Orladeyo is a brand-name prescription medication. It’s FDA-approved to help prevent hereditary angioedema (HAE) attacks in adults as well as children ages 12 years and older.

HAE is a genetic condition. It causes episodes of swelling in areas such as your hands, feet, face, tongue, throat, or intestines. Sometimes HAE attacks can be very serious and may cause difficulty breathing.

Note: Orladeyo has limitations of use. For details, see the “Orladeyo for HAE” section below.

Drug details

Orladeyo contains the active drug berotralstat, which belongs to a class of medications called plasma kallikrein inhibitors. Orladeyo works to help prevent HAE attacks from occurring.

Orladeyo comes as a capsule that you take by mouth. It comes in two strengths: 150 milligrams (mg) and 110 mg.

FDA approval

The Food and Drug Administration (FDA) approved Orladeyo in 2020. It’s the first oral drug approved to help prevent HAE attacks. At this time, all other medications that are used to help prevent HAE attacks are given as injections.

Effectiveness

For information about the effectiveness of Orladeyo, see the “Orladeyo for HAE” section below.

Orladeyo is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Orladeyo contains the active drug berotralstat.

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


The cost you find on GoodRx.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.

Keep in mind that you may be able to get a 90-day supply of Orladeyo. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

It’s important to note that you’ll have to get Orladeyo 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 Orladeyo, 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 Orladeyo, contact your insurance company.

Financial and insurance assistance

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

BioCryst Pharmaceuticals Inc., the manufacturer of Orladeyo, offers a program called Empower Patient Services. Through this program, you may find cost assistance for Orladeyo as well as other resources. For more information and to find out if you’re eligible for support, call 866-5-EMPOWER (866-536-7693) or visit the program website.

Mail-order pharmacies

Orladeyo may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Orladeyo, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Orladeyo is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

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

Orladeyo is approved to help prevent hereditary angioedema (HAE) attacks in adults as well as children ages 12 years and older.

Note: Orladeyo has limitations of use. The drug should not be used to treat HAE attacks that are currently happening. It’s not known if Orladeyo is safe or effective when used for this purpose. In addition, using the drug more than once a day or taking multiple doses could lead to a type of abnormal heart rhythm called long QT syndrome.

HAE explained

HAE is a genetic condition. It causes episodes of swelling in areas such as your hands, feet, face, tongue, throat, or intestines.

HAE attacks that affect your tongue or throat are considered a medical emergency and need to be treated right away. If the attacks aren’t treated, they can lead to difficulty breathing.

Some people may not experience symptoms before an HAE attack. Others may develop symptoms including:

In some cases, triggers cause HAE attacks. These triggers can include certain foods, insect bites, and weather changes. But most people don’t know what causes their HAE attack to happen.

How often HAE attacks occur is different for each person. Most attacks last between 2 and 5 days.

Effectiveness for HAE

Orladeyo is an effective option to help prevent HAE attacks from occurring.

When the United States Hereditary Angioedema Association issued its most recent treatment guidelines in 2013, the FDA hadn’t yet approved Orladeyo. But the active drug in Orladayo (berotralstat) is mentioned in the guidelines as an option.

For information on how Orladeyo performed in clinical studies, see the drug’s prescribing information.

Orladeyo and children

Orladeyo is approved to help prevent HAE attacks in children ages 12 years and older. It’s not known if Orladeyo is a safe or effective treatment option for HAE in children younger than age 12 years.

The Orladeyo dosage your doctor prescribes will depend on several factors. These include:

  • other conditions you may have
  • other medications you may take
  • if you’re experiencing side effects from Orladeyo

Your doctor will prescribe the smallest dosage that provides the desired effect.

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

Orladeyo comes as an oral capsule. It’s available in two strengths: 150 milligrams (mg) and 110 mg.

Dosage for HAE

The usual Orladeyo dosage to help prevent hereditary angioedema (HAE) attacks is 150 mg once per day.

In some situations, your doctor may prescribe the 110-mg strength of Orladeyo. These include having digestive problems due to Orladeyo, having liver problems, or taking certain medications with Orladeyo.

Children’s dosage

Orladeyo is approved for use in children ages 12 years and older. The dosage for children is the same as the dosage for adults. See “Dosage for HAE” above.

If you have any questions about the correct dosage of Orladeyo for your child, talk with your child’s doctor.

What if I miss a dose?

If you miss a dose of Orladeyo, you should take it as soon as you remember. But if it’s almost time for your next dose, skip the missed dose and take your next dose as usual.

If you miss a dose and are unsure when to take your next dose, talk with your doctor or pharmacist. They can help you determine the best time for your next dose.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Orladeyo is meant to be used as a long-term treatment. If you and your doctor determine that Orladeyo is safe and effective for you, you’ll likely take it long term.

