Why choose Berinert?

Abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) can leave you feeling isolated, worried about the next attack, or reluctant to make plans. But now you have an on-demand treatment option that works when and where you need it most.

Berinert is effective

Berinert can be self-administered via intravenous infusion by patients or by a healthcare professional. In clinical studies, patients experiencing an abdominal or facial attack had a median onset of relief of 48 minutes. In an extension study, patients experiencing a laryngeal attack had a median onset of relief of 15 minutes.

Berinert is safe

The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.

In addition, Berinert and the human plasma from which it’s made have been processed and screened to remove or inactivate known viruses.

Because Berinert is made from human plasma, the risk that it may transmit infectious agents cannot be completely eliminated.

Berinert is self-administered on demand

Berinert is an on-demand hereditary angioedema treatment, which means it will be used only when you have an acute abdominal, facial, or laryngeal attack – and not to prevent an attack. Patients can now self-administer Berinert with the right training. Find support materials here.

Work with your doctor to determine if self-administration of Berinert via intravenous infusion is right for you. By creating an individualized treatment plan, you'll know how to handle an acute abdominal, facial, or laryngeal attack of HAE.

Berinert features weight-based dosing

The recommended Berinert dosage is 20 units (U) per kilogram of body weight. Because dose is calculated by weight, you get an amount of medicine that is individualized to your body. In addition, because Berinert is only given for acute attacks, you only get the medicine when you need it.

Berinert is stored at room temperature

Berinert doesn’t require refrigeration and can be stored for up to 30 months, making it easy for you to keep it at home or carry with you. Until you are ready to use it, it’s important to keep Berinert in its original carton to protect it from light. Also, do not freeze Berinert.

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.