This medication is used to help prevent severe swelling attacks due to a certain inherited immune disease (hereditary angioedema-HAE). Berotralstat works by binding to a natural substance made by the body (kallikrein) and blocking its effect. This blocking effect lowers the amount of another natural substance (bradykinin) that causes symptoms during an attack of HAE.

Berotralstat should not be used to treat an acute HAE attack. If an HAE attack occurs, use your usual rescue medication as prescribed.

Read the Patient Information Leaflet if available from your pharmacist before you start using berotralstat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once a day. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Abdominal pain, vomiting, heartburn, gas, and diarrhea may occur as your body adjusts to the medication. Headache, back pain, and tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using berotralstat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• dialysis

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of berotralstat from your body, which may affect how berotralstat works. Examples include rifamycins (such as rifampin, rifabutin), St. John's wort, among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include asunaprevir, elacestrant, flibanserin, lomitapide, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fast/irregular heartbeat, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as liver function) may be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.