Introduction

Leaflet: information for the user

Icatibanto Stada 30 mg injectable solution in pre-filled syringe EFG

Read 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to use Icatibanto Stada

3.How to use Icatibanto Stada

4.Possible side effects

5.Storage of Icatibanto Stada

6.Contents of the pack and additional information

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

Icatibanto Stada contains the active ingredient icatibanto.

This medication is used for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children over 2 years old.

In HAE, blood concentrations of a substance called bradykinin increase, producing symptoms such as swelling, pain, nausea, and diarrhea.

Icatibanto blocks bradykinin activity and thereby slows the progression of HAE symptoms during an episode.

2. What you need to know before starting to use Icatibant Stada

No use Icatibanto Stada

-if you are allergic to icatibant or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before starting to use icatibant:

-if you have angina pectoris (reduced blood flow to the heart).

-if you have recently had a stroke.

The side effects related to icatibant are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the crisis worsen after icatibant is administered.

Additionally:

-You or your caregiver must learn the technique of subcutaneous injection (under the skin) before self-administering or having your caregiver administer this medication.

-Immediately after self-administering icatibant or having your caregiver administer it while experiencing a laryngeal crisis (obstruction of the upper airway), you must seek medical attention at a medical institution.

-If your symptoms do not resolve after an icatibant injection self-administered or administered by your caregiver, you must consult your doctor about the administration of additional injections of this medication. In adult patients, up to 2 additional injections may be administered within 24 hours.

Children and Adolescents

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

Other Medications and Icatibanto Stada

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

No interactions of icatibant with other medications are known. If you are taking an angiotensin-converting enzyme inhibitor (ACEI) (e.g., captopril, enalapril, ramipril, quinapril, lisinopril) to reduce blood pressure or for any other reason, inform your doctor before using this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before starting to use icatibant.

If you are breastfeeding, do not breastfeed your child for 12 hours after the last administration of icatibant.

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy due to an AEH crisis or after using icatibant.

Icatibanto Stada contains sodium

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

3. How to use Icatibant Stada

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

If you have never received icatibant before, the first dose must always be injected by medical or nursing staff. Your doctor will discharge you when they consider it safe for you to go home.

After analyzing it with your doctor or nurse, and after learning the technique for subcutaneous injections (under the skin), you or the person caring for you can administer this medication if you have an acute angioedema attack.

It is essential to inject icatibant subcutaneously (under the skin) as soon as you notice an acute angioedema attack. Healthcare personnel will teach you and the person caring for you how to inject this medication safely, following the prospectus instructions.

When and how often should you use Icatibanto Stada?

Your doctor has determined the exact dose of this medication and will tell you how often to use it.

Adults

-The recommended dose of icatibant is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the acute angioedema attack (for example, with increased skin swelling, especially on the face and neck, or increased abdominal pain).

-If you do not notice an improvement in symptoms, after six hours, ask your doctor about the administration of additional icatibant injections. In adults, up to two additional injections can be administered within 24 hours.

-You should not receive more than 3 injections in a 24-hour period and if you need more than 8 injections in a month, ask your doctor.

Children and adolescents aged 2 to 17 years

-The recommended dose of icatibant is one injection of 1 ml up to a maximum of 3 ml based on body weight administered subcutaneously (under the skin) as soon as symptoms of an acute angioedema attack are noticed (for example, increased skin swelling, especially on the face and neck, or increased abdominal pain).

-See the usage instructions section to see the dose you should inject.

-If you are unsure about the dose you should inject, consult your doctor, pharmacist, or nurse.

-If your symptoms worsen or do not improve, ask your doctor immediately.

Administration form

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

This medication is injected with a short needle in the fatty tissue located under the skin of the abdomen (stomach).

If you have any other doubts about the use of this medication, 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 old (who weigh at least 12 kg).

