Icatibant Teva

Package leaflet: Information for the user

Icatibant Teva 30 mg, solution for injection in pre-filled syringe

Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Icatibant Teva contains the active substance icatibant.
Icatibant Teva is used to treat the symptoms of hereditary angioedema (HAE) in adults,
adolescents, and children aged 2 years and older.
In HAE, levels in the blood of a substance called bradycinin increase, causing symptoms such as
swelling, pain, nausea, and diarrhoea.
Icatibant Teva blocks the activity of bradykinin and thus stops the progression of symptoms.

2. What you need to know before using Icatibant Teva

Do not use Icatibant Teva

• 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 Teva:

• if you suffer from angina (reduced blood flow to the heart muscle);
• if you have recently had a stroke.

Some of the side effects associated with Icatibant Teva are similar to the symptoms of the disease you have. Inform your doctor immediately if you notice that your attack symptoms worsen after administration of Icatibant Teva.
Additionally:

• You or the person caring for you must have been trained in the subcutaneous injection technique (under the skin) before self-administering or administering Icatibant Teva.
• In case of a laryngeal attack (obstruction of the upper airways), immediately after self-administering Icatibant Teva or after Icatibant Teva has been administered by the caregiver, you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administering or after having received an injection of Icatibant Teva, consult a doctor for additional injections of Icatibant Teva. For adult patients, up to 2 additional injections may be administered within 24 hours.

Children and adolescents
The use of Icatibant Teva 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 Icatibant Teva
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interactions of Icatibant Teva with other medicines are known. If you are taking a medicine known as an angiotensin-converting enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril), which is used to lower blood pressure or for other reasons, inform your doctor before taking Icatibant Teva.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
If you are breastfeeding, you must not breastfeed for 12 hours following the last administration of Icatibant Teva.
Driving and using machines
Do not drive or operate machinery if you feel tired or dizzy after an HAE attack or after administration of Icatibant Teva.
Icatibant Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 3 ml, i.e. essentially "sodium-free".

3. How to use Icatibant Teva

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
If you have never received Icatibant Teva before, your first dose of Icatibant Teva will always be
administered by your doctor or nurse. Your doctor will advise you when it is safe for you to return home.
After discussing with your doctor or nurse and receiving training on the subcutaneous (under the skin)
injection technique, you may self-administer Icatibant Teva during an HAE attack, or have it administered
by your caregiver. It is important that Icatibant Teva is injected subcutaneously (under the skin) as soon
as an angioedema attack begins.
Your healthcare provider will train you and your caregiver on how to safely inject Icatibant Teva,
following the instructions in the package leaflet.

When and how often to use Icatibant Teva?
Your doctor has determined the exact dose of Icatibant Teva and will advise you on the frequency of use.

Adults

• The recommended dose of Icatibant Teva is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as symptoms of angioedema appear (e.g., increasing swelling of the skin, especially on the face and neck, or worsening abdominal pain).
• If you do not notice symptom relief within 6 hours, contact your doctor for additional Icatibant Teva injections. In adults, up to 2 additional injections may be administered within 24 hours.
• Do not administer more than 3 injections within 24 hours, and if more than 8 injections are needed in one month, consult your doctor.

Children and adolescents aged 2 to 17 years

• The recommended dose of Icatibant Teva is one subcutaneous (under the skin) injection of 1 ml up to a maximum of 3 ml, depending on body weight, administered at the first sign of an angioedema attack (e.g., increasing skin swelling, especially on the face and neck, or worsening abdominal pain).
• For the exact dose to inject, see the section on instructions for use.
• If you are unsure which dose to administer, consult your doctor, pharmacist, or nurse.
• If symptoms worsen or you do not experience relief, seek immediate medical assistance.

How should Icatibant Teva be administered?
Icatibant Teva is injected subcutaneously (under the skin). Each syringe must be used only once.
Icatibant Teva is injected with a short needle into the fatty tissue under the skin of the abdomen (stomach).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

Step-by-step instructions are provided for:

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

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
   2b) Preparation of the syringe and needle for injection (all patients)
2. Preparation of the injection site
3. Injection of the solution
4. Disposal of injection materials

Step-by-step injection instructions

1) General information:

• Before starting the procedure, clean the work area (surface) to be used.
• Wash your hands with soap and water.
• Remove the pre-filled syringe from its packaging.
• Unscrew and remove the cap from the end of the pre-filled syringe.
• After removing the cap, place the syringe on a flat surface.

2a) Preparation of the syringe for children and adolescents (aged 2–17 years) weighing ≤65 kg
Important information for healthcare professionals and caregivers:
When the dose is less than 30 mg (3 ml), the following materials are required to withdraw the appropriate dose (see below):
a) Pre-filled syringe of Icatibant Teva (containing icatibant solution)
b) Connector (adapter)
c) Graduated 3 ml syringe

The required injection volume in ml must be withdrawn into an empty graduated 3 ml syringe (see table below).
Table 1: Dosing regimen for children and adolescents
Body weight Injection volume
12–25 kg 1.0 ml
26–40 kg 1.5 ml
41–50 kg 2.0 ml
51–65 kg 2.5 ml
Patients weighing over 65 kg will use the entire contents of the pre-filled syringe (3 ml).

