Firazyr

Firazyr 30 mg solution for injection pre-filled syringe

WHAT FIRAZYR IS AND WHAT IT IS USED FOR

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.

BEFORE YOU USE FIRAZYR

Do not use Firazyr

If you know that 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.

Using other medicines

Firazyr is not known to interact with other medicines, but please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor. 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.

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.

Driving and using machines

Do not drive or use machinery 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 TO USE FIRAZYR

Firazyr will always be injected by your doctor or nurse. Your doctor will tell you when it is safe for you to go home.

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 becoming moderately or severely worse (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).

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. The reaction may include burning sensations, reddening of the skin (erythema), pain, swelling, feeling of warmth, itching (pruritus) and skin irritation. These effects are usually mild and clear up by themselves 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 (burning sensations, reddening of the skin, pain, swelling, feeling of warmth, itching and skin irritation.)

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

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.

Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr.

HOW TO STORE FIRAZYR

Keep out of the reach and sight of children.

Do not use Firazyr after the expiry date stated on the label. The expiry date refers to the last day of the month stated on the label.

Do not store above 25 °C. 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.

FURTHER INFORMATION

What Firazyr contains

The active substance is icatibant 30 milligrams (as acetate) in 3 ml solution for injection in 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.