Orladeyo is used to prevent attacks of hereditary angioedema (HAE) in adults and children at least 12 years old.

Orladeyo is not for use in treating an HAE attack that has already begun.

It is not known if Orladeyo is safe and effective in children under 12 years of age.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Taking Orladeyo with certain other medicines may affect the way other medicines work and other medicines may affect how berotralstat works.

Use Orladeyo exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed.Follow all directions on your prescription label and read all medication guides or instruction sheets.

The recommended dosage of Orladeyo is one 150 mg capsule taken orally once daily with food.

Follow your doctor's dosing instructions very carefully. Taking too much of this medicine can cause serious heart rhythm problems.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you are ready to take a pill. Each carton contains a tamper evident seal. Do not use Orladeyo if the tamper evident seal is broken or missing.

To make sure Orladeyo is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease (or if you are on dialysis); or

• heart rhythm problems.

Tell your doctor if you are pregnant or breastfeeding.

Orladeyo is not approved for use by anyone younger than 12 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not share this medicine with another person, even if they have HAE.

Get emergency medical help if you have signs of an allergic reaction to Orladeyo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Orladeyo side effects may include:

• stomach pain, heartburn, vomiting;

• diarrhea; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with berotralstat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.