Riociguat

What is Riociguat?

Riociguat can be used to treat CTEPH in patients who are unable to undergo surgery or who still suffer from symptoms after surgery. Riociguat is used to treat CTEPH symptoms and improve your ability to exercise. Riociguat can also be used to treat pulmonary hypertension (PAH). Riociguat improves your ability to exercise and can help PAH get worse. Riociguat can only be obtained by women under a specific program. You must register in the program, and you must understand the risks and benefits of riociguat. Riociguat can be used in other ways not mentioned in this guide.

Side effects of Riociguat

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of your lips, face, tongue, or throat.

Riociguat can cause serious side effects. If you experience:

• Asthenia: an uncomfortable sensation like you might faint.
• Any unusual bleeding or abnormal vaginal bleeding
• Vomiting or spouting blood or vomit that looks similar to coffee grounds
• Low red blood cells (anemia)--pale or pale-colored skin, feeling of being light-headed, shortness of breath, or a sense that you are not well-rested;
• Buildup of liquid in your lungs—anxiety, sweating, and pale skin. Severe shortness of breath, wheezing or gasping, coughing up foamy mucus

Riociguat can cause the following side effects:

• Headache, dizziness;
• Indigestion, nausea, vomiting, diarrhea,
• You may experience swelling of your legs, feet, or hands.

There may be other side effects. Need medical advice regarding potential side effects? Make an appointment to meet with a physician. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

Sildenafil, Tadalafil, Adcirca, Revatio, Ambrisentan, and Opsumit

Warnings

Riociguat may cause birth defects. Do not use riociguat if you're pregnant. Use highly effective contraception during and after taking the drug. Avoid unprotected sexual activity.

Before you take this drug

If you have an allergy to riociguat, or:

• You are pregnant or could become pregnant while undergoing treatment.
• You have PAH if you also suffer from a condition known as idiopathic pulmonary interstitial pneumonitis (PH-IIP).

Some medications can have unwanted or harmful effects when combined with riociguat. If you are also taking

• Dipyridamole;
• Theophylline;
• Erectile disorder medicines such as Viagra, Cialis, Levitra, and others.
• A nitrate medication for chest pains or heart problems.
• Other medicines for PAH treatment (adcirca and revatio)

Do not take Riociguat 24 hours prior to or after taking Sildenafil Revatio or Viagra, or 24 or 48 hours before taking Tadalafil Adcirca or Cialis.

Tell your doctor about any of the following:

• Blood circulation problems;
• Low blood pressure
• A condition known as pulmonary veno occlusive disease (PVOD);
• A cough that produces bloody mucus or bleeds from the lungs;
• Liver disease
• If you have kidney disease or are currently on dialysis,
• If you smoke.

Avoid using riociguat while pregnant. This drug could cause birth defects or harm to the unborn child. Use birth control while taking riociguat and for at least one month after treatment. Inform your doctor immediately if you have missed a period or believe you might be pregnant while on treatment. Before starting the treatment, you will need a negative pregnancy result. You will be tested every month while you are taking the medicine and again one month after stopping it. Avoid unprotected sexual activity. Women and girls who can get pregnant while taking riociguat must use two highly effective methods of birth control or both.

Even if you don't plan to get pregnant, you can still become pregnant if you:

• You have reached puberty, even if your period has not yet begun.
• You have not had a hysterectomy or had your ovaries taken out.
• You have not experienced menopause. (You have never missed a period for 12 consecutive months.)

Riociguat includes patient instructions on acceptable birth control methods to use when taking this medication. Please follow the instructions carefully. If you have questions, ask your doctor or pharmacist. You must use a second form of birth control, even if your partner has undergone a vasectomy. This can be a hormonal method (birth-control pills or injections), a skin patch, or a vaginal ring. Even if your child has not started menstruating, if you are a parent or caregiver and you notice signs of puberty in a girl (e.g., pubic hair or breast development), you should speak to her doctor. This medicine should not be used while breastfeeding.

How to take Riociguat?

Read all the instructions or guides that come with your medication and follow the directions. Sometimes, your doctor will change the dose. You must take the medication exactly as prescribed. Take riociguat either with or without food. If you are unable to swallow the tablet whole, crush it and mix it with water or soft foods (such as applesauce). The mixture should be swallowed immediately without chewing. Don't save the mixture for later. You will need to check your blood pressure often. Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for pulmonary hypertension:

Initial dose: Take 1 mg three times daily.
Maximum dose: 2.5 mg orally, 3 times per day.
Comments:
Consider a starting dosage of 0.5mg orally, 3 times per day, for patients who are unable to tolerate the hypotensive effects. If the systolic pressure is still greater than 95 mmhg and there are no signs of hypertension in the patient, you can increase the dose by 0.5mg orally three times per day.
Dose increases shouldn't be more than once every two weeks.
Uses:
persistent or 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 combined with endothelin antagonists or prostanoids for the treatment of pulmonary arterial hypertension. (WHO Group 1), to improve exercise capability, improve WHO Functional Class, and delay clinical worsening.

What happens if I miss the dose?

Do not take the missed dose. Use your next dose as usual. Do not take two doses at the same time.If you have missed your doses for three consecutive days or more, call your doctor.

What happens if I overdose?

Reach out immediately if a poisonous substance comes your way by dialling 1-800-222-1222, or seeking immediate medical care.

What should be avoided?

Do not have unprotected sexual activity while taking Riociguat. Use birth control during the treatment period and for 30 days following your stoppage of riociguat. Avoid taking antacids within an hour of taking riociguat. Some antiacids may make it more difficult for your body to absorb riociguat. Smoking may reduce the effectiveness of riociguat. Inform your doctor if smoking has started or stopped while taking this medication. Adjust your dose as necessary.Do not drive or engage in hazardous activities until you have determined how the medicine will affect you. You may have impaired reactions. You may feel dizzy if you get up quickly from a seated or lying position.

Interaction with other drug

Other drugs, such as vitamins and herbal remedies, may also affect riociguat. Inform your doctor of all the medicines you are taking and those that you stop or start using.