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

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

Berotralstat may also be used for purposes not listed in this medication guide.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Berotralstat is usually taken once per day with food.

Follow your doctor's dosing instructions very carefully. Taking too much of berotralstat 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.

Usual Adult Dose for Angioedema:

Recommended dose: 150 mg orally once daily with food
Maximum dose: 150 mg once daily

Comments:
-This drug should not be used for treatment of acute hereditary angioedema (HAE) attacks.
-Additional doses or doses higher than 150 mg once daily are not recommended due to the potential for QT prolongation.

Use: To prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older

Usual Pediatric Dose for Angioedema:

12 years of age and older:
Recommended dose: 150 mg orally once daily with food
Maximum dose: 150 mg once daily

Comments:
-The safety and effectiveness of this drug in patients younger than 12 years old have not been established.
-This drug should not be used for treatment of acute hereditary angioedema (HAE) attacks.
-Additional doses or doses higher than 150 mg once daily are not recommended due to the potential for QT prolongation

Use: To prevent attacks of hereditary angioedema (HAE) in pediatric patients 12 years of age and older

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.

Berotralstat 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 berotralstat with another person, even if they have HAE.

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

Common side effects of berotralstat 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 affect 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.