Icatibant zentiva

Package leaflet: Information for the user

Icatibant Zentiva 30 mg solution for injection in prefilled syringe
Icatibant
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Icatibant Zentiva contains the active substance icatibant.
This medicine is used to treat symptoms of hereditary angioedema (HAE)
in adults, adolescents, and children aged 2 years and above.
In HAE, levels of a substance called bradykinin increase in the blood,
leading to symptoms such as swelling, pain, nausea, and diarrhoea.
Icatibant Zentiva blocks the activity of bradykinin, thereby interrupting the progression of an HAE attack.

2. Important information before using Icatibant Zentiva

When not to use Icatibant Zentiva

• if the patient is allergic to icatibant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Icatibant Zentiva, discuss the following with a doctor:

• if the patient has angina pectoris (reduced blood flow to the heart muscle);
• if the patient has recently had a stroke.

Adverse reactions associated with the use of Icatibant Zentiva are similar to symptoms
of the disease.
If worsening of symptoms occurs after receiving the medicine, the doctor should be contacted immediately.
Furthermore:

• Before self-injecting the medicine or having it administered by a caregiver, the patient or caregiver must be trained in performing subcutaneous injections.
• A patient experiencing an attack involving the larynx (upper airway obstruction), whether self-administering Icatibant Zentiva or receiving it from a caregiver, should seek immediate medical assistance at a healthcare facility.
• If symptoms do not resolve after a single self-administered dose of Icatibant Zentiva or a single dose administered by a caregiver, the patient should seek medical attention or the caregiver should take the patient to a doctor for consideration of a subsequent injection. Adult patients should not receive more than two additional injections within a 24-hour period.

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 this age group.
Icatibant Zentiva and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
No interactions between Icatibant Zentiva and other medicines are known. However, if the patient is taking an angiotensin-converting enzyme (ACE) inhibitor (e.g., captopril, enalapril, ramipril,
quinapril, lisinopril) used to lower blood pressure or for any other reason, the doctor should be informed before using this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before starting treatment with this medicine.
The patient should not breastfeed for 12 hours after taking this medicine.
Driving and operating machinery
Do not drive or operate machinery if the patient experiences fatigue or dizziness caused by an HAE attack or after using Icatibant Zentiva.
Icatibant Zentiva contains sodium
The medicine contains less than 1 mmol (23 milligrams) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Icatibant Zentiva

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor.
If the patient is receiving Icatibant Zentiva for the first time, the first dose is always
administered by a doctor or nurse. The doctor will inform the patient when it is safe to
return home.
After speaking with the doctor or nurse and receiving training in performing subcutaneous
injections, the patient may self-administer Icatibant Zentiva, or a caregiver may administer
Icatibant Zentiva to the patient, in the event of an attack of hereditary angioedema (HAE).
It is important to administer the subcutaneous injection of Icatibant Zentiva as soon as possible
after the onset of symptoms of angioedema. The treating physician will train the patient and
caregiver on how to safely administer this medicine according to the instructions provided in the
"Patient Leaflet".
When and how often to use Icatibant Zentiva
The doctor will determine the exact dose and advise the patient on how often the medicine should be used.
Adults

• The recommended dose of Icatibant Zentiva is one subcutaneous injection (3 mL, 30 mg), administered immediately after recognition of an angioedema attack (e.g., pronounced swelling of the skin, particularly on the face and neck, or worsening abdominal pain).
• If symptoms have not improved after 6 hours, seek medical advice regarding administration of a second injection of Icatibant Zentiva. No more than two injections should be given to adult patients within a 24-hour period.
• Do not administer more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, consult a doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Zentiva is one subcutaneous injection of 1 mL up to a maximum of 3 mL, depending on body weight, administered immediately after recognition of symptoms of an angioedema attack (e.g., pronounced swelling of the skin, particularly on the face and neck, or worsening abdominal pain).
• For further information on dosing, see "Detailed Injection Instructions".
• If the patient is unsure of the correct dose, consult a doctor, pharmacist, or nurse.
• If symptoms worsen or do not improve, seek immediate medical assistance.

How to administer Icatibant Zentiva
Icatibant Zentiva is intended for subcutaneous administration. Each syringe must be used only once.
This medicine is injected using a short needle into the fatty tissue under the skin of the abdomen.
If there are any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
The following detailed instructions apply to:

• Self-administration (adults)
• Administration by a caregiver or healthcare professional to adults, adolescents, and children aged over 2 years (with body weight of at least 12 kg).

The instructions include the following main steps:

1. General information
   2a) Preparation of the pre-filled syringe for children and adolescents (aged 2–17 years) with body weight of 65 kg or less
   2b) Preparation of the pre-filled syringe and injection needle (all patients)
2. Preparation of the injection site
3. Administration of the solution
4. Disposal of injection equipment
   Detailed Injection Instructions
   1) General information

• Before beginning, clean the work surface.
• Wash hands with water and soap.
• Open the packaging by peeling off the seal.
• Remove the pre-filled syringe from the packaging.
• Remove the cap from the end of the pre-filled syringe by unscrewing it.
• After unscrewing the cap, set aside the pre-filled syringe.

