Icatibant fresenius

Package leaflet: Information for the user

Icatibant Fresenius, 30 mg, solution for injection in pre-filled syringe
Icatibantum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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. How to store Icatibant Fresenius
6. Contents of the pack and other information

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

Icatibant Fresenius contains the active substance icatibant.
Icatibant Fresenius is intended for the treatment of symptoms of hereditary angioedema (HAE) in adults, adolescents, and children aged 2 years and older.
In HAE, levels of a substance called bradykinin increase in the blood, leading to symptoms such as swelling, pain, nausea, and diarrhoea.
Icatibant Fresenius blocks the activity of bradykinin, thereby interrupting the progression of HAE attack symptoms.

2. Important information before using Icatibant Fresenius

When not to use Icatibant Fresenius:

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

Warnings and precautions
Before starting treatment with Icatibant Fresenius, discuss the following with your doctor:

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

Some of the adverse reactions associated with the use of Icatibant Fresenius are similar to
the symptoms of the disease.
If worsening of attack symptoms occurs after administration of Icatibant Fresenius, the doctor should be
notified immediately.
Moreover:

• Before self-administering Icatibant Fresenius or before administering Icatibant Fresenius 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), who self-administers Icatibant Fresenius or receives it from a caregiver, should immediately seek medical assistance at a specialized medical facility.
• If symptoms do not subside after a single self-administration of Icatibant Fresenius or a single administration 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 of Icatibant Fresenius. Adult patients should not receive more than two additional injections within 24 hours.

Children and adolescents
The use of Icatibant Fresenius 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 Fresenius with other medicines
Inform the doctor about all medicines currently used, recently used, or planned to be used.
No interactions between Icatibant Fresenius and other medicines are known. However, if the patient is taking a medicine known as an angiotensin-converting enzyme (ACE) inhibitor (e.g. captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, the doctor should be informed before using Icatibant Fresenius.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might 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 administration of Icatibant Fresenius.
Driving and operating machinery
Patients should not drive or operate machinery if they experience fatigue or dizziness due to an HAE attack or following administration of Icatibant Fresenius.
Icatibant Fresenius contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Icatibant Fresenius

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor.
If the patient is using Icatibant Fresenius for the first time, the first dose is always administered
by a doctor or nurse. The doctor will advise the patient when it is safe to return home. After
consultation with the doctor or nurse and training in subcutaneous injections, the patient may
self-administer Icatibant Fresenius, or the caregiver may administer Icatibant Fresenius to the
patient, in case of an attack of hereditary angioedema (HAE).
It is important to administer the subcutaneous injection of Icatibant Fresenius as soon as
possible after the onset of an angioedema attack. The treating physician will train the patient
and caregiver on how to safely administer Icatibant Fresenius, according to the instructions
provided in the patient leaflet.

When and how often to use Icatibant Fresenius
The doctor will determine the exact dose of Icatibant Fresenius and advise the patient on how
often it should be used.

Adults

• The recommended dose of Icatibant Fresenius is one subcutaneous injection (3 ml, 30 mg), administered immediately after the onset of an angioedema attack (e.g., severe swelling of the skin, particularly in the face and neck area, worsening abdominal pain).
• If symptoms have not improved after 6 hours, consult the doctor for administration of a second injection of Icatibant Fresenius. No more than two additional injections should be given to adult patients within 24 hours.
• Do not administer more than 3 injections within 24 hours. If the patient requires more than 8 injections per month, contact the doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Fresenius is one subcutaneous injection of 1 ml up to a maximum of 3 ml, depending on body weight, administered immediately after the onset of symptoms of an angioedema attack (e.g., severe skin swelling, particularly in the face and neck area, worsening abdominal pain).
• For further information on dosing, see “Detailed Injection Instructions”.
• If the patient is unsure about the dose to administer, consult the doctor, pharmacist, or nurse.
• If symptoms worsen or do not improve, seek immediate medical attention.

