FIRAZYR 30 mg Injectable Solution

Зміст інструкції

1. Firazyr 30 mg injectable solution in pre-filled syringe
   1. What is Firazyr and what is it 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

Firazyr 30 mg injectable solution in pre-filled syringe

icatibant

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Firazyr and what is it used for

Firazyr contains the active substance icatibant.
Firazyr is used for the treatment of symptoms of hereditary angioedema (HAE) in adults,
adolescents and children from 2 years of age.
In HAE, the levels in the blood of a substance called bradykinin increase, and this causes symptoms
such as swelling, pain, nausea and diarrhoea.
Firazyr blocks the activity of bradykinin and therefore stops the progression of the symptoms of an attack
of HAE.

2. What you need to know before using Firazyr

Do not use Firazyr

• if you are allergic to icatibant or 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 undesirable effects associated with Firazyr are similar to the symptoms of the disease
you are affected by. Immediately inform your treating doctor if you find that the symptoms
of the attack worsen after the administration of Firazyr
Also:

• You or the person who cares for you must have been trained in the subcutaneous (under the skin) injection technique before self-administering/administering Firazyr.
• Immediately after self-administration of Firazyr or administration of Firazyr by the person who cares for you during a laryngeal attack (upper airway obstruction), you must seek medical assistance at a healthcare facility.
• If your symptoms have not resolved after self-administration or after you have been given an injection of Firazyr, consult a doctor to receive additional injections of Firazyr. For adult patients, a maximum of 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
because it has not been studied in these patients.

Other medicines and Firazyr
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known for Firazyr. 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, tell your doctor before taking Firazyr.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor for advice before starting to take Firazyr.
If you are breastfeeding, you should not breastfeed for 12 hours after the last administration of Firazyr.

Driving and operating machinery
Do not drive or operate machinery if you feel tired or dizzy after an HAE attack or
after the administration of Firazyr.

Firazyr contains sodium
The injectable solution contains less than 1 mmol (23 mg) of sodium per syringe, i.e.
essentially ‘sodium-free’.

3. How to use Firazyr

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
If you have never received Firazyr before, the first dose of Firazyr will be injected by your doctor or a
nurse. The doctor will advise when you can return home.
After discussing with your doctor or nurse and being trained in the subcutaneous injection technique (under the skin), during an HAE attack you may self-administer, or the person who
cares for you may administer to you, Firazyr. It is important that Firazyr is injected subcutaneously (under the skin) at the first sign of an angioedema attack. The healthcare
professional who follows you will teach you and the person assisting you how to inject Firazyr safely.

When and how often to use Firazyr?
The doctor has established the exact dose of Firazyr and will indicate how often to use it.

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, increased skin swelling, especially at face and neck level, or increasing abdominal pain).
• If you do not feel an improvement in symptoms after 6 hours, consult a doctor to receive additional Firazyr injections. For adults, a maximum of 2 additional injections can be administered within 24 hours.
• Do not administer more than 3 injections in a 24-hour period and, if more than 8injections are needed in a month, consult a doctor.

Children and adolescents in the age group 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 symptoms of an angioedema attack (for example, increased skin swelling, especially at face and neck level, increasing abdominal pain).
• For the specific dose to inject, see the instructions for use section.
• If you are not sure which dose to inject, consult your doctor, pharmacist or nurse.
• If your symptoms worsen or you do not experience any relief, seek immediate medical attention.How should Firazyr be administered?

Firazyr is intended for use by subcutaneous injection (under the skin). 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 (belly).
If you have any doubts about the use of 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 bodyweight 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 (age 2-17 years) weighing 65 kg or less 2b) Preparation of the syringe and needle for injection (all patients)

• 3) Preparation of the injection site
• 4) Injection of the solution
• 5) Disposal of the injection kit

Step-by-step injection instructions

• 1) General information
• Before starting the process, clean the work (surface) area to be used.
• Wash your hands with soap and water.
• Open the tray by detaching the seal.
• Remove the pre-filled syringe from the tray.
• By unscrewing, remove the cap from the end of the pre-filled syringe.
• After unscrewing the cap, place the syringe on a flat surface.

2a) Preparation of the syringe for
children and adolescents (age 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 materials are required to extract the appropriate dose (see below):
a) Pre-filled syringe of Firazyr (containing the icatibant solution)
b) Connector (adapter)
c) 3 ml graduated syringe

The volume in ml needed for the injection must be drawn into an empty 3 ml graduated syringe
(see table below).

Table 1: Dosage regimen for children and adolescents
Body weightInjection 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 than65 kgwill 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 and 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, making sure both connections are securely fastened.

Transfer the icatibant solution into the graduated syringe:

• 1) To begin transferring the icatibant solution, lower the plunger of the pre-filled syringe (all the way to the left in the figure below).

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

• 3) Continue to lower the plunger of the pre-filled syringe until the necessary injection volume (dose) is transferred into the graduated syringe. For dosage information, see Table 1.

If there is air in the graduated syringe:

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

• Lower the plunger of the graduated syringe so that the air is re-transferred into the pre-filled syringe (this step may need to be repeated several times).
• Withdraw the necessary volume of icatibant solution.
• 4) Detach the pre-filled syringe and the 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 cap containing the needle from the blister pack.
• Rotate the protective cap of the needle cap to break the seal (the needle must still be in the cap).

