berotralstat

Pronunciation: BER oh TRAL stat

Brand: Orladeyo

What is the most important information I should know about berotralstat?

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 is 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.

What should I discuss with my healthcare provider 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.

How should I take berotralstat?

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 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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking berotralstat?

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

What are the possible side effects of berotralstat?

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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about berotralstat.

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