Patient Information Leaflet

Icatibanto Glenmark 30 mg Pre-filled Syringe EFG

Icatibanto

Read this leaflet carefully before you start using this medicine, as 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. Do not give it to others even if they have similar symptoms, 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.

Table of Contents

1. What Icatibanto Glenmark is and what it is used for
2. What you need to know before using Icatibanto Glenmark
3. How to use Icatibanto Glenmark
4. Possible side effects
5. Storage of Icatibanto Glenmark
6. Contents of the pack and additional information

Icatibanto Glenmark 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, there are increased concentrations of a substance present in the blood called bradykinin, 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 Glenmark

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

Warnings and Precautions

Consult your doctor before starting to use icatibanto:

• if you suffer from 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 this medication.
• Immediately after self-administering icatibanto or having your caregiver administer it while experiencing a laryngeal crisis (upper airway obstruction), you must seek medical attention at a medical institution.
• If your symptoms do not resolve after an icatibanto injection self-administered or administered by your caregiver, you must consult your doctor about the administration of additional icatibanto injections. In adult patients, up to 2 additional injections may be administered within a 24-hour period.

Children and Adolescents

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

Other Medications and Icatibanto Glenmark

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 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 icatibanto.

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 this medication.

Icatibanto Glenmark contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per syringe, 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 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 Icatibanto Glenmark if you have an acute AEH attack.

It is essential to inject Icatibanto Glenmark subcutaneously (under the skin) as soon as you notice an acute angioedema attack. Healthcare personnel will teach you and your caregiver how to inject icatibant safely, following the prospectus instructions.

When and how often you should use Icatibanto Glenmark

Your doctor has determined the exact dose of icatibant 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, seek medical advice on the administration of additional Icatibanto Glenmark 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, seek medical advice.

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, seek medical advice immediately.

Administration of Icatibanto Glenmark

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

This medication 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)Preparation of the syringe for children and adolescents (2-17 years) who weigh 65 kg or less

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

1. Preparation of the injection site
2. Injection of the solution
3. Disposal of injection materials

Step-by-step instructions for your administration

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Almost all patients who receive Icatibanto Glenmark 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.

Consult your doctor immediately if you notice that your AEH crisis symptoms worsen after receiving this medication.

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
• Skin redness
• 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature 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.

Medicines 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. In this way, you will help protect the environment.

Composition of Icatibanto Glenmark

• 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 (for pH adjustment) and water for injectable preparations (see section 2).

Appearance of Icatibanto Glenmark and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell,

Germany

Manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate, Paola,

PLA 3000,

Malta

or

Eurofins PROXY Laboratories B.V.

Archimedesweg 25 2333 CM Leiden

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:September 2021.

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