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. Inform your healthcare provider of all medications you are taking and of any medical conditions, especially any history of blood-clotting problems.
Blood clots have occurred in patients receiving Berinert. Tell your healthcare provider if you have an indwelling catheter, a history of heart or blood vessel disease or stroke, or have been immobile for some time. Certain medications, such as birth control pills, may also increase your risk of clotting problems.
Report to your physician or an emergency room any signs and symptoms of a blood clot, including pain and/or swelling or discoloration of an arm or leg, with warmth over affected area; unexplained shortness of breath; chest pain or discomfort that worsens on deep breathing; rapid pulse; and numbness or weakness on one side of the body.
In addition, report immediately any signs or symptoms of allergic reactions to Berinert, including hives, chest tightness, wheezing, turning blue, facial swelling and fast heartbeat.
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.
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.
Call your doctor right away if swelling is not controlled after use of Berinert.
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 the 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.