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

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

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

Mild side effects

Mild side effects* of Orladeyo can include:

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 Orladeyo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Orladeyo’s patient information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Orladeyo 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 and their symptoms, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Abnormal heart rhythm

Abnormal heart rhythm is rare but may occur with Orladeyo use. The specific change in heart rhythm that can occur is called long QT syndrome. This side effect can be serious and, in rare cases, may be life threatening.

Abnormal heart rhythm occurred when people took more than the recommended dosage of 150 milligrams (mg) once per day. It’s important that you do not take more than one dose of Orladeyo per day. If you do, you may increase your risk for developing an abnormal heart rhythm.

To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information. If you have any questions about this side effect, talk with your doctor before you start taking Orladeyo.

Abdominal pain

Some people may experience pain in the abdomen (belly) from taking Orladeyo. Abdominal pain was the most common side effect reported with Orladeyo in clinical studies.

To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

If you develop abdominal pain while taking Orladeyo, talk with your doctor. They may want to lower your dosage of Orladeyo to ease this side effect. They may also be able to recommend other ways to ease your abdominal pain.

Vomiting and diarrhea

Vomiting and diarrhea have occurred in people taking Orladeyo. Vomiting and diarrhea were common side effects reported by people taking Orladeyo in clinical studies.

To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

If you have vomiting or diarrhea while taking Orladeyo, talk with your doctor. They may be able to recommend ways to relieve this side effect.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Orladeyo. But this side effect wasn’t reported in clinical studies.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)

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 Orladeyo, 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.

Orladeyo isn’t known to interact with alcohol. But it’s possible that both Orladeyo and alcohol may cause vomiting to occur. So taking Orladeyo and drinking alcohol may increase your risk for vomiting.

If you drink alcohol, talk with your doctor about how much is safe for you to drink while taking Orladeyo.

Orladeyo can interact with several other medications. It can also interact with certain supplements. Orladeyo isn’t known to interact with any foods.

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

Orladeyo and other medications

Below is a list of medications that can interact with Orladeyo. This list does not contain all drugs that may interact with Orladeyo.

Before taking Orladeyo, talk with your doctor or 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.

Drugs that can interact with Orladeyo include:

  • Certain monoamine oxidase inhibitors (MAOIs). Taking Orladeyo with an MAOI may increase your risk for side effects from the MAOI. Examples of these MAOIs include:
    • thioridazine
    • pimozide
  • Fentanyl (Duragesic). Taking Orladeyo with fentanyl may increase your risk for side effects from fentanyl.
  • Digoxin (Lanoxin). Taking Orladeyo with digoxin may increase your risk for side effects from digoxin.
  • Cyclosporine (Gengraf, Neoral). Taking Orladeyo with cyclosporine may increase your risk for side effects from both drugs in your body. Your doctor may prescribe a lower dose of Orladeyo than usual.
  • Rifampin (Rimactane). Taking Orladeyo with rifampin may make Orladeyo less effective than usual.

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

Orladeyo and herbs and supplements

You should not use an herb called St. John’s wort while taking Orladeyo.

St. John’s wort is often used for depression or mood problems. But taking St. John’s wort with Orladeyo may make Orladeyo less effective than usual.

Before taking Orladeyo, tell your doctor if you’re using St. John’s wort. They may recommend that you stop using the supplement or take a drug other than Orladeyo.

Orladeyo and foods

No foods have been specifically reported to interact with Orladeyo. If you have any questions about eating certain foods with Orladeyo, talk with your doctor.

You should take Orladeyo according to the instructions from your doctor or other healthcare professional.

Orladeyo comes as capsules that you swallow.

When to take

You’ll usually take Orladeyo once per day. You should try to take your dose at about the same time each day. This helps keep a steady level of medication in your body so it can work effectively.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Orladeyo with food

You should take Orladeyo with food.

Can Orladeyo be crushed, split, or chewed?

The manufacturer of Orladeyo hasn’t stated whether the capsules can be crushed, split, or chewed. If you have trouble swallowing the capsules, talk with your doctor or pharmacist.

Orladeyo is used to help prevent hereditary angioedema (HAE) attacks. HAE is a genetic condition that causes episodes of swelling in the hands, feet, face, tongue, throat, or intestines. Sometimes HAE attacks can be very serious and may cause difficulty breathing.

If you have HAE, your body makes too much of a chemical called kallikrein. This chemical is responsible for releasing a protein called bradykinin into your blood. Too much bradykinin is what causes swelling and HAE attacks to occur.

Orladeyo works by blocking the action of kallikrein. As a result, kallikrein releases less bradykinin into your blood. This can help prevent HAE attacks from occurring.

How long does it take to work?

It may take between 6 and 12 days of using Orladeyo before you have a consistent level of medication in your body to help prevent HAE attacks.

