Icatibant Medical Vallei

Leaflet attached to the packaging: information for the user

Icatibant Medical Valley, 30 mg, solution for injection in a pre-filled syringe

Icatibant

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Icatibant Medical Valley and what is it used for

Icatibant Medical Valley contains the active substance icatibant.
Icatibant Medical Valley is intended for the treatment of symptoms of hereditary angioedema (HAE) in adult patients and adolescents and children aged 2 years and older.
In HAE, there is an increase in the blood level of a substance called bradykinin, which leads to symptoms such as swelling, pain, nausea, and diarrhea.
Icatibant Medical Valley blocks the activity of bradykinin, thereby interrupting the development of HAE attack symptoms.

2. Important information before using Icatibant Medical Valley

When not to use Icatibant Medical Valley

Warnings and precautions

Before starting treatment with Icatibant Medical Valley, discuss it with your doctor:

Some of the side effects associated with the use of Icatibant Medical Valley are similar to the symptoms of the disease.
If the patient notices worsening of symptoms or exacerbation of the attack after receiving Icatibant Medical Valley, they should immediately inform their doctor.
Additionally:

• Before self-administering Icatibant Medical Valley or before administering Icatibant Medical Valley by a caregiver, the patient or caregiver should be trained in performing subcutaneous injections.
• A patient with a laryngeal attack (upper airway obstruction) who self-administers Icatibant Medical Valley or is administered Icatibant Medical Valley by a caregiver should seek medical help immediately in a healthcare facility.
• If, after a single self-administration of Icatibant Medical Valley or a single administration of Icatibant Medical Valley by a caregiver, the symptoms do not subside, the patient should consult a doctor for further administration of Icatibant Medical Valley. Adult patients should not receive more than two additional injections within 24 hours.

Children and adolescents

Icatibant Medical Valley should not be used in children under 2 years of age or weighing less than 12 kg, as it has not been studied in this age group.

Icatibant Medical Valley and other medicines

Tell your doctor or pharmacist 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 Icatibant Medical Valley and other medicines are known. If the patient is taking an angiotensin-converting enzyme (ACE) inhibitor (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, the doctor should be informed before using Icatibant Medical Valley.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before starting treatment with this medicine.
The patient should not breastfeed for 12 hours after receiving Icatibant Medical Valley.

Driving and using machines

Do not drive or operate machinery if the patient experiences fatigue or dizziness due to an HAE attack or after using Icatibant Medical Valley.

Icatibant Medical Valley contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, which means it is considered "sodium-free".

3. How to use Icatibant Medical Valley

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, consult your doctor.
If the patient is receiving Icatibant Medical Valley for the first time, the first dose of the medicine is always administered by a doctor or nurse. The doctor will tell the patient when they can safely go home.
After discussing with the doctor or nurse and being trained in performing subcutaneous injections, the patient may self-administer Icatibant Medical Valley or a caregiver may administer Icatibant Medical Valley to the patient if they experience an HAE attack. It is essential to administer Icatibant Medical Valley subcutaneously as soon as possible after noticing the symptoms of an HAE attack. The attending physician will teach the patient and their caregiver how to safely administer Icatibant Medical Valley according to the instructions provided in the "Patient Leaflet".

When and how often to use Icatibant Medical Valley

The doctor will determine the exact dose of Icatibant Medical Valley and tell the patient how often to use it.

Adults

• The recommended dose of Icatibant Medical Valley is one injection (3 mL, 30 mg), administered subcutaneously immediately after noticing the symptoms of an HAE attack (e.g., severe skin swelling, especially on the face and neck, or abdominal pain).
• If the symptoms do not subside after 6 hours, the patient should consult their doctor about administering another dose of Icatibant Medical Valley. Adult patients should not receive more than two additional injections within 24 hours.
• Do not take more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, they should consult their doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Medical Valley is one injection of 1 mL to a maximum of 3 mL, depending on body weight, administered subcutaneously immediately after noticing the symptoms of an HAE attack (e.g., severe skin swelling, especially on the face and neck, or abdominal pain).
• For more information on dosing, see "Detailed injection instructions".
• If the patient is unsure about the volume of the solution to be administered, they should consult their doctor, pharmacist, or nurse.
• If the symptoms worsen or do not subside, the patient should seek medical help immediately.

