Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Your dose may need to be changed several times in order to find what works best for you.

It is very important that you understand the requirements of the Macitentan-Containing Products REMS program and Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

You may take this medicine with or without food.

Swallow the tablet whole with water. Do not cut, crush, or chew it.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For pulmonary arterial hypertension (patient never had PAH treatment or is transitioning from ERA monotherapy):
      • Adults—One tablet once a day for 1 week. Each tablet contains 10 milligrams (mg) of macitentan and 20 mg of tadalafil. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For pulmonary arterial hypertension (patient already had PAH treatment):
      • Adults—One tablet once a day. Each tablet contains 10 milligrams (mg) of macitentan and 40 mg of tadalafil.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Portions of this document last updated: June 01, 2024

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