Because of the risk of serious birth defects, females can only receive Adempas through a restricted program called the Adempas REMS program. Your doctor will enroll you before you can receive Adempas.
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Chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4)
treated with surgery but who continue to have high pulmonary blood pressure (persistent) or it comes back after surgery (recurrent), or that cannot be treated with surgery
Pulmonary arterial hypertension (PAH) (WHO Group 1)
The Adempas clinical studies included mostly patients with WHO functional class II–III symptoms. It is unknown if Adempas is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Adempas can cause serious birth defects if taken during pregnancy.
- Females must not be pregnant when they start taking Adempas (riociguat) tablets or become pregnant during treatment with Adempas.
Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with Adempas, each month during treatment, and 1 month after you stop treatment with Adempas. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do the test.
- Females who are able to get pregnant are females who:
- Have entered puberty, even if they have not started their period, have a uterus, and have not gone through menopause (have not had a period for at least 12 months for natural reasons, or have had their ovaries removed).
- Females who are not able to get pregnant are females who:
- Have not yet entered puberty, do not have a uterus, or have gone through menopause.
- Females who are able to get pregnant are females who:
- If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used alone and no other form of birth control is needed.
- Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out how to prevent pregnancy during treatment with Adempas.
- Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
- Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.
Do not take Adempas if:
- you are pregnant, plan to become pregnant, or become pregnant during treatment with Adempas. Adempas can cause serious birth defects.
- you take:
- a nitrate medicine to treat high blood pressure or heart disease, such as nitroglycerin, or a medicine called a nitric oxide donor, such as amyl nitrite
- certain other medicines that contain sildenafil (Revatio or Viagra), tadalafil (Adcirca or Cialis), vardenafil (Levitra or Staxyn), dipyridamole, or theophylline. Revatio and Adcirca are also used to treat PAH
Before you take Adempas, tell your doctor if you:
- smoke; have recently had serious bleeding from your lungs, or if you have had a medical procedure called bronchial arterial embolization to stop you from coughing up blood; have problems with your heart or blood circulation; have low blood pressure; have liver problems; have kidney problems or are on dialysis; have narrowing of the pulmonary veins, a condition called pulmonary veno-occlusive disease or PVOD; have any other medical conditions.
What should I avoid while taking Adempas?
- Do not get pregnant while taking Adempas. If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
- It is not known if Adempas passes into your breast milk. You should not breastfeed if you take Adempas. Talk to your doctor about the best way to feed your baby if you take Adempas.
- Adempas may make you feel dizzy. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Adempas affects you. Talk with your doctor if you are concerned about when it is safe for you to do these activities.
- Smoking. Adempas may not work as well if you smoke during treatment. Tell your doctor if you stop smoking or start smoking during treatment with Adempas, because your dose of Adempas may need to be changed.
Adempas can cause serious side effects including:
- Serious birth defects.
- Reduced blood pressure. This may cause symptoms of low blood pressure, such as lightheadedness, chest pain, and dizziness especially in people who are dehydrated, have a severe blockage of blood flow out of the heart, or have certain other medical problems. Your doctor will check you for any of these problems.
- Increased risk of bleeding, including bleeding from the respiratory tract. Tell your doctor right away if you cough up blood during treatment with Adempas.
- Worsening of symptoms in people with Pulmonary Veno-Occlusive Disease (PVOD). If you have PVOD, treatment with Adempas may cause a build-up of fluid in your lungs (pulmonary edema) which may result in shortness of breath. Your doctor may tell you to stop taking Adempas and switch you to a different medicine.
The most common side effects of Adempas are:
- Headache; dizziness; indigestion; swelling of your hands, legs, feet, and ankles (peripheral edema); nausea; diarrhea; and vomiting
Adempas is a prescription medicine used to treat adults with:
- chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) treated with surgery but who continue to have high pulmonary blood pressure (persistent) or it comes back after surgery (recurrent), or that cannot be treated with surgery.
- CTEPH is a type of high blood pressure in the arteries of your lungs caused by blood clots that narrow or block blood flow. Adempas can improve your ability to exercise (measured by 6-minute walk distance) and can help to improve some of your symptoms.
- pulmonary arterial hypertension (PAH) (WHO Group 1)
- PAH is a type of high blood pressure in the arteries of your lungs. Adempas can improve your ability to exercise (measured by 6-minute walk distance), improve some of your symptoms, and help slow down the worsening of your physical condition [this includes death, heart/lung transplant, a surgery to reduce pressure in your lung, hospitalization for worsening of pulmonary hypertension, start of a new PAH-specific treatment, continued decline in your ability to exercise (measured by 6-minute walk distance) and some of your symptoms].