Aprocitentan

IMPORTANT WARNING:

Do not take aprocitentan if you are pregnant or plan to become pregnant. Aprocitentan may harm the fetus. If you are able to become pregnant, you should not begin taking aprocitentan until a pregnancy test has shown that you are not pregnant. You must use two reliable methods of birth control during treatment with this medication and for 1 month after stopping treatment. Do not have unprotected sex. Talk to your doctor about birth control methods that will work for you.

Call your doctor immediately if you have unprotected sex, think your birth control failed, miss a menstrual period, or think that you may be pregnant while you are taking aprocitentan.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with aprocitentan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Talk to your doctor about the risks of taking aprocitentan.

WHY is this medicine prescribed?

Aprocitentan is used to treat high blood pressure. Aprocitentan is in a class of medications called endothelin receptor antagonists. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard.

High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

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?

Aprocitentan comes as a tablet to take by mouth. Take once a day with or without food. Take aprocitentan at around the same time every day.

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

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

What SPECIAL PRECAUTIONS should I follow?

Before taking aprocitentan,

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

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are receiving dialysis treatments or if you have or have ever had anemia (condition in which red blood cells do not bring enough oxygen to the organs), heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body) or other heart problems, or kidney or liver disease.

• tell your doctor if you are breastfeeding. Do not breastfeed if you are taking aprocitentan.

• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking aprocitentan.

What SPECIAL DIETARY instructions should I follow?

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

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

Skip the missed dose and continue your regular dosing schedule at the next time. Do not take two doses on the same day.

What SIDE EFFECTS can this medicine cause?

Aprocitentan may cause side effects. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• nausea, vomiting, fever, pain in the upper right part of your stomach, loss of appetite, itchy skin, dark urine, yellowing of the skin or eyes, or extreme tiredness
• unusual weight gain
• trouble breathing
• swelling of the hands, legs, ankles or feet
• rash; redness; swelling of the face, throat, tongue, lips, and eyes

Aprocitentan 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 light, 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 andaway 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 takethem. Do not flush this medication down the toilet. Use a medicine take-back program. Talk toyour pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal ofMedicines 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.

Symptoms of overdose may include:

• headache
• runny nose, nasal congestion, sneezing, sore throat, or cough
• nausea

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to aprocitentan.

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) medicinesvitamins, minerals, and dietary supplements you are taking. Bring this list with you each timeyou visit a doctor or if you are admitted to the hospital. You should carry the list with you incase of emergencies.