Aprocitentan (a-proe-sye-TEN-tan)

Treats high blood pressure.

Brand Name(s):

Tryvio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablets whole.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You must have a negative pregnancy test before you can take this medicine. You will also be required to have a pregnancy test every month during treatment and for 1 month after treatment with this medicine. Use a highly effective birth control (including IUD, implants) or 2 forms of effective birth control (condoms or spermicide along with your pills) before starting, during treatment, and for at least 1 month after your last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, anemia, or heart failure.
• This medicine may cause the following problems:
  • Liver problems
  • Fluid retention (too much water in the body) and edema (swelling)
  • Anemia
• This medicine may decrease sperm count in some males and could cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088