Aprocitentan

Aprocitentan is used in adults to treat high blood pressure (hypertension) in combination with other high blood pressure (antihypertensive) medicines.

Aprocitentan is available only under a special program. You must be registered in the program and understand the risks and benefits of aprocitentan.

Aprocitentan may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Aprocitentan is usually taken once per day, with or without food.

You will need blood tests to check your liver function and red blood cell counts.

Swallow the tablet whole and do not crush, chew, or break it.

Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

Store at room temperature away from moisture, heat, and light.

Do not use if you are pregnant. Use effective birth control.

You will need to take a pregnancy test before, during, and after treatment with aprocitentan.

You should not take aprocitentan if you are allergic to it.

Tell your doctor if you have ever had:

• low red blood cells (anemia);
• heart failure;
• liver disease; or
• kidney disease (or if you are on dialysis).

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while using aprocitentan and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

You will need to take a pregnancy test before, during, and after treatment with aprocitentan.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aprocitentan on the baby.

Do not breastfeed.

Aprocitentan may affect fertility in men. Talk to your doctor about options for fertility preservation, like sperm banking.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Aprocitentan may cause serious side effects. Call your doctor at once if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection); or
• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Your treatment with aprocitentan may be discontinued if you have certain side effects.

Common side effects of aprocitentan may include:

• fluid retention; or
• anemia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypertension:

12.5 mg orally once a day with or without foodComments:-Verify negative pregnancy status in patients of childbearing potential before initiating treatment; pregnancy should be excluded with negative pregnancy tests monthly during treatment and 1 month after the last dose.-No controlled trials have shown a reduction of risk of fatal and nonfatal cardiovascular events (primarily stokes and myocardial infarctions) with this drug.Use: In combination with other antihypertensive drugs, for the treatment of hypertension in patients whose blood pressure is not adequately controlled on other drugs

Skip the missed dose and take the next regularly scheduled dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect aprocitentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.