How to administer Icatibant Medical Valley

Icatibant Medical Valley is intended for subcutaneous administration. Each syringe should be used only once.
Icatibant Medical Valley is administered using a short needle into the fatty tissue under the skin of the abdomen.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

The following detailed instructions apply to:

• -self-administration (adults)
• -administration by a caregiver or healthcare professional to adults, adolescents, and children over 2 years of age (with a body weight of not less than 12 kg).

The instructions include the following main steps:

• 1) General information

2a)
Preparing the pre-filled syringe for children and adolescents (2-17 years) with a body weight of 65 kg or less
2b)
Preparing the pre-filled syringe and needle for injection (all patients)

• 3) Preparing the injection site
• 4) Injecting the solution
• 5) Disposing of injection equipment

Detailed injection instructions

• 1)

General information

• Before starting, clean the surface you are using.
• Wash your hands with water and soap.
• Remove the pre-filled syringe from its packaging.
• Remove the cap from the tip of the pre-filled syringe by twisting it.
• After removing the cap, put the pre-filled syringe down. Do not let the exposed tip of the syringe come into contact with any surface.

2a) Preparing the pre-filled syringe for children and adolescents (2-17 years) with a body weight of 65 kg or less:

Important information for healthcare professionals and caregivers:

If the dose is less than 30 mg (3 mL), to obtain the correct dose from the pre-filled syringe, you will need:
a)
A pre-filled syringe with Icatibant Medical Valley (containing icatibant solution)
b)
An adapter (connector)
c)
A 3 mL syringe with graduations

Draw up the required dose volume in milliliters into an empty 3 mL syringe with graduations (see the table below).

Table 1: Administration schedule for children and adolescents

Body weight Solution volume

12 kg to 25 kg
1.0 mL
26 kg to 40 kg
1.5 mL
41 kg to 50 kg
2.0 mL
51 kg to 65 kg
2.5 mL
Patients with a body weight over 65 kgshould receive the entire contents of the pre-filled syringe (3 mL).

If the patient is unsure about the volume of the solution to be drawn up, they should consult their doctor, pharmacist, or nurse.

• 1) Remove the protector from both ends of the adapter.

Avoid touching the tip and nozzle of the adapter and syringe to prevent contamination.

• 2) Screw the adapter onto the pre-filled syringe.
• 3) Attach the syringe with graduations to the other end of the adapter, making sure both ends are securely connected.

Withdrawing icatibant solution into the syringe with graduations:

• 1) To withdraw the dose of icatibant solution, press 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 syringe with graduations, gently pull the syringe plunger until the solution starts flowing into it (see the illustration below).

• 3) Continue pressing the plunger of the pre-filled syringe until the required volume (dose) has flowed into the syringe with graduations. Information on dosing can be found in Table 1.

If there is air in the syringe with graduations, the following steps should be taken:

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

• Press the plunger of the syringe with graduations so that the air returns to the pre-filled syringe (this step may need to be repeated several times).
• Draw up the required volume of icatibant solution.
• 4) Disconnect the pre-filled syringe with adapter from the syringe with graduations.
• 5) Place the pre-filled syringe with adapter in a special container for sharp objects.

2b) Preparing the pre-filled syringe and needle for injection:

All patients (adults, children, and adolescents)

• •Remove the needle protector from its packaging. Do not remove the needle from the protector.
• Twist the top part of the needle protector to break the seal (the needle should still remain in the protector).

