Berinert is a brand-name prescription medication. It’s FDA-approved to treat acute attacks of hereditary angioedema (HAE) in adults and children.

HAE is a rare genetic condition that causes episodes of sudden, severe swelling. These are called HAE attacks. They can happen in any part of your body. But they most commonly affect the arms, legs, face, tongue, throat, stomach, and intestines. HAE attacks can cause severe pain, and those affecting the throat can cause trouble breathing.

Berinert is approved to treat HAE attacks affecting the face, throat, stomach, or intestines.

Drug details

Berinert contains the active drug C1 esterase inhibitor (human). This is a protein that’s found naturally in human blood. It helps to control swelling in the body. People with HAE have low levels or faulty versions of this protein.

Berinert is administered by intravenous (IV) infusion to treat HAE attacks. An IV infusion is an injection into a vein that’s given slowly over a period of time. Your healthcare provider can teach you how to give yourself Berinert infusions.

Berinert comes as a powder in a single-use vial. The powder is mixed with sterile water to make a liquid solution for infusion.

Effectiveness

For information about the effectiveness of Berinert, see the “Berinert uses” section below.

Berinert is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

A biologic drug is made using living cells, whereas other drugs are made using chemicals. It’s not possible to produce exact copies of brand-name biologic drugs. But exact copies of brand-name drugs made using chemicals can be produced. These are called generics. Biosimilars are drugs that are similar to a brand-name biologic drug.

Both generics and biosimilars are considered as safe and effective as their brand-name counterparts. Generics and biosimilars usually cost less than brand-name drugs.

As with all medications, the cost of Berinert can vary. To find current prices for Berinert in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Berinert at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Berinert, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Berinert, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Berinert, or if you need help understanding your insurance coverage, help is available.

CSL Behring, the manufacturer of Berinert, offers a program called Berinert Connect. For more information and to find out if you’re eligible for support, call 877-236-4HAE (877-236-4423) or visit the program website.

Generic or biosimilar version

Berinert is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

A biologic drug is made using living cells, whereas other drugs are made using chemicals. It’s not possible to produce exact copies of brand-name biologic drugs. But exact copies of brand-name drugs made using chemicals can be produced. These are called generics. Biosimilars are drugs that are similar to a brand-name biologic drug.

Both generics and biosimilars are considered as safe and effective as their brand-name counterpart. Generics and biosimilars usually cost less than brand-name drugs.

The Berinert dosage your doctor prescribes depends on your body weight.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Berinert comes as a powder in a single-use vial. Each vial contains 500 international units (IU) of active drug.

The powder in each vial is mixed with 10 milliliters (mL) of sterile water. This makes a liquid solution containing 50 IU per mL.

The prescribed dosage of the solution is administered by intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given slowly over a period of time.

Dosage for hereditary angioedema

The typical dosage of Berinert to treat an attack of hereditary angioedema (HAE) is 20 IU per kilogram (kg) of body weight. This should be administered by IV infusion at a rate of about 4 mL per minute.

You may need to use more than one vial of Berinert to make up the dosage your doctor has prescribed.

Berinert is only used to treat attacks of HAE. It isn’t used on a regular basis to prevent HAE attacks. The recommended dosage frequency (how often you should receive Berinert) is as often as needed to treat attacks.

Children’s dosage

The usual dosage of Berinert for children is the same as that recommended for adults. See the “Dosage for hereditary angioedema” section just above.

What if I miss a dose?

Berinert isn’t used to prevent HAE attacks, so you don’t need to receive it every day. You’ll only use it when you need to treat an HAE attack.

Will I need to use this drug long term?

Berinert is meant to be used as a long-term treatment. If you and your doctor determine that Berinert is safe and effective for you, you’ll likely use it whenever you need to treat an HAE attack.

You should use Berinert according to your doctor’s or healthcare provider’s instructions.

Berinert is administered by intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given slowly over a period of time.

Your healthcare provider can give you Berinert infusions. Or if you prefer, they can teach you or your caregiver how to administer the infusion. This means you can use Berinert as soon as possible whenever you need it.

