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Overview: Orladeyo is a medicine that is used to help prevent attacks of a rare, inherited condition called hereditary angioedema (HAE). Do not use this medicine to treat a HAE attack. Stomach pain, diarrhea, and vomiting are common side effects. Tell your health care provider if you have any of these side effects that do not go away. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat. Orladeyo comes as capsules or pellets that you swallow.

Uses

What is Orladeyo used for?

Orladeyo (berotralstat) is used to prevent attacks of a rare, inherited condition called hereditary angioedema (HAE).

How Orladeyo Works for Hereditary Angioedema

Orladeyo may also be used for other conditions as determined by your health care provider.

How does Orladeyo work (mechanism of action)?

People with hereditary angioedema have too much of a substance called kallikrein. When there is too much kallikrein in the body, it can cause fluid to build up where it should not. Orladeyo blocks kallikrein from working, which reduces the amount of fluid that builds up in the body. This can help to prevent swelling attacks in people with this condition. 

How is Orladeyo supplied (dosage forms)?

Orladeyo is available in the following dosage forms that are taken by mouth.

  • 110 mg and 150 mg oral capsules
  • 72 mg, 96 mg, 108 mg, 132 mg, or 150 mg oral pellets in single-dose packets

How should I store Orladeyo?

Orladeyo should be stored at room temperature, between 20 F and 25 F (68 C and 77 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Orladeyo?

The most common side effects of Orladeyo are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Acid reflux (gastroesophageal reflux disease, or GERD)
  • Back pain
  • Diarrhea
  • Stomach pain
  • Vomiting

There may be other side effects of Orladeyo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Orladeyo?

While less common, the most serious side effects of Orladeyo are described below, along with what to do if they happen.

Severe Allergic Reactions. Orladeyo may cause allergic reactions, which can be serious. Stop taking Orladeyo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Orladeyo may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes when used at doses higher than those prescribed. Do not use more Orladeyo than directed. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat. 

Warnings & Precautions

Who should not use Orladeyo?

Allergies to Ingredients. People who are allergic to any of the following should not take Orladeyo.

  • Berotralstat
  • Orladeyo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Orladeyo.

What should I know about Orladeyo before using it?

Do not take Orladeyo unless it has been prescribed to you by a health care provider. Take it as prescribed. Taking Orladeyo more often than prescribed may increase the risk of serious side effects.

Do not share Orladeyo with other people, even if they have the same condition as you. It may harm them.

Keep Orladeyo out of the reach of children.

Orladeyo is a medicine used daily to help prevent symptoms (swelling attacks), but it does not treat swelling attacks when they occur. If you are having a swelling attack, seek medical help or use a different medicine that was prescribed by your health care provider to treat the attack.

Tell your health care provider if you have stomach pain, vomiting, or diarrhea that will not go away. Your health care provider may decide to stop Orladeyo or lower your dose. Do not make any changes on your own. Follow the directions of your health care provider.

If you are taking Orladeyo oral pellets, do not crush or chew them. You can pour them onto your tongue and swallow right away with water or milk. Or, you can pour the pellets onto a tablespoon of soft, non-acidic food at room temperature like creamed corn, pudding, mashed potatoes, or pureed bananas, carrots, or peas. Do not use any acidic food like yogurt or applesauce because the coating on the pellets can dissolve, and the medicine may taste bitter. The coating only remains intact for 10 minutes after pellets are placed onto food. If not swallowed within 10 minutes, throw away any pellets placed onto food.

What should I tell my health care provider before using Orladeyo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Orladeyo is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Kidney problems, including if you are on dialysis
  • Liver problems

Other Medicines and Supplements. Orladeyo may interact with other medicines and supplements. Before taking Orladeyo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Orladeyo could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Orladeyo passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Orladeyo while breastfeeding.

How can I get more information about Orladeyo?

For more information about Orladeyo, you can visit the drugmaker’s website at www.orladeyo.com or call them at 833-633-2279.

Interactions

Does Orladeyo interact with foods or drinks?

There are no known interactions between Orladeyo and foods or drinks. Each dose of Orladeyo should be taken with food. If you are taking the oral pellets, you should eat a meal just before or after each dose. The oral pellets should not be sprinkled on acidic foods, such as yogurt or applesauce.

It is unknown if drinking alcohol will affect Orladeyo.

Does Orladeyo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

In particular, make sure that you discuss if you are taking a hormonal birth control medicine that contains desogestrel (Bekyree, Cyclessa, and others).

Some other medicines may alter the blood levels of Orladeyo, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Orladeyo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Orladeyo?

If you or someone else has used too much Orladeyo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Orladeyo?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.