The instructions include the following main steps:

1)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)

3)Preparation of the injection site

4)Injection of the solution

5)Disposal of injection materials

Step-by-step instructions for injection

1) General information

Clean the work surface area to be used before starting the process.
Wash your hands with water and soap
Remove the preloaded syringe from the packaging
Unscrew and remove the cap from the end of the preloaded syringe
Leave the preloaded 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 needed to extract the correct dose (see information below):

a) Preloaded syringe of icatibant (with icatibant solution)

b) Connector (adapter)

c) 3 ml graduated syringe

The required injection volume in ml must be prepared in a 3 ml graduated syringe (see table below).

Table 1: Dosage 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 weighingmore than 65 kgwill use the entire contents of the preloaded syringe (3 ml).

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

1) Remove the caps from each end of the connector.

Avoid touching the connector ends and needle tips to prevent contamination

2) Screw the connector onto the preloaded syringe.

3) Connect the graduated syringe to the other end of the connector, ensuring both connections fit securely.

Transfer the icatibant solution to the graduated syringe:

1) To initiate the transfer of the icatibant solution, push the plunger of the preloaded syringe (on the left end of the image below).

2) If the icatibant solution does not start to transfer to the graduated syringe, pull a little on the plunger of the graduated syringe until the icatibant solution starts to flow into the graduated syringe (see the image below).

3) Continue pushing the plunger of the preloaded syringe until the required injection volume (dose) is transferred to the graduated syringe. See Table 1 for dosage information.

If there is air in the graduated syringe:

•Turn the connected syringes so that the preloaded syringe is on top (see the image below).

•Push the plunger of the graduated syringe to transfer the air back to the preloaded syringe (this step may need to be repeated several times).

•Extract the required volume of icatibant solution.

4) Remove the preloaded syringe and connector from the graduated syringe.

5) Dispose of the preloaded syringe and connector in the sharp object container for disposal of materials that can harm others if not handled correctly.

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

•Remove the needle cap from the blister

•Remove the seal from the needle cap (the needle should remain inside the cap)

•Hold the syringe firmly. Carefully connect the needle to the preloaded syringe with the colorless solution.

•Secure the preloaded syringe to the needle, still fixed 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

3) Preparation of 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, to one side or the other. The area should be at least 5 cm (2 inches) away from any scars. Do not choose an area with hematomas, inflammation, or pain.

•Clean the injection site by rubbing with an alcohol wipe, and let it dry.

4) Injection of the solution

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

•Verify that there is no air in the syringe, by pressing the plunger until the first drop appears at the needle tip

•Hold the syringe with the needle pointing at the skin at an angle of 45 to 90 degrees

•Hold the syringe in one hand, and with the other, take a skin fold between your thumb and fingers, in the previously disinfected area

•Hold the skin fold, bring the syringe close, and quickly insert the needle into the skin fold

•Slowly push the plunger with firm pressure, 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 remove the needle gently

5) Disposal of injection materials

•Dispose of the syringe, needle, and cap in the sharp object container for disposal of materials that can harm others if not handled correctly.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive icatibant notice a reaction at the injection site (such as skin irritation, inflammation, pain, itching, skin redness, and burning). These effects are usually mild and improve without the need for additional treatment.

Inform your doctor immediately if you notice that the symptoms of the crisis worsen after receiving icatibant.

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

Additional reactions at the injection site (sensation of pressure, bruising, decreased sensitivity and/or numbness, increased skin rash with itching and heat).

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

Nausea

Headache

Dizziness

Fever

Itching

Rash

Redness of the skin

Abnormal liver function tests

Unknown Frequency(cannot be estimated from available data):

Hives (urticaria)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of Icatibanto Stada

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

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

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

Do not use this medication if you observe that the syringe or needle container is damaged or if you observe visible signs of deterioration; for example, if the solution is cloudy, if it contains floating particles, or if the solution color has changed.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Icatibanto Stada

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

Appearance of Icatibanto Stada and contents of the packaging

Icatibanto is presented as a transparent and colorless injectable solution in a 3 ml pre-filled glass syringe. The packaging contains a hypodermic needle.

Icatibanto is available in a single pre-filled syringe with a needle or in a multiple packaging of three pre-filled syringes with three needles.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for themanufacturing

Holder of the marketing authorization

Stada Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible for the manufacturing

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

Netherlands

Last review date of this leaflet:September 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/