You can find instructions for preparing and administering Berinert in the leaflet that comes with the medication. There are also step-by-step instructions on the manufacturer’s website. You should only administer Berinert yourself if you have been trained how to do so.

When to administer

You should use Berinert as soon as possible after you notice symptoms of an acute attack of hereditary angioedema (HAE) starting.

An acute HAE attack causes sudden, severe swelling. But you may also have other symptoms. These can start any time from a few minutes to a couple of days before the swelling. Berinert can be used to treat HAE attacks that affect your face, throat, stomach, or intestines.

Early symptoms of HAE attacks can include:

Talk with your doctor about any symptoms of an HAE attack that you may have. Also talk with your doctor about possible triggers for these attacks. Be sure to follow your doctor’s instructions about when you should give yourself a dose of Berinert.

Don’t self-administer Berinert if your symptoms might stop you from fully preparing or giving yourself the drug. If your attack has already progressed to this point, you should get medical help at your nearest healthcare facility. Take your Berinert with you. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Other drugs are available that can help manage hereditary angioedema (HAE). Some may be a better fit for you than others. If you’re interested in finding an alternative to Berinert, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Examples of other drugs that may be used to treat HAE attacks include:

  • recombinant C1 esterase inhibitor (Ruconest)
  • icatibant acetate (Firazyr)
  • ecallantide (Kalbitor)

Examples of drugs that may be used to prevent HAE attacks include:

The Food and Drug Administration (FDA) approves prescription drugs such as Berinert to treat certain conditions.

Berinert for hereditary angioedema attacks

Berinert is FDA-approved to treat acute attacks of hereditary angioedema (HAE) in adults and children. Specifically, Berinert is approved to treat HAE attacks affecting the face, larynx (voice box), or abdomen (stomach and intestines).

HAE is a rare genetic condition in which you have episodes of sudden, severe swelling under your skin or mucous membranes. (Mucous membranes are the moist linings that protect certain parts of your body, such as the inside of your mouth.) Episodes of swelling are called acute HAE attacks. HAE attacks most often affect the arms, legs, face, tongue, throat, stomach, and intestines. The swelling can be painful.

HAE attacks can cause different symptoms depending on the part of the body affected.

  • Facial attacks cause swelling around your eyes and mouth.
  • Laryngeal attacks cause swelling of the voice box in your throat. This can cause you to lose your voice. The swelling can also affect your tongue and the soft tissue at the back of your mouth. It can sometimes affect your lips as well. Laryngeal attacks can restrict your airway and cause trouble breathing. This can be life threatening.
  • Abdominal attacks can cause belly pain, nausea, vomiting, and diarrhea.

HAE attacks can be triggered by many different things. These include:

  • dental procedures
  • surgery
  • injuries
  • infections
  • stress
  • hormonal changes
  • certain foods

Without treatment, HAE attacks can last for 2 to 4 days. Taking Berinert to treat an attack can relieve the symptoms within a few hours.

Effectiveness for hereditary angioedema attacks

Berinert has been found to be effective in treating HAE attacks. It’s recommended as a treatment option in guidelines for managing HAE from the United States Hereditary Angioedema Association. For information on how the drug performed in clinical studies, see the prescribing information for Berinert.

Berinert and children

Berinert is FDA-approved for use in children. Its approval for children was based on clinical studies that involved children ages 5 years and older.

Berinert can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Berinert. These lists do not include all possible side effects.

For more information about the possible side effects of Berinert, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it’s approved. If you would like to notify the FDA about a side effect you’ve had with Berinert, you can do so through MedWatch.

Mild side effects

Mild side effects* of Berinert can include:

  • unpleasant taste in your mouth
  • headache
  • cold symptoms, such as a runny or stuffy nose

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Berinert. To learn about other mild side effects, talk with your doctor or pharmacist, or view Berinert’s important safety information.

Serious side effects

Serious side effects from Berinert aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects can include:

For more information about these side effects, see “Side effect details” below.

