Generic Name: riociguat (RYE oh SIG ue at)
Brand Name: Adempas
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 should I discuss with my healthcare provider before taking riociguat?
You should not use riociguat if you are allergic to it, or if you are pregnant or might become pregnant during treatment.
Some medicines can interact with riociguat and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:
erectile dysfunction medicine such as sildenafil, tadalafil, or vardenafil;
a nitrate drug for chest pain or heart problems (amyl nitrite, nitroglycerin, and others); or
other medicines to treat PAH (Adcirca or Revatio).
To make sure riociguat is safe for you, tell your doctor if you have:
blood circulation problems;
low blood pressure;
a condition called pulmonary veno-occlusive disease (PVOD);
a recent history of coughing up blood or bleeding from your lung;
kidney disease (or if you are on dialysis);
if you smoke; or
if you are dehydrated.
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 this medicine 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.
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).
While taking riociguat you must use a highly effective form of birth control, or two methods together.
A tubal ligation alone is an effective birth control method.
An intrauterine device (IUD) or birth control implant alone are also effective birth control methods.
If you use birth control pills, injections, skin patches, or vaginal rings, you must use a back-up barrier form of birth control, such as a condom or diaphragm or cervical cap. Always use a spermicide gel or insert together with a barrier form of birth control.
If you use only a barrier method, you must use a second barrier method as a back-up. For example, use a diaphragm or cervical cap in addition to a condom, plus a spermicide gel or insert.
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).
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.
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.
It is not known whether riociguat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take riociguat?
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Riociguat is usually taken 3 times per day. Space your doses 6 to 8 hours apart.
You may take riociguat with or without food.
You may need frequent medical tests to help your doctor determine how long to treat you with riociguat.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Call your doctor if you miss your doses for 3 days in a row or longer.
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.
Riociguat 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:
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.
See also: Side effects (in more detail)
Riociguat dosing information
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
-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.
-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.
What other drugs will affect riociguat?
Other drugs may interact with riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
More about riociguat
- Other brands: Adempas
Related treatment guides
Where can I get more information?
- Your pharmacist can provide more information about riociguat.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2016-03-07, 8:11:42 AM.