Adempas

Name: Adempas

Adempas Side Effects

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

Stop using riociguat and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • abnormal vaginal bleeding, or any other unusual bleeding;
  • vomiting or coughing up bright red blood, or vomit that looks like coffee grounds;
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • new lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects may include:

  • dizziness;
  • headache;
  • heartburn, upset stomach, nausea, vomiting;
  • diarrhea, constipation; or
  • swelling in your hands, legs, or feet.

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.

Why is this medication prescribed?

Riociguat is used to treat pulmonary arterial hypertension (PAH; high blood pressure in the vessels that carry blood to the lungs). Riociguat is also used to treat chronic thromboembolic pulmonary hypertension (CTEPH; high blood pressure in the lung arteries caused by blood clots that narrow or block blood flow) in adults who cannot have surgery or for those treated with surgery who continue to have high lung blood pressure levels after surgery. Riociguat may improve the ability to exercise in people with PAH and CTEPH and may slow the worsening of symptoms in people with PAH. Riociguat is in a class of medications called soluble guanylate cyclase (sGC) stimulators. It works by relaxing the blood vessels in the lungs to allow blood to flow easily.

What is riociguat?

Riociguat lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Riociguat is used to treat chronic thromboembolic pulmonary hypertension (CTEPH) in people who cannot be treated with surgery, or in people who have undergone surgery but still have symptoms. Riociguat can treat certain symptoms of CTEPH and can improve your ability to exercise.

Riociguat is used to treat pulmonary arterial hypertension (PAH). Riociguat can improve your ability to exercise and help prevent PAH from getting worse.

Riociguat is available to women only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication.

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

What is the most important information I should know about riociguat?

Do not use riociguat if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your treatment ends.

You will need to have a negative pregnancy test before starting taking riociguat. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

Riociguat is available to women only under a special program from a certified pharmacy.

What happens if I overdose?

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

What should I avoid while taking riociguat?

Do not have unprotected sex while taking riociguat. You must use birth control to prevent pregnancy during treatment and for at least 30 days after you stop taking this medicine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Smoking can make riociguat less effective. Tell your doctor if you start or stop smoking while you are taking this medicine. Your dose needs may need to be changed

Avoid taking an antacid within 1 hour before or after you take riociguat. Some antacids can make it harder for your body to absorb riociguat.

What should I avoid while taking Adempas?

Do not have unprotected sex while taking Adempas. You must use birth control to prevent pregnancy during treatment and for at least 30 days after you stop taking this medicine.

Adempas can cause dizziness and may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking an antacid within 1 hour before or after you take Adempas. Some antacids can make it harder for your body to absorb riociguat.

Smoking can make Adempas less effective. Tell your doctor if you start or stop smoking while you are taking this medicine. Your dose needs may need to be changed

In Summary

Common side effects of Adempas include: dyspepsia, gastritis, and headache. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to riociguat: oral tablet

Along with its needed effects, riociguat (the active ingredient contained in Adempas) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking riociguat:

More common
  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • nosebleeds
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain or swelling
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or black, tarry stools
  • bruising or purple areas on the skin
  • coughing or spitting up blood
  • decreased alertness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • heavy non-menstrual vaginal bleeding
  • rapid weight gain
  • troubled breathing with exertion
  • vomiting of blood or material that looks like coffee grounds

Some side effects of riociguat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • headache
  • heartburn or indigestion
  • nausea or vomiting
  • stuffy nose
Less common
  • Difficulty having a bowel movement (stool)

Other Comments

Administration advice:
-May be taken without regard to meals.
-If a dose is missed, continue with the next regularly scheduled dose. If therapy is interrupted for 3 days or more, retitration is required.
-May crush tablets and mix with water or soft foods (such as applesauce) immediately before administration in patients unable to swallow whole tablets.

Monitoring:
-Cardiovascular: Monitor for hypotension
-Female patients: Pregnancy tests should be obtained prior to initiation and monthly during treatment.

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