Riociguat (rye-oh-SIG-ue-at)

Treats pulmonary hypertension.

Brand Name(s):

Adempas

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.
• If you have trouble swallowing the tablet, you may crush and mix with water or soft foods (including applesauce) and take it right away.
• 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 double doses. If you missed your dose for 3 days, call your doctor right away.
• 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 together with dipyridamole, theophylline, amyl nitrite or a similar medicine, nitroglycerin or another nitrate medicine, or a medicine for impotence.
• Some medicines can affect how riociguat works. Tell your doctor if you are using any of the following:
  • Carbamazepine, phenobarbital, phenytoin, rifampin, or St John's wort
  • Medicine to treat fungal infection (including itraconazole, ketoconazole)
  • Medicine to treat high blood pressure
  • Medicine to treat HIV/AIDS (including ritonavir)
• If you are using an antacid that contains aluminum or magnesium, take it 1 hour after you take riociguat.

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 your treatment and for 1 month after treatment with this medicine. Use a highly effective form of birth control (including IUD, implants) or 2 forms of effective birth control (condoms or spermicide along with your pills) while you are using this medicine and for at least 1 month after your last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, bleeding problems, blood vessel problems, heart or blood circulation problems, or lung problems. Tell your doctor if you smoke.
• This medicine may cause the following problems:
  • Low blood pressure
  • Increased risk of bleeding (may be life-threatening)
• This medicine may make you dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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
• Bloody or black, tarry stools
• Chest pain, trouble breathing, increased sweating, or coughing that may produce a pink frothy sputum
• Coughing or spitting up blood
• Lightheadedness, dizziness, or fainting
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• Headache
• Nausea, vomiting
• Stomach pain or upset

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