Firazyr
icatibant
icatibant
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Firazyr is and what it is used for
What you need to know before you use Firazyr
How to use Firazyr
Possible side effects
How to store Firazyr
Contents of the pack and other information
Firazyr contains the active substance icatibant.
Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms.
If you are allergic to icatibant, or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor before taking Firazyr:
if you are suffering from angina (reduced blood flow to the heart muscle)
if you have recently suffered a stroke
Some of the side effects connected with Firazyr are similar to the symptoms of your disease. Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr
In addition:
You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with Firazyr.
Immediately after you self-inject Firazyr or your caregiver injects you with Firazyr while you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution.
If your symptoms are not resolved following one self- or caregiver administered injection of Firazyr, you should seek medical advice regarding additional injections of Firazyr. For adult patients, up to 2 additional injections may be given within 24 hours.
Firazyr is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Tell your doctor if you are taking, have recently taken or might take any other medicines. Firazyr is not known to interact with other medicines. 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 your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before starting to use Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr.
Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using Firazyr.
The injection solution contains less than 1 mmol (23 milligrams) of sodium per syringe, so it is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
If you have never received Firazyr previously, your first dose of Firazyr will always be injected by your doctor or nurse. Your doctor will tell you when it is safe for you to go home. After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Firazyr or your caregiver may inject Firazyr for you when you have an HAE attack. It is important that Firazyr is injected subcutaneously (under the skin) as soon as you notice an attack of angioedema. Your healthcare provider will teach you and your caregiver how to safely inject Firazyr by following the instructions in the Package Leaflet.
Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
The recommended dose of Firazyr is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
If you experience no relief of symptoms after 6 hours, you should seek medical advice regarding additional injections of Firazyr. For adults, up to 2 additional injections may be given within 24 hours.
The recommended dose of Firazyr is one injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of an angioedema attack (for example increased skin swelling, particularly affecting the face and neck, increasing tummy pain).
See section on instructions for use for the dose to inject.
If you are not sure which dose to inject, ask your doctor, pharmacist or nurse.
Firazyr is intended for subcutaneous injection (under the skin). Each syringe should only be used once.
Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy). If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The instructions include the following main steps:
1) General Information
2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients)
Preparing the injection site
Injecting the solution
Disposal of the injection material
1) General Information |
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2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less: |
Important information for healthcare professionals and caregivers: Where the dose is less than 30 mg (3 ml), the following equipment is required to extract the appropriate dose (see below):
The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below). |
Body Weight | Injection Volume |
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 weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
Remove the caps on each end of the connector.
Screw the connector onto the pre-filled syringe.
Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.
To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).
Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe. Refer to table 1 for dosage information.
Turn the connected syringes so that the pre-filled syringe is on top (see below image).
Push the plunger of the graduated syringe so that any air is transferred back into the pre-filled syringe (this step may need to be repeated several times).
Withdraw the required volume of icatibant solution.
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2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children) |
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3) Preparing the injection site |
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4) Injecting the solution |
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5) Disposal of the injection material |
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Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Firazyr will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation). These effects are usually mild and clear up without the need for any additional treatment.
Very common (may affect more than 1 in 10 people):
Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).
Common (may affect up to 1 in 10 people): Feeling sick
Headache Dizziness
Fever Itching Rash
Skin redness
Abnormal liver function test
Not known (frequency cannot be estimated from the available data): Hives (urticaria)
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate). The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. Hypodermic needle is included in the pack.
Firazyr is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.
Not all pack sizes may be marketed.
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
D02 Y754, Ireland Tel: +800 66838470
E-mail: medinfoemea@takeda.com
Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
D02 Y754, Ireland
Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
D02 Y754, Ireland
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