Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FIRAZYR.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including FIRAZYR have risks and benefits. Your doctor has weighed the risks of you having FIRAZYR against
the benefits they expect it will have for you.
If you have any concerns about this medicine, ask your doctor, nurse or pharmacist.
Keep this leaflet.
You may need to read it again.
What FIRAZYR is used for
FIRAZYR is used for treating the symptoms of an acute attack of hereditary angioedema (HAE).
During attacks of HAE, levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms
like swelling, pain, nausea, and diarrhoea.
How it works
FIRAZYR blocks the activity of bradykinin and therefore, helps reduce the symptoms of an HAE attack.
Before you use FIRAZYR
When you must not be given it
Do not use FIRAZYR if you have an allergy (hypersensitivity) to icatibant, or any of the other ingredients listed at the end
of this leaflet.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body, skin rash, itching or hives.
It is important to be able to tell when you might be having an allergic reaction as the symptoms are very similar to those
of an attack of HAE, so you should discuss this with your doctor.
If you are pregnant or plan on 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.
Do not give FIRAZYR to a child under 18 years.
The safety and effectiveness of FIRAZYR in children under 18 years have not been established.
Do not use FIRAZYR after the expiry date printed on the pack.
Do not use FIRAZYR if the packaging is torn or shows signs of tampering.
Do not use FIRAZYR if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating
particles, or if the solution is not colourless.
If you are not sure whether you should use FIRAZYR, talk to your doctor or pharmacist.
Before you are given it
Consult your doctor before using FIRAZYR if you are suffering from angina (reduced blood flow to the heart muscle).
Inform your doctor before using 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 your blood pressure or for any
Consult your doctor before using FIRAZYR if you have recently suffered a stroke.
Tell your doctor if you have allergies to:
Any other medicines
Any other substances, such as foods, preservatives or dyes.
Tell your doctor if you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using FIRAZYR during pregnancy.
Tell your doctor if you are breast-feeding. You should not breast-feed for 12 hours after you have received FIRAZYR.
It is not known whether FIRAZYR passes into your breast milk.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from
your pharmacy, supermarket or health food shop.
FIRAZYR can interact with other medicines eg ACE inhibitors (as previously discussed).
Food and drink have no effect on the action of FIRAZYR.
How FIRAZYR is used
Injections are usually administered by healthcare professionals. If you wish to inject FIRAZYR yourself and the doctor agrees
it is appropriate (e.g. if you have a lot of HAE attacks or if you live far from a hospital or doctor), you will be trained
on how to give yourself an injection.
The following information is for patients who have been trained to inject themselves:
As HAE attacks can often be serious, it is best to contact your doctor or hospital when you experience an attack.
If the HAE attack involves your face, lips, throat, or voice box, or if you have any difficulty breathing, you should always
contact your doctor or hospital.
If your HAE attack has not shown signs of improvement within 2 hours of the injection of FIRAZYR; or if the attack spreads
to your face, lips, throat, or voice box, or you develop any difficulty breathing, you should contact your doctor or hospital
It is possible to have further injections of FIRAZYR if you do not have relief from the HAE symptoms following the first injection;
however, this should be done by your doctor or in hospital (see below) - or following the advice of your doctor.
FIRAZYR comes in a ready-to-use syringe. A needle is packed separately which you need to attach before use.
FIRAZYR is intended for subcutaneous injection (under the skin). FIRAZYR is injected into the fatty tissue under the skin
in the abdomen (tummy).
Each syringe should only be used once.
Please see step-by-step instructions for injecting FIRAZYR at the end of this leaflet.
How much and when it is given
Your doctor will determine the exact dose of FIRAZYR and will tell you how often it should be used.
The recommended dose of FIRAZYR is one injection (30 mg in 3 mL) given subcutaneously (under the skin) as soon as the symptoms
of an attack of HAE (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain)
If the HAE symptoms are still present, or return after initial relief, an additional injection of FIRAZYR (3 mL) may be given
after 6 hours.
If after a further 6 hours you still experience symptoms you may need a third injection of FIRAZYR (3 mL).
You should have no more than 3 injections in a 24-hour period and no more than 8 injections in a month.
