
macitentan
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.
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 Brands | Opsumit |
|---|---|
| Drug Class | Endothelin receptor antagonist |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | Lower-cost generic available |
| Availability | Prescription only |
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%)
Less Common Side Effects
- Stuffy nose
- Swelling of the body (e.g., arms, feet, ankles)
- Low blood pressure
Opsumit (macitentan) 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
The following Opsumit (macitentan) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Headache
- Runny or stuffy nose
- Sore throat
- Swelling of the ankles, hands, or feet
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Pros and cons of Opsumit (macitentan)
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)
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 for Opsumit (macitentan)
- 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.
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.
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.
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.
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).
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.
Opsumit (macitentan) dosage
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 10mg | 30 tablets | $792.77 | $26.43 |
Typical dosage for Opsumit (macitentan)
The typical dose is 10 mg by mouth once per day.
How much does Opsumit (macitentan) cost?
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
What are alternatives to Opsumit (macitentan)?
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