Firazyr 30 mg solution for injection in pre-filled syringe

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.

Do not use Firazyr

• If you are allergic (hypersensitive) to icatibant, or any of the other ingredients of Firazyr.

Take special care with Firazyr

• 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.
• If you are suffering from angina (reduced blood flow to the heart muscle), please consult your doctor before using Firazyr.
• If you have recently suffered a stroke, please consult your doctor before using Firazyr.
• You must be trained on subcutaneous (under the skin) injection technique before you self-inject Firazyr.
• If you self-inject Firazyr or if your caregiver injects you with Firazyr while experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care immediately.
• If your symptoms are not resolved following one self-administered injection of Firazyr, you should seek medical advice for further treatment.

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?.

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 8injections 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

• Wash your hands with soap and water before beginning the process
• Open the blister by peeling back the seal
• Remove the pre-filled syringe from the blister tray
• Remove the cap from the end of the pre-filled syringe by unscrewing the cap
• Put down the pre-filled syringe after unscrewing the cap

2) Preparing the syringe and needle for injection

• Remove the needle cap from the blister
• Remove the seal from the needle cap (the needle should be still in the needle cap)
• Grip the syringe firmly. Carefully attach the needle to the pre-filled syringe containing the colourless solution
• Screw the pre-filled syringe on the needle still fixed in the needle cap
• Remove the needle from the needle cap by pulling the syringe. Do not pull up on the plunger
• The syringe is now ready for injection

3) Preparing the injection site

• Choose the injection site. The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side. This area should be at least 5 cm (2 inches) away from any scars. Do not choose an area that is bruised, swollen, or painful
• Clean the injection site with a rubbing alcohol pad and allow it to dry

4) Injecting the Solution

• Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger
• Make sure that there is no air bubble in the syringe by pressing the plunger until the first drop

appears on the tip of the needle

4) Injecting the Solution (cont?d)

• Hold syringe between 45-90 degrees angle to skin with needle facing the skin
• Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site
• Hold the fold of skin, bring the syringe to the skin and quickly insert the needle into the skin

fold

• Slowly push the plunger of the syringe with a steady hand until all the fluid is injected into the skin and no liquid remain in the syringe
• Press slowly so that this takes approximately 30 seconds
• Release the skin fold and gently pull the needle out

5) Disposal of the injection material

• Discard the syringe, needle and needle cap into the sharp container for throwing away waste that might hurt others if not handled properly.

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.

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.

What Firazyr contains

• The active substance is icatibant 30 milligrams (as acetate) in 3 ml solution for injectionin each pre-filled syringe.
• The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection. The solution does not contain any preservative.

What Firazyr looks like and contents of the pack

Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml. Hypodermic needle (25 G; 16 mm) 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.

Marketing Authorisation Holder and Manufacturer

Jerini AG
Invalidenstr. 130
10115 Berlin
Germany

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