All About Orladeyo

What is Orladeyo used for?

Orladeyo is used to help prevent swelling attacks caused by hereditary angioedema (HAE). Orladeyo can be used in adults and in children ages 12 years and older for this use.

Orladeyo helps prevent HAE attacks by blocking a protein in your body called kallikrein.

It’s important to note that Orladeyo should not be used to treat a swelling attack that’s currently happening. Instead, Orladeyo is taken regularly to help prevent attacks from occurring.

Your doctor will give you details on how to be prepared in case you experience an attack, and how to treat it. This may include using a rescue medication that works quickly to relieve swelling.

About HAE

HAE is a rare genetic (inherited) condition that causes severe swelling attacks. This swelling most often affects the face, feet, and hands. It may also occur in the airways, genitals, digestive tract, and other areas of the body.

The swelling can be painful. Other symptoms may occur, depending on which areas of your body are affected. For example, if the swelling affects your digestive tract, you may have abdominal pain or vomiting. If the swelling affects your airway, you may have trouble breathing, which can be life threatening in severe cases.

What are Orladeyo’s side effects?

Like most drugs, Orladeyo may cause mild or serious side effects. The lists below describe some of the more common side effects that Orladeyo may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Orladeyo. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Orladeyo can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Orladeyo’s prescribing information.

Mild side effects of Orladeyo may include:

• abdominal pain
• vomiting
• diarrhea
• back pain
• acid reflux
• headache
• fatigue (low energy)
• flatulence (gas)
• skin rash
• increased liver enzymes
• mild allergic reaction (to learn more about this side effect, see the “Allergic reaction” section on this page)

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

No serious side effects were reported during studies of Orladeyo. But an allergic reaction could occur in some people. (To learn more, see the “Allergic reaction” section on this page.)

In addition, taking more than your prescribed dosage of the drug may cause severe side effects. For more details, see the “What should be done in case of overdose?” section on this page.

If you think you’re having a serious side effect from Orladeyo, call your doctor right away. If you think you’re having a medical emergency, call 911 or your local emergency number.

Allergic reaction

Some people may have an allergic reaction to Orladeyo. Although allergic reaction wasn’t reported in studies of Orladeyo, it’s still possible.

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 of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Orladeyo. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What are some frequently asked questions about Orladeyo?

Find answers to some commonly asked questions about Orladeyo.

Is Orladeyo similar to Takhzyro?

Yes. Orladeyo and Takhzyro are both used to help prevent swelling attacks caused by hereditary angioedema. They belong to the same group of drugs, and they work in a similar way.

But Orladeyo and Takhzyro have a few differences:

• Form and how they’re administered: Orladeyo comes as a capsule that you swallow. Takhzyro comes as a liquid solution that’s given as an injection under your skin.
• Ages for use: Orladeyo is used in adults and in children ages 12 years and older. Takhzyro is used in adults and in children ages 2 years and older.
• Dosing schedule: Orladeyo is taken once per day, while Takhzyro is given once every 2 to 4 weeks.

How does Orladeyo work?

Orladeyo helps prevent swelling attacks in people with hereditary angioedema (HAE). With this condition, you have too much of a certain protein called bradykinin in the blood. This can lead to swelling attacks.

Orladeyo works by blocking a protein called kallikrein. This protein stimulates the release of a different protein called bradykinin. By blocking kallikrein, Orladeyo helps lower the amount of bradykinin in the blood. This helps to prevent HAE attacks.

What does Orladeyo cost?

Costs of prescription drugs can vary depending on many factors. These factors include whether you have insurance and, if so, what your insurance plan covers.

Note that Orladeyo is only available through a special pharmacy that’s associated with the drug manufacturer, BioCryst Pharmaceuticals. If your doctor prescribes Orladeyo, the drug will be shipped to your home.

If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A program called Empower Patient Services may also be available.

You can also check out this article on how to save money on prescriptions.

What is Orladeyo’s dosage?

Your doctor will recommend the dosage of Orladeyo that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.

Form and strengths

Orladeyo comes as a capsule that you swallow. It’s available in two strengths: 110 milligrams (mg) and 150 mg.

Recommended dosages

The usual dose of Orladeyo is 150 mg taken once per day, taken with food.

