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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

icatibant

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, consult 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents

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

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

Icatibanto Glenmark contains the active substance icatibant.

Icatibant 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, causing 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 Glenmark

Do not use Icatibanto Glenmark

• 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.

The adverse effects associated with icatibant are similar to the symptoms of your own disease. Contact your doctor immediately 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 this medicine administered by your caregiver.
• Immediately after self-administering icatibant or after it has been 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 icatibant injections. In adult patients, up to 2 additional injections may be given 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 Glenmark

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 icatibant.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

Icatibanto Glenmark contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per syringe and is therefore considered essentially "sodium-free".

3. How to use Icatibanto Glenmark

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

If you have never been administered icatibanto before, the first dose must always be injected 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 after learning the technique for subcutaneous injections (under the skin), you or your caregiver may administer Icatibanto Glenmark to yourself during an HAE attack.

It is important to inject Icatibanto Glenmark subcutaneously (under the skin) as soon as you notice an angioedema attack. Healthcare professionals will teach you and your caregiver how to safely inject icatibanto, following the instructions in the package leaflet.

When and how often to use Icatibanto Glenmark

Your doctor has determined the exact dose of icatibanto 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 (for example, increasing skin swelling, especially in the face and neck, or increasing abdominal pain).
• If you do not notice improvement of symptoms, after six hours you should seek medical advice regarding the administration of additional injections of Icatibanto Glenmark. 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 a month, you should seek medical advice.

Children and adolescents aged 2 to 17 years

• The recommended dose of icatibant is one 1 ml injection 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, increasing skin swelling, especially in the face and neck, or increasing abdominal pain).
• Refer to the instructions for use 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, you must seek immediate medical advice.

Administration of Icatibant Glenmark

Icatibant Glenmark is administered by subcutaneous injection (under the skin). Each syringe must be used only once.

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

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) 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 administration instructions

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Almost all patients receiving Icatibant Glenmark 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.

Contact your doctor immediately if you notice that your HAE attack symptoms worsen after receiving this medicine.

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

Additional injection site reactions (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
• Skin redness
• Abnormal liver function tests

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

• Hives (urticaria)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Glenmark

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated 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 Glenmark

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

What Icatibanto Glenmark looks like and contents of the pack

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

Icatibanto Glenmark is available in 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 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

Eurofins PROXY Laboratories B.V.

Archimedesweg 25

2333 CM Leiden

The Netherlands

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last 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 Medical Devices (AEMPS) (http://www.aemps.gob.es/).