30 mg solution for injection, pre-filled syringe 
icatibant

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 2 years of age and older.

In HAE, the level of a substance in the blood, called bradykinin, is elevated, and this leads to symptoms such as swelling, pain, nausea, and diarrhea. 

Firazyr blocks the activity of bradykinin and thus reduces the development of symptoms in an HAE attack. 

2. What you need to know before you use Firazyr

Do not use Firazyr

  • if you are allergic to icatibant or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before taking Firazyr.

  • if you suffer from angina (angina) (decreased blood flow to the heart muscle)
  • if you have recently had a stroke

Some of the side effects associated with Firazyr are similar to the symptoms of your disease. If you notice that your symptoms of seizures worsen after receiving Firazyr, tell your doctor straight away.

Also:

You or your health care provider must have practiced the subcutaneous (under the skin) injection technique before you or your health care provider gives you the injection with Firazyr.

Immediately after you or your healthcare provider have injected you with Firazyr when you have a laryngeal seizure (obstruction of the upper respiratory tract), you must seek medical attention immediately.

If your symptoms do not go away after you or your healthcare provider has injected Firazyr, you should seek medical advice regarding further injections of Firazyr. For adult patients, up to two additional injections may be given within 24 hours.

Children and young people

Firazyr is not recommended for use in children below 2 years of age or weighing less than 12 kg as studies are lacking in these patients.

Other medicines and Firazyr

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Firazyr is not known to affect or be affected by other medicines. If you are taking a medicine called ACE inhibitor (such as captopril, enalapril, ramipril, quinapril, lisinopril) to lower your blood pressure or for any other reason, you should tell your doctor before taking Firazyr.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Firazyr.

If you are breast-feeding, do not breast-feed your baby for 12 hours after you last receive Firazyr.

Driving and using machines

Do not drive or use machines if you feel tired or dizzy after an HAE attack or after using Firazyr.

Firazyr contains sodium

The solution for injection contains less than 1 mmol (23 milligrams) of sodium per syringe, ie it is almost sodium-free.

3. How to use Firazyr

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

If you have never been given Firazyr before, the first dose of Firazyr will always be injected by a doctor or nurse. The doctor will tell you when it is safe for you to go home.

After discussing with your doctor or nurse and after practicing the subcutaneous (under the skin) injection technique, you or your healthcare provider may inject Firazyr when you have angioedema. Firazyr must be injected subcutaneously(under the skin) as soon as you notice the onset of hereditary angioedema  Your doctor or nurse will teach you and your healthcare provider how to inject Firazyr safely by following the instructions for injection in the package leaflet.

When and how often should you use Firazyr?

Your doctor has decided exactly what dose of Firazyr you should have and will tell you how often to use the medicine.

Adults

The recommended dose of Firazyr is an injection (3 ml, 30 mg) that is injected subcutaneously (under the skin) as soon as you have an attack of angioedema (eg increased skin swelling, especially affecting the face and neck, or increased abdominal pain).

If symptoms have not resolved after 6 hours, you should seek medical advice regarding further injections of Firazyr. For adults, up to two additional injections may be given to you within 24 hours.

You should not receive more than 3 injections in 24 hours and if you need more than 8 injections of Firazyr in one month, you should consult a doctor.

Children and adolescents aged 2 to 17 years

  • The recommended dose of Firazyr is an injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of angioedema (eg increased skin swelling that particularly affects the face and neck, increased abdominal pain).
  • See the section on user instructions for injection for the dose to be injected.
  • If you are not sure which dose to inject, consult a doctor, pharmacist, or nurse.
  • If symptoms worsen or do not improve, seek medical attention immediately.

How is Firazyr used?

Firazyr is given as a subcutaneous injection (under the skin). Each syringe should be used only once.

Firazyr is injected with a short injection needle into the adipose tissue under the skin of the abdomen.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The following instructions for injection are step-by-step and are intended for:

  • self-injection (adults)
  • the injection is given by a healthcare provider or healthcare professional to adults, adolescents, or children over 2 years of age (weighing at least 12 kg).

The user manual includes the following main steps:

1) General information

2a) Preparation of syringe for children and adolescents (2‑17 years) weighing 65 kg or less

2b) Preparation of syringe and needle for injection (all patients)

3) Preparation of injection site

4) Injection of the solution

5) Disposal of syringe, needle, and needle guard

Step-by-step instructions for injection


1) General information

  • Start by cleaning the work surface to be used to prepare the syringe.
  • Then wash your hands with soap and water.
  • Open the package by pulling off the closure.
  • Take the pre-filled syringe out of the package.
  • Remove the protective cap from the end of the pre-filled syringe by unscrewing the protective cap.
  • When the protective cap has been unscrewed, place the pre-filled syringe on a flat surface.

2a) Preparation of syringe for children and adolescents (2‑17 years) 
weighing 65 kg or less:

Important information for healthcare professionals and caregivers:

If dose one is less than 30 mg (3 ml), the following equipment is required to extract the correct dose (see below):

  1. Firazyr pre-filled syringe (containing icatibant solution)

  2. Connection (adapter)

  3. 3 ml graduated syringe
the syringe

The required volume of injection in ml should be drawn up into an empty 3 ml graduated syringe (see table below).

