Aprocitentan Tablets

What is this medication?

APROCITENTAN (A proe sye TEN tan) treats high blood pressure. It is often prescribed when other medications have not worked well enough or cannot be tolerated. It works by relaxing blood vessels, which decreases the amount of work the heart has to do.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TRYVIO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart failure
• Kidney disease
• Liver disease
• Low red blood cell levels
• An unusual or allergic reaction to aprocitentan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Swallow the tablets whole. You can take it with our without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Check your blood pressure as directed. Know what your blood pressure should be and when to contact your care team.

You may need blood work done while you are taking this medication.

Do not treat yourself for coughs, colds, or pain while you are using this medication without asking your care team for advice. Some medications may increase your blood pressure.

Talk to your care team if you may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended before starting this medication, during treatment, and for 1 month after the last dose. Your care team can help find the option that works for you.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging. Protect from light and moisture. Keep the container tightly closed. Do not throw out the packet or canister in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.