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Opsumit Coupon - Opsumit 10mg tablet

Opsumit

macitentan
Used for Pulmonary Hypertension
Used for Pulmonary Hypertension

Opsumit (macitentan) is a medication for treating people with pulmonary arterial hypertension (PAH), or high blood pressure in the blood vessels in the lungs. It can be used alone or together with other PAH medications. Opsumit (macitentan) has several benefits, including lowering the risk of worsening of PAH and hospitalization due to PAH. But, it also has some side effects, such as headache, sore throat, and anemia.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Cydnee Ng, PharmD
Last reviewed on March 28, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsContraindicationsAlternativesLatest newsImagesReferencesPricesMedicare
basics-icon

What is Opsumit (macitentan)?

What is Opsumit (macitentan) used for?

  • Pulmonary arterial hypertension (PAH)

How Opsumit (macitentan) works

Opsumit (macitentan) is an endothelin receptor antagonist. It works by blocking the effects of a protein in your body called endothelin. Doing so relaxes the blood vessels that go from your heart to your lungs and allows more blood to flow through. This lowers the amount of work your heart needs to pump blood to your lungs to get oxygen for your body. As a result, it's easier for you to exercise and breathe.

Drug Facts

Common BrandsOpsumit
Drug ClassEndothelin receptor antagonist
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Opsumit (macitentan)?

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

  • Cold-like symptoms or a sore throat (20%)
  • Headache (14%)
  • Anemia (13%)
  • Bronchitis (12%)
  • Urinary tract infection (9%)
  • Flu (6%)

Other Side Effects

  • Stuffy nose
  • Swelling of the body (e.g., arms, feet, ankles)
  • Low blood pressure

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Liver problems: swelling of your stomach, yellowing of your skin or the whites of your eyes, confusion, dark or brown urine
  • Fluid buildup in the body: shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; chest pain; unable to exercise; tiredness; unusual weight gain

Source: DailyMed

The following 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

Decrease in the amount of urine

noisy, rattling breathing

pale skin

swelling of the fingers, hands, feet, or lower legs

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Less common

Abdominal or stomach pain or tenderness

clay colored stools

dark urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

muscle aches and pains

difficulty with breathing

tightness in the chest

yellow eyes or skin

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:

More common

Chills or fever

cough

sore throat

stuffy or runny nose

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

Pros and cons of Opsumit (macitentan)

thumbs-up

Pros

Works well to slow down the worsening of PAH and make it easier to breathe, exercise, and walk longer distances

Taken by mouth once per day with or without food

Might work better than ambrisentan (Letairis) or bosentan (Tracleer)

thumbs-down

Cons

Not a cure for PAH

Can cause side effects like headache, fluid buildup in the body, and anemia

Not safe to use during pregnancy

Not recommended for breastfeeding mothers because we don't know if it's safe

pharmacist-tips

Pharmacist tips for Opsumit (macitentan)

pharmacist

  • 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 make sure Opsumit (macitentan) is safe for you to take. For example, your provider will need to check your liver health regularly and your blood cell counts periodically.

    • Take Opsumit (macitentan) with or without food at the same time day every day.

      • Swallow Opsumit (macitentan) tablets whole. Don't split, crush, or chew the tablets. If you're having trouble swallowing the tablets, contact your provider.

        • Opsumit (macitentan) can cause your body to hold onto too much fluid and swell up. Contact your provider if you notice shortness of breath, unexpected weight gain, or swelling in the ankles or feet.

          • Opsumit (macitentan) interacts with a lot of medications (prescription and over-the-counter), including amiodarone (Pacerone), diltiazem (Cardizem), and fluconazole (Diflucan), among many others. Make sure to let your provider know about all the medications you're taking (including vitamins and supplements) before starting Opsumit (macitentan) so that they can check for interactions. If there are interactions, your provider might switch you to a different medication to prevent harmful effects.

            • If you're a woman who's able to have children, it's recommended that you use birth control during treatment with Opsumit (macitentan) and for at least 1 month after your last dose. In addition, you'll need to do a pregnancy test every month while you take Opsumit (macitentan). Let your provider know right away if you get pregnant while taking this medication. Opsumit (macitentan) can potentially harm an unborn baby.

