Idanuz

Package leaflet: information for the patient

Idanuz, 30 mg, solution for injection
in pre-filled syringe
Icatibant
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Idanuz is and what it is used for
2. Important information before using Idanuz
3. How to use Idanuz
4. Possible side effects
5. How to store Idanuz
6. Contents of the pack and other information

1. What Idanuz is and what it is used for

Idanuz contains the active substance icatibant.
This medicine is intended for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children aged 2 years and above.
In HAE, there is an increased level in the blood of a substance called bradykinin, which leads to the development of symptoms such as swelling, pain, nausea, and diarrhoea.
Idanuz blocks the activity of bradykinin, thereby interrupting the progression of HAE attack symptoms.

2. Important information before using Idanuz

When not to use Idanuz

• if the patient is allergic to icatibant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Idanuz, discuss the following with your doctor:

• if the patient has angina pectoris (reduced blood flow to the heart muscle);
• if the patient has recently had a stroke.

Adverse reactions associated with the use of Idanuz are similar to the symptoms of the disease.
If worsening of attack symptoms is observed after administration of this medicine, the doctor should be notified immediately.
Additionally:

• Before self-injecting or having the medicine administered by a caregiver, the patient or caregiver must be trained in subcutaneous (under the skin) injection techniques.
• A patient experiencing an attack in the larynx (upper airway obstruction), whether self-administering Idanuz or receiving it from a caregiver, should seek immediate medical assistance at a healthcare facility.
• If symptoms do not resolve after a single self-injection of Idanuz or a single dose administered by a caregiver, the patient should seek medical attention or the caregiver should take the patient to a doctor for consideration of a subsequent injection of Idanuz. Adult patients should not receive more than two additional injections within 24 hours.

Children and adolescents
Idanuz is not recommended for use in children under 2 years of age or weighing less than 12 kg, as it has not been studied in this age group.

Idanuz and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Idanuz and other medicines are known. However, if the patient is taking an angiotensin-converting enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) used to lower blood pressure or for any other reason, the doctor should be informed before using this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before starting treatment with this medicine.
The patient should not breastfeed for 12 hours after taking Idanuz.

Driving and using machines
Do not drive or operate machinery if the patient experiences fatigue or dizziness due to an HAE attack or following administration of Idanuz.

Idanuz contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Idanuz

This medicine should always be used exactly as directed by the doctor. If in doubt, consult your doctor.
If the patient is receiving Idanuz for the first time, the first dose will always be administered by a doctor or nurse. The doctor will inform the patient when it is safe to go home.
After speaking with the doctor or nurse and receiving training in performing subcutaneous injections, the patient may self-administer Idanuz, or a caregiver may administer the medicine to the patient, in the event of an attack of hereditary angioedema (HAE).
It is important to administer the subcutaneous injection of Idanuz as soon as possible after the onset of an angioedema attack. The treating doctor will teach the patient and caregiver how to safely administer this medicine according to the instructions provided in the patient leaflet.

When and how often to use Idanuz

The doctor will determine the exact dose of Idanuz and inform the patient how often it should be used.

Adults

• The recommended dose of Idanuz is one subcutaneous injection (3 mL, 30 mg), administered immediately after the onset of an angioedema attack (e.g., worsening skin swelling, particularly on the face and neck, or worsening abdominal pain).
• If symptoms have not improved after 6 hours, seek medical advice regarding administration of a second injection of Idanuz. No more than two additional injections should be given to adult patients within 24 hours.
• Do not administer more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, consult the doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Idanuz is one subcutaneous injection of 1 mL up to a maximum of 3 mL, depending on body weight, administered immediately after the onset of symptoms of an angioedema attack (e.g., worsening skin swelling, particularly on the face and neck, or worsening abdominal pain).
• Dosing information is provided in the instructions for use section.
• If the patient is unsure of the correct dose to administer, consult a doctor, pharmacist, or nurse.
• If symptoms worsen or do not improve, seek immediate medical help.

How to administer Idanuz

Idanuz is intended for subcutaneous administration. Each syringe must be used only once.
This medicine is administered using a short needle into the fatty tissue beneath the skin of the abdomen.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

The following detailed instructions apply to:

• Self-administration (adults)
• Administration by a caregiver or healthcare professional to adults, adolescents, and children aged over 2 years (with body weight of at least 12 kg).

The instructions include the following main steps:

1. General information
   2a) Preparation of the pre-filled syringe for children and adolescents (2–17 years) weighing 65 kg or less
   2b) Preparation of the pre-filled syringe and injection needle (all patients)
2. Preparation of the injection site
3. Administration of the solution
4. Disposal of injection equipment

Detailed injection instructions

1) General information

• Before starting, clean the work surface.
• Wash hands with soap and water.
• Remove the pre-filled syringe from its packaging.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing the cap, set aside the pre-filled syringe.

2a) Preparation of the pre-filled syringe for children and adolescents (aged 2 to 17 years) weighing 65 kg or less:
Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 mL), the following items are required to obtain the correct dose from the pre-filled syringe (see below):
a) Pre-filled syringe containing Idanuz (solution of icatibant)
b) Adapter
c) 3 mL graduated syringe

The required dose volume in milliliters should be drawn into an empty 3 mL graduated syringe (see table below).
Table 1: Dosing schedule for children and adolescents

For patients with body weight above 65 kg, administer the entire contents of the pre-filled syringe (3 mL).