Side effects in children

Side effects of Berinert in children are similar to those reported in adults taking the drug. These are described above and below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Blood clots

Taking Berinert may increase your risk for serious blood clots. These include deep vein thrombosis (blood clot in a vein in your leg or arm) and pulmonary embolism (blood clot in your lungs). They also include blood clots that can lead to heart attack or stroke.

It’s not known how often blood clots occur in people taking Berinert. However, certain factors may increase your risk for this side effect. These include having a serious blood clot in the past, obesity, being unable to move around for long periods of time, or taking birth control pills. (To read more about factors that increase the risk of blood clots with Berinert, see the “Berinert precautions” section below.)

If you have symptoms of a blood clot after taking Berinert, see your doctor right away. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Symptoms of a blood clot may include:

  • pain, redness, warmth, or swelling in an arm or leg
  • chest pain
  • fast heart rate
  • shortness of breath
  • weakness or numbness on one side of your body
  • slurred speech

For more information about the possible risk of blood clots with Berinert, talk with your doctor or pharmacist.

Risk of contracting certain blood diseases

Berinert is made from human blood plasma. As a result, if you use Berinert, you may have a small risk for contracting certain blood diseases. These are infections that are transmitted through blood.

Berinert has been purified and pasteurized (heated to kill germs). Other measures have also been taken to minimize the risk of transmitting viruses that could cause infections. However, Berinert may still carry a small risk of transmitting blood diseases such as variant Creutzfeldt-Jakob disease (vCJD).

To date, Berinert is not known to have caused any cases of transmitted blood disease. If you have any questions about the potential risk of contracting certain blood diseases with Berinert, talk with your doctor or pharmacist.

Throat swelling and pain

Some people taking Berinert to treat an HAE attack may have throat swelling or increased pain. Throat swelling can restrict your airway and cause trouble breathing. These symptoms may happen due to worsening of an HAE attack. It’s uncommon for this to happen with Berinert. To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

If you have new or worsening symptoms, particularly throat swelling, after taking Berinert, get medical help in a healthcare facility right away. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

For more information about throat swelling with Berinert, talk with your doctor or pharmacist.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Berinert. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Berinert, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Alcohol isn’t known to interact with Berinert. If you have questions about the safety of drinking alcohol with Berinert, talk with your doctor.

Berinert isn’t known to interact with other medications. And it’s not known to interact with supplements or foods. However, this doesn’t mean interactions aren’t possible.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Before taking Berinert, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Berinert is used to treat acute attacks of hereditary angioedema (HAE).

What happens with HAE

HAE is a genetic condition that causes episodes of sudden, severe, painful swelling. These episodes of swelling are called HAE attacks. They typically affect your face, throat, tongue, stomach, or intestines. If your throat or tongue start swelling, this can restrict your airway and cause trouble breathing. If your stomach or intestines are affected, this can cause belly pain, nausea, vomiting, or diarrhea.

HAE attacks happen when fluid leaks out of your blood vessels and builds up in the surrounding tissues, causing swelling. A protein called bradykinin causes this to happen. Your body produces bradykinin during inflammatory and immune reactions that are triggered in certain situations. These include physical and emotional stress.

Bradykinin levels are usually controlled by another protein called C1 esterase inhibitor. With HAE, your body makes low levels or faulty versions of C1 esterase inhibitor. As a result, your body makes too much bradykinin. This leads to excessive amounts of fluid leaking out of your blood vessels, which causes severe swelling.

What Berinert does

Berinert contains C1 esterase inhibitor that’s normally found in healthy human blood. When you take it to treat an HAE attack, it acts as a replacement for your missing or faulty C1 esterase inhibitor. It lowers your bradykinin levels, which stops fluid leaking out of your blood vessels. This reduces the swelling and relieves the symptoms of the HAE attack.

How long does it take to work?

For HAE attacks affecting the throat, Berinert may take about 15 minutes to start working. It may take about 8 hours to fully reduce swelling and relieve symptoms.

For HAE attacks affecting the face, stomach, or intestines, Berinert may take about 50 minutes to start working. It may take about 5 hours to fully reduce swelling and relieve symptoms.