Table 1: Dosage regimen for children and adolescents how

Bodyweight Injection volume
12 kg to 25 kg 1.0 ml
26 kg to 40 kg 1.5 ml
41 kg to 50 kg 2.0 ml
51 kg to 65 kg 2.5 ml

Patients weighing more than 65 kg should use the full contents of the pre-filled syringe (3 ml).

Warning

If you are not sure how much solution (volume) to draw into the syringe, contact your doctor, pharmacist or nurse.

1) Remove the lids on each end of the connection.

Warning triangle

Do not touch the ends of the connector and syringe tips to prevent contamination (sources of infection)

2) Screw the connection to the pre-filled syringe.

3) Connect the graduated syringe to the other end of the connection and check that both connections are securely fastened.

Connect the syringe

Transfer icatibant solution to the graduated syringe:

1) Start the transfer of the icatibant solution by pressing the plunger of the pre-filled syringe (far left in the picture below).

Transfer

2) If the icatibant solution does not begin to transfer to the graduated syringe, gently pull the graduated syringe plunger until the icatibant solution begins to flow to the graduated syringe (see image below).

Lightly pull the plunger of the graduated syringe

3) Continue to push the plunger of the pre-filled syringe until the desired injection volume ( dose ) has been transferred to the graduated syringe. See Table 1 for dosing information.

If there is air in the graduated syringe:

  • Turn the connected syringe so that the pre-filled syringe is at the top (see picture below).
Turn the syringe over
  • Press the plunger of the graduated syringe so that any air is returned to the pre-filled syringe (this step may need to be repeated several times).
  • Draw up the amount (volume) of the icatibant solution prescribed.

4) Remove the pre-filled syringe and the connection from the graduated syringe.

5) Dispose of the pre-filled syringe and connection in a waste container for sharp objects.

2b) Preparation of syringe and needle for injection

All patients (adults, adolescents, and children)

Remove the needle cover
  • Remove the needle cover from the blister pack.
  • Remove the closure from the needle cover (the needle should remain in the needle cover).
Attach the needle to the syringe
  • Take a firm grip on the syringe. Carefully attach the needle to the pre-filled syringe containing the colorless solution.
  • Screw the pre-filled syringe onto the needle while it is still in the needle cover.
  • Remove the needle from the needle cover by pulling on the syringe barrel. Do not pull out the plunger.
  • The syringe is now ready for injection.

3) Preparation of injection site

Clean the injection site
  • Select injection site. The injection site should be a fold of skin on the abdomen, approximately 5–10 cm below the navel on either side. This area should be at least 5 cm from any scars. Do not select an area that has bruises, is swollen, or hurts.
  • Clean the injection site by rubbing with an alcohol swab and letting it dry.

4) Injection of the solution

Press the plunger

Hold the syringe in one hand between two fingers with your thumb on the end of the plunger.

Make sure there are no air bubbles in the syringe by pushing on the plunger until the first drop is visible on the needle tip.

Push in the piston
  • Hold the syringe at a 45-90 degree angle to the skin with the needle pointing at the skin.
  • While holding the syringe in one hand, use the other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site.
  • While holding the skin fold, insert the syringe against the skin and quickly insert the needle into the skin fold.
  • Slowly push the syringe plunger in with a steady hand until all liquid has been injected into the skin and no liquid remains in the syringe.
  • Push the plunger in so slowly that it takes about 30 seconds.
  • Release the skin fold and gently pull out the needle.

5) Disposal of syringe, needle, and needle guard

Discard the syringe
  • Dispose of the syringe, needle, and needle guard in a waste container for sharp objects, which is intended for waste that can cause damage if handled improperly.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Almost all patients receiving Firazyr experience a reaction at the injection site (such as skin irritation, swelling, pain, itching, reddening of the skin, and a burning sensation). The reaction may be a burning sensation, reddening of the skin ( erythema ), pain, swelling, feeling hot, itching, and skin irritation. The side effects are usually mild and disappear without the need for any further treatment.

Very common (may affect more than 1 user in 10):

Other reactions at the injection site (feeling of pressure, bruising, decreased sensation and/or numbness, increased itchy skin rash, and feeling of heat).

Common (may affect up to 1 in 10 people):

Nausea

Headache

Dizziness

Fever

Itching

Rash

Reddening of the skin

Abnormal liver function test

No known frequency (cannot be calculated from the available data):

Hives ( urticaria )

Tell your doctor immediately if you notice that the symptoms of the attack worsen after receiving Firazyr.

5. How to store Firazyr

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

Do not use this medicine if you notice that the packaging of the syringe or needle is damaged or if there are any visible signs of deterioration, e.g. if the solution is cloudy or contains liquid particles, or if the color of the solution has changed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is icatibant. Each pre-filled syringe contains 30 milligrams of icatibant (as acetate).
  • The other ingredients are sodium chloride, glacial acetic acid, sodium hydroxide, and water for injections.

What the medicine looks like and the contents of the pack

Firazyr is a clear, colorless solution for injection in a pre-filled syringe (3 ml).

An injection needle is included in the package.

Firazyr is available as a single pack containing a pre-filled syringe with an injection needle or as a multi-pack containing three pre-filled syringes with three injection needles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

D02 Y754, Ireland

Tel: +800 66838470 

Muhammad Nadeem

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