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.
Pulmonary arterial hypertension (PAH) in adults
Chronic thromboembolic pulmonary hypertension (CTEPH) in adults
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.
Source:Â DailyMed
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.
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
Not safe to use while pregnant or breastfeeding
Taken 3 times per day
Can lower your blood pressure and cause bleeding
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.
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.
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.
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.
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.
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).
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.
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.
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.
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)
Pulmonary arterial hypertension (PAH) in adults
Chronic thromboembolic pulmonary hypertension (CTEPH) in adults
Pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH)
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