Suzetrigine

WHY is this medicine prescribed?

Suzetrigine is used as a short-term treatment to relieve moderate to severe pain. Suzetrigine is in a class of medications called sodium channel blockers. It works by blocking pain signals in the body.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Suzetrigine comes as a tablet to take by mouth. Take every 12 hours (twice a day). Take your first dose on an empty stomach, at least 1 hour before or 2 hours after eating food. After the first dose, take suzetrigine with or without food. Take suzetrigine at around the same times every day.

Swallow the tablets whole; do not split, chew, or crush them.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking suzetrigine,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• some medications should not be taken with suzetrigine. Other medications may cause dosing changes or extra monitoring when taken with suzetrigine. Make sure you have discussed any medications you are currently taking or plan to take before starting suzetrigine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking suzetrigine, please get the advice of your doctor or pharmacist.

• the following herbal product may interact with suzetrigine: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking suzetrigine. Do not start this medication while taking suzetrigine without discussing with your healthcare provider.

• you should know that suzetrigine may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You may need to use another method of contraception to prevent pregnancy while taking suzetrigine and for 28 days after your final dose. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

• tell your doctor if you have or have ever had liver problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking suzetrigine, call your doctor.

• you should know that suzetrigine may temporarily cause infertility in women (difficulty in becoming pregnant). However, you should not assume you cannot get pregnant during your treatment with suzetrigine.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

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.

If you miss 2 or more doses, talk to your doctor before starting to take it again.

What SIDE EFFECTS can this medicine cause?

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

• itching
• rash
• muscle spasms
• nausea
• vomiting

Suzetrigine 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).

What should I know about STORAGE and DISPOSAL of this medication?

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 reachhttps://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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.