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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire 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 you should not give it to other people, even if they have the same symptoms as you, because 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

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

2. What you need to know before using Icatibant Fresenius

3. How to use Icatibant Fresenius

4. Possible side effects

5. Storage of Icatibant Fresenius

6. Contents of the pack and other information

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

This medicine contains the active substance icatibant.

Icatibant is used for the treatment of 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 starting to use Icatibant Fresenius

Do not use Icatibanto Fresenius

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

Warnings and precautions

Consult your doctor before starting to use Icatibanto Fresenius:

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

The adverse effects associated with Icatibant are similar to the symptoms of your own illness. Immediately consult your doctor if you notice that your attack symptoms worsen after receiving Icatibant.

Additionally:

• You or your caregiver must learn the technique for administering subcutaneous injections (under the skin) before self-administering or having your caregiver administer Icatibant.
• Immediately after self-administering Icatibant or having it administered by your caregiver during a laryngeal attack (upper airway obstruction), 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, you should consult your doctor regarding the administration of additional Icatibant injections. In adult patients, up to 2 additional injections may be administered within 24 hours.

Children and adolescents

The use of Icatibant is not recommended in 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 Fresenius

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

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

Pregnancy and lactation

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

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

Driving and operating machinery

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

Icatibant Fresenius contains sodium

This medicine contains less than 23 milligrams (1 mmol) of sodium per dose, therefore it is considered essentially "sodium-free".

3. How to use Icatibant Fresenius

Follow exactly the administration instructions for this medicine as given by your doctor.

If in doubt, consult your doctor again.

If you have never been administered Icatibant before, the first dose must always be given by medical or nursing personnel. 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 Icatibant to yourself during an HAE attack. It is important to inject Icatibant subcutaneously (under the skin) as soon as you notice an angioedema attack. Healthcare professionals will teach you and your caregiver how to safely inject Icatibant, following the instructions in this leaflet.

When and how often should you use Icatibanto Fresenius?

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

Adults

• The recommended dose of Icatibant is one injection (3 ml, 30 mg) administered 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).

• If you do not experience symptom improvement after six hours, seek medical advice regarding the administration of additional Icatibant injections. 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, you must seek medical advice.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant is one subcutaneous injection (under the skin) of 1 ml up to a maximum of 3 ml, depending on body weight, administered 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 determine the correct dose to inject.

• If you are unsure about the dose to administer, consult your doctor, pharmacist, or nurse.

-If your symptoms worsen or do not improve, you must seek immediate medical advice.

How should Icatibanto Fresenius be administered?

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

Icatibanto Fresenius is injected with a short needle into the fatty tissue beneath the skin of the abdomen (tummy). 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:

1. General information

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

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

3. Preparing the injection site
4. Injecting the solution
5. Disposing of injection materials

Step-by-step instructions for the injection

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Almost all patients receiving Icatibant experience a reaction at the injection site (such as skin irritation, swelling, pain, pruritus, redness of the skin, and burning sensation). 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 (feeling of pressure, bruising, decreased sensitivity and/or numbness, increased 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)

Immediately inform your doctor if you notice that the symptoms of the attack worsen after receiving Icatibant.

If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Fresenius

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

Do not use this medicine after the expiry date stated on the carton and on the prefilled syringe after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Do not freeze.

Use immediately after opening and only if the packaging is undamaged. For single use only.

Do not use this medicine if you notice that the syringe or needle packaging is damaged 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 Fresenius

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. The other components are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injections.

Appearance of the product and contents of the pack

Icatibanto Fresenius is presented as a clear, colourless injectable solution in a pre-filled syringe.

3 ml of solution in a 3 ml pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber coated with fluorocarbon polymer). One hypodermic safety needle (25 G; 16 mm) is supplied in the carton.

Packaged as a single pre-filled syringe with one needle or as a multiple pack of three pre-filled syringes with three safety needles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

C/Marina 16-18

08005 Barcelona

Spain

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz

Austria

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: April 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/