PATIENT INFORMATION ORLADEYO® (or-luh-DAY-oh) (berotralstat) capsules, for oral use
This Patient Information has been approved by the U.S. Food and Drug Administration.					03/2022
What is ORLADEYO? ORLADEYO is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 12 years of age and older. ORLADEYO is not used to treat an acute HAE attack. Do not take more than one capsule of ORLADEYO a day because extra doses can cause heart rhythm problems. It is not known if ORLADEYO is safe and effective to treat an acute HAE attack. It is not known if ORLADEYO is safe and effective in children under 12 years of age.
Before you take ORLADEYO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems or are on kidney dialysis. are pregnant or planning to become pregnant. It is not known if ORLADEYO can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ORLADEYO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking ORLADEYO. Tell your healthcare provider about all of the medicines you take, including other medicines for HAE, prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ORLADEYO with certain other medicines may affect the way other medicines work and other medicines may affect how ORLADEYO works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ORLADEYO? Take ORLADEYO exactly as your healthcare provider tells you to take it. Take 1 capsule, by mouth, 1 time every day with food.
What are the possible side effects of ORLADEYO? Taking more than one capsule of ORLADEYO a day may cause serious side effects, including: heart rhythm problems. A heart rhythm problem called QT prolongation can happen in people who take more than one capsule of ORLADEYO a day. This condition can cause an abnormal heart beat. Do not take more than one capsule of ORLADEYO a day. The most common side effects of ORLADEYO include:
	abdominal pain	vomiting	diarrhea	back pain	heartburn
Less common side effects include increases in liver function tests. Rarely, some patients had a brief, itchy rash. These are not all of the possible side effects of ORLADEYO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ORLADEYO? Store ORLADEYO at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Each carton contains a tamper evident seal. Do not use ORLADEYO if the tamper evident seal is broken or missing. Keep ORLADEYO and all medicines out of the reach of children.
General information about the safe and effective use of ORLADEYO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ORLADEYO for a condition for which it was not prescribed. Do not give ORLADEYO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ORLADEYO that is written for health professionals.
What are the ingredients in ORLADEYO? Active ingredient: berotralstat dihydrochloride Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and pregelatinized starch
Manufactured for: BioCryst Pharmaceuticals, Inc., Durham, NC 27703 ORLADEYO® is a registered trademark of BioCryst Pharmaceuticals, Inc. © 2022 BioCryst. All rights reserved. For more information, visit www.ORLADEYO.com or call 1-833-633-2279.

berotralstat

Product monograph

Family members