Berinert (C1 Esterase Inhibitor [Human]) for HAE

Berinert (C1 esterase inhibitor [human]) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat acute abdominal, facial, or throat swelling attacks caused by hereditary angioedema (HAE) in adults and children.

How Berinert Works and How It’s Taken

Berinert is a C1 esterase inhibitor replacement treatment. It replaces a blood protein that is missing or does not work properly in people with HAE.

Berinert inactivates proteins called kallikrein and factor XIIa (12a). This is thought to reduce the production of bradykinin, a substance that can cause blood vessels to leak fluid and lead to swelling.

Doctors prescribe Berinert to treat acute HAE attacks that affect the abdomen, face, or throat.

It is given as a slow injection into a vein. The recommended injection rate is approximately 4 milliliters per minute. With proper training, an appropriate person or caregiver may give Berinert when they recognize the symptoms of an HAE attack.

Each vial is for one-time use and contains no preservative. After mixing, use the solution promptly and within eight hours. Do not refrigerate or freeze the mixed solution. Throw away any unused solution.

Typical Dosing for HAE

The recommended dose of Berinert for HAE is 20 international units per kilogram of body weight for each acute HAE attack. It is given by intravenous injection.

The dose is based on body weight. Doses lower than 20 international units per kilogram should not be given.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Berinert Side Effects

In clinical studies, the most common side effects of Berinert occurred in about 5 percent of people. These include:

Changes in taste (a bad or unusual taste in the mouth)
Increase in the severity of pain associated with HAE

Serious Side Effects and Warnings

Berinert can cause serious side effects that may require immediate medical attention. These include:

Hypersensitivity (allergic) reactions — Allergic reactions can include anaphylaxis, which may cause hives, widespread itchy welts, chest tightness, wheezing, low blood pressure, or trouble breathing during or after the infusion.
Thromboembolic events (blood clots) — Clots in veins or arteries can lead to problems like deep vein thrombosis, pulmonary embolism, heart attack, or stroke. Symptoms may include pain, swelling, warmth, or discoloration in an arm or leg, sudden shortness of breath, chest pain that worsens with deep breathing, a fast heartbeat, or sudden weakness or numbness on one side of the body.
Risk of transmitting infections from human blood products — Because Berinert is made from human blood, there is a risk of transmitting viruses or other infectious agents despite careful screening and processing.

Get medical help right away if you think you are having a serious reaction.

How To Save on Berinert

CSL Behring, the manufacturer of Berinert, offers Berinert Connect. The Berinert Co-Pay Program helps eligible people with commercial insurance pay for out-of-pocket costs associated with Berinert.

Berinert Connect also offers personalized support from a dedicated case manager, self-administration education for people with HAE, parents, and caregivers, and assistance with insurance navigation and other financial support programs for eligible individuals.

To learn more, visit the Berinert Connect website or call 877-236-4423.

What To Know Before Taking Berinert

Before using Berinert, tell your doctor if you have had blood clots or have risk factors for blood clots. These may include:

Heart or blood vessel disease
A previous stroke or blood clot
An indwelling catheter in a vein
Severe obesity
Being unable to move for a long time
Use of birth control pills or certain androgens

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not use Berinert if you have had a life-threatening allergic reaction, including anaphylaxis, to a C1 esterase inhibitor product.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Berinert, talk with your doctor about the risks and benefits. Berinert should be used during pregnancy only if clearly needed.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Berinert for HAE?

In a study of 124 adults and children with moderate to severe abdominal or facial HAE attacks, people received either Berinert or a placebo. People who received Berinert at 20 international units per kilogram had a median time to the start of symptom relief of 48 minutes. For people who received placebo, the median time was more than four hours.

Within 60 minutes, 62.8 percent of people treated with Berinert had started to feel relief, compared with 26.2 percent of people who received placebo. Within four hours, 69.8 percent of people treated with Berinert had started to feel relief, compared with 42.9 percent of people who received placebo.

In an extension study of laryngeal HAE attacks, the median time to the start of symptom relief was 0.25 hours, or 15 minutes.

How long does Berinert take to work for HAE?

For acute abdominal or facial HAE attacks, the median time to the start of symptom relief was 48 minutes with the recommended dose of 20 international units per kilogram.

In an extension study of laryngeal HAE attacks, the median time to the start of symptom relief was 0.25 hours, or about 15 minutes.

Can I self-administer Berinert for HAE?

Yes. You or a caregiver may self-administer Berinert after a healthcare provider confirms that you are an appropriate candidate and provides training on IV injection. You should be able to recognize HAE attack symptoms and safely prepare and inject the medicine.

Do not start self-administration if the attack has progressed so far that you cannot safely prepare or give Berinert. After treating a laryngeal (throat) attack, seek medical care immediately because the swelling may block your airway.