Firazyr

Package leaflet: Information for the user

Firazyr 30 mg solution for injection in pre-filled syringe

icatibant
Please read all of this leaflet carefully before you start using 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Firazyr is and what it is used for

Firazyr contains the active substance icatibant.
Firazyr is used to treat the symptoms of hereditary angioedema (HAE) in adults,
adolescents, and children from the age of 2 years.
In HAE, levels in the blood of a substance called bradykinin increase, causing symptoms
such as swelling, pain, nausea, and diarrhea.
Firazyr blocks the activity of bradykinin and thereby stops the progression of symptoms during an HAE attack.

2. What you need to know before using Firazyr

Do not use Firazyr

• 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 Firazyr:

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

in case some of the side effects associated with Firazyr are similar to the symptoms of your underlying disease. Immediately inform your doctor if you notice that your attack symptoms worsen after administration of Firazyr.
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 Firazyr.
• Immediately after self-administering Firazyr or receiving Firazyr from a caregiver during a laryngeal attack (obstruction of the upper airways), you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administering or after receiving an injection of Firazyr, consult a doctor for additional injections of Firazyr. For adult patients, up to 2 additional injections may be administered within 24 hours.

Children and adolescents
The use of Firazyr 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 Firazyr
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
No interactions of Firazyr 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), used to lower blood pressure or for other reasons, inform your doctor before taking Firazyr.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before starting to take Firazyr.
If you are breastfeeding, you must not breastfeed for 12 hours after the last administration of Firazyr.
Driving and using machines
Do not drive or operate machinery if you feel tired or dizzy after an HAE attack or after receiving Firazyr.
Firazyr contains sodium
The injectable solution contains less than 1 mmol (23 milligrams) of sodium per syringe, i.e. essentially ‘sodium-free’.

3. How to use Firazyr

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

When and how often to take Firazyr?
Your doctor has determined the exact dose of Firazyr and will indicate how often it should be used.

Adults

• The recommended dose of Firazyr is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) at the first sign of an angioedema attack (for example, increasing swelling of the skin, especially in the face and neck, or increasing abdominal pain).
• If you do not experience symptom relief within 6 hours, contact a doctor for additional Firazyr injections. In adults, up to 2 additional injections may be administered within 24 hours.
• Do not administer more than 3 injections within a 24-hour period, and if more than 8 injections are needed in one month, consult a doctor.

Children and adolescents aged 2–17 years

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

How should Firazyr be administered?
Firazyr is intended for subcutaneous (under the skin) injection. Each syringe must be used only once.
Firazyr should be injected with a short needle into the fatty tissue under the skin of the abdomen (stomach).
If you have any doubts about using this medicine, consult your doctor or pharmacist.

The following are step-by-step instructions 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 (aged 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 the injection kit

Step-by-step injection instructions
1) General information

• Before beginning, clean the work area (surface) to be used.
• Wash your hands with soap and water.
• Open the tray by removing the seal.
• Remove the pre-filled syringe from the tray.
• 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 extract the appropriate dose (see below):
a) Pre-filled syringe of Firazyr (containing icatibant solution)
b) Connector (adapter)
c) Graduated 3 ml syringe

The required volume in ml should be drawn 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 more than 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.

Transfer the icatibant solution into the graduated syringe:

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

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

3. Continue pushing down the plunger of the pre-filled syringe until the required injection volume (dose) is transferred into the graduated syringe. For dosing information, see Table 1.
   If air is present 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.
• Rotate the protective cap of the needle cap to break the seal (the needle should still be inside the cap).

• Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe containing the clear solution.
• Screw the pre-filled syringe onto the needle while the needle is still inside the cap.
• Remove the needle from the cap by pulling the syringe, without pulling the plunger.
• The syringe is now ready for injection.

3) Preparation of the injection site

• Choose the injection site, which should be a skin fold on the abdomen approximately 5–10 cm to the right or left below the navel. The area should be at least 5 cm away from any scars. Do not select an area that is bruised, swollen, or tender.
• Clean the injection site by wiping it with an alcohol-soaked cotton swab 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.
• With one hand holding the syringe, 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 close and quickly insert the needle into the skin fold.
• Slowly and steadily push the plunger of the syringe until all the liquid is injected and the syringe is empty.
• Push slowly: the injection should take approximately 30 seconds.
• Release the skin fold and gently withdraw the needle.

5) Disposal of the injection kit

• Dispose of the syringe, needle, and its cap in a designated container for sharps and other 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 gets them.
Almost all patients treated with Firazyr experience a reaction at the injection site (such as skin irritation, swelling, pain, itching, erythema, and burning sensation). The reaction may include a burning sensation, skin redness, pain, swelling, warmth, itching, and skin irritation. These effects are usually mild in intensity and resolve spontaneously without requiring further treatment.

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

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

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

Contact your doctor immediately if you notice that the symptoms of the attack worsen after administration of Firazyr.

If you experience any side effect, including those not listed in this leaflet, consult your doctor.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Firazyr

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 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 packaging of the syringe or needle 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Firazyr contains
The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as
acetate). The excipients are sodium chloride, glacial acetic acid, sodium hydroxide and water for
injections.

Description of the appearance of Firazyr and contents of the pack
Firazyr is supplied as a clear, colourless injectable solution in a glass pre-filled syringe (3 ml).
A hypodermic needle is included in the package.
Firazyr is available in single packs containing one pre-filled syringe and one needle, or in multiple packs containing three pre-filled syringes and three needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50–58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50–58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50–58 Baggot Street Lower
Dublin 2
D02 Y754
Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]

България Luxembourg/Luxemburg
Такеда България ЕООД Takeda Belgium NV
Тел.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]

Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel: +36 1 270 7030
[email protected] [email protected]

Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]

Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]

Eesti Norge
Takeda Pharma AS Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]

Ελλάδα Österreich
Takeda ΕΛΛΑΣ Α.Ε. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]

España Polska
Takeda Farmacéutica España S.A Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel: +48223062447
[email protected] [email protected]

France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél: +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]

Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]

Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]

Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]

Κύπρος Sverige
A.POTAMITIS MEDICARE LTD Takeda Pharma AB
Τηλ: +357 22583333 Tel: 020 795 079
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Takeda Latvia SIA Takeda UK Ltd
Tel: +371 67840082 Tel: +44 (0) 2830 640 902
[email protected] [email protected]

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and their treatments are also provided.