In certain situations, your doctor may prescribe a lower dosage of 110 mg taken once per day. Your doctor may prescribe a lower dose if you:

• have liver issues
• have digestive problems from taking Orladeyo
• take certain other medications with Orladeyo

Questions about Orladeyo’s dosing

Below are some common questions about Orladeyo’s dosing.

• What if I miss a dose of Orladeyo? If you miss a dose of Orladeyo, take the missed dose as soon as you remember. But if it’s almost time for your next scheduled dose, just skip the missed dose and next your next dose at its regular time. You should not take two doses at once to make up for a missed dose.
• Will I need to use Orladeyo long term? Most likely. As long as Orladeyo works well for you and doesn’t cause bothersome side effects, you’ll likely take it long term.
• How long does it take for Orladeyo to work? Orladeyo starts working right after you take your first dose, and the number of HAE attacks are usually reduced within the first month. If you have questions about what to expect from your Orladeyo treatment, talk with your doctor.

How to take Orladeyo

Your doctor will explain how you should take Orladeyo. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Taking Orladeyo

Orladeyo comes as a capsule that you’ll take with food. You should take your dose at the same time each day. This helps keep a steady level of the drug in your body.

Questions about taking Orladeyo

Below are some common questions about taking Orladeyo.

• Can Orladeyo be chewed, crushed, or split? You should swallow the Orladeyo capsule whole. The drug’s manufacturer hasn’t provided guidance on whether the capsules can be taken any other way. If you have trouble swallowing these capsules, talk with your doctor. They may recommend a different treatment option.
• Should I take Orladeyo with food? Yes. You should take Orladeyo with food.
• Is there a best time of day to take Orladeyo? You’ll take Orladeyo once per day. There isn’t a specific time of day that’s best. But you should take Orladeyo at the same time each day so that your doses are 24 hours apart. Taking your doses too close together can increase the risk of harmful effects.

Taking more than your prescribed dose of Orladeyo each day may cause a serious heart problem. For more details, see the “Overdose” section on this page.

What should be considered before taking Orladeyo?

When considering Orladeyo treatment, there are some important factors to discuss with your doctor. These include any medical conditions you have and any medications you take.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before taking Orladeyo, be sure to tell your doctor about all medications you take, including prescription and over-the-counter types. Also let them know about any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these may cause with Orladeyo.

For information about drug-condition interactions, see the “Warnings” section on this page.

Interactions with drugs or supplements

Orladeyo can interact with several kinds of drugs. Examples include:

• cyclosporine (Gengraf, Neoral), an immunosuppressant
• rifampin (Rimactane), an antibiotic
• the antipsychotic drug thioridazine
• pimozide, a drug used for Tourette syndrome
• fentanyl, a pain medication
• digoxin (Lanoxin), a heart medication
• St. John’s wort, an herbal supplement

This list does not contain all types of drugs that may interact with Orladeyo. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with use of Orladeyo.

Orladeyo and alcohol

There’s no known interaction between Orladeyo and alcohol.

If you drink alcohol, talk with your doctor about how much may be safe for you to drink during Orladeyo treatment.

Pregnancy and breastfeeding

It’s not known whether Orladeyo is safe to use during pregnancy or while breastfeeding.

The drug may pass into breastmilk, but it’s not known what effects (if any) this could have on a child who’s breastfed.

If you’re pregnant or breastfeeding, or planning on either in the near future, talk with your doctor. They can discuss the risks and benefits of Orladeyo treatment.

Warnings

Orladeyo may cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Orladeyo is a good treatment option for you.

Talk with your doctor about your health history before you take Orladeyo. Be sure to tell them if any of the following factors apply to you:

Liver problems: Your liver is responsible for breaking down Orladeyo so that it can be cleared from your system. If you have a condition that affects your liver function, the drug may build up in your body. This can raise your risk of side effects. Because of this risk, your doctor may prescribe a lower dose of Orladeyo.

Severe kidney problems or dialysis: It isn’t known if Orladeyo is safe to take if you have severe kidney problems or receive dialysis. If you have kidney problems or receive dialysis, talk with your doctor. They can determine whether a different treatment option would be better for you.

Allergic reaction: If you’ve had an allergic reaction to Orladeyo or any of its ingredients, your doctor will likely not prescribe Orladeyo. Ask them what medications are better options for you.

Digestive issues: Some people may experience digestive problems when taking Orladeyo. If your digestive issues don’t get better, your doctor will likely reduce your dose of Orladeyo. Or they may switch you to a different medication.