Icatibant Cipla 30 mg solution for injection in pre-filled syringe EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read all of 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, 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 may 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 this leaflet

What Icatibant Cipla is and what it is used for
What you need to know before using Icatibant Cipla
How to use Icatibant Cipla
Possible side effects
How to store Icatibant Cipla
Contents of the pack and other information

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

Icatibanto Cipla contains the active substance icatibanto.

This medicine 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.

Icatibanto blocks the activity of bradykinin and thereby halts the progression of symptoms during an HAE attack.

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

Do not use Icatibanto Cipla

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

Warnings and precautions

Consult your doctor before starting to use Icatibanto Cipla:

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

Adverse effects associated with icatibant are similar to the symptoms of your own disease. Immediately consult your doctor if you notice that your attack symptoms worsen after administration of this medicine.

Additionally:

You or your caregiver must learn the technique for subcutaneous injection (under the skin) before self-administering or having this medicine administered by your caregiver.
Immediately after self-administering Icatibanto Cipla or after administration 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 Icatibanto Cipla, consult your doctor regarding administration of additional injections of this medicine. In adult patients, up to 2 additional injections may be administered within 24 hours.

Children and adolescents

Use of this medicine 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 Cipla

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

No interactions between Icatibanto Cipla and other medicines are known. If you are taking a 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 this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 this medicine.

Driving and use of machines

Do not drive or operate machinery if you feel tired or dizzy due to an HAE attack or after using this medicine.

Icatibanto Cipla contains sodium

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

3. How to use Icatibanto Cipla

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

If you have never been administered Icatibanto Cipla before, the first dose must always be injected by a healthcare professional or nurse. Your doctor will discharge you when it is considered safe for you to return home.

After discussing with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver may administer this medicine to you if you experience an HAE attack.

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

When and how often should you use Icatibanto Cipla?

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

Adults

The recommended dose of Icatibanto Cipla 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 notice symptom improvement within 6 hours, seek medical advice regarding additional injections of Icatibanto Cipla. In adults, up to 2 additional injections may be administered within 24 hours.
Do not receive more than 3 injections within a 24-hour period, and if you require more than 8 injections in one month, consult your doctor.

Children and adolescents aged 2 to 17 years

The recommended dose of this medicine is one subcutaneous (under the skin) injection of 1 ml up to a maximum of 3 ml depending on body weight, 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 see the dose you should inject.
If you are unsure about the dose to inject, consult your doctor, pharmacist, or nurse.
If your symptoms worsen or do not improve, you must seek immediate medical advice.

How should Icatibanto Cipla be administered?

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

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

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:

General information

2a) Syringe preparation for children and adolescents (2–17 years) weighing 65 kg or less

2b) Syringe and needle preparation for injection (all patients)

Preparation of the injection site
Injection of the solution
Disposal of injection materials

Step-by-step injection instructions

General information

Clean the work area (surface) to be used before starting the procedure.
Wash your hands with soap and water.
Remove the pre-filled syringe from the carton.
Unscrew and remove the cap from the end of the pre-filled syringe.
Leave the pre-filled syringe uncapped after removing the cap.

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 required to withdraw the appropriate dose (see information below):

Icatibant Cipla pre-filled syringe (containing icatibant solution)
Connector (adapter)
3 ml graduated syringe

Medical diagram with three syringes labeled A, B, and C showing different stages of assembly and configuration of the injection device

The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below).

Table 1: Dosing 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 weighing more than 65 kg will use the entire contents of the pre-filled syringe (3 ml).

Warning symbol consisting of a black exclamation mark inside If you are unsure about the volume of solution to withdraw, consult your doctor, pharmacist, or nurse

Remove the caps from each end of the connector.

Warning symbol with a black exclamation mark inside Avoid touching the ends of the connector and the syringe tips to prevent contamination.

Screw the connector onto the pre-filled syringe.

Attach the graduated syringe to the other end of the connector, ensuring both connections are securely fitted.

Technical diagram of a syringe showing two stages: the first with the plunger advanced, and the second with black arrows indicating pulling motion

Transfer the icatibant solution to the graduated syringe:

To begin transferring the icatibant solution, push the plunger of the pre-filled syringe (on the left end of the image below).

Technical diagram of a syringe showing the plunger movement toward the

If the icatibant solution does not start transferring into the graduated syringe, gently pull back on the plunger of the graduated syringe until the icatibant solution begins to flow into it (see image below).

Technical diagram of a syringe with plunger and cylindrical barrel, with a black arrow indicating movement to the right

Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) has been transferred to the graduated syringe. Refer to Table 1 for dosing information.

If there is air in the graduated syringe:

Rotate the connected syringes so that the pre-filled syringe is on top (see image below).

Vertical medical syringe with plunger and graduated cylindrical barrel, with a black double-headed arrow indicating extraction movement

Push the plunger of the graduated syringe to move the air back into the pre-filled syringe (this step may need to be repeated several times).
Withdraw the required volume of icatibant solution.

Remove the pre-filled syringe and connector from the graduated syringe.

Dispose of the pre-filled syringe and connector in a sharps or puncture-resistant container.

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

A hand holds by the upper part a dropper with a thin, elongated body tilted downward

Remove the needle cap from the blister pack
Remove the seal from the needle cap (the needle should remain inside the cap)

Technical drawing of a syringe with needle pointing diagonally downward, with an arrow indicating the tip of the

Firmly hold the syringe. Carefully attach the needle to the prefilled syringe containing the clear solution.
Screw the prefilled syringe onto the needle, which is 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

Preparing the injection site

Schematic drawing of a hand pinching the skin of the

Select the injection site. The injection site should be a fold of skin on the abdomen, approximately 5–10 cm (2–4 inches) below the navel, to either side. The area should be at least 5 cm (2 inches) away from any scars. Do not choose an area with bruising, swelling, or pain.

Clean the injection site by wiping with an alcohol swab, and allow it to dry.

Injecting the solution

A hand holding a syringe with needle pointing upward

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

Check that there is no air in the syringe by pressing the plunger until the first drop appears at the tip of the needle

Schematic drawing of two hands holding a syringe to inject medication into the lower part of the

Hold the syringe with the needle pointing toward the skin at an angle between 45 and 90 degrees
While holding the syringe in one hand, use the other hand to gently pinch a skin fold between your thumb and fingers at the previously disinfected site
Holding the skin fold, bring the syringe forward and quickly insert the needle into the skin fold
Slowly press the plunger steadily until all the fluid has been injected under the skin and no liquid remains in the syringe
Press slowly so that the process takes approximately 30 seconds
Release the skin fold and gently withdraw the needle

Disposal of injection materials

A hand holds a tilted syringe being inserted downward through a hole in a flat, square surface

Dispose of the syringe, needle, and needle cap into the sharps container designated for disposal of waste materials that could injure others if not handled properly.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Almost all patients receiving Icatibant Cipla notice 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.

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

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, increase in 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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Icatibant Cipla

Keep this medicine out of the 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 Cipla

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 (see section 2).

Nature and contents of the container

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

Icatibanto Cipla 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

Cipla Europe NV
De Keyserlei 60C, Bus-1301,
2018 Antwerp, Belgium

Manufacturer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Eurofins PROXY Laboratories (PRX)
Archimedesweg 25
2333 CM Leiden
The Netherlands

Local representative

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edif. Britannia
28003 Madrid, Spain

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

Germany	Icatibant Cipla 30 mg solution for injection in pre-filled syringe
Spain	Icatibant Cipla 30 mg solution for injection in pre-filled syringe EFG
Norway	Icatibant Cipla

Date of the most recent review 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/)