Berotralstat

Berotralstat is used to prevent attacks of hereditary angioedema (HAE; genetic condition that causes repeat episodes of swelling). Berotralstat is in a class of medications called plasma kallikrein inhibitors. It works by blocking a substance in the body that causes symptoms of angioedema.

Berotralstat comes as a capsule and pellets to take by mouth. Take with a meal once a day. Take berotralstat at around the same time every day.

Take berotralstat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

To avoid a bitter aftertaste, do not chew or crush the pellets. Pellets can be taken directly in your mouth or sprinkled on soft food and swallowed immediately.

To take the pellets directly, sprinkle the entire contents of a packet directly into your mouth. Swallow right away with water or milk.

To take the pellets with soft food, sprinkle the entire contents of a packet on about 1 tablespoon of cool or room temperature, non-acidic soft food such as pudding; mashed potatoes; creamed corn; or pureed peas, bananas, or carrots. Do not sprinkle pellets on yogurt or applesauce. Swallow the entire mixture immediately (within 10 minutes). Do not store the mixture for more than 10 minutes.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking berotralstat,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking berotralstat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking berotralstat, call your doctor immediately.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Berotralstat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• stomach pain
• heartburn
• back pain
• rash
• headache
• gas or bloating
• unusual tiredness or weakness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast or pounding heartbeat
• feeling faint, lightheaded, or dizzy

Berotralstat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• fast, pounding, or irregular heartbeat
• feeling faint, lightheaded, or dizzy

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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