Product image of Opsumit (Macitentan) supplied by GNH India

Opsumit

Active Ingredient:
Macitentan
Origin:
EU

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

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

Manufacturer / TM Owner

Janssen-Cilag International Nv

1
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Indications & Clinical Uses

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.

How It Works

  • Macitentan selectively binds to endothelin‑A and endothelin‑B receptors, blocking the vasoconstrictive and proliferative actions of endothelin‑1. This inhibition leads to relaxation of pulmonary arterial smooth‑muscle, reduced vascular remodeling, and lower pulmonary arterial pressure.

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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