If the patient is unsure about the volume of solution to withdraw, consult a
physician, pharmacist, or nurse.

1. Remove the protective cap from both ends of the adapter.

Avoid touching the tip of the adapter or the syringe to prevent
contamination.
2) Screw the adapter onto the pre-filled syringe.
3) Attach the graduated syringe to the other end of the adapter, ensuring both ends are securely connected.

Withdrawing the icatibant solution into the graduated syringe:

1. To withdraw the icatibant solution, push the plunger of the pre-filled syringe (on the left in the illustration below).

2. If the icatibant solution does not start flowing into the graduated syringe, gently pull back on the plunger of the graduated syringe until the solution begins to flow into it (see illustration below).

3. Continue pushing the plunger of the pre-filled syringe until the required volume of solution (dose) has transferred into the graduated syringe. Dosing information is provided in Table 1.
   If there is air in the graduated syringe:

• Rotate the connected syringes so that the pre-filled syringe is positioned on top (see illustration below).

• Push the plunger of the graduated syringe to return the air into the pre-filled syringe (this step may need to be repeated several times).
• Withdraw the required volume of icatibant solution.

4. Disconnect the pre-filled syringe with adapter from the graduated syringe.
5. Place the pre-filled syringe with adapter into a designated sharps container.
   2b) Preparing the pre-filled syringe and needle for injection:
   All patients (adults, adolescents, and children)

• Remove the needle with protective cap from the blister pack.
• Remove the seal from the needle cap (the needle should remain inside the cap).

• Hold the syringe firmly. Carefully attach the needle to the syringe containing the clear solution.
• Screw the syringe onto the needle while the needle is still in the protective cap.
• Remove the needle from the cap by pulling the syringe away. Do not pull on the plunger.
• The syringe is now ready for injection.

3) Preparing the injection site

• Select the injection site. The injection site should be a skin fold on the abdomen, approximately 5–10 cm (2–4 inches) below the navel, on either side. This area should be at least 5 cm (2 inches) away from any scars. Do not use skin areas with bruising, swelling, or tenderness for injection.
• Clean the injection site by wiping it with an alcohol swab and allow it to dry.

4) Administering the injection

• Hold the syringe in one hand, between two fingers, with the thumb on the plunger end.
• Ensure there are no air bubbles in the syringe by pressing the plunger until the first drop appears at the tip of the needle.

• Hold the syringe at a 45–90 degree angle to the skin, with the needle pointing toward the skin.
• While holding the syringe in one hand, use the other hand to gently pinch the skin fold at the previously disinfected site between the thumb and fingers.
• Keeping the skin pinched, bring the syringe close to the skin and quickly insert the needle into the skin fold.
• Slowly push the plunger steadily with one hand until all the liquid is injected into the skin and the syringe is completely empty.
• Push the plunger slowly over approximately 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of injection materials

• Place the syringe, needle, and needle cap into a designated sharps container intended for disposal of waste materials that may cause injury.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Injection site reactions (such as irritation, swelling, pain, itching, redness of the skin, and a burning sensation) occur in almost all patients receiving Idanuz. These reactions are usually mild and resolve without the need for additional treatment.
If the patient notices a worsening of disease flare symptoms after administration of this medicine, the physician should be informed immediately.

Very common (may affect more than 1 in 10 people):
Additional injection site reactions (feeling of pressure, bruising, sensory disturbances and/or numbness, itchy and raised rash, and sensation of warmth).

Common (may affect up to 1 in 10 people):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Skin redness
Abnormal liver function test results

Frequency not known (frequency cannot be estimated from the available data):
Urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Idanuz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated after EXP on the label and
carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze.
Do not use this medicine if the syringe or needle packaging is damaged or
if there are any visible signs of deterioration, for example if the solution is cloudy,
contains floating particles, or if its colour has changed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Idanuz contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each mL of solution contains 10 mg of icatibant.
• Other ingredients are: sodium chloride, glacial acetic acid, sodium hydroxide (for pH adjustment) and water for injections (see section 2).

What Idanuz looks like and contents of the pack
Idanuz is a clear, colourless solution for injection in a 3 mL glass pre-filled syringe. A needle for subcutaneous administration is included in the pack.
Idanuz is available in individual packs containing one pre-filled syringe with one needle, or in multipacks containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Norameda UAB
Meistrų g. 8A,
02189 Vilnius,
Lithuania
Tel.: +48 504 278 778

Manufacturer
Pharmadox Healthcare Ltd.
KW20a Kordin Industrial Park
Paola, PLA 3000
Malta

Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 CM Leiden
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Denmark - Idanuz 30 mg/3 ml injektionsvæske, opløsning
Estonia - Idanuz
Lithuania - Idanuz 30 mg injekcinis tirpalas užpildytame švirkšte
Latvia - Idanuz 30 mg šķīdums injekcijām pilnšļircē
Malta - Idanuz 30mg solution for injection in a pre-filled syringe
Poland - Idanuz