• Hold the syringe firmly. Carefully attach the needle to the pre-filled syringe containing the colorless solution.
• Screw the pre-filled syringe onto the needle while the needle is still in the cap.
• Remove the needle from the cap by pulling the syringe, but 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 of about 5-10 cm located to the right or left below the navel. The area should be at least 5 cm away from any scars. Do not choose an area that is bruised, swollen or painful.
• Clean the injection site by rubbing it with a cotton swab soaked in alcohol and let it dry.
• 4) Injection of the solution

• Hold the syringe between two fingers of one hand with your thumb on the plunger.
• Make sure there are no air bubbles in the syringe by pushing the plunger until the first drop appears at the tip of the needle.
• Hold the syringe at an angle of 45-90 degrees to the skin, with the needle pointing towards the injection point.
• Holding the syringe in one hand, use the other to gently hold a skin fold between your thumb and fingers at the previously disinfected injection point.
• Keeping the skin fold, bring the syringe and quickly insert the needle into the fold.
• Slowly push the syringe plunger with a steady hand until all the liquid has been injected and the syringe is empty.
• Push slowly: the injection should last about 30 seconds.
• Release the skin fold and gently remove the needle.

• 5) Disposal of the injection kit

• Dispose of the syringe, needle and its cap in the appropriate container for disposing 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 everybody gets them.
Almost all patients treated with Firazyr have a reaction at the injection site (such as
skin irritation, swelling, pain, itching, erythema and a burning sensation). The reaction may
include a burning sensation, skin redness, pain, swelling, a feeling of warmth,
itching and skin irritation. These effects are usually mild and resolve on their own without
the need for further treatment.
Very common (may affect more than 1 in 10 people):
Further reactions at the injection site (feeling of compression, bruising, loss of sensation and/or
numbness, raised, itchy rash and warmth).
Common (may affect up to 1 in 10 people):
Feeling unwell
Headache
Dizziness
Fever
Itching
Skin rashes
Skin redness
Abnormal liver function tests
Not known (frequency cannot be estimated from available data):
Urticaria
Tell your doctor immediately if you notice that the symptoms of the attack worsen after
administration of Firazyr.
If any side effects occur, including those not listed in this leaflet, please
tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
to 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 at a temperature 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, if it contains
floating particles or if the colour of the solution has changed.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Firazyr contains
The active ingredient 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 Firazyr and contents of the pack
Firazyr is supplied as a clear and colourless injection solution, in a glass pre-filled syringe
(3 ml).
The pack also includes a hypodermic needle.
Firazyr is available in a single pack, containing one pre-filled syringe and one needle, or in
multi-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, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Lietuva
Takeda, UAB
Tel: +370 521 09 070
[email protected]

България
Такеда България ЕООД
Тел.: +359 2 958 27 36
[email protected]

Luxembourg/Luxemburg
Takeda Belgium NV
Tél/Tel: +32 2 464 06 11
[email protected]

Česká republika
Takeda Pharmaceuticals Czech Republic s.r.o.
Tel: +420 234 722 722
[email protected]

Magyarország
Takeda Pharma Kft.
Tel: +36 1 270 7030
[email protected]

Danmark
Takeda Pharma A/S
Tlf: +45 46 77 10 10
[email protected]

Malta
Drugsales Ltd
Tel: +356 21419070
[email protected]

Deutschland
Takeda GmbH
Tel: +49 (0)800 825 3325
[email protected]

Nederland
Takeda Nederland B.V.
Tel: +31 20 203 5492
[email protected]

Eesti
Takeda Pharma AS
Tel: +372 6177 669
[email protected]

Norge
Takeda AS
Tlf: +47 800 800 30
[email protected]

Ελλάδα
Τakeda ΕΛΛΑΣ Α.Ε.
Tηλ: +30 210 6387800
[email protected]

Österreich
Takeda Pharma Ges.m.b.H.
Tel: +43 (0) 800-20 80 50
[email protected]

España
Takeda Farmacéutica España S.A
Tel: +34 917 90 42 22
[email protected]

Polska
Takeda Pharma Sp. z o.o.
Tel: +48223062447
[email protected]

France
Takeda France SAS
Tél: + 33 1 40 67 33 00
[email protected]

Portugal
Takeda Farmacêuticos Portugal, Lda.
Tel: + 351 21 120 1457
[email protected]

Hrvatska
Takeda Pharmaceuticals Croatia d.o.o.
Tel: +385 1 377 88 96
[email protected]

România
Takeda Pharmaceuticals SRL
Tel: +40 21 335 03 91
[email protected]

Ireland
Takeda Products Ireland Ltd
Tel: 1800 937 970
[email protected]

Slovenija
Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: + 386 (0) 59 082 480
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000
[email protected]

Slovenská republika
Takeda Pharmaceuticals Slovakia s.r.o.
Tel: +421 (2) 20 602 600
[email protected]

Italia
Takeda Italia S.p.A.
Tel: +39 06 502601
[email protected]

Suomi/Finland
Takeda Oy
Puh/Tel: 0800 774 051
[email protected]

Κύπρος
A.POTAMITIS MEDICARE LTD
Τηλ: +357 22583333
[email protected]

Sverige
Takeda Pharma AB
Tel: 020 795 079
[email protected]

Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]

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

Other 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. Additionally, links to other websites on rare diseases and
related therapeutic treatments are provided.