If Berinert doesn’t relieve your symptoms, see your doctor right away.

It’s not known if Berinert is safe to take during pregnancy. It hasn’t been specifically studied in people who are pregnant. However, one study looked at information from 20 females who took Berinert to treat HAE attacks while pregnant. No harmful effects were seen in babies born to the females in this study.

If you’re pregnant or planning to become pregnant, talk with your doctor about the possible risks and benefits of taking Berinert.

It’s not known if Berinert is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Berinert.

For more information about taking Berinert during pregnancy, see the “Berinert and pregnancy” section above.

It’s not known if Berinert is safe to take while breastfeeding. The drug hasn’t been studied in people who are breastfeeding. It’s not known if it passes into breast milk.

If you’re breastfeeding or planning to breastfeed, talk with your doctor about the possible risks and benefits of taking Berinert.

Here are answers to some frequently asked questions about Berinert.

Does Berinert prevent symptoms of hereditary angioedema?

It’s not known. Berinert hasn’t been studied for preventing attacks of hereditary angioedema (HAE). It’s only approved to treat HAE attacks. If you’re interested in taking treatment to help prevent HAE attacks, talk with your doctor.

Will I need to see a doctor after using Berinert for my symptoms?

Yes, you sometimes might.

For example, if you take Berinert for a laryngeal HAE attack (affecting your throat), you should also get medical help right away. Attacks affecting your throat can restrict your airway and cause trouble breathing. This can be life threatening.

If Berinert doesn’t reduce the swelling in your throat fast enough, you may need additional treatment to help you breathe. Go to your nearest healthcare facility right after taking Berinert, or call 911 or your local emergency number.

If you take Berinert for an abdominal HAE attack (affecting your stomach or intestines), you should call your doctor afterward. Your doctor may want to check that your symptoms aren’t caused by another serious medical condition, such as appendicitis or pancreatitis. Other conditions can also cause similar symptoms to abdominal HAE attacks.

You should also see a doctor after taking Berinert if it doesn’t relieve your symptoms.

Can older people use Berinert?

Yes, they usually can. Berinert has been studied in people up to 83 years of age. It was found to be just as safe in older people as it was in younger people.

If you have any questions about taking Berinert given your age, talk with your doctor.

Before taking Berinert, talk with your doctor about your health history. Berinert may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Risk of blood clots. Berinert may increase the risk of serious blood clots. These include deep vein thrombosis and pulmonary embolism. They also include blood clots that can lead to heart attack or stroke. Certain factors may increase your risk for blood clots with Berinert. Talk with your doctor before taking Berinert if any of these factors apply to you:
    • a serious blood clot in the past
    • atherosclerosis (hardening of your arteries)
    • an indwelling catheter in a vein (a tube that delivers medication or fluids into your bloodstream)
    • immobility (unable to move around) for long periods of time
  • Allergic reaction. If you’ve had an allergic reaction to Berinert or any of its ingredients, you shouldn’t take Berinert. Ask your doctor about which other medications are better options for you.
  • Pregnancy. It’s not known if Berinert is safe to take during pregnancy. For more information, see the “Berinert and pregnancy” section above.
  • Breastfeeding. It’s not known if Berinert is safe to take during breastfeeding. For more information, see the “Berinert and breastfeeding” section above.

Note: For more information about the potential negative effects of Berinert, see the “Berinert side effects” section above.

Do not use more Berinert than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Berinert

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Don’t use Berinert after the expiration date printed on the carton and vial label.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Berinert vials should be stored at a temperature of 36°F to 86°F (2°C to 30°C). This can be at room temperature or in a fridge. Be sure not to freeze Berinert. Keep the vials in their cartons to protect the drug from light.

Disposal

Right after you’ve used a syringe, needle, or autoinjector, dispose of it in an FDA-approved sharps disposal container. This helps prevent others, including children and pets, from taking the drug by accident or harming themselves with the needle. You can buy a sharps container online, or ask your doctor, pharmacist, or health insurance company where to get one.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.