Patient Medication Information: uses, side effects, how to take - Orladeyo
What is ORLADEYO used for?
ORLADEYO is a medicine that is used to prevent attacks of hereditary angioedema (HAE) in adults and adolescents (12 years and older).
ORLADEYO should not be used to treat an acute HAE attack. In the event of an acute attack, seek medical attention.
How does ORLADEYO work?
In HAE, your blood does not have enough of a protein called C1 inhibitor, or the C1 inhibitor protein does not work properly. This causes the enzyme called plasma kallikrein to be overactive, which increases the levels of bradykinin in your bloodstream. Too much bradykinin leads to symptoms like swelling and pain.
ORLADEYO belongs to a group of medicines called plasma kallikrein inhibitors. It works by blocking the activity of plasma kallikrein and reduces the levels of bradykinin. This helps prevent the swelling and pain that HAE can cause.
What are the ingredients in ORLADEYO?
Medicinal ingredient: berotralstat hydrochloride
Non-medicinal ingredients: Black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, indigo carmine (FD&C Blue #2), magnesium stearate, pharmaceutical grade printing ink, pregelatinized starch, red iron oxide, titanium dioxide.
ORLADEYO comes in the following dosage forms:
Capsules: 150 mg berotralstat (as berotralstat hydrochloride)
Do not use ORLADEYO if:
- You are allergic to berotralstat or any other ingredients in this medicine or the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ORLADEYO. Talk about any health conditions or problems you may have, including if you:
- have moderate or severe liver problems. This can increase the levels of this medicine in your blood.
- have severe kidney problems.
- are at risk for a certain heartbeat abnormality, known as QT prolongation.
are pregnant or are planning to become pregnant. It is not known if ORLADEYO can harm your unborn baby.
- are breastfeeding or are planning to breastfeed. It is not known if ORLADEYO passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while taking ORLADEYO.
Children and adolescents:
- ORLADEYO is not recommended for use in children under 12 years of age. It is not known if ORLADEYO is safe and effective in this age group.
- ORLADEYO has not been studied in adolescents weighing less than 40 kg.
Tell your healthcare professional about all medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ORLADEYO:
- Thioridazine or Pimozide (medicines used to treat mental disorders)
- Midazolam (a medicine used to treat sleeping disorders)
- Dextromethorphan (a medicine used to treat coughs, in certain cold medicines)
- Fentanyl (an opioid used to relieve pain)
- Cyclosporine (a medicine that is often used to prevent rejection of a transplanted organ)
- Digoxin (a medicine used to treat heart disorders)
- Rifampicin (an antibiotic used to treat various kinds of bacterial infections)
- St. John’s Wort (a natural health product used for mood disorders)
- Oral birth control (medicines used to prevent pregnancy)
How to take ORLADEYO:
- Take exactly as your healthcare professional tells you. Talk to your healthcare professional if you are not sure.
Take with food at approximately the same time each day.
- Do not take more than 150 mg (one capsule) of ORLADEYO a day. Taking extra doses can cause heart rhythm problems.
Usual dose:
Adults and adolescents (12 years and older and weighing 40 kg or more):
150 mg (one capsule), once a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much ORLADEYO, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canda’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you miss a dose of ORLADEYO, take the missed dose as soon as you remember. You can take your next dose the following day at the usual time.
Do not take two doses at the same time to make up for a dose you have missed.
What are the possible side effects from using ORLADEYO?
These are not all the possible side effects you may have when taking ORLDEYO. If you experience any side effects not listed here, tell your healthcare professional.
- abdominal discomfort
- nausea
- vomiting
- diarrhea
- back pain
- headache
- heartburn
- gas
- rash
- liver function test elevations (shown in blood tests)
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store at room temperature (20°C to 25°C).
Keep out of the reach and sight of children.
If you want more information about ORLADEYO:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Website:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://www.biocryst.ca or by calling 1-877-339-3043
Last revised: MAY 07, 2025
ORLADEYO® is a registered trademark of BioCryst Pharmaceutical, Inc.
©2025 BioCryst. All rights reserved.