Firazyr - Consumer Medicine Information
|Manufacture:||Shire US, Inc.|
|Class:||Cardiovascular agents, Miscellaneous cardiovascular agents|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||icatibant acetate, sodium hydroxide, acetic acid, sodium chloride, water|
About This Medication
What the Medication is Used for
FIRAZYR is used for treating acute attacks of hereditary angioedema (HAE) in adults with a deficiency of a protein called C1-esterase inhibitor.
What it Does
In HAE, levels of a substance in your bloodstream called bradykinin are increased leading to symptoms like swelling, pain, nausea, and diarrhea. FIRAZYR blocks the activity of bradykinin and ends further progression of the symptoms of an HAE attack.
When it Should not be Used
Do not use FIRAZYR if you are allergic to icatibant or any other ingredients in FIRAZYR or the container.
What the medicinal ingredient is
What the Nonmedicinal Ingredients are
acetic acid glacial, sodium chloride, sodium hydroxide, and water for injection.
What dosage forms it comes in
FIRAZYR is a solution for subcutaneous injection containing 10 mg/mL icatibant as acetate. FIRAZYR is available in a single dose pre-filled syringe containing 30 mg/3mL icatibant as acetate. A patient self-administration kit, containing a travel case, needle protection devices and alcohol wipes can also be obtained through Shire's HAE support program.
Warnings and Precautions
You or your caregiver should receive proper training from a healthcare professional on how to give subcutaneous (under the skin) injections of FIRAZYR.
If you have a laryngeal attack (obstruction of the upper airway causing difficulty breathing) inject FIRAZYR and then go to the emergency room of the nearest hospital for medical help right away.
BEFORE you use FIRAZYR talk to your doctor or pharmacist if you:
- have heart problems such as unstable angina (reduced blood flow to the heart muscle)
- have recently suffered a stroke
- are pregnant or plan to become pregnant
- are breastfeeding
FIRAZYR is not recommended for use in patients under 18 years of age.
Driving and Using Machinery
FIRAZYR may cause tiredness, dizziness or sleepiness. DO NOT drive or operate machinery after using FIRAZYR if you feel tired or dizzy.
Interactions With this Medication
Tell your doctor or pharmacist about all of the medicines you take, including the ones you can buy without prescription, vitamins, and natural health products.
FIRAZYR may affect how an angiotensin converting enzyme (ACE) inhibitor works. An ACE inhibitor is used to lower blood pressure.
Proper Use of This Medication
A healthcare professional may give you your first dose of FIRAZYR injection, then tell you when it is safe to go home.
A healthcare professional will also teach you how to safely inject FIRAZYR before you can give yourself an injection.
You should be able to read and follow step-by-step instructions for injection provided under the heading "Step-by-Step Instructions for Injection".
Usual Adult Dose
- One injection (30 mg/3 mL) to be injected under the skin (subcutaneous) as directed by your doctor when you have symptoms of an HAE attack.
- If you have a laryngeal attack (obstruction of the upper airway), inject FIRAZYR and then go to the emergency room of the nearest hospital for medical help right away.
- If the symptoms continue or come back, you may repeat another injection (30 mg/3mL) after at least 6 hours from the first injection.
Do not use more than 3 injections in 24 hours. Talk with your doctor before using more than 8 doses per month.
Step-by-Step Instructions for Injection
Getting Started With Firazyr
You Will Need the Following Supplies
- Your FIRAZYR blister pack, which includes 1 single-use, prefilled syringe and 1 needle
- An alcohol wipe. See Figure A
The medicine inside your FIRAZYR prefilled syringe should be clear and colorless. Do not use your FIRAZYR prefilled syringe if the solution contains particles, is cloudy, or has an unusual color. If you believe that your FIRAZYR injection is not fit for use or is faulty in any way, please contact Shire at 1-888-867-7426.
Remember to wash your hands with soap and water before handling any of the items needed for your injection, and always handle supplies carefully to avoid contamination.
Preparing Your Dose of Firazyr
- Remove the prefilled syringe and needle from the blister pack
- Remove the seal from the needle cap (the needle should remaininside the protective needle cap until ready to use). See Figure B
- Hold the syringe firmly and remove the protective cap from theprefilled syringe.
- Carefully attach the needle to the prefilled syringe containing thecolorless FIRAZYR solution. See Figure C
- Firmly screw the needle on the prefilled syringe. Be careful not to remove the needle from the needle cap. See Figure D
Preparing the Injection Site
- Choose the injection site. The injection site should be a fold of skin on your stomach, about 5 to 10 centimeters (2 to 4 inches) below your belly button on either side. See Figure E
The area you choose for injection should be at least 5 centimeters (2inches) away from any scars. Do not choose an area that is bruised, swollen, or painful.
- Clean your FIRAZYR injection site with an alcohol wipe and allow it to dry. See Figure F
- Remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. Do not pull up on the plunger. See Figure G
- Hold the FIRAZYR prefilled syringe in 1 hand, between your fingers and thumb. See Figure H
- Use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. See Figure I
- Hold the syringe between a 45 to 90 degree angle to your skin with the needle facing the fold of skin you are holding. See Figure J
- Hold the fold of skin. Bring the syringe to the skin and quickly insert the needle into the skin fold. See Figure K
- Push the plunger, at the top of the syringe, over at least 30 seconds until no FIRAZYR is in the syringe. See Figure L
- Release the skin fold and gently pull the needle out. See Figure M
Disposing of Your Used Firazyr Prefilled Syringe
- Place the used FIRAZYR syringe, with the needle attached, in a sharps container (such as a biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Seal the container and throw it away the right way. There may be provincial and local laws about the right way to throw away used syringes and needles. Ask your healthcare provider or pharmacist how to throw away used syringes and needles. See Figure N
|In case of drug overdose, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side Effects and What to do About Them
Side effects may include:
- burning, redness, swelling, pain, itching, or warmth at the injection site
- abdominal pain or distension
- upper respiratory tract infection
- inflammation of the sinuses
- urinary tract infection
- increased liver enzymes called transaminases (ALT,AST)
- worsening or recurrence of HAE
- nasal congestion
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom / effect||Talk with your|
|Unknown||heart and non-heart|
related chest pain
|acute heart attack||X|
Tell your healthcare professional if you have any side effect that bothers you or that does not go away.
This is not a complete list of side effects. For any unexpected effects while taking FIRAZYR, contact your doctor or pharmacist.
How to Store it
Store at: 2-25° C Do not freeze.
Store FIRAZYR in the original carton until you are ready to use it.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your healthcare professional. The Canada Vigilance Program does not provide medical advice.
If you want more information about FIRAZYR: