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INDICATIONS

CINRYZE™ is a C1 esterase inhibitor indicated for the routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Contraindications

CINRYZE™ is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

Important Safety Information

Severe hypersensitivity reactions may occur. Because hypersensitivity reactions and HAE attacks may have similar symptoms, distinguishing between the two is important. Epinephrine should be immediately available to treat any acute severe hypersensitivity reaction and CINRYZE™ should be discontinued.

Thrombotic events have been reported in association with C1 esterase inhibitor products when used off-label at high doses. Monitor patients with known risk factors for thrombotic events.

CINRYZE™ is made from human plasma. Products made from human plasma may contain infectious agents (e.g. viruses and, theoretically, the Creutzfeldt-Jakob Disease agent). The risk that such products will transmit an infectious agent has been reduced by screening donors, testing for the presence of infections, and by inactivating or removing a broad range of viruses during the manufacturing process.

In the clinical trial, the most common adverse reactions observed by ≥ 5% of the 24 evaluable subjects after receiving CINRYZE™ were upper respiratory tract infection, sinusitis, rash, and headache.

Before prescribing CINRYZE™, please read the Full Prescribing Information.

DD0054                                                                                                                           06/2009

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