After using FIRAZYR
Things you must do
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received FIRAZYR.
Some of the side effects connected with FIRAZYR are similar to the symptoms of your disease.
If you use too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your
nearest hospital if you think that an overdose has happened. Do this even if there are no signs of discomfort or poisoning.
When high doses have been given, patients have experienced a drop in blood pressure.
Things to be careful of
Do not drive or operate any machinery if you feel tired or dizzy as a result of your HAE attack or after using FIRAZYR.
FIRAZYR has minor to moderate influence on the ability to drive and operate machinery.
Tell your doctor or pharmacist as soon as possible if you do not feel well after using FIRAZYR.
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. The reaction may include burning
sensations, reddening of the skin (erythema), pain, swelling, feeling of warmth, and itching (pruritus). These effects are
usually mild and clear up by themselves without the need for any additional treatment.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following symptoms and they worry you:
Pain in the abdomen (tummy)
Redness of the skin
These are the more common side effects of FIRAZYR. Mostly, these are mild and short-lived.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that
is making you feel unwell.
Do not be alarmed by this list of possible side effects as all medicines can cause side-effects.
You may not experience any of them.
Keep FIRAZYR out of the reach and sight of children.
Keep FIRAZYR in the original pack until it is time for it to be used.
Keep it below 25°C. Do not freeze FIRAZYR.
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.
What it looks like
FIRAZYR is supplied in one single use pre-filled glass syringe with a grey plunger stopper. The solution is clear and colourless
and free from visible particles. A hypodermic needle (25 G; 16 mm) is included in the package.
Icatibant acetate (equivalent to 30 mg of icatibant) in 3 mL solution for injection in each pre-filled syringe.
Acetic acid - glacial
Water for injections.
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially 'sodium-free'.
FIRAZYR does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Name and address of Sponsor and supplier
Shire Australia Pty Limited
123 Epping Road,
Freecall: 1800 012 612
AUST R number 160313
Date of preparation: November 2012
® Registered trade mark of Shire Orphan Therapies GmbH, Germany
Step-by-step instructions for injecting FIRAZYR
Step 1. Preparing your dose of FIRAZYR
Wash your hands with soap and water
You will need the following items:
Your FIRAZYR carton that includes 1 single-use FIRAZYR prefilled syringe and 1 needle
An alcohol wipe
The medicine inside your FIRAZYR prefilled syringe should be clear and colourless. Do not use your FIRAZYR prefilled syringe
if the solution contains particles, is cloudy, or an unusual colour.
Step 2. Remove prefilled syringe and needle from the carton.
Step 3. Remove the seal from the needle cap
(the needle should remain inside the protective needle cap until ready to use).
Step 4. Hold the syringe firmly. Carefully attach the needle to the prefilled syringe containing the colourless FIRAZYR solution.
Step 5. Firmly screw the needle on the prefilled syringe. Be careful not to remove the needle from the needle cap.
Preparing the Injection Site
Step 6. Choose the injection site. The injection site should be a fold of skin on your stomach, about 5 to 10 cm below your
belly button on either side.
The area you choose for injection should be at least 5 cm away from any scars. Do not choose an area that is bruised, swollen,
Step 7. Clean your FIRAZYR injection area with an alcohol wipe and allow it to dry.
Step 8. Remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. Do not pull on
Step 9. Hold the FIRAZYR syringe in one hand, between your fingers and thumb.
Step 10. Use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers
for your injections
Step 11. Hold the syringe between a 45 to 90 degree angle to your skin with the needle facing the fold of skin you are holding.
Step 12. Hold the fold of the skin. Bring the syringe to the skin and quickly insert the needle into the skin fold.
Step 13. Push the plunger, at the top of the syringe, over at least 30 seconds until no FIRAZYR is in the syringe.
Step 14. Release the skin fold and gently pull the needle out.
Step 15. Place the used syringe with the needle attached in a sharps container which is made of hard materials and is sealable
(such as biohazard container). Seal the container and throw it away the right way. There may be state and local laws about
the right way to throw away used syringes and needles. Ask your healthcare providers or pharmacist how to throw away used
syringes and needles.