If you are unsure about the volume of solution to withdraw, consult your doctor, pharmacist, or nurse.

1. Remove the caps from both ends of the connector.

Avoid touching the ends of the connector or the tips of the syringes to prevent contamination.
2) Screw the connector onto the pre-filled syringe.
3) Attach the graduated syringe to the other end of the connector, ensuring both connections are securely fastened.

Transferring the icatibant solution:

1. To begin transferring the icatibant solution, push the plunger of the pre-filled syringe (far left in the figure below).

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

3. Continue pushing the plunger of the pre-filled syringe until the required injection volume (dose) has been transferred into the graduated syringe. For dosing information, see Table 1.
   If there is air in the graduated syringe:

• Invert the connected syringes so that the pre-filled syringe is on top (see figure below).

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

4. Detach the pre-filled syringe and connector from the graduated syringe.
5. Dispose of the pre-filled syringe and connector in a sharps container.

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

• Remove the needle cap from its blister pack.
• Peel off the film from the cap (the needle should still be inside the cap).
• Hold the syringe firmly. Carefully attach the needle to the syringe containing the clear solution.
• Screw the syringe onto the needle while the needle is still in the cap.
• Remove the needle from the cap by pulling the syringe. Do not pull the plunger.

• The syringe is now ready for injection.

3) Preparation of the injection site

• Choose the injection site. The injection site should be a skin fold on the abdomen located approximately 5–10 cm (2–4 inches) below the navel, on either side. The area should be at least 5 cm (2 inches) away from any scars. Do not select an area that is bruised, swollen, or tender.
• Disinfect the injection site by wiping it with an alcohol-soaked cotton ball and allow it to dry.

4) Injection of the solution

• Hold the syringe between two fingers of one hand, with your thumb on the plunger.
• Ensure there are no air bubbles in the syringe by pushing 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 injection site.
• 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 injection site.
• While holding the skin fold, bring the syringe to the skin and quickly insert the needle into the fold.
• Slowly and steadily push the syringe plunger until all the liquid has been injected and the syringe is empty.
• Push slowly: the injection should take about 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of injection materials

• Dispose of the syringe, needle, and its cap in a sharps container intended for the disposal of waste that could injure others if not handled properly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Almost all patients treated with Icatibant Teva develop a reaction at the injection site (such as skin irritation, swelling, pain, itching, redness of the skin, and burning sensation). These effects are usually mild in severity and resolve spontaneously without requiring further treatment.

Very common (may affect more than 1 in 10 people):
Additional reactions at the injection site (feeling of pressure, bruising, loss of sensitivity and/or numbness, itchy and swollen skin rash, and warmth).

Common (may affect up to 1 in 10 people):
Feeling unwell
Headache
Dizziness
Fever
Itching
Skin rash
Skin redness
Abnormal liver function tests

Not known (frequency cannot be estimated from the available data):
Urticaria

Immediately inform your doctor if you notice that the symptoms of the attack worsen after administration of Icatibant Teva.
If you experience any side effect, including those not listed in this leaflet, consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Icatibant Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
"Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are
obvious signs of deterioration, for example if the solution is cloudy, contains floating particles or if the colour of the solution has changed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Icatibant Teva contains

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

Description of the appearance of Icatibant Teva and package contents
The solution is a clear, colourless liquid. 3 ml of solution contained in a 3 ml glass pre-filled syringe with a piston seal. A hypodermic needle (25G, 16 mm) is included in the package.
Icatibant Teva is available in single packs containing one pre-filled syringe and one needle, or in multiple packs containing three boxes, each containing one pre-filled syringe and one needle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Icatibant ratiopharm 30 mg Injektionslösung in einer Fertigspritze
Belgium: Icatibant Teva 30 mg oplossing voor injectie in een voorgevulde spuit / solution injectable en seringue préremplie / Injektionslösung in einer Fertigspritze
Bulgaria: Икатибант Тева 30 mg инжекционен разтвор в предварително напълнена спринцовка
Croatia: Ikatibant Teva 30 mg otopina za injekciju u napunjenoj štrcaljki
Czech Republic: Icatibant Teva
Denmark: Icatibant Teva
Estonia: Icatibant Teva
Finland: Icatibant ratiopharm 30 mg injektioneste, liuos, esitäytetty ruisku
Hungary: Icatibant Teva 30 mg oldatos injekció előretöltött fecskendőben
Italy: Icatibant Teva
Lithuania: Icatibant Teva 30 mg injekcinis tirpalas užpildytame švirkšte
The Netherlands: Icatibant Teva 30 mg oplossing voor injectie, in voorgevulde spuit
Norway: Icatibant Teva
Sweden: Icatibant Teva
United Kingdom (Northern Ireland): Icatibant Teva 30 mg Solution for Injection in Pre-filled Syringe