Consumer medicine information

Fyzant 30 mg/3 mL Solution for injection

Icatibant

BRAND INFORMATION

Brand name

Fyzant

Active ingredient

Icatibant

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fyzant 30 mg/3 mL Solution for injection.

1. Why am I using FYZANT?


FYZANT contains the active ingredient icatibant. FYZANT is used for treating the symptoms of an acute attack of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
For more information, see Section 1. Why am I using Fyzant? in the full CMI.

2. What should I know before I use FYZANT?


Do not use if you have ever had an allergic reaction to icatibant or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use FYZANT? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with FYZANT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FYZANT?


Your doctor will determine the exact dose of FYZANT and will tell you how often it should be used. Please see step-by-step instructions for injecting FYZANT in children and adolescents.
More instructions can be found in Section 4. How do I use FYZANT? in the full CMI.

5. What should I know while using FYZANT?

Things you should do
  • Tell your doctor immediately if you notice that your symptoms of the attack get worse after you use FYZANT.
  • Remind any doctor, dentist or pharmacist you visit that you are using FYZANT.
  • Tell your doctor immediately if you become pregnant while using this medicine
Things you should not do
  • If you are about to be started on any new medicine, remind your doctor, dentist or pharmacist that you are taking FYZANT.
Driving or using machines
  • Do not drive or operate any machinery if you feel tired or dizzy as a result of your HAE attack or after using FYZANT.
Looking after your medicine
  • Keep your medicine in a cool dry place where the temperature stays below 25°C. Do not freeze it.
  • Keep your medicine in the original pack until it is time to use them.
  • Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

For more information, see Section 5. What should I know while using FYZANT? in the full CMI.

6. Are there any side effects?


Almost all patients receiving FYZANT will experience a reaction at the site of the injection. Tell your doctor or pharmacist if you notice nausea, pain in the abdomen (tummy), weakness, dizziness, headache, blocked nose, rash, vomiting, fatigue, fever, sore throat, weight gain, asthma, cough, itching, redness of the skin, hot flushes, muscle spasm, hives, abnormal liver function test, (symptoms may include yellowing of the skin and eyes (jaundice)).
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Fyzant

Active ingredient

Icatibant

Schedule

S4

 

1 Name of Medicine

Icatibant acetate.

2 Qualitative and Quantitative Composition

Each pre-filled syringe delivers 3 mL containing icatibant acetate equivalent to 30 mg icatibant. Each mL of the solution contains 10 mg of icatibant.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Fyzant is supplied as a sterile solution for injection in single use pre-filled syringes. The solution should be clear and colourless and free from visible particles. The pH of the injection is approximately 5.5.

4 Clinical Particulars

4.9 Overdose

No clinical information on overdose is available.
A dose of 3.2 mg/kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching, flushing, or hypotension in healthy subjects. No therapeutic intervention was necessary.
For information on the management of overdose, contact the Poisons Information Centre on 131126 in Australia, or the National Poisons Centre on 0800 POISON (0800 764766) in New Zealand.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In a standard battery of in vitro and in vivo tests icatibant was not genotoxic.
Carcinogenicity. In a 2 year study to evaluate the carcinogenic potential of icatibant in rats, daily SC doses up to 6 mg/kg/day (11-fold the anticipated clinical exposure in patients administered 240 mg icatibant per month, based on monthly AUC) had no effect on the incidence or morphology of tumours. Results do not indicate a carcinogenic potential for icatibant.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical name of icatibant: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-L-seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)octahydroindol-2-ylcarbonyl]-L-arginine.
Icatibant is isolated as the acetate salt, containing approximately 1-4 equivalents of acetic acid.
Chemical structure of icatibant:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSICATIB.gif Chemical formula of icatibant: C59H89N19O13S.
Molecular weight of icatibant: 1304.55.
CAS number. CAS number of icatibant: 130308-48-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FYZANTST.gif