Opsynvi Dosage & Drug Information

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Core Prescribing Info

Contents

Macitentan, tadalafil

Indications/Uses

Long-term treatment of pulmonary arterial HTN [PAH, World Health Organization (WHO) group 1] in adult patients of WHO functional class (FC) II-III.

Dosage/Direction for Use

Adult ≥18 yr Maintenance dose: 10/40 mg once daily. Patient who are treatment naïve to any PAH specific therapy or those transitioning from endothelin receptor antagonist (ERA) monotherapy Starting dose: 10/20 mg once daily for 1 wk. Maintenance dose: If tolerated, up titrate to 10/40 mg once daily. Patient transitioning from phosphodiesterase 5 inhibitor (PDE5i) monotherapy or those on therapeutic dose of ERA & PDE5i as separate tab 10/40 mg once daily. Patient who are currently treated w/ macitentan 10 mg & tadalafil 20 mg as separate tab 10/20 mg once daily.

Administration

May be taken with or without food: Swallow whole w/ water, do not chew/divide/crush.

Contraindications

Hypersensitivity. Acute MI w/in the last 90 days. Severe hypotension (<90/50 mmHg). Patients who are using any form of organic nitrate. Co-administration w/ guanylate cyclase stimulators (eg, riociguat). Patients who have vision loss in 1 eye because of non-arteritic anterior ischemic optic neuropathy. Severe hepatic impairment w/ or w/o cirrhosis (Child-Pugh class C) or clinically significant elevated hepatic aminotransferases >3x ULN. Women who are or may become pregnant. Lactation.

MIMS Class

Other Antihypertensives

ATC Classification

C02KX54 - macitentan and tadalafil ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.

Regulatory Classification

POM

Presentation/Packing

Form

Opsynvi FC tab 10/20 mg

Packing/Price

1's

Form

Opsynvi FC tab 10/40 mg

Packing/Price

1's

Opsynvi

Manufacturer:

Penn Pharmaceutical Services Limited