What is Adempas?

Adempas (riociguat) is a prescribed medicine manufactured by Bayer that increases exercise capacity in adults suffering from different forms of pulmonary hypertension (high blood pressure in the lungs). Pulmonary hypertension is a chronic condition that can be inherited from a parent, acquired from drug exposure, or can be a complication from conditions such as connective tissue disease or human immunodeficiency virus (HIV) infection.

Adempas treats multiple forms of pulmonary hypertension. The first is chronic thromboembolic pulmonary hypertension (CTEPH), which is due to blood clots blocking blood vessels in the lungs. Adempas is used to treat reoccurring CTEPH and those with inoperable CTEPH.

Adempas also treats the World Health Organization Group I pulmonary hypertension (PH), also known as pulmonary arterial hypertension (PAH). PAH occurs when the arteries in the lungs have been thickened, stiffened, or narrowed.

Adempas can treat patients with functional class II or functional class III CTEPH or PAH. Functional class III is a more serious form of the disease. Adempas is also the first and only treatment approved for both PAH (WHO Group 1) and CTEPH (WHO Group 4).

The goal of Adempas is to improve WHO functional class, delay clinical worsening, and improve exercise capacity. Adempas may be used alone or in combination with other medications for PAH called endothelin receptor antagonists.

How does Adempas work?

Adempas (riociguat) is a soluble guanylate cyclase stimulator (sGC). It works by causing vasodilation, meaning it relaxes the blood vessels in the lungs to allow more blood to flow through. As a result, your heart can pump better, your body gets more oxygen, and you should be able to breathe and exercise easier.

What doses of Adempas are available?

Adempas is available in the following dosage form and strengths:

0.5 mg tablet
1 mg tablet
1.5 mg tablet
2 mg tablet
2.5 mg tablet

How do you use Adempas?

Adempas is a prescription medication that can only be provided by a certified pharmacy. Your doctor will tell you which pharmacy can dispense this medication. Make sure to take Adempas exactly as your doctor tells you. Don’t change your dose or stop taking Adempas without talking to your doctor first.

Your doctor will take your blood pressure about every 2 weeks at the beginning of treatment to determine the correct dose of Adempas for you. Your doctor may change your dose of Adempas during treatment, especially when you first begin taking this medication. Make sure to report any symptoms of hypotension (low blood pressure) during this time, such as dizziness, lightheadedness, or fainting to your doctor.

Usually, you will take Adempas 3 times each day, with a starting dose of 1mg, about 6 to 8 hours apart. Adempas can be taken with or without food.

Do not exceed 7.5 mg of Adempas in 1 day unless your doctor tells you to do so. If you exceed 7.5 mg, call your healthcare provider immediately, or go to the nearest ER.

If you take a heartburn medicine (antacid) that contains aluminum hydroxide or magnesium hydroxide, do not take it within 1 hour of taking Adempas.

If you miss a dose, take your next dose at the regular time. Call your doctor if you miss 3 or more days of treatment with Adempas for instructions about how to restart.

We strongly recommend carefully reviewing the FDA-approved patient labeling, including the Medication Guide, Prescribing Information, and Instructions for Use, before initiating treatment with Adempas. It contains essential information regarding the medication and its usage.

What are the side effects of Adempas?

The most common side effects of Adempas in clinical trials compared to placebo include:

Dizziness
Headache
Nausea
Diarrhea
Indigestion or stomach irritation (gastritis)
Vomiting
Low red blood cell counts (anemia)
Reflux or heartburn (dyspepsia)
Constipation
Bloating
Nosebleed
Stuffy nose

Contact your healthcare provider immediately if you experience any of the serious side effects, including:

Extremely low blood pressure
Serious bleeding
Severe, life-threatening allergic reaction

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Bayer’s Adempas. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adempas drug interactions

When Adempas is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Always consult your healthcare provider with any medications or supplements you take. Some drug interactions with Adempas include:

Any specific PDE 5 inhibitors used for erectile dysfunction or PAH such as tadalafil (Cialis or Adcirca), sildenafil (Viagra or Revatio), or vardenafil (Levitra or Staxyn)
- Do not take Adempas within 24 hours of sildenafil
- Do not take Adempas 24 hours before or within 48 hours after tadalafil
Any nonspecific PDE inhibitors such as dipyridamole or theophylline
Other soluble guanylate cyclase stimulators
Nitrates such as nitroglycerin or nitric oxide donors such as amyl nitrite, which are often used to treat heart disease, chest pain, and high blood pressure, or as recreational drugs

Boxed warnings

Adempas should not be administered to pregnant females due as it may cause birth defects. Females must take a pregnancy test to prove they are not pregnant before the start of treatment, every month during treatment, and 1 month after treatment has been discontinued. The use of effective birth control is necessary during treatment with Adempas to help prevent pregnancy. If the patient is able to become pregnant, Adempas is only available through a restricted program called the Adempas Risk Evaluation and Mitigation Strategies or Adempas REMS program.

Adempas precautions

You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

Are thinking about breastfeeding. The manufacturer, Bayer, recommends that you do not breastfeed while taking Adempas.
Have pulmonary veno-occlusive disease (PVOD). PVOD can cause fluid build-up in the lungs (pulmonary edema) and can get worse if you take Adempas.
Have pulmonary hypertension connected with idiopathic interstitial pneumonia (PH-IIP).
Have severely reduced liver function, have kidney problems, or have been on dialysis.
Have a systolic blood pressure below 95 mmHg.
Have heart disease or high blood pressure and take a nitrate medicine, such as nitroglycerin, or a nitric oxide donor, such as amyl nitrite, to treat it. This combination may lead to severely low blood pressure (hypotension).