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According to the European Medicines Agency, brand name Opsumit originating from Europe is manufactured at the following site(s):
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Information about Opsumit (Macitentan)
Opsumit is a prescription medication that contains macitentan, a selective endothelin receptor antagonist (ERA). It is used to treat pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. Macitentan works by blocking the effects of endothelin-1, a protein that causes blood vessels to constrict. By blocking endothelin receptors, Opsumit helps to relax and dilate the blood vessels, lowering pulmonary artery pressure and improving blood flow, thereby reducing the symptoms of PAH and improving exercise capacity.
Product Highlights
- Opsumit is primarily used for the treatment of PAH to improve exercise capacity, reduce the risk of hospitalization, and delay the progression of the disease. It is typically used in patients with idiopathic PAH or PAH related to connective tissue diseases.
- It may be used alone or in combination with other treatments, such as phosphodiesterase-5 inhibitors (PDE-5 inhibitors) or prostacyclin analogs, for better management of PAH.
Key Ingredient
Key Benefits
- Opsumit helps increase the ability to exercise and perform daily activities by improving pulmonary artery blood flow and reducing symptoms of PAH.
- By reducing pulmonary arterial pressure and improving vascular function, Opsumit may slow the progression of PAH, helping patients maintain a better quality of life over time.
- The convenience of taking Opsumit once daily makes it easier for patients to manage their condition without the complexity of multiple doses throughout the day.
- Clinical studies have shown that Opsumit reduces the risk of PAH-related hospitalization, helping to manage the disease and prevent exacerbations.
- Opsumit is generally well-tolerated in most patients with PAH, offering a beneficial treatment option with minimal side effects.
Direction of Use
- The recommended dose of Opsumit for adults is 10 mg once daily.
- It is important to take Opsumit at the same time every day to help remember the dose. Opsumit can be taken with or without food, according to your preference.
- The tablets should be swallowed whole with a glass of water. Swallow the tablet whole; do not chew, crush, or break it.
- Regular monitoring by your healthcare provider is necessary to assess the effectiveness of the treatment and manage potential side effects. Liver function tests and blood pressure monitoring may be required during treatment.
Safety Concerns
- Opsumit may cause birth defects and is contraindicated in pregnancy. Women of childbearing age should use effective contraception during treatment and for at least 30 days after stopping the medication.
- Opsumit can affect liver function, so liver function tests should be performed before starting treatment and periodically during treatment.
- Macitentan may cause anemia (low red blood cell count), so regular monitoring of hemoglobin levels is recommended, particularly during the first months of treatment.
- Although not common, Opsumit may cause a drop in blood pressure. Patients should be monitored for signs of hypotension, especially during the initial phase of treatment.
- In some cases, patients with severe PAH may develop pulmonary edema (fluid in the lungs). Seek medical attention if you experience unusual difficulty breathing or swelling.
- Macitentan may interact with other medications, particularly those that affect liver enzymes or blood pressure. Make sure to tell your healthcare provider about all the medications you are using, including any over-the-counter drugs and herbal supplements.
Avoid Opsumit (Macitentan) If
- You are pregnant or planning to become pregnant, as Opsumit can cause serious harm to the fetus, including birth defects.
- You are breastfeeding, as it is not known if Opsumit passes into breast milk.
- You have severe liver disease (such as cirrhosis) or impaired liver function.
- You are allergic to macitentan or any other ingredient in Opsumit.
- You are taking medications that interfere with liver enzymes, especially strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole).
- You have severe pulmonary edema or a history of fluid retention due to heart failure.