riociguat

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

What is riociguat?

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 also 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. You must be registered in the program and understand the risks and benefits of this medicine.

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

What should I discuss with my healthcare provider before taking riociguat?

• you are pregnant or might become pregnant during treatment; or
• you have PAH related to a condition called idiopathic interstitial pneumonias (PH-IIP).

Some medicines can cause unwanted or dangerous effects when used with riociguat. Your doctor may change your treatment plan if you also use:

• dipyridamole;
• theophylline;
• erectile dysfunction medicine such as Viagra, Cialis, Levitra, and others;
• a nitrate drug for chest pain or heart problems (amyl nitrite, nitroglycerin, and others); or
• other medicines to treat PAH (Adcirca or Revatio).

Tell your doctor if you have ever had:

• heart disease, blood circulation problems;
• low blood pressure;
• a condition called pulmonary veno-occlusive disease (PVOD);
• a cough with bloody mucus, or bleeding from your lung;
• liver disease;
• kidney disease (or if you are on dialysis); or
• if you smoke.

You will need to have a negative pregnancy test before starting this treatment. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine. Do not have unprotected sex.

While taking riociguat, girls and women who are able to get pregnant must use highly effective birth control, or two methods together.

Even if you are not planning a pregnancy, you are considered able to become pregnant if:

• you have entered puberty (even if you have not yet started having periods);
• you have never had a hysterectomy or had your ovaries removed; or
• you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).

Riociguat comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Even if your sexual partner has had a vasectomy, you must still use a second method of birth control--either a barrier method or a hormonal form (birth control pills, injections, skin patch, or vaginal ring).

If you are the parent or caregiver of a female child taking this medication, talk to the child's doctor once you notice any signs of puberty (breast development or pubic hair), even if menstrual periods have not yet begun.

How should I take riociguat?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take riociguat with or without food.

If you cannot swallow a tablet whole, you may crush the tablet and mix it with water or soft food (such as applesauce). Swallow the mixture right away without chewing. Do not save it for later use.

Your blood pressure will need to be checked often.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking riociguat?

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

What are the possible side effects of riociguat?

• 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, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• build-up of fluid in your lungs --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:

• headache, dizziness;
• indigestion, nausea, vomiting, diarrhea; 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.

What other drugs will affect riociguat?

Other drugs may affect riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about riociguat.