Adempas
Adempas (riociguat) is a medication used to treat adults with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), both of which are types of high blood pressure in the lungs. It's available as tablets taken by mouth every 8 hours. Common side effects include headache, indigestion, and dizziness. Adempas (riociguat) can also cause severe and life-threatening harm to unborn babies, so the medication is only available to females through the Adempas REMS program.
What is Adempas (riociguat)?
What is Adempas (riociguat) used for?
- Pulmonary arterial hypertension (PAH) in adults
- Chronic thromboembolic pulmonary hypertension (CTEPH) in adults
How Adempas (riociguat) works
Adempas (riociguat) is a soluble guanylate cyclase (sGC) stimulator. It works by activating sGC, a protein that helps relax the blood vessels in the lungs and allows more blood to flow through. As a result, your heart is able to pump better, your body gets more oxygen, and you should be able to breathe and exercise easier.
Drug facts
Side effects of Adempas (riociguat)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (27%)
- Indigestion or stomach irritation (21%)
- Dizziness (20%)
- Nausea (14%)
- Diarrhea (12%)
- Low blood pressure (10%)
- Vomiting (10%)
- Anemia (7%)
- Reflux or heartburn (5%)
- Constipation (5%)
Less Common Side Effects
- Stuffy nose
- Nosebleed
- Difficulty swallowing
- Bloating
- Fluid build-up (edema) in arms or legs
Adempas (riociguat) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Dangerously low blood pressure: dizziness, lightheadedness, pale skin, feeling faint
- Severe bleeding: feeling faint, lightheadedness, dizziness, vomiting blood, bloody or dark-colored stools, severe stomach pain or discomfort
- Blockage in the lungs: dizziness, trouble breathing, irregular heartbeat, chest pain, sweating, coughing
More on Adempas (riociguat) side effects
The following Adempas (riociguat) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
nosebleeds
unusual tiredness or weakness
Less common
Bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or black, tarry stools
bruising or purple areas on the skin
coughing or spitting up blood
decreased alertness
fast, irregular, pounding, or racing heartbeat or pulse
heavy non-menstrual vaginal bleeding
rapid weight gain
stomach pain or swelling
troubled breathing with exertion
vomiting of blood or material that looks like coffee grounds
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Difficulty having a bowel movement
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Adempas (riociguat)
Pros
- Makes it easier to exercise and perform normal day-to-day activities
- Taken by mouth
- Can crush and mix with water or soft foods if you're having difficulty swallow pills
Cons
- Not safe to use while pregnant or breastfeeding
- Taken 3 times per day
- Can lower your blood pressure and cause bleeding
Pharmacist tips for Adempas (riociguat)
- Make sure to mark your appointments on your calendar for when you need to see your provider. These appointments are important to discuss how treatment is going for you and to make sure Adempas (riociguat) is safe for you to take.
- Take Adempas (riociguat) with or without food at the same time every day. But Adempas (riociguat) commonly causes nausea, so taking it with food might help reduce stomach side effects.
- If you're having trouble swallowing the tablets, you can crush them and mix with water or soft foods such as applesauce right before taking your dose.
- Adempas (riociguat) can lower your blood pressure and make you dizzy. Make sure to stay hydrated. Don't drive or operate machinery until you know how this medication affects you. Let your provider know if you're taking medication for high blood pressure and if you feel lightheaded, dizzy, or feeling like you're about to faint.
- Although rare, Adempas (riociguat) can cause serious and unusual bleeding (e.g., vomiting blood, bloody nose). Seek medical help if you notice any unusual bleeding or have difficulty stopping a bleed.
- Adempas (riociguat) can interact with other medications. Make sure to tell your provider about all the medications you're taking, including over-the-counter medications and supplements, before starting Adempas (riociguat). For example, don't take aluminum- or magnesium-containing antacids (e.g., Mylanta (aluminum hydroxide / magnesium hydroxide / simethicone), Rolaids (calcium carbonate / magnesium hydroxide)) within 1 hour of Adempas (riociguat) because they can affect how well Adempas (riociguat) is absorbed into your body. Don't start any new medications while taking Adempas (riociguat) without talking to your provider or pharmacist first.
- If you're a female who's able to have children, you should use two forms of birth control during treatment with Adempas (riociguat) and for at least 1 month after your last dose. In addition, you'll need to do a pregnancy test every month while you to take Adempas (riociguat). Let your provider know right away if you get pregnant while taking this medication. Adempas (riociguat) can potentially harm an unborn baby.
- You shouldn't breastfeed during, and for at least 3 days after, treatment with Adempas (riociguat) because it's not known if it's safe for your baby. If stopping breastfeeding isn't an option for you, talk to your provider about switching you to a different medication.
- If you miss a dose, skip the missed dose and resume your normal dose at the next scheduled time. Don't double-up the dose to make up for the missed dose. If you miss 3 or more days of Adempas (riociguat), contact your provider to see how you can safely restart the medication.
Common questions about Adempas (riociguat)
No, Adempas (riociguat) isn't a blood thinner (a group of medications that's taken to prevent blood clots). But rather, it's a medication that's taken to lower blood pressure in the vessels of the lungs. Like blood thinners, Adempas (riociguat) does carry a risk for bleeding, but this risk is very low. When you take Adempas (riociguat), look out for symptoms of bleeding (including bleeding inside of your body). If you notice any unusual bleeding (e.g., coughing up or vomiting blood, blood in urine or stool, or bleeding that's difficult to stop), seek medical help right away.
In clinical studies, people taking Adempas (riociguat) started to see improvement within 2 weeks of starting the medication. Specifically, researchers checked for any improvements in how far people were able to walk in 6 minutes, a common test providers use to see if your condition has progressed. Starting week 2, people taking Adempas (riociguat) in both the PAH and CTEPH group were able to walk farther in 6 minutes compared to people who took placebo.
