Important Safety Information
Berinert®, C1 Esterase Inhibitor (Human), is used in adults and children to treat swelling and/or painful attacks of hereditary angioedema (HAE) affecting the abdomen, face or throat. 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, including anaphylaxis, or severe hypersensitivity to the product. Inform your healthcare provider of all medications you are taking and any medical conditions you may have, including pregnancy and any history of blood-clotting problems.
Blood clots have occurred in patients receiving Berinert. Tell your healthcare provider if you have a history of heart or blood vessel disease, stroke, or blood clots; or have thick blood, an indwelling catheter/access device in a vein, 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 rash, hives, chest tightness, wheezing, difficulty breathing, turning blue, faintness, facial swelling and fast heartbeat.
If you have been trained to self-administer Berinert, immediately prepare the prescribed dose at the first symptoms of an attack. Seek immediate medical attention and do not begin to self-administer if an HAE attack has progressed to a point where you will be unable to prepare or administer a dose 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.
Call your doctor right away if swelling is not controlled after use of Berinert.
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). Tell your healthcare provider about any side effect that bothers you or does not go away.
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.
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.