Prospect: information for the user

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

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• Consult your doctor or pharmacist if you experience any adverse effects,including those not listed in this prospect. See section 4.

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

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

3.How to use Icatibanto Fresenius

4.Possible adverse effects

5Storage of Icatibanto Fresenius

6.Contents of the package and additional information

This medication contains the active ingredient icatibanto.

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

In HAE, the concentrations of a substance present in the blood called bradykinin increase, which produces symptoms such as swelling, pain, nausea, and diarrhea.

Icatibanto blocks the activity of bradykinin and, therefore, slows the progression of symptoms of an HAE crisis.

No use Icatibanto Fresenius

• 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 useIcatibanto Fresenius:

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

The side effects related to Icatibanto are similar to the symptoms of your own disease. Consult your doctor immediately if you notice that the symptoms of the crisis worsen after Icatibanto 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 Icatibanto.
• Immediately after self-administering Icatibanto 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 injection of self-administered or caregiver-administered Icatibanto, you must consult your doctor about the administration of additional Icatibanto injections. In adult patients, up to 2 additional injections may be administered within 24 hours.

Children and Adolescents

Icatibanto is not recommended for use in 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 Fresenius

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

No interactions of Icatibanto 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 Icatibanto.

Pregnancy and Lactation

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 this medication.

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

Driving and Operating Machines

Do not drive or operate machines if you feel tired or dizzy due to the AEH crisis or after using Icatibanto Fresenius.

Icatibanto Fresenius Contains Sodium

This medication contains less than 23 milligrams (1 mmol) of sodium per dose, making it essentially “sodium-free”.

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 been administered Icatibanto 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 Icatibanto if you have an AEH crisis. It is essential to inject Icatibanto subcutaneously (under the skin) as soon as you notice a crisis of angioedema. Healthcare personnel will teach you and the person caring for you how to inject Icatibanto safely, following the prospectus instructions.

When and how often should you use Icatibanto Fresenius?

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

Adults

• The recommended dose of Icatibanto is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice the crisis of angioedema (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, you should seek medical advice on the administration of additional Icatibanto injections. In adults, up to two additional injections can be administered within 24 hours.

• You should not receive more than three injections in a 24-hour period, and if you need more than 8 injections in a month, you should seek medical advice.

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 based on body weight administered subcutaneously (under the skin) as soon as you notice symptoms of an angioedema crisis (for example, increased skin swelling, especially on the face and neck, or increased abdominal pain).

• Consult the usage instructions 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, you should seek medical advice immediately..

¿How should Icatibanto Fresenius be administered?

Icatibanto Fresenius is administered by subcutaneous injection (under the skin). Each syringe should only be used once.

Icatibanto Fresenius is injected with a short needle into 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)Preparing the syringe for children and adolescents (2-17 years) who weigh 65 kg or less

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

1. Preparing the injection site
2. Injecting the solution
3. Disposing of the injection materials

Step-by-step instructions for the injection

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Almost all patients who receive Icatibanto 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.

Very common (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).

Common (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)

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

If you experience adverse effects, consult your doctor, even if they are adverse effects that do not appear in this prospectus.

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 Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not store at a temperature above 30°C. Do not freeze.

Use immediately after opening and only in undamaged containers. For single use only.

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 containers and medications that you no longer need. This will help protect the environment.

Composition of Icatibanto Fresenius

The active ingredient is icatibanto. Each pre-filled syringe contains 30 milligrams of icatibanto (in the form of acetate). Each milliliter of solution contains 10 mg of icatibanto. The other components are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

Icatibanto Fresenius is presented as a transparent and colorless injectable solution in a pre-filled syringe.

3 ml of solution in a 3 ml pre-filled syringe (type I glass) with a stopper (bromobutyl covered with fluorocarbon polymer). In the box, a safety hypodermic needle (25 G; 16 mm) is supplied.

Unit package of one pre-filled syringe with a needle or in a multiple package of three pre-filled syringes with three safety needles.

Only some package sizes may be commercially available.

Marketing authorization holder

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leaflet: April2022

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