Prescribing Information

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Important Safety Information

Berinert®, C1 Esterase Inhibitor (Human) is for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established.

Immediately report to your physician or an emergency department any signs or symptoms of allergic or hypersensitivity reactions to Berinert, including hives, chest tightness, wheezing, turning blue, fast heartbeat, and shock. Also report any signs and symptoms of thrombosis, such as swelling and pain in the limbs or abdomen, chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech. If necessary, your doctor will immediately discontinue administration and initiate appropriate treatment.

Because Berinert is made from human blood, the risk that it may transmit infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

In clinical studies, the most serious adverse reaction reported in subjects who received Berinert was an increase in the severity of pain associated with HAE. The most common adverse reactions, reported in over 4% of the subjects who received Berinert, were headache, abdominal pain, nausea, muscle spasms, pain, diarrhea, and vomiting.

Berinert has not been evaluated in pregnant women or nursing mothers; inform your doctor if you are pregnant or are planning to become pregnant, or if you are breastfeeding or plan to breastfeed. The safety and efficacy of Berinert have not been established in children (ages 0 through 12) or in the elderly.

Please see prescribing information for Berinert, with patient product information.

You are encouraged to report negative effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.