infusion bag containing 50 mL of 0.9% sodium chloride solution (9 mg/mL).
Invert the infusion bag several times to ensure thorough mixing. The infusion bag must always be protected from light.
Before administration, visually inspect the infusion solution for particulate matter or discoloration. Discard the solution if particulate matter or discoloration is observed.

Administration
The entire infusion, fully diluted, should be administered over 15 minutes using an infusion set with an in-line, sterile, pyrogen-free, low-protein-binding filter (pore size 0.2 μm). At the end of the infusion, flush the intravenous catheter with a sodium chloride 9 mg/mL (0.9%) solution for infusion to ensure complete delivery of the dose. Do not store unused infusion solution for later use.