GNH USA

Europe — EMA

Opsumit (Macitentan)

GNH USA

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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 treats pulmonary arterial hypertension in adults. GNH USA supplies Opsumit as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

GNH USA supplies Opsumit as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and pharmacies worldwide.

What is Macitentan used for?

Opsumit is an endothelin receptor antagonist used in the management of pulmonary arterial hypertension, a disease affecting the pulmonary vascular pathway.

- Pulmonary arterial hypertension (PAH): Improves exercise capacity and delays disease progression. - WHO Group 1 PAH: Reduces risk of clinical worsening. - Chronic thromboembolic pulmonary hypertension (CTEPH) after operable disease: Supports long‑term management.

What are the side effects of Macitentan?

Opsumit may cause a range of adverse reactions, most of which are mild to moderate in severity.

Common Side Effects: - Headache - Nasal congestion - Upper respiratory tract infection - Peripheral edema - Fatigue - Dizziness

Serious or Rare Side Effects: - Liver enzyme elevation - Anemia - Pulmonary edema - Severe hypotension - Drug‑induced hepatitis - Fatal hemorrhage

What precautions apply to Macitentan?

When prescribing Opsumit, clinicians should consider several safety aspects and patient‑specific factors.

- Pregnancy avoidance: Teratogenic risk; use effective contraception. - Liver function monitoring: Check enzymes before and during therapy. - Anemia monitoring: Periodic hemoglobin assessment recommended. - Drug interactions: Review concomitant medications for endothelin‑related effects. - Renal impairment: Use with caution in severe renal dysfunction. - Store at below 25°C: Keep in the original packaging, protect from moisture.

What does Macitentan interact with?

Opsumite may interact with several medications, requiring attention to the interaction’s clinical significance.

Major Interactions (Avoid): - Cytochrome P450 3A4 inhibitors (e.g., ketoconazole) – increase macrotin  t  t  t  t  t  t  t  t  t  t  t  t. - Strong CYP 3P  t  t t  t  t  t  t  t  t  t.

Moderate  t  t  t  t  t: - Rifampicin  t  t  t  t  t  t  t  t  t  t  t. - Calcium‑channel  t  t  t  t  t  t  t  t  t  t  t.

Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Macitentan
Route
Oral Use
Manufacturer
Janssen-Cilag International Nv
Origin
EU

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