• Hold the pre-filled syringe firmly. Carefully attach the needle to the pre-filled syringe containing the colorless solution.
• Screw the pre-filled syringe onto the needle still secured in the protector.
• Remove the needle from the protector by pulling on the pre-filled syringe. Do not pull on the plunger of the pre-filled syringe.
• The pre-filled syringe is now ready for injection.
• 3)

Preparing the injection site

• Choose an injection site. The injection site should be a skin fold on the abdomen, about 5-10 cm below the navel, on either side. This area of skin should be at least 5 cm away from any scars. Do not choose an area of skin with bruising, swelling, or pain for injection.
• Clean the injection site by wiping it with a swab moistened with alcohol and let it dry.
• 4)

Injecting the solution

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

• Hold the pre-filled syringe at an angle of 45-90 degrees to the skin, with the needle pointing towards the skin.
• Holding the pre-filled syringe with one hand, use the other hand to gently grasp the skin fold at the injection site that was previously disinfected.
• Hold the skin fold, bring the pre-filled syringe close to the skin, and quickly insert the needle into the skin fold.
• Slowly press the plunger of the pre-filled syringe, keeping your hand still, until the entire liquid has been injected into the skin and the pre-filled syringe is completely empty.
• Press the plunger slowly, over about 30 seconds.
• Release the skin fold and gently pull out the needle.
• 5)

Disposing of injection equipment

• Place the pre-filled syringe, needle, and needle protector in a container for sharp objects, intended for disposing of waste that can cause puncture wounds.

4. Possible side effects

Like all medicines, Icatibant Medical Valley can cause side effects, although not everybody gets them.
Almost all patients treated with Icatibant Medical Valley experience a reaction at the injection site (irritation, swelling, pain, itching, redness of the skin, and a burning sensation). These reactions are usually mild and resolve without the need for additional treatment.
Very common (may affect more than 1 in 10 people):
Additional reactions at the injection site (feeling of pressure, bruising, altered sensation, and (or) numbness, itchy rash elevated above the surrounding skin, and a feeling of warmth).
Common (may affect up to 1 in 10 people):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Redness of the skin
Abnormal liver test results
Frequency not known (frequency cannot be estimated from the available data):
Urticaria
If the patient notices an exacerbation of symptoms or worsening of the attack after receiving Icatibant Medical Valley, they should immediately inform their doctor.
If side effects occur, including any side effects not listed in this leaflet, the patient should consult their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Icatibant Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Do not store above 30°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, such as the solution being cloudy, containing solid particles, or having changed color.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Icatibant Medical Valley contains

• The active substance of Icatibant Medical Valley is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as icatibant acetate).
• The other ingredients are: sodium chloride, glacial acetic acid, sodium hydroxide, and water for injections.

What Icatibant Medical Valley looks like and contents of the pack

Icatibant Medical Valley is a clear, colorless solution for injection in a glass pre-filled syringe with a capacity of 3 mL. A subcutaneous needle is attached to the packaging.
Icatibant Medical Valley is available in a cardboard box containing one pre-filled syringe and one needle.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer

Universal Farma S.L.
Calle El Tejido 2, Polígono Industrial Miralcampo
19200 Azuqueca De Henares, Guadalajara
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark
Icatibant Medical Valley
Spain
Icatibant Exeltis 30 mg solution for injection in a pre-filled syringe
Netherlands
Icatibant Xiromed 30 mg solution for injection in a pre-filled syringe
Iceland
Icatibant Medical Valley 30 mg solution for injection in a pre-filled syringe.
Germany
Icatibant AXiromed 30 mg solution for injection in a pre-filled syringe
Norway
Icatibant Medical Valley
Poland
Icatibant Medical Valley
Sweden
Icatibant Medical Valley 30 mg solution for injection in a pre-filled syringe
Date of last revision of the leaflet:06.2024

Other sources of information

Detailed information on this medicine can be found on the European Medicines Agency website http://www.ema.europa.eu . There are also links to websites about rare diseases and treatments.