Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - idefirix

Document Subject

Generated Narrative: MedicinalProductDefinition mp3713afe50f1010dc6d3a525f7492a818

identifier: http://ema.europa.eu/identifier/EU/1/20/1471/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Idefirix 11 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3713afe50f1010dc6d3a525f7492a818

identifier: http://ema.europa.eu/identifier/EU/1/20/1471/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - idefirix

Attesters

What is in 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

Idefirix contains the active substance imlifidase, which belongs to a group of medicines called immunosuppressants. It is given before your kidney transplantation to prevent the immune system (your 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 from a bacterium called Streptococcus pyogenes.

You must not be given Idefirix

• If you are allergic to imlifidase or 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), that results in blood clots forming in small blood vessels throughout the body.

Warnings and precautions

Infusion reactions Idefirix contains a protein and it can cause allergic reactions in some people. You will receive medicines to reduce the risk of an allergic reaction. If you get any symptoms of an allergic reaction, such as severe rash, shortness of breath, feeling hot, flushing, during the infusion ( drip ), the infusion may need to be slowed down or stopped. When these symptoms go away, or improve, the infusion can be continued.

Infections IgG is important for protecting you against 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, which may attack the transplanted kidney. Your doctor will monitor you closely and you will receive medicines to reduce the risk of rejection.

Children and adolescents Do not give this medicine to children and adolescents under 18 years of age because 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 can affect the way some medicines work, and the dose of these may have to be adjusted.

As Idefirix breaks down IgG, IgG-based medicines may not work if given at the same time as Idefirix. This includes the following medicines:

• basiliximab (used to prevent rejection of kidney transplants)
• rituximab (used to treat cancers such as non-Hodgkin s lymphoma and chronic lymphocytic leukaemia 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 abnormally low immunoglobulin levels in the blood or to treat inflammatory diseases such as Guillain-Barr syndrome, Kawasaki disease and chronic inflammatory demyelinating polyneuropathy).

Pregnancy and breast-feeding Idefirix is not recommended during pregnancy. Talk to your doctor if you think you may be pregnant.

It is not known whether Idefirix passes into breast milk. You should not breast-feed if you are being treated with Idefirix.

Idefirix contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

Idefirix will be prescribed by a doctor with experience in kidney transplantation and it is for use in a hospital. The medicine will be given by infusion into your vein over about 15 minutes.

A healthcare professional will calculate the right dose for you based on your weight. Idefirix is usually given as a single dose, but your doctor may decide to give a second dose before the transplantation.

Information for healthcare professionals on dose calculation, preparation and infusion of Idefirix is given at the end of this leaflet.

If you receive more Idefirix than you should During and after the infusion you will be closely monitored. Healthcare professionals will check for any side effects.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following:

• 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, flushing (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), infections of the blood (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 (IgG antibodies will try to reject your donor kidney and you can feel general discomfort)
• High or low blood pressure (symptoms of low blood pressure can be dizziness and symptoms of high blood pressure can be headache)
• Low number of red blood cells (anaemia)
• Dizziness at change of body position, e.g. when standing up
• Headache
• Burst blood vessel in the eye
• Decreased vision
• Increased heart rate
• Infusion site pain
• Increased liver enzymes (seen in blood tests)

Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2-8 C). Do not freeze. Store in the original package in order to protect from light.

Chemical and physical in-use stability 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 medicine if you notice particulate matter or discolouration after reconstitution.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Idefirix contains

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

What Idefirix looks like and contents of the pack

• Idefirix is supplied as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate). The powder is a white freeze-dried cake.
• Packs contain 1 or 2 vials.

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

Manufacturer Biotechnologines farmacijos centras Biotechpharma UAB Mokslininku street 4 LT-08412 Vilnius Lithuania

Propharma Group The Netherlands B.V. Schipholweg 2316 ZL, Leiden Netherlands

This leaflet was last revised in

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: