Europe — EMA
Opsumit (Macitentan)
Macitentan, the active ingredient in Opsumit, is an endothelin receptor antagonist presented as a tablet for oral use. It is indicated for the treatment of pulmonary arterial hypertension in adults.
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What is Macitentan?
Macitentan, the active ingredient in Opsumit, is an endothelin receptor antagonist presented as a tablet for oral use. It is indicated for the treatment of pulmonary arterial hypertension in adults. GNH USA supplies Opsumit as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and specialty clinics worldwide.
GNH USA supplies Opsumit as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and specialty clinics worldwide.
What is Macitentan used for?
Opsumit is used to target the endothelin pathway in pulmonary arterial hypertension, helping to improve exercise capacity and delay disease progression. - Pulmonary arterial hypertension (PAH): Improves functional class and exercise capacity. - WHO Group 1 PAH: Reduces risk of clinical worsening. - Chronic thromboembolic pulmonary hypertension (CTEPH) after surgical evaluation: Supports long‑term management.
What are the side effects of Macitentan?
Common Side Effects: - Headache: mild to moderate intensity. - Nasopharyngitis: typical upper‑respiratory infection symptoms. - Peripheral edema: swelling of the lower limbs. - Anemia: reduced hemoglobin levels. - Fatigue: general tiredness. - Nasal congestion: stuffy nose.
Serious or Rare Side Effects: - Liver injury: elevated transaminases or hepatitis. - Severe anemia: marked drop in hemoglobin. - Pulmonary edema: fluid accumulation in lungs. - Hypotension: significant blood‑pressure reduction. - Drug‑induced lupus‑like syndrome. - Severe hypersensitivity reactions.
What precautions apply to Macitentan?
Patients should be monitored regularly for liver function, hemoglobin levels and signs of fluid retention. - Liver monitoring: perform baseline and periodic liver enzyme tests. - Hemoglobin checks: assess for anemia before and during therapy. - Fluid retention: watch for peripheral edema or sudden weight gain. - Pregnancy avoidance: contraindicated in pregnancy due to teratogenic risk. - Drug interactions: review concomitant medications for CYP3A4 substrates. - Store at ambient temperature: keep in original packaging, protect from moisture and direct sunlight.
What does Macitentan interact with?
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