In clinical studies, people taking Adempas (riociguat) were able to walk longer distances (118 to 147 feet further) after 3 to 4 months of treatment compared to people who took placebo. Keep in mind that everyone responds differently to Adempas (riociguat). For this reason, your provider will regularly follow up with you to make sure Adempas (riociguat) is helping your condition.
In clinical studies, people didn't report weight gain as a side effect of Adempas (riociguat).
You shouldn't take any nitrates, like nitroglycerin (Nitrostat)), or any medications that raise nitric oxide levels with Adempas (riociguat) because this combination can cause your blood pressure to be dangerously low. In addition, avoid taking Adempas (riociguat) with PDE-5 inhibitors (e.g., sildenafil (Viagra)) at the same time - you must separate them by 24 to 48 hours or else you'll be at risk for dangerously low blood pressure. This isn't a complete list of Adempas (riociguat) and its medication interactions. Make sure to tell your provider and pharmacist about all of the medications you're taking before and during treatment with Adempas (riociguat).
Yes. This is because smoking can lower the blood levels of Adempas (riociguat) by about half, so people who smoke might need higher doses of Adempas (riociguat). Make sure to tell your provider if you smoke regularly, or if you decide to start or stop smoking while taking Adempas (riociguat), because your dose will need to be adjusted.
Since Adempas (riociguat) can cause severe and life-threatening harm to babies when taken during pregnancy, the medication is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) for females. The program for this medication is called the Adempas REMS program. All providers who prescribe Adempas (riociguat), pharmacies that dispense Adempas (riociguat), and females who take Adempas (riociguat) must register with the REMS program and follow the requirements in the program. This is to make sure the medication is distributed and taken under the safest conditions possible for you.
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Risks and warnings for Adempas (riociguat)
Adempas (riociguat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not safe to use during pregnancy
Adempas (riociguat) shouldn't be taken during pregnancy because it might cause severe and life-threatening harm to unborn babies. Because of this risk, Adempas (riociguat) is available only through the Adempas REMS program. If you're a female who's able to have children, your provider will ask you take a pregnancy test before you start Adempas (riociguat), monthly during treatment, and once more a month after you stop the medication. Females who are able to get pregnant should use two forms of birth control during treatment with Adempas (riociguat) and for at least 1 month after completing treatment. If you're pregnant or thinking of becoming pregnant, talk to your provider about the risks and benefits of using Adempas (riociguat) during pregnancy.
Low blood pressure
- Risk factors: Certain heart problems | Low fluids in the body | Also taking erectile dysfunction medications | Also taking blood pressure-lowering medications
Adempas (riociguat) can cause your blood pressure to drop too much, which can make you feel dizzy, tired, or lightheaded. Some medications can interact with Adempas (riociguat), making these effects worse. When you take Adempas (riociguat), make sure to sit down for the first few minutes to avoid dizziness or fainting. Change positions slowly until your body is used to the medication. Get emergency help if you feel like you're going to pass out in addition to having an irregular heartbeat, nausea, vomiting, weakness, changes in vision, sweating, cold and clammy skin, or worse chest pain.
Bleeding
- Risk factors: Taking other medications that raise the risk for bleeding
Although rare, Adempas (riociguat) can raise your risk for bleeding. Your risk is higher if you're also taking other medications that can cause bleeding. Tell your provider right away if you notice any abnormal bleeding, see any blood in your stool or urine, or feel more dizzy. Get medical help right away if you have a fall, head injury, or other kinds of physical injury since you might have bleeding inside your body. And contact your provider right away if you have dark or tarry stool or bleeds that are difficult to stop.
Blockage in the lungs
Rarely, fibrous tissue can build up in the small veins of the lungs and lead to a problem called pulmonary veno-occlusive disease, or POVD. Contact your provider if you notice signs of pulmonary edema (e.g., shortness of breath, tiredness, chest pain, sweating, or coughing that doesn't go away) so you can be tested. If you're diagnosed with this rare form of pulmonary hypertension, you'll need to stop Adempas (riociguat).
Adempas (riociguat) dosage
Typical dosage for Adempas (riociguat)
The typical starting dose is 0.5 mg to 1 mg by mouth 3 times a day. If needed, your provider will raise your dose every 2 weeks. The maximum dose is 2.5 mg by mouth 3 times a day.
Your provider will adjust your dose based on how well it's helping your condition, if you're having side effects, if you're taking a medication that interacts with Adempas (riociguat), and if you smoke.
More on Adempas (riociguat) dosage
Interactions between Adempas (riociguat) and other drugs
More on Adempas (riociguat) interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Aminophylline
- Amyl Nitrite
- Avanafil
- Caffeine
- Cobicistat
- Dipyridamole
- Dyphylline
- Erythrityl Tetranitrate
- Isosorbide Dinitrate
- Isosorbide Mononitrate
- Lopinavir
- Nelfinavir
- Nitric Oxide
- Nitroglycerin
- Papaverine
- Pentaerythritol Tetranitrate
- Pentoxifylline
- Propatyl Nitrate
- Ritonavir
- Saquinavir
- Sildenafil
- Tadalafil
- Telaprevir
- Theophylline
- Vardenafil
- Vericiguat
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Adempas (riociguat) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Adempas (riociguat) will not be safe for you to take.
- Pregnancy
- Taking nitrates, nitric oxide donors (e.g., amyl nitrite), or other sGC stimulators
- Taking phosphodiesterase inhibitors (e.g., sildenafil (Viagra), theophylline) at the same time as Adempas (riociguat)
- History of idiopathic interstitial pneumonias (PH-IIP)
What are alternatives to Adempas (riociguat)?
