Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Icatibanto Stada 30 mg solution for injection in pre-filled syringe EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are

adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Icatibanto Stada is and what it is used for
What you need to know before using Icatibanto Stada
How to use Icatibanto Stada
Possible adverse effects
How to store Icatibanto Stada
Contents of the pack and other information

1. What Icatibanto Stada is and what it is used for

Icatibanto Stada contains the active substance icatibant.

This medicine is used to treat the symptoms of hereditary angioedema (HAE) in adults, adolescents, and children over 2 years of age.

In HAE, levels of a substance in the blood called bradykinin increase, leading to symptoms such as swelling, pain, nausea, and diarrhea.

Icatibant blocks the activity of bradykinin and thus halts the progression of symptoms during an HAE attack.

2. What you need to know before using Icatibanto Stada

Do not use Icatibanto Stada

if you are allergic to icatibant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before using icatibant:

If you suffer from angina pectoris (reduced blood flow to the heart).
If you have recently had a stroke.

Adverse effects associated with icatibant are similar to the symptoms of your own condition. Contact your doctor immediately if you notice that your attack symptoms worsen after receiving icatibant.

Additionally:

You or your caregiver must learn the subcutaneous injection technique (under the skin) before self-administering or having this medicine administered by your caregiver.
Immediately after self-administering icatibant or having it administered by your caregiver during a laryngeal attack (obstruction of the upper airway), you must seek medical attention at a medical facility.
If your symptoms do not resolve after a self-administered or caregiver-administered injection of icatibant, consult your doctor regarding the administration of additional injections of this medicine. In adult patients, up to 2 additional injections may be given within 24 hours.

Children and adolescents

This medicine is not recommended for children under 2 years of age or weighing less than 12 kg, as it has not been studied in these patients.

Other medicines and Icatibanto Stada

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

No interactions between icatibant and other medicines are known. If you are taking any medicine that is an angiotensin-converting enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) to reduce blood pressure or for any other reason, inform your doctor before using this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using icatibant.

If you are breastfeeding, you should not breastfeed your child during the 12 hours following the last administration of icatibant.

Driving and use of machines

Do not drive or operate machinery if you feel tired or dizzy as a result of an HAE attack or after using icatibant.

Icatibanto Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

3. How to use Icatibanto Stada

Follow exactly the administration instructions for this medicine as given by your doctor. If you have any doubts, consult your doctor again.

If you have never been administered icatibanto before, the first dose must always be injected by medical or nursing staff. Your doctor will discharge you when it is considered safe for you to go home.

After discussing with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver may administer this medicine to you during an HAE attack.

It is important to inject icatibanto subcutaneously (under the skin) as soon as you notice an angioedema attack (for example, increased skin swelling, especially in the face and neck, or increased abdominal pain). Healthcare professionals will teach you and your caregiver how to safely inject this medicine, following the instructions in the package leaflet.

When and how often should you use Icatibanto Stada?

Your doctor has determined the exact dose of this medicine and will tell you how often it should be used.

Adults

The recommended dose of icatibanto is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice an angioedema attack.
If you do not notice improvement in symptoms, after six hours, ask your doctor about administering additional injections of icatibanto. In adults, up to 2 additional injections may be given within 24 hours.
You must not receive more than 3 injections within a 24-hour period, and if you require more than 8 injections in one month, consult your doctor.

Children and adolescents aged 2 to 17 years

The recommended dose of icatibanto is one injection of 1 ml up to a maximum of 3 ml, depending on body weight, administered subcutaneously (under the skin) as soon as symptoms of an angioedema attack appear (for example, increased skin swelling, especially in the face and neck, or increased abdominal pain).
Refer to the instructions for use section to see the dose you should inject.
If you are unsure about the dose to inject, consult your doctor, pharmacist, or nurse.
If your symptoms worsen or do not improve, ask your doctor immediately.

Method of administration

Icatibanto is administered by subcutaneous injection (under the skin). Use each syringe only once.

This medicine is injected with a short needle into the fatty tissue beneath the skin of the abdomen (stomach).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

The following step-by-step instructions are intended for:

Self-administration (adults)
Administration by a caregiver or healthcare professional for adults, adolescents, or children over 2 years of age (weighing at least 12 kg).

The instructions include the following main steps:

General information

2a) Preparation of the syringe for children and adolescents (2–17 years) weighing 65 kg or less

2b) Preparation of the syringe and needle for injection (all patients)

Preparation of the injection site
Injection of the solution
Disposal of injection materials

Step-by-step injection instructions

General information

Clean the work area (surface) to be used before starting the procedure.
Wash hands with water and soap.
Remove the pre-filled syringe from the case.
Unscrew and remove the cap from the end of the pre-filled syringe.
Leave the pre-filled syringe once the cap has been unscrewed.

2a) Preparation of the syringe for children and adolescents (2–17 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 equipment is required to withdraw the appropriate dose (see information below):

Icatibant pre-filled syringe (with icatibant solution)

Connector (adapter)

Graduated 3 ml syringe

Technical diagram with three syringes labeled A, B, and C showing the disassembled and assembled components of an injection medical device

The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below).