              • If you're a man and are prescribed Opsumit (macitentan), let your provider know if there's a possibility you might want to have children in the future. This medication might not be the best option for you because Opsumit (macitentan) can lower your sperm count. It's not known if this effect is reversible after you stop the medication.

                faqs

                Frequently asked questions about Opsumit (macitentan)

                What is pulmonary arterial hypertension (PAH)?
                Pulmonary arterial hypertension (PAH) is when the pressure in the arteries (blood vessels) that go from your heart to your lungs gets too high. This high blood pressure causes the arteries to become narrower, which makes it harder for blood to get to the lungs for oxygen. As a result, your heart has to work harder to pump blood to the lungs, which can lead to heart muscle damage and heart failure in the long run. Symptoms of PAH include shortness of breath, tiredness, dizziness, irregular heartbeat, chest pain, and swelling in the ankles and feet. Opsumit (macitentan) can help relax these blood vessels, allow more blood to flow through, lessen the work your heart needs to do, and get oxygen to the rest of your body.
                How well does Opsumit (macitentan) work to treat PAH?
                In clinical studies, people taking Opsumit (macitentan) had better improvements in walking distance at month 6 of treatment than people who took placebo. Six months into the study, people taking Opsumit (macitentan) also had less chest pain, fatigue, and shortness of breath with physical activity than those who took placebo. In addition, Opsumit (macitentan) lowered the chance of worsening of PAH and hospitalization for PAH each by almost half. Keep in mind that some people included in this study were also taking other PAH medications at the same time. Everyone responds differently to Opsumit (macitentan). For this reason, your provider will regularly follow up with you to make sure Opsumit (macitentan) is helping your PAH.
                What's the difference between Opsumit (macitentan), ambrisentan (Letairis), and bosentan (Tracleer)?
                Opsumit (macitentan), ambrisentan (Letairis), and bosentan (Tracleer) are from the same family of medications called endothelin receptor antagonists and are all used for PAH. One recent study showed that people who switched from ambrisentan (Letairis) or bosentan (Tracleer) to Opsumit (macitentan) had better improvements in walking speed, walking distance, and their overall PAH condition. All three medications generally have similar side effects. But, Opsumit (macitentan) is more likely to cause anemia, ambrisentan (Letairis) is more likely to cause swelling in the legs and feet, and bosentan (Tracleer) is more likely to cause liver problems. Finally, Opsumit (macitentan) and ambrisentan (Letairis) are taken once per day, whereas bosentan (Tracleer) is taken twice per day.
                What is a REMS program, and why is Opsumit (macitentan) under this program?
                Opsumit (macitentan) is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Opsumit REMS program. Because of the medication's risk of causing severe and life-threatening harm to unborn babies if taken during pregnancy, the REMS program makes sure Opsumit (macitentan) is distributed and taken under the safest conditions possible. All providers who prescribe Opsumit (macitentan), pharmacies that dispense the medication, and women who are able to get pregnant and are prescribed Opsumit (macitentan) must register with the REMS program. Under the Opsumit REMS program, you're required to get monthly pregnancy tests and use birth control during treatment if you're a woman who can have children and are taking the medication. These requirements don't apply for men who are prescribed Opsumit (macitentan).
                How does Opsumit (macitentan) affect fertility and family planning?
                If you're thinking about having a baby, there are a few things you should consider before starting Opsumit (macitentan). If you get pregnant during treatment, you'll need to stop the medication because there's a risk for severe and life-threatening harm to unborn babies. For this reason, women who are able to get pregnant must enroll in the Opsumit REMS program, use birth control while taking Opsumit (macitentan) and for at least 1 month after the last dose, and get monthly pregnancy tests during treatment. Additionally, it's possible that Opsumit (macitentan) might lower sperm counts in men, which might affect their ability to have children. It's not completely clear if this effect is reversible after stopping the medication. Make sure to discuss with your provider about family planning before starting Opsumit (macitentan).
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                What are the risks and warnings for Opsumit (macitentan)?

                Opsumit (macitentan) 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.

                risk-warning

                Not safe to use during pregnancy

                Opsumit (macitentan) shouldn't be taken during pregnancy. While it hasn't been studied in human pregnancy, animal studies show that it can cause severe and life-threatening harm to unborn babies. Because of this risk, Opsumit (macitentan) is available only through the Opsumit REMS program. If you're a woman who's able to have children, your provider will ask you take a pregnancy test before you start Opsumit (macitentan), monthly during treatment, and once more a month after you stop the medication. Women who are able to get pregnant should use birth control during treatment with Opsumit (macitentan) 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 Opsumit (macitentan) during pregnancy.

                risk-warning

                Liver damage

                Opsumit (macitentan) can cause liver problems that can sometimes lead to liver failure. You'll need to get blood tests to check your liver health before and during treatment. These blood tests make sure your liver is working properly. Get medical attention right away if you notice symptoms of liver problems, such as swelling of your stomach, stomach pain, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), nausea, vomiting, or dark or brown urine. You might need to stop taking Opsumit (macitentan) to prevent further liver damage.