How to administer Icatibant Fresenius
Icatibant Fresenius is intended for subcutaneous administration. Each pre-filled syringe must be
used only once.
Icatibant Fresenius 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 the doctor
or pharmacist.

The detailed injection instructions below 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 to 17 years) with
   body weight of 65 kg or less
   2b) Preparation of the pre-filled syringe and needle for injection (all patients)
2. Preparation of the injection site
3. Injection of the solution
4. Disposal of injection equipment

Detailed Injection Instructions
1) General Information

• Before starting, 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.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing 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 (see below):
a) pre-filled syringe containing Icatibant Fresenius (solution of icatibant),
b) adapter (connector),
c) 3 ml syringe with graduations.

The required volume of solution in millilitres should be drawn into an empty 3 ml syringe with
graduations (see table below).
Table 1. Dosing schedule for children and adolescents
Body weight     Volume of solution
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 with body weight above 65 kg should receive the full content of the pre-filled syringe (3 ml).
If the patient is uncertain about the volume of solution to draw, consult the

doctor, pharmacist, or nurse.

1. Remove the caps from both ends of the adapter.
   Avoid touching the ends or tip of the adapter and syringe to prevent contamination.

2. Screw the adapter onto the pre-filled syringe.
3. Attach the graduated 3 ml syringe to the other end of the adapter, ensuring a tight connection.

Drawing icatibant solution into the graduated syringe:

1. To begin drawing the 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 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 transferred into the graduated syringe. Dosing information is provided in Table 1.

If there is air in the graduated syringe:

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

• 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 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) Preparation of the pre-filled syringe and needle for injection
All patients (adults, adolescents, and children)

• Remove the needle with safety shield from its packaging.
• Remove the protective seal from the needle (the needle should remain in its protective cover).

• Hold the syringe firmly. Carefully attach the needle to the syringe containing the clear solution. Press and turn clockwise firmly to secure.

• Pull the needle safety shield towards the syringe, away from the needle.

• Remove the needle from its cover by pulling the syringe body. Do not pull the plunger.

• The syringe is now ready for injection.

3) Preparation of 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 should be at least 5 cm away from any scars. Do not select injection sites with bruises, swelling, or tenderness.
• Clean the injection site by wiping with an alcohol-soaked gauze pad and allow it to dry.

4) Injection of the solution

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

• Hold the syringe at a 45–90 degree angle to the skin, with the needle pointing toward the skin.
• While holding the sy游戏副本

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences 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 Fresenius. These reactions are usually mild and resolve 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, impaired sensation and/or numbness, raised itchy rash on the skin, and feeling of warmth).
Common (may affect up to 1 in 10 people):

• nausea;
• headache;
• dizziness;
• fever;
• itching;
• rash;
• skin redness;
• abnormal liver function test results.

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

• urticaria.

If you notice worsening of symptoms or exacerbation of the disease episode after administration of Icatibant Fresenius, inform your doctor immediately.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 enables the collection of further information on the safety of the medicine.

5. How to store Icatibant Fresenius

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the prefilled syringe after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze.
Use immediately after opening and only use undamaged packaging.
For single use only.
Do not use this medicine if the prefilled syringe or the needle packaging is damaged, or if there are any visible signs of deterioration, for example if the solution is cloudy, contains particles, or has changed colour.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Icatibant Fresenius contains

• The active substance is icatibant. Each pre-filled syringe contains 30 mg of icatibant (as acetate). Each ml of solution contains 10 mg of icatibant.
• The other ingredients are: sodium chloride, glacial acetic acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.

What Icatibant Fresenius looks like and contents of the pack
Icatibant Fresenius is a clear, colourless solution for injection in a pre-filled syringe (made of colourless type I glass) with a capacity of 3 ml, fitted with a plunger stopper made of bromobutyl rubber coated with a fluoropolymer, placed in a cardboard carton.
A single-use subcutaneous needle with safety device (25G; 16 mm) is supplied with each pre-filled syringe.
Icatibant Fresenius is available in packs containing one pre-filled syringe with one safety-protected needle or three pre-filled syringes with three safety-protected needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Austria

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

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