Key takeaways:
Opsumit (macitentan) is an oral medication used to manage pulmonary arterial hypertension (PAH) in adults. It’s often taken in combination with other PAH medications, such as tadalafil (Adcirca).
Opsumit comes in a 10 mg tablet. The typical Opsumit dosage is 10 mg by mouth once daily.
If there’s a possibility you could get pregnant, you’ll be enrolled in a risk management program before taking Opsumit. This is because Opsumit can harm a growing fetus when taken during pregnancy. As part of the program, you’ll need to take regular pregnancy tests.
If you’re an adult living with pulmonary arterial hypertension (PAH), your healthcare team may recommend a medication like Opsumit (macitentan). Opsumit is often taken in combination with other PAH medications, such as tadalafil (Adcirca), to help people avoid hospitalization and slow the progression of the disease.
Before starting treatment with Opsumit, there are a few things you should know. Below, we cover the recommended Opsumit dosage, how to handle a missed dose, and more.
If there’s a possibility you could get pregnant, there are some additional steps you’ll need to take when you’re prescribed Opsumit. That’s because the medication has a boxed warning, the FDA’s strictest medication warning, about the potential for harm to a growing fetus.
To avoid this possibility, you’ll be enrolled in a Risk Evaluation and Mitigation Strategies (REMS) program. The program requires a negative pregnancy test prior to starting treatment with Opsumit. And you’ll need to take monthly pregnancy tests during treatment. If you stop taking Opsumit, a final pregnancy test is required 1 month after your last dose. As part of the program, you’ll also be asked to use effective birth control methods to prevent pregnancy.
If you’re a man and having children is important to you, you should also speak to your prescriber before starting Opsumit. The medication may decrease your sperm count, which could affect your ability to have a child.
Opsumit is available in a 10 mg tablet. The FDA-approved Opsumit dosage is 10 mg by mouth once daily. Higher dosages have not been studied in people with PAH. You can take Opsumit with or without food, at any time of the day. Though, it’s helpful to pick a specific time and stick with it.
If you miss a dose of Opsumit, take the medication as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed one and take your next dose at the regular time. You should not take an extra dose of Opsumit to make up for a missed one.
If you take too much Opsumit, you may experience symptoms such as headache, nausea, and vomiting. If you believe you’ve taken too much of the medication, inform your prescriber right away. They will walk you through the next steps. You can also contact Poison Control online or at 1-800-222-1222 for guidance. If you have any symptoms that feel life-threatening, call 911 or go to the nearest ER.
Opsumit is considered a specialty medication. That means you’ll likely receive it in the mail from a specialty pharmacy. If you have health insurance, the pharmacy staff will work with your insurance provider on coverage details. They will also help you determine if you’re eligible for financial assistance.
If you have commercial insurance and qualify, you could pay as little as $5 for Opsumit with a copay savings card from the manufacturer. Or if you don’t have insurance, you may qualify for the manufacturer’s patient assistance program. Your specialty pharmacy can help you navigate ways to save on the medication.
Opsumit (macitentan) is an oral medication for pulmonary arterial hypertension (PAH) in adults. The typical Opsumit dosage is 10 mg by mouth once daily. You can take your dose with or without food, at any time of day. Try to pick a time that’s convenient for you and stick with it.
If you miss your Opsumit dose, take it as soon as you remember. But do not take a double dose to make up for a missed one. And if you think you’ve taken too much, contact your prescriber or Poison Control for guidance.
Actelion Pharmaceuticals US, Inc. (2024). Opsumit - macitentan tablet, film coated [package insert].
MedlinePlus. (2023). Macitentan.
Pulido, T., et al. (2013). Macitentan and morbidity and mortality in pulmonary arterial hypertension. The New England Journal of Medicine.
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