Description

Opsutan 10 mg (Macitentan) – Oral ERA Therapy for Pulmonary Arterial Hypertension

Opsutan 10 mg contains macitentan, a dual endothelin receptor antagonist used to treat WHO Group I pulmonary arterial hypertension (PAH) by blocking both ETA and ETB receptors—reducing pulmonary vascular resistance and improving cardiac performance 

Key Benefits:

Once‑daily dosing simplifies management and enhances adherence 
Significant reduction in PAH-related hospitalization and disease progression—~50% reduction at 10 mg dose 
Improves functional capacity and quality of life in PAH patients

How It Works

Macitentan blocks endothelin-1 from binding ETA and ETB receptors, leading to pulmonary vasodilation, reduced right heart strain, and slowed vascular remodeling. It’s a long-acting once-daily oral medication. 

Recommended Dosage

Standard adult dose: 10 mg once daily, taken with or without food. Titration should begin with lower doses in select populations (e.g., hepatic impairment). Do not exceed 10 mg. 

Possible Side Effects

Common: headache, upper airway symptoms (nasal congestion, sore throat), anemia, peripheral edema, bronchitis 
Serious: liver injury—manifested as dark urine, jaundice, nausea, abdominal pain; pulmonary edema; decreased sperm count or male infertility

Precautions & Interactions

Contraindicated in pregnancy due to fetal toxicity—women of childbearing potential must use two reliable forms of contraception and have monthly pregnancy testing
Baseline and periodic monitoring of liver function and hemoglobin recommended
Use caution in patients with anemia, liver or kidney disease, or pulmonary veno‑occlusive disease 
Avoid strong CYP3A4 inhibitors/inducers (e.g., ketoconazole, rifampin) which may alter macitentan levels

Why Choose Opsutan?

Generic alternative to Opsumit with equivalent efficacy and safety profile 
Once-daily oral use without injectable routes—ideal for long-term PAH management
Backed by extensive SERAPHIN trial data showing substantial reduction in hospital events

Frequently Asked Questions (FAQs)

1. What is Opsutan 10 mg used for?

Opsutan is prescribed to manage pulmonary arterial hypertension (WHO Group I), aiming to delay clinical worsening and hospital admissions. 

2. How long does it take to work?

Therapeutic benefit is seen over weeks to months; significant reductions in hospitalization and disease progression emerge over longer follow-up (as seen in SERAPHIN trial). 