INDICATION
CINRYZE® (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema
attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
IMPORTANT SAFETY INFORMATION
CINRYZE is contraindicated in patients who have manifested life-threatening immediate
hypersensitivity reactions, including anaphylaxis to the product.
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 patients receiving CINRYZE for routine prophylaxis
and in patients receiving 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.