Macitentan (ma-si-TEN-tan), Tadalafil (ta-DAL-a-fil)

Treats pulmonary arterial hypertension.

Brand Name(s):

Opsynvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablets whole with water. Do not cut, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take 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.

• Do not use this medicine if you are also taking riociguat or a nitrate medicine. You may use a nitrate medicine at least 48 hours after your last dose of tadalafil. Do not take other medicines that contain tadalafil or similar medicines, including sildenafil or vardenafil.
• Some medicines can affect how macitentan/tadalafil works. Tell your doctor if you are using any of the following:
  • Bosentan, carbamazepine, erythromycin, fluconazole, ketoconazole, phenobarbital, phenytoin, rifampicin, rifampin, ritonavir
  • Blood pressure medicine (including amlodipine, bendroflumethiazide, enalapril, metoprolol, ARBs)
• Do not have 4 or more alcohol-containing drinks in a short period of time while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 will be allowed to 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, lung problems, anemia, cancer (including leukemia, multiple myeloma), diabetes, heart or blood vessel disease (including heart attack, heart failure), sickle cell anemia, high or low blood pressure, problems with your penis, eye or vision problems, or hearing problems. Tell your doctor if you also smoke or drink alcohol.
• This medicine may cause the following problems:
  • Liver problems
  • Low blood pressure
  • Anemia
  • Hearing or vision problems
  • Fluid retention (too much water in the body) and edema (swelling)
  • Painful or prolonged erection
• This medicine may decrease sperm count in some males and may 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
• Lightheadedness, fainting
• Painful erection or an erection that lasts longer than 4 hours with or without pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden decrease in hearing or hearing loss, ringing in the ears, dizziness
• Sudden loss of vision
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache

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