2a) Preparation of the pre-filled syringe for children and adolescents (aged 2 to 17 years) with body weight of 65 kg or less:
Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 mL), the following are required to obtain the correct dose from the pre-filled syringe:
a) pre-filled syringe containing Icatibant Zentiva (solution of icatibant)
b) adapter
c) 3 mL graduated syringe

The required dose volume in milliliters should be drawn into an empty 3 mL graduated syringe (see table below).
Table 1: Dosing schedule for children and adolescents

For patients with body weight above 65 kg, the entire contents of the pre-filled syringe (3 mL) should be administered.

If the patient is unsure about the volume of solution to draw up, they should consult a
doctor, pharmacist, or nurse.

1. Remove the protective cap from both ends of the adapter.

Avoid touching the tip and nozzle of the adapter and syringe to prevent
contamination.
2) Screw the adapter onto the pre-filled syringe.
3) Attach the graduated syringe to the other end of the adapter so that both ends are securely connected.

1. To draw up the dose of icatibant solution, press the plunger of the pre-filled syringe (on the left in the illustration below).

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

3. Continue pressing the plunger of the pre-filled syringe until the required volume of solution (dose) has passed into the graduated syringe. Dosing information is provided in Table 1.
   If there is air in the graduated syringe:

• Turn the connected syringes so that the pre-filled syringe is on top.

• Press the plunger of the graduated syringe to return the air into the pre-filled syringe (this step may need to be repeated several times).
• Draw up the required volume of icatibant solution.

4. Disconnect the pre-filled syringe with adapter from the graduated syringe.
5. Place the pre-filled syringe with adapter into a designated sharps container.
   2b) Preparing the pre-filled syringe and needle for injection:
   All patients (adults, children, and adolescents)

• Remove the needle cap from its packaging.
• Remove the sealing layer from the needle cap (the needle should remain in the cap).

• Firmly hold the pre-filled syringe. Carefully place the needle onto the pre-filled syringe containing the clear solution.
• Screw the pre-filled syringe onto the needle, which is still attached to the cap.
• Remove the needle from the cap by pulling the body of the pre-filled syringe. Do not pull the plunger of the pre-filled syringe.
• The pre-filled syringe is now ready for injection.

3) Preparing the injection site

• Select the injection site. The injection site should be a skin fold on the abdomen, approximately 5–10 cm below the navel, on either side. This area of skin should be at least 5 cm away from any scars. Do not select areas of skin with bruises, swelling, or tenderness.
• Clean the injection site by wiping it with an alcohol-soaked gauze pad and allow it to dry.

4) Injecting the solution

• Hold the pre-filled syringe in one hand, between two fingers, with the thumb on the plunger tip.
• Ensure there are no air bubbles in the pre-filled syringe by pressing the plunger until the first drop appears at the needle tip.

• Hold the pre-filled syringe at a 45–90 degree angle to the skin, with the needle pointing toward the skin.
• While holding the pre-filled syringe with one hand, gently grasp the skin fold between the thumb and fingers at the previously disinfected site with the other hand.
• Hold the skin fold, bring the pre-filled syringe close to the skin, and quickly insert the needle into the skin fold.
• Slowly press the plunger of the pre-filled syringe while keeping the hand steady, until all the liquid has been injected into the skin and the pre-filled syringe is completely emptied.
• Press the plunger slowly over approximately 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of injection equipment

• Place the pre-filled syringe, needle, and needle cap into a designated sharps container intended for the disposal of waste materials that may cause cuts or injuries.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
A reaction at the injection site (irritation, swelling, pain, itching, redness of the skin, and burning sensation) occurs in almost all patients receiving Icatibant Zentiva.
These reactions are usually mild and resolve without the need for additional treatment.
Patients should immediately inform their doctor if they notice that symptoms of an attack worsen after taking this medicine.

Very common (may occur in more than 1 in 10 patients):
Additional reactions at the injection site (feeling of pressure, bruising, impaired sensation and/or numbness, itchy raised rash above the surrounding skin surface, and sensation of warmth).

Common (may occur in not more than 1 in 10 patients):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Skin redness
Abnormal liver function tests

Frequency unknown (frequency cannot be estimated from the available data):
Urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Icatibant Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not freeze.
Do not use this medicine if the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, contains solid particles, or if its colour has changed.
Medicines should not be disposed of via the wastewater system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Icatibant Zentiva contains

• The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). Each millilitre 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 Icatibant Zentiva looks like and contents of the pack
Icatibant Zentiva is a clear, colourless solution for injection in a 3 mL glass pre-filled syringe.
A subcutaneous needle is included in the pack.
Icatibant Zentiva is available in single packs containing one pre-filled syringe with one needle, or in multipacks containing three pre-filled syringes with three needles, all in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva k.s
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA 3000, Paola, Malta
Eurofins PROXY Laboratories B.V.
Archimedesweg 25
2333 Leiden
The Netherlands

For further information about this medicinal product, please contact the representative
of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00