Indication and Important Safety Information

SAJAZIR™ (Icatibant) injection is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject SAJAZIR and then go to the nearest hospital emergency room right away.

The most common side effects of SAJAZIR 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

These are not all of the possible side effects of SAJAZIR. Tell your healthcare provider if you have any side effects.

Also tell your healthcare provider if you have any other medical conditions, are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. SAJAZIR has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if SAJAZIR is right for you.

If your symptoms continue or come back, you may repeat your SAJAZIR injection at least 6 hours apart. Do not use more than 3 doses of SAJAZIR in a 24-hour period.

Tiredness, drowsiness, and dizziness have been reported following the use of SAJAZIR. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

For more detailed information, please refer to the Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-800-836-4380, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.