Table 1: Dosing schedule for children and adolescents

Body weight	Injection 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 weighing more than 65 kg will use the entire contents of the prefilled syringe (3 ml).

If you are unsure about the volume of solution to withdraw, consult your doctor, pharmacist, or nurse

Remove the caps from each end of the connector.

Avoid touching the ends of the connector and the syringe tips to prevent contamination

Screw the connector onto the prefilled syringe.

Attach the graduated syringe to the other end of the connector, ensuring both connections are securely fitted.

Diagram of a horizontal syringe with three black curved arrows indicating the pulling motion

Transfer the icatibant solution to the graduated syringe:

To begin transferring the icatibant solution, push the plunger of the prefilled syringe (on the left end of the image shown below).

Technical drawing of a horizontal syringe with two black arrows indicating the movement for withdrawing and inserting the plunger

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

Technical drawing of a horizontal syringe composed of two interlocking parts with a black arrow indicating movement to the right

Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) has been transferred to the graduated syringe. Refer to Table 1 for dose information.

If there is air in the graduated syringe:

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

Vertical medical syringe with plunger and transparent cylindrical barrel, showing motion indicated by a black double-headed arrow

Push the plunger of the graduated syringe to transfer the air back into the pre-filled syringe (this step may need to be repeated several times).

Withdraw the required volume of icatibant solution.

Remove the pre-filled syringe and the syringe connector.

Dispose of the pre-filled syringe and connector in a sharps or puncture-resistant container.

2b) Prepare the syringe and needle for injection: All patients (adults, adolescents, and children)

A hand holds the upper part of a thin, elongated cylindrical container tilted downward

Remove the needle cap from the blister pack
Remove the seal from the needle cap (the needle should remain inside the cap)

Technical drawing of a syringe with needle oriented diagonally downward, with an arrow indicating the lower part of the syringe body

Firmly hold the syringe. Carefully attach the needle to the pre-filled syringe containing the clear solution.

Screw the pre-filled syringe onto the needle, which is still secured in the cap

Pull the syringe to remove the needle from the cap. Do not pull the plunger.

The syringe is now ready for injection

Prepare the injection site

Line drawing showing a hand pinching the skin of the

Select the injection site. The injection should be administered into a skin fold on the abdomen, approximately 5–10 cm (2–4 inches) below the navel, either to the left or right. The area should be at least 5 cm (2 inches) away from any scars. Do not choose an area that is bruised, swollen, or painful.

Clean the injection site by wiping with an alcohol swab, and allow it to dry.

Inject the solution

A hand holds a tilted syringe with an arrow indicating thumb pressure on the plunger to expel liquid

Hold the syringe between two fingers, with your thumb on the end of the plunger

Check that there is no air in the syringe by pressing the plunger until the first drop appears at the tip of the needle

A hand holds a syringe and the tip of the

Hold the syringe with the needle pointing toward the skin at an angle between 45 and 90 degrees

While holding the syringe in one hand, use the other hand to gently pinch a fold of skin between your thumb and fingers at the previously disinfected injection site

Holding the skin fold, bring the syringe forward and quickly insert the needle into the skin fold

Slowly push the plunger firmly until all the fluid has been injected into the skin and no liquid remains in the syringe

Push slowly so that the process takes approximately 30 seconds

Release the skin fold and gently remove the needle

Disposal of injection materials

A hand grips a syringe and pushes it downward with an arrow indicating the direction of

Dispose of the syringe, needle, and needle cap into the sharps container designated for waste materials that may injure others if not handled properly.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Almost all patients receiving icatibant notice a reaction at the injection site (such as skin irritation, swelling, pain, pruritus, redness of the skin, and burning). These effects are usually mild and improve without the need for additional treatment.

Immediately inform your doctor if you notice that your attack symptoms worsen after receiving icatibant.

Very common (may affect more than 1 in 10 people):

Additional reactions at the injection site (feeling of pressure, bruising, decreased sensitivity and/or numbness, increase in skin rash with itching and warmth).

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

Nausea
Headache
Dizziness
Fever
Itching
Rash
Redness of the skin
Abnormal liver function tests

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

Hives (urticaria)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Do not freeze.

Do not use this medicine if you notice damage to the syringe or needle packaging, or if there are visible signs of deterioration; for example, if the solution is cloudy, contains floating particles, or if the solution has changed colour.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Icatibanto Stada

The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as icatibant acetate). Each ml of solution contains 10 mg of icatibant.
The other components are: sodium chloride, glacial acetic acid, sodium hydroxide (to adjust pH), and water for injections.

Appearance of Icatibanto Stada and contents of the pack

Icatibant is presented as a clear, colourless injectable solution in a 3 ml pre-filled glass syringe. The pack contains a hypodermic needle.

Icatibant is available in either a single pack containing one pre-filled syringe with one needle, or in a multiple pack containing three pre-filled syringes with three needles.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio Stada, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare Ltd.,

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

STADA Arzneimittel GmbH

Muthgasse 36/2 1190 Wien,

Austria

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Eurofins PROXY Laboratories (PRX)

Archimedesweg 25 2333 CM Leiden

The Netherlands

Date of the most recent revision of this leaflet: September 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Icatibant Stada 30 mg solution for injection in pre-filled syringe EFG