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How Supplied


FIRAZYR® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.


Recommended Dosing

The recommended dose of FIRAZYR is 30 mg administered by subcutaneous (SC) injection in the abdominal area. Additional doses may be administered at intervals of at least 6 hours if response is inadequate or if symptoms recur. No more than 3 doses may be administered in any 24 hour period.

Administration Instructions

FIRAZYR should be inspected visually for particulate matter and discoloration prior to administration. The drug solution should be clear and colorless. Do not administer if the product contains particulates or is discolored.

Attach the provided 25 gauge needle to the syringe hub and screw on securely. Do not use a different needle. Disinfect the injection site and administer FIRAZYR by subcutaneous injection over at least 30 seconds.

Patients may self-administer FIRAZYR upon recognition of symptoms of an HAE attack after training under the guidance of a healthcare professional [see PATIENT INFORMATION].


Dosage Forms And Strengths

FIRAZYR injection is supplied in a prefilled syringe delivering 30 mg icatibant. Each syringe delivers 3 mL solution with a concentration of 10 mg per mL.

FIRAZYR is supplied as a single-use, prefilled syringe for subcutaneous administration. Each syringe delivers 3 mL of a sterile solution of icatibant 30 mg (as icatibant acetate). Each glass syringe has a bromobutyl plunger stopper, which is not made of latex natural rubber.

FIRAZYR is available in cartons containing one single-use, prefilled syringe and one 25 G Luer lock needle. NDC 54092-702-02.

FIRAZYR is also available in a pack containing 3 cartons; each carton contains one single-use, prefilled syringe and one 25 G Luer lock needle. NDC 54092-702-03.

Storage And Handling

Keep out of the reach of children. Store between 2 -25° C (36 -77° F). Do not freeze. Store in carton until time of administration.

Manufactured for: Shire Orphan Therapies, LLC., 300 Shire Way Lexington, MA 02421. Revised: November2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/7/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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