Berotralstat

Generic name: Berotralstat
Brand names: Orladeyo
Dosage form: oral capsule (110 mg; 150 mg)
Drug class: Hereditary angioedema agents

Usage of Berotralstat

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.

Berotralstat side effects

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.

Before taking Berotralstat

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.

Relate drugs

How to use Berotralstat

Usual Adult Dose for Angioedema:

Recommended dose: 150 mg orally once daily with foodMaximum dose: 150 mg once dailyComments:-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 foodMaximum dose: 150 mg once dailyComments:-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 prolongationUse: To prevent attacks of hereditary angioedema (HAE) in pediatric patients 12 years of age and older

Warnings

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.

What other drugs will affect Berotralstat

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.

Disclaimer

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