Because Orladeyo takes some time to work, you should not use it as a treatment for an HAE attack that’s already occurring.

It’s not known if Orladeyo is safe to take during pregnancy. There isn’t enough information about the use of Orladeyo in pregnant females.*

In animal studies, no birth abnormalities (birth defects) were noted in the offspring of pregnant animals that were given Orladeyo. But keep in mind that animal studies don’t always predict how the drug will affect humans.

If you’re pregnant or planning to become pregnant, talk with your doctor before you start taking Orladeyo. They can advise you on the pros and cons of the medication.

* Sex and gender exist on spectrums. Use for the term “female” in this article refers to sex assigned at birth.

It’s not known if Orladeyo 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 Orladeyo.

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

It’s not known if Orladeyo is safe to take while you’re breastfeeding. It’s not known if the drug passes into human breast milk or what effects it may have on a child who is breastfed.

Animal studies show that Orladeyo does pass into the breast milk of lactating animals given the medication. Although animal studies don’t always indicate what may happen in humans, it’s likely that Orladeyo will also pass into human breast milk.

If you’re breastfeeding or thinking about it, talk with your doctor before you start taking Orladeyo. They can advise you on whether the drug is right for you and suggest healthy ways to feed your child.

Here are answers to some frequently asked questions about Orladeyo.

Does Orladeyo treat HAE attacks as they’re happening?

No, Orladeyo does not treat hereditary angioedema (HAE) attacks that are already occurring. The drug is used to help prevent future attacks.

You should not use Orladeyo if you’re having an HAE attack. Instead, you should treat it with medication for an acute (sudden) attack. Examples of drugs that may be used for an HAE attack that’s already occurring include ecallantide (Kalbitor) and icatibant (Firazyr).

If you have difficulty breathing due to an HAE attack, immediately call 911 or your local emergency number, or go to the nearest emergency room.

Talk with your doctor about the best treatment plan for your HAE and whether Orladeyo is right for you.

Will Orladeyo cure HAE?

No, Orladeyo does not cure hereditary angioedema (HAE). But it does help prevent HAE attacks from occurring.

At this time, there are no cures for HAE. For Orladeyo to continue to work for you, you should take your dose each day as recommended by your doctor.

If you have other questions about Orladeyo, talk with your doctor or pharmacist.

How will my Orladeyo dosage change if I have liver or kidney problems?

For some liver problems, your doctor may adjust your Orladeyo dosage. But if you have kidney problems, you likely won’t need a dosage adjustment.

If you have a moderate to severe liver condition, your doctor may recommend a decreased dose of Orladeyo. This is because the drug is removed from your body through your liver. If your liver doesn’t remove the drug quickly enough, it can build up in your body. This can raise your risk for side effects.

Your doctor typically won’t need to adjust your Orladeyo dose if you have a kidney problem. If you have end stage renal disease (ESRD), they may recommend a different medication. Orladeyo hasn’t been studied in people with ESRD, so it’s not known if the drug is a safe treatment for them.

Before you start taking Orladeyo, tell your doctor about any liver or kidney conditions you have. They can review how serious your condition is and the best dosage of Orladeyo for you.

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

  • Liver problems. If you have liver problems, tell your doctor before you start taking Orladeyo. The drug is removed from your body by your liver. If your liver isn’t working well, it may not be able to remove the drug from your body as it should. Your doctor may recommend that you take a decreased dose of Orladeyo if you have certain liver problems.
  • Kidney problems or kidney dialysis. If you have kidney problems or are receiving dialysis, talk with your doctor before you start taking Orladeyo. It’s not known if the drug is safe to use if you have serious kidney problems or are receiving dialysis. Your doctor may recommend a different medication for you.
  • Allergic reaction. If you’ve had an allergic reaction to Orladeyo or any of its ingredients, you shouldn’t take Orladeyo. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if Orladeyo is a safe medication to take during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor. For more information, see the “Orladeyo and pregnancy” section above.
  • Breastfeeding. It’s not known if Orladeyo is safe to take while you’re breastfeeding or what effects it may have on a breastfed child. For more information, see the “Orladeyo and breastfeeding” section above.

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

Using more than the recommended dosage of Orladeyo can lead to serious side effects.

Do not use more Orladeyo than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include heart rhythm problems.

What to do in case of overdose

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 its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Orladeyo from the pharmacy, the pharmacist will add an expiration date to the label on the package. This date is typically 1 year from the date they dispensed the medication.

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 with your pharmacist about whether you might still be able to use it.

Storage

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

You should store Orladeyo tablets at a room temperature between 68°F and 77°F (20°C and 25°C) in a tightly sealed container. If needed, you can keep Orladeyo tablets between 59°F and 86°F (15°C and 30°C) for short periods.

Disposal

If you no longer need to take Orladeyo and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

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 another 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.