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 riociguat.

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

Riociguat can cause birth defects. Do not use if you are pregnant. You must use highly effective birth control while taking riociguat and for at least 1 month after your last dose. Do not have unprotected sex.

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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 1 mg orally 3 times a day
Maximum dose: 2.5 mg orally 3 times a day

Comments:
-For patients who cannot tolerate the hypotensive effect, consider a starting dose of 0.5 mg orally 3 times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs of hypotension, the dose may be titrated up by 0.5 mg orally 3 times a day.
-Dose increases should be no more frequent than every 2 weeks.

Uses:
-Persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
-As monotherapy or in combination with endothelin receptor antagonists or prostanoids to treat pulmonary arterial hypertension (PAH) (WHO group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.

You should not use riociguat if you are allergic to it, or if:

• 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).

Do not take riociguat within 24 hours before or after taking sildenafil (Revatio, Viagra), or within 24 hours before or 48 hours after taking tadalafil (Adcirca, Cialis).

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.

Do not use riociguat if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using riociguat and for at least 1 month after your treatment ends. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.

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.

You should not breast-feed while using this medicine.

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

Call your doctor if you miss your doses for 3 days in a row or longer.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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 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.

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 driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Riociguat may cause serious side effects. 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, 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 of riociguat 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.

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.

Keep all appointments with your doctor. Your doctor will check your blood pressure regularly during your treatment with riociguat.

Do not let anyone else take your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.