Aprocitentan

Do not take aprocitentan if you are pregnant or plan to become pregnant. Aprocitentan may harm the fetus. If you are a female and 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. Do not wait until your next appointment to discuss this with your doctor.

Because of the risk of birth defects, aprocitentan is available to females only through a special restricted distribution program. A program called TYRVIO REMS ( Risk Evaluation and Mitigation Strategy) has been set up to make sure that female patients have appropriate lab tests before and while they are receiving aprocitentan. Women can get aprocitentan only if they are registered with this program. Your doctor must enroll you in this program. You can only receive the medication from a pharmacy that participates in the program. Ask your doctor if you have any questions about participating in the program or how to get your medication.

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.

Aprocitentan is used in combination with other medications to treat high blood pressure that has not responded to other medications. Aprocitentan is in a class of medications called endothelin receptor antagonists. It lowers blood pressure by stopping the action of endothelin, a natural substance that causes blood vessels to narrow, so blood vessels relax and 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.

Aprocitentan comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take aprocitentan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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.

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

Before taking aprocitentan,

• tell your doctor and pharmacist if you are allergic to aprocitentan, any other medications, or any of the ingredients in aprocitentan tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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 kidney disease, 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 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 and women. Talk to your doctor about the risks of taking aprocitentan.

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.

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
• 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 (http://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 light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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