Important Treatment Considerations

FIRAZYR^® (icatibant injection) is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

• Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject FIRAZYR and then go to the nearest hospital emergency room right away
• 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 other medical conditions, if you are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. FIRAZYR has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if FIRAZYR is right for you
• If your symptoms continue or come back, you may repeat your FIRAZYR injection at least 6 hours apart
• Do not use more than 3 doses of FIRAZYR in a 24-hour period
• Tiredness, drowsiness, and dizziness have been reported following the use of FIRAZYR. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information about FIRAZYR, ask your healthcare provider. For further information, please see the Full Prescribing Information.

To report suspected adverse events, please contact Shire Human Genetic Therapies, Inc. at 1-866-888-0660 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For assistance with medical inquiries about FIRAZYR, please contact Medical Information at 1-866-888-0660 option 2 or US_ShireHGT_MedicalInformation@shire.com.