What is it and how is it used?
Firazyr is a solution for injection that contains the active substance icatibant.
Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adult patients. 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 of an HAE attack.
What do you have to consider before using it?
Do not use Firazyr
Take special care with Firazyr
Use in Children and adolescents
Firazyr is not recommended for use in children and adolescent under 18 years of age.
Using 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Firazyr with food and drink
Food and drink have no effect on the action of Firazyr.
Pregnancy and breast feeding
If you are pregnant or plan becoming pregnant, discuss this with your doctor before starting to use Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have received Firazyr.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you feel tired or dizzy as a result of your HAE attack or after using Firazyr.
Important information about some of the ingredients of Firazyr
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘sodium-free’.
How is it used?
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 the attack of hereditary angioedema. Your healthcare provider will teach you and your caregiver how to safely inject Firazyr by following the instructions in the Package 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. The recommended dose of Firazyr is one injection (3 ml, 30 mg) applied subcutaneously (under the skin) as soon as you notice the attack of hereditary 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, an additional injection of Firazyr (3 ml) can be given. If after a further 6 hours you still experience no relief you might have a third injection Firazyr (3 ml).
You should not have more than 3 injections in a 24 hour period and no more than 8 injections of Firazyr in total per month.
How should Firazyr be administered?
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 following step-by-step instruction is intended for self-administration only
The instructions include the following main steps:
1) General Important Information
2) Preparing the syringe and needle for injection
3) Preparing the injection site
4) Injecting the solution
5) Disposal of the injection material
Step-by-Step Instructions for Injection
1) General Important Information
2) Preparing the syringe and needle for injection
3) Preparing the injection site
4) Injecting the Solution
appears on the tip of the needle
4) Injecting the Solution (cont’d)
fold
5) Disposal of the injection material
What are possible side effects?
Like all medicines, Firazyr 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, erythema and burning sensation). These effects are usually mild and clear up without the need for any additional treatment.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), very rare (affects less than 1 user in 10,000), not known (frequency cannot be estimated from the available data).
Very common:
Injection site reactions (skin irritation, swelling, pain, itchiness, erythema and burning sensation).
Common:
Abnormal results from some blood test
Headache
Dizziness
Itching
Rash
Skin redness
Uncommon:
Abnormal liver function test
Asthma
Blocked nose
Bruising
Cough
Fever
Hot flushes
Increased amount of uric acid in the blood (which may indicate gout)
Increased amount of blood glucose
Muscle spasm
Nausea or vomiting
Hives
Shingles
Sore throat
Positive test for protein in your urine
Tiredness
Weakness
Weight gain
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Firazyr 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 25C. Do not freeze.
Firazyr should not be used if 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.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