                risk-warning

                Fluid buildup in the body

                • Risk factors: Heart failure

                  Opsumit (macitentan) can cause fluid buildup in the body, leading to swelling or shortness of breath. If you have a history of heart failure, this fluid buildup can be severe and worsen your heart condition. Fluid buildup can start to happen within weeks of starting Opsumit (macitentan). If you have any heart problems or heart failure, let your provider know before starting Opsumit (macitentan). Contact your provider if you have any signs of heart failure, like shortness of breath; swelling in the legs, ankles, or feet; irregular heartbeat; not able to exercise; or tiredness while taking Opsumit (macitentan).

                  risk-warning

                  Anemia (low red blood cell count)

                  • Risk factors: Severe anemia

                    Opsumit (macitentan) might cause your hemoglobin levels to go down. Hemoglobin is the protein on your red blood cells that carries oxygen to the rest of your body. Low hemoglobin levels can lead to anemia. You will need regular blood tests while taking Opsumit (macitentan) to make sure your hemoglobin stays at a healthy level. If you have a history of anemia, speak with your provider before taking Opsumit (macitentan) so they can make sure it's safe for you to take. If you experience weakness, shortness of breath, dizziness, fast or irregular heartbeat, or pale skin while taking Opsumit (macitentan), let your provider know.

                    dosage

                    Opsumit (macitentan) dosage forms

                    Typical dosing for Opsumit (macitentan)

                    The typical dose is 10 mg by mouth once per day.

                    interactions

                    Interactions between Opsumit (macitentan) and other drugs

                    Opsumit (macitentan) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Opsumit (macitentan). Please note that only the generic name of each medication is listed below.

                    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.

                    contraindications-icon

                    Opsumit (macitentan) 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 Opsumit (macitentan) will not be safe for you to take.

                    • Pregnancy

                    alternatives

                    What are alternatives to Opsumit (macitentan)?

                    There are a number of medications that your doctor can prescribe in place of Opsumit (macitentan). Compare a few possible alternatives below.
                    Opsumit (macitentan)
                    Used for:

                    • Pulmonary arterial hypertension (PAH)

                    View Prices
                    Bosentan (Tracleer)
                    Used for:

                    • Pulmonary arterial hypertension (PAH)

                    View Prices
                    Ambrisentan (Letairis)
                    Used for:

                    • Pulmonary arterial hypertension (PAH)

                    View Prices
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                    Opsumit (macitentan) images

                    White Round 10 - Opsumit 10mg Tablet
                    This medicine is White, Round Tablet Imprinted With "10".White Round 10 - Opsumit 10mg Tablet

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                    References

                    Best studies we found

                    Actelion Pharmaceuticals US, Inc. (2023). Opsumit- macitentan tablet, film coated [package insert]. DailyMed.

                    Actelion Pharmaceuticals US, Inc. (n.d.). Benefits of OPSUMIT®.

                    American Heart Association. (2023). Pulmonary hypertension - High blood pressure in the heart-to-lung system.

                    View All References (10)

                    Billett, H. H. (1990). Chapter 151: Hemoglobin and hematocrit. Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd edition.

                    Canadian Agency for Drugs and Technologies in Health. (2015). Drugs for pulmonary arterial hypertension. CADTH Report/Project in Briefs.

                    Centers for Disease Control and Prevention. (2019). Pulmonary hypertension.

                    Fagan, K. A., et al. (2001). Role of endothelin-1 in lung disease. Respiratory Research.

                    Humbert, M., et al. (2022). 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: Developed by the task force for the diagnosis and treatment of pulmonary hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Endorsed by the International Society for Heart and Lung Transplantation (ISHLT) and the European Reference Network on rare respiratory diseases (ERN-LUNG). European Heart Journey.

                    Li, J., et al. (2022). Efficacy and safety of switching from bosentan or ambrisentan to macitentan in pulmonary arterial hypertension: A systematic review and meta-analysis. Frontiers in Cardiovascular Medicine.

                    Macitentan REMS. (n.d.). A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the Food and Drug Administration (FDA) to manage serious risks associated with a drug product.

                    MedlinePlus. (n.d.). Hemoglobin test.

                    U.S. Food and Drug Administration. (2023). Risk evaluation and mitigation strategies | REMS.

                    Zhang, Y., e tal. (2019). A network meta-analysis for safety of endothelin receptor antagonists in pulmonary arterial hypertension. Cardiovascular Diagnosis & Therapy.

                    GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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