FDA Approves New Drug Firazyr

Firazyr

Generic Name: icatibant
Date of Approval: August 25, 2011
Company: Shire plc

Treatment for: Hereditary Angioedema

The U.S. Food and Drug Administration (FDA) has granted marketing approval for Firazyr (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Firazyr has orphan drug designation status in the EU and US for the treatment of acute HAE. Firazyr is supplied in a pre-filled syringe that can be stored at room temperature (up to 77degrees Fahrenheit), making it portable and accessible for immediate treatment of HAE attacks. Firazyr's active substance, icatibant, is a potent and selective bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously administered approach to the treatment of HAE attacks. By inhibiting the effects of bradykinin, which is thought to be responsible for HAE symptoms of localized swelling, inflammation, and pain, Firazyr treats the clinical symptoms of an acute HAE attack.

Firazyr Patient Information

Please read this Patient Information before you use Firazyr and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Firazyr?

Firazyr is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if Firazyr is safe or effective for children under 18 years of age.

Before taking Firazyr

Before you use Firazyr, tell your healthcare provider if you:

• have any other medical conditions.
• are breastfeeding or plan to breastfeed. It is not known if Firazyr passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use Firazyr.
• are pregnant or plan to become pregnant. It is not known if Firazyr will harm your unborn baby. You and your healthcare provider will decide if Firazyr is right for you.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I use Firazyr?

• Use Firazyr exactly as your healthcare provider tells you to use it.
• Your healthcare provider will prescribe the right dose of Firazyr for you and tell you when to use it.
• Your healthcare provider will teach you or a caregiver how to give Firazyr injections
• Read the Instructions for Use at the end of the Patient Information for information about the right way to use Firazyr.
• If your symptoms continue or come back, you may repeat your Firazyr injection at least six hours apart.
• Do not use more than 3 doses in 24 hours.
• If you have a laryngeal attack, inject Firazyr and then go to the nearest hospital emergency room right away.

What should I avoid while using Firazyr?

Tiredness, drowsiness, and dizziness can occur in people who take Firazyr. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

 

Firazyr side effects

The most common side effects of Firazyr include:

• redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
• fever
• too much of an enzyme called transaminase in your blood
• dizziness
• nausea
• headache
• rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Firazyr. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Firazyr?

• Store Firazyr between 36°F to 77°F (2°C to 25°C).
• Do not freeze.
• Store Firazyr in the original carton until you are ready to use it.

Keep Firazyr and all medicines out of the reach of children.

General information about the safe and effective use of Firazyr

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Firazyr for a condition for which it was not prescribed. Do not give Firazyr to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Firazyr. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Firazyr that is written for health professionals.

For more information, go to www.firazyr.com or call 1-866-888-0660.

What are the ingredients in Firazyr?

Active ingredient: icatibant acetate

Inactive Ingredients: sodium chloride, glacial acetic acid, sodium hydroxide, and water