Firazyr 30 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Firazyr 30 mg solution for injection in pre-filled syringe
Icatibant
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Firazyr is and what it is used for
- What you need to know before using Firazyr
- How to use Firazyr
- Possible side effects
- How to store Firazyr
- 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 over 2 years of age.
In HAE, levels of a substance in the blood called bradykinin increase, leading to symptoms such as swelling, pain, nausea, and diarrhea.
Firazyr blocks the activity of bradykinin and thus halts 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 starting to use Firazyr:
- If you suffer from angina pectoris (reduced blood flow to the heart).
- If you have recently had a stroke.
Adverse reactions associated with Firazyr are similar to the symptoms of your own disease.
Contact your doctor immediately if you notice that your attack symptoms worsen after receiving Firazyr.
Additionally:
- You or your caregiver must learn the technique for subcutaneous injection (under the skin) before self-administering or having your caregiver administer Firazyr.
- Immediately after self-administering Firazyr or after your caregiver administers it during a laryngeal attack (obstruction of the upper airway), you must seek medical attention at a medical facility.
- If your symptoms do not resolve after a self-administered or caregiver-administered injection of Firazyr, consult your doctor about administering additional injections of Firazyr. In adult patients, up to 2 additional injections may be given 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
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
No interactions between Firazyr and other medicines are known. If you are taking any medicine that is an angiotensin-converting enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) to lower blood pressure or for any other reason, inform your doctor before using Firazyr.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before starting to use Firazyr.
If you are breastfeeding, you must not breastfeed your child during the 12 hours following the last dose of Firazyr.
Driving and using machines
Do not drive or operate machinery if you feel tired or dizzy as a result of an HAE attack or after using Firazyr.
Firazyr contains a small amount of sodium
This medicine contains less than 23 milligrams (1 mmol) of sodium per syringe and is therefore considered essentially "sodium-free".
3. How to use Firazyr
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.
If you have never been administered Firazyr before, the first dose must always be injected by a healthcare or nursing professional. Your doctor will discharge you when it is considered safe for you to go home. After discussing with your doctor or nurse and learning the technique for subcutaneous injections (under the skin), you or your caregiver may administer Firazyr to yourself during an HAE attack. It is important to inject Firazyr subcutaneously (under the skin) as soon as you notice an angioedema attack (for example, increased skin swelling, especially in the face and neck, or increased abdominal pain). Healthcare professionals will teach you and your caregiver how to safely inject Firazyr, following the instructions in this leaflet.
When and how often should you use Firazyr?
Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
Adults
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The recommended dose of Firazyr is one injection (3 ml, 30 mg) administered subcutaneously (under the skin) as soon as you notice an angioedema attack (for example, increased skin swelling, especially in the face and neck, or increased abdominal pain).
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If you do not experience symptom improvement within six hours, seek medical advice regarding additional Firazyr injections. In adults, up to two additional injections may be administered within 24 hours.
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Do not receive more than three injections within a 24-hour period, and if you require more than eight injections in one month, seek medical advice.
Children and adolescents aged 2 to 17 years
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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, as soon as symptoms of an angioedema attack appear (for example, increased skin swelling, especially in the face and neck, or increased abdominal pain).
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Refer to the instructions for use section to determine the correct dose to inject.
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If you are unsure about the dose to inject, consult your doctor, pharmacist, or nurse.
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If your symptoms worsen or do not improve, seek immediate medical advice.
How should Firazyr be administered?
Firazyr is administered by subcutaneous injection (under the skin). Each syringe should be used only once.
Firazyr is injected with a short needle into the fatty tissue beneath the skin of the abdomen (stomach area).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
The following step-by-step instructions are intended for:
- Self-administration (adults)
- Administration by a caregiver or healthcare professional for adults, adolescents, or children over 2 years of age (weighing at least 12 kg).
The instructions include the following main steps:
- General information
2a) Preparation of the syringe for children and adolescents (2–17 years) weighing 65 kg or less
2b) Preparation of the syringe and needle for injection (all patients)
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Preparation of the injection site
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Injection of the solution
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Disposal of injection materials
Step-by-step injection instructions
- General information
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Clean the work area (surface) to be used before starting the procedure.
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Wash your hands with soap and water.
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Open the tray by removing the seal.
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Remove the pre-filled syringe from the tray.
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Unscrew and remove the cap from the end of the pre-filled syringe.
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Set aside the pre-filled syringe after removing the cap.
2a) Preparation of the syringe for children and adolescents (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 equipment is required to withdraw the appropriate dose (see information below):
The required injection volume in ml should be prepared in an empty 3 ml graduated syringe (see table below). Table 1: Dosing regimen for children and adolescents
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
Avoid touching the ends of the connector and the tips of the syringes to prevent contamination
Transfer the icatibant solution to the graduated syringe:
If there is air in the graduated syringe:
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2b) Preparation of the syringe and needle for injection: All patients (adults, adolescents, and children) | ||||||||||||
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4. Possible adverse effects
Like all medicines, Firazyr can cause adverse effects, although not everyone experiences them. Almost all patients receiving Firazyr experience 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 and improve 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, decreased sensitivity and/or numbness, increased skin rash with itching and warmth).
Common (may affect up to 1 in 10 people):
Nausea
Headache
Dizziness
Fever
Itching
Rash
Skin redness
Abnormal liver function tests
Frequency not known (cannot be estimated from available data):
Hives (urticaria)
Inform your doctor immediately if you notice that your attack symptoms worsen after receiving Firazyr.
If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Firazyr
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Do not store above 25 °C. Do not freeze.
Do not use this medicine if you notice damage to the syringe or needle packaging, or if you observe any visible signs of deterioration; for example, if the solution is cloudy, contains floating particles, or if the solution has changed colour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Firazyr
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, sodium hydroxide, and water for injections.
Appearance of Firazyr and contents of the pack
Firazyr is presented as a clear, colourless injectable solution in a 3 ml pre-filled glass syringe.
The pack contains one hypodermic needle.
Firazyr is available in a single pack containing one pre-filled syringe with one needle, or in a multiple pack containing three pre-filled syringes with three needles.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Shire Pharmaceutical Ireland Limited
Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
D02 Y754, Ireland
Tel: +44(0)1256 894 959
E-mail: [email protected]
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu. The site also provides links to other websites on rare diseases and orphan medicinal products.