Important Safety Information
Berinert®, C1 Esterase Inhibitor (Human), is for the treatment of ongoing, acute attacks of hereditary angioedema (HAE) affecting the abdomen, face or throat in adults and adolescents. The safety and efficacy of Berinert in preventing HAE attacks have not been established.
Do not use Berinert if you have experienced life-threatening allergic reactions or severe hypersensitivity to the product. Immediately report to your physician or an emergency department any signs or symptoms of allergic reactions to Berinert, including hives, chest tightness, wheezing, turning blue, fast heartbeat, and shock. Also report signs and symptoms of thrombosis that occur after infusing: including swelling and pain in the limbs or abdomen, chest pain, shortness of breath, loss of sensation or motor power, or altered consciousness or speech.
Berinert can be self-administered if you have been trained and advised to do so by your healthcare provider. Seek immediate medical attention if an HAE attack has progressed to a point where you will be unable to prepare or administer Berinert.
Call your doctor right away if swelling is not controlled after use of Berinert.
If you self-administer to treat a laryngeal attack, immediately seek medical attention afterward. If you self-administer for an abdominal attack, inform your physician so that other possible causes can be ruled out.
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 increased severity of pain associated with HAE. In the placebo-controlled clinical trial, the most common adverse reaction reported more often among
subjects who received Berinert than those receiving placebo was dysgeusia (a bad taste in mouth).
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 effectiveness of Berinert have not been established in children under 12 or adults over 65 years of age.
Please see full prescribing information for Berinert, including patient product information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.