Prospect: information for the user

Idefirix 11 mg powder for concentrate for solution for infusion

imlifidasa

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may have. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor.
• If you experience adverse effects, consult your doctor, even if they are adverse effects that do not appear in this prospect. See section 4.

Idefirix contains the active ingredient imlifidasa, which belongs to a group of medications called immunosuppressants. It is administered before a kidney transplant to prevent the immune system (the body's defenses) from rejecting the donated kidney.

Idefirix breaks down a type of antibody in the body, immunoglobulin G (IgG), which is involved in the destruction of 'foreign' or harmful substances.

The imlifidasa is a protein from a bacterium calledStreptococcus pyogenes.

Do not use Idefirix

• If you are allergic to imlifidasa or any of the other components of this medication (listed in section 6).
• If you have a severe infection.
• If you have a blood disorder called «thrombotic thrombocytopenic purpura» (TTP), which produces the formation of blood clots in small blood vessels throughout the body.

Warnings and precautions

Reactions to infusion

Idefirix contains a protein and may cause allergic reactions in some people. You will receive medications to reduce the risk of an allergic reaction. If you experience any of the symptoms of an allergic reaction, such as acute skin rash, difficulty breathing, flushing, redness, during the infusion («infusion»), it is possible that the infusion may need to be slowed down or stopped. When these symptoms disappear, or improve, the infusion may be continued.

Infections

Immunoglobulin G (IgG) is important to protect you from infections and since Idefirix breaks down IgG, you will receive antibiotics to reduce the risk of infections.

Antibody-mediated rejection (AMR)

Your body will produce new IgG antibodies that may attack the transplanted kidney. Your doctor will closely monitor you and you will receive medications to reduce the risk of rejection.

Children and adolescents

This medication should not be administered to children and adolescents under 18 years of age, as the administration of this medication has not been studied in this age group.

Other medications and Idefirix

Inform your doctor if you are using, have used recently, or may need to use any other medication. Idefirix may affect the functioning of some medications and it may be necessary to adjust the dose of these medications.

Idefirix breaks down IgG, so it is possible that IgG-based medications may not work if administered at the same time as Idefirix. This includes the following medications:

• Basiliximab (used to prevent rejection of kidney transplants);
• Rituximab (used to treat 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 antithymocyte globulin (rATG) (used to prevent rejection of kidney transplants);
• Intravenous immunoglobulin (IgIV) (used to increase low levels of immunoglobulin in the blood or treat inflammatory diseases such as Guillain-Barré syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy).

Pregnancy and breastfeeding

Idefirix is not recommended during pregnancy. Consult your doctor if you think you may be pregnant.

The excretion of Idefirix in breast milk is unknown. Do not breastfeed if you are receiving treatment with Idefirix.

Idefirix contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially «sodium-free».

Idefirix will be prescribed by an experienced kidney transplant physician and is intended for use in a hospital. The medication will be administered through a vein infusion over a period of approximately 15 minutes.

A healthcare professional will calculate the appropriate dose for you based on your weight. Idefirix is usually administered as a single dose, but your doctor may decide to administer a second dose before the transplant.

The information for healthcare professionals on calculating the dose, preparing, and infusing Idefirix is provided at the end of this leaflet.

If you use more Idefirix than you should

You will be closely monitored during and after the infusion. Healthcare professionals will check for the presence of adverse reactions.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor immediately if you experience any of the following adverse effects:

• Signs of infection, such as fever, chills, cough, weakness, or general discomfort (very frequent: may affect more than 1 in 10 people).
• Signs of reaction to infusion, such as acute skin rash, respiratory difficulty, hot flashes, redness (frequent: may affect up to 1 in 10 people).
• Muscle pain or fatigue (myalgia symptoms) (frequent: may affect up to 1 in 10 people).

Other adverse effects are:

Frequent(may affect up to 1 in 10 people):

• Infections: pneumonia, septicemia, abdominal infection, upper respiratory tract infection, adenovirus infection, parvovirus infection, urinary tract infection, flu, wound infection, postoperative wound infection, catheter site infection.
• Transplant rejection (IgG antibodies may attempt to reject the donor kidney and may feel general discomfort).
• Low or high blood pressure (symptoms of low blood pressure may be dizziness and symptoms of high blood pressure may be headache).
• Low red blood cell count (anemia).
• Dizziness when changing body position, for example, when standing up.
• Headache.
• Explosion 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children. Idefirix is stored in the hospital pharmacy.

Do not use this medication after the expiration date that appears on the vial label and on the box after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze. Store in the original packaging to protect it from light.

Chemical and physical stability in use after reconstitution and dilution has been demonstrated for 24 hours at 2-8 °C and for 4 hours at 25 °C during this period.

Do not use this medication if you observe the presence of particles or discoloration after reconstitution.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Idefirix

• The active ingredient is imlifidasa. Each vial contains 11 mg of imlifidasa. After reconstitution, each ml of concentrate contains 10 mg of imlifidasa.
• The other components are mannitol, polisorbate 80, tromethamine, disodium edetate dihydrate, and hydrochloric acid (to adjust the pH). See section 2 "Idefirix contains sodium".

Appearance of the product and contents of the pack

• Idefirix is supplied in a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate). The powder is presented in the form of a white lyophilized disc.
• The pack contains 1 or 2 vials.

Marketing Authorization Holder

Hansa Biopharma AB

PO Box 785

220 07 Lund

Sweden

Responsible Person

Biotechnologines farmacijos centras Biotechpharma UAB

Mokslininku street 4

LT-08412 Vilnius

Lithuania

Propharma Group The Netherlands B.V.

Schipholweg 59

2316 ZL, Leiden

Netherlands

Last update of the leaflet:

This medicine has been authorised under a 'conditional approval'. This type of approval means that more information is expected to be obtained about this medicine.

The European Medicines Agency will review the new information about this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu

This information is intended for healthcare professionals only:

Reconstitution of the powder

Introduce 1.2 ml of sterile water for injections into the Idefirix vial, taking care to direct the water towards the glass wall and not towards the powder.

Move the vial gently in circles for at least 30 seconds to dissolve the powder completely. Do not agitate, to minimize the risk of foam formation. The vial will now contain imlifidasa 10 mg/ml and up to 1.1 ml of solution can be withdrawn.

The reconstituted solution must be transparent and colourless. It must not be used if particles or discoloration of the solution are observed. It is recommended to transfer the reconstituted solution from the vial to the infusion bag immediately.

Preparation of the infusion solution

Add the correct amount of reconstituted imlifidasa solution slowly to an infusion bag containing 50 ml of sodium chloride 9 mg/ml (0.9%) infusion solution. Invert the infusion bag several times to mix the solution well. The infusion bag must be protected from light.

Before use, the infusion solution must be visually inspected for particulate matter or discoloration. Discard the solution if particles or discoloration are observed.

Administration

The complete and fully diluted infusion must be administered over 15 minutes with an infusion set and a non-pyrogenic, low protein affinity filter in line (pore size 0.2 μm). At the end of the infusion, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) infusion solution to ensure the patient receives the full dose. Do not store unused infusion solution for later use.