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Riociguat

Generic Name: riociguat (RYE-oh-SIG-ue-at)
Brand Name: Adempas

Riociguat may cause serious birth defects if you take it while you are pregnant. Women who are pregnant should not take riociguat. You must have a negative pregnancy test before you start to take riociguat, monthly while you take it, and for 1 month after you stop taking it. You must also use effective forms of birth control while you take riociguat and for 1 month after you stop taking it. Talk with your doctor about the use of effective birth control while you use riociguat.

For female patients, riociguat is only available through a special program called Adempas Risk Evaluation and Mitigation Strategy Program (REMS). Talk to your doctor to be sure you are enrolled in this program and that you meet all of its requirements.


Riociguat is used for:

Treating high blood pressure in the lungs.

Riociguat is an soluble guanylate cyclase (sGC) stimulator. It works by increasing a certain substance in the lungs, which helps to decrease blood pressure in the lungs.

Do NOT use riociguat if:

  • you are allergic to any ingredient in riociguat
  • you are pregnant, may become pregnant, or plan to become pregnant
  • you have a certain lung problem called pulmonary veno-occlusive disease (PVOD)
  • you are taking amyl nitrate, avanafil, dipyridamole, nitrates (eg, isosorbide, nitroglycerin), sildenafil, tadalafil, theophylline, or vardenafil

Contact your doctor or health care provider right away if any of these apply to you.

Before using riociguat:

Some medical conditions may interact with riociguat. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of bleeding problems or bleeding from your lung, or if you have had bronchial arterial embolization to stop you from coughing up blood
  • if you have liver or kidney problems, or if you are on dialysis
  • if you have heart problems, low blood pressure, low blood volume, or circulation problems, or if you are dehydrated
  • if you smoke

Some MEDICINES MAY INTERACT with riociguat. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amyl nitrite, avanafil, cilostazol, dipyridamole, medicines for high blood pressure, milrinone, nitrates (eg, isosorbide, nitroglycerin), roflumilast, sildenafil, tadalafil, theophylline, or vardenafil because severe low blood pressure with dizziness, light-headedness, and fainting may occur
  • Azole antifungals (eg, itraconazole, ketoconazole) or HIV protease inhibitors (eg, ritonavir) because they may increase the risk of riociguat's side effects
  • Carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease riociguat's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if riociguat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use riociguat:

Use riociguat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Riociguat comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get riociguat refilled.
  • Take riociguat by mouth with or without food.
  • Do not take an antacid that has aluminum or magnesium in it within 1 hour before or after you take riociguat.
  • Take riociguat on a regular schedule to get the most benefit from it. Taking riociguat at the same times each day will help you to remember to take it.
  • Continue to take riociguat even if you feel well. Do not miss any doses.
  • If you miss a dose of riociguat, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss 3 or more days of riociguat, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use riociguat.

Important safety information:

  • Riociguat may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use riociguat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Riociguat may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose, change your dose, or stop taking riociguat without checking with your doctor.
  • Riociguat may not work as well if you smoke. Tell your doctor if you start or stop smoking while taking riociguat.
  • Serious and sometimes fatal bleeding problems have been reported with the use of riociguat. To prevent bleeding, avoid situations where bruising or injury may occur. Tell your doctor right away if you have symptoms of unusual bruising or bleeding (eg, coughing up blood; black, tarry, or bloody stools; severe stomach pain; vomit that looks like coffee grounds; severe nose bleeds; unusual vaginal bleeding).
  • Women who are able to become pregnant must have a negative pregnancy test before they start to take riociguat, monthly while they are taking it, and for 1 month after they stop taking it. Talk with your doctor for more information.
  • Women who are able to become pregnant must use effective forms of birth control while they take riociguat and for at least 1 month after they stop taking it. Talk with your doctor about the use of effective birth control while you use riociguat. Talk with your doctor right away if you miss a menstrual period, have unprotected sex, think your birth control has failed, or think you may be pregnant.
  • Tell your doctor or dentist that you take riociguat before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including blood pressure or lung function, may be performed while you use riociguat. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use riociguat with caution in the ELDERLY; they may be more sensitive to its effects.
  • Riociguat should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use riociguat if you are pregnant. It has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not know if riociguat is found in breast milk. Do not breast-feed while taking riociguat.

Possible side effects of riociguat:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; indigestion; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; irregular heartbeat; new or worsening shortness of breath; pale skin; severe or persistent tiredness, weakness, dizziness, light-headedness, headache, or nausea; stomach swelling; swelling of the hands, legs, ankles, or feet; trouble swallowing; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of riociguat:

Store riociguat at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original container away from heat, moisture, and light. Do not store in the bathroom. Keep riociguat out of the reach of children and away from pets.

General information:

  • If you have any questions about riociguat, please talk with your doctor, pharmacist, or other health care provider.
  • Riociguat is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take riociguat or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about riociguat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to riociguat. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using riociguat.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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