OPSYNVI FILM-COATED TABLETS 10MG/20MG [SIN17241P]

Product Info

OPSYNVI FILM-COATED TABLETS 10MG/20MG

[SIN17241P]

Indication

Indications

OPSYNVI® is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 inhibitor (PDE5i) indicated for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II–III.

Dosing

Dosage and Administration

Dosage – Adults 18 years of age and older

The recommended maintenance dose of OPSYNVI®, as a single-tablet combination therapy, is one 10 mg/40 mg tablet taken once daily.

For patients who are treatment naïve to any PAH specific therapy

The recommended starting dose of OPSYNVI® is one 10 mg/20 mg tablet taken orally once daily for one week. If tolerated, up titrate OPSYNVI® to one 10 mg/40 mg tablet taken orally once daily as the maintenance dose.

For patients transitioning from ERA monotherapy

The recommended starting dose of OPSYNVI® is one 10 mg/20 mg tablet taken orally once daily for one week. If tolerated, up titrate OPSYNVI® to one 10 mg/40 mg tablet taken orally once daily as the maintenance dose.

For patients transitioning from PDE5i monotherapy

The recommended dose of OPSYNVI® is one 10 mg/40 mg tablet taken orally once daily.

For patients on therapeutic dose of ERA and PDE5i as separate tablets

The recommended dose of OPSYNVI® is one 10 mg/40 mg tablet taken orally once daily.

For patients who are currently treated with 10 mg macitentan and 20 mg tadalafil as separate tablets

The recommended dose of OPSYNVI® is one 10 mg/20 mg tablet taken orally once daily.

Special populations

Pediatrics (17 years of age and younger)

The safety and efficacy of OPSYNVI® have not been established in children and adolescent patients aged 17 years and younger.

Elderly (65 years of age and older)

No dose adjustment is required in patients over the age of 65 years.

Renal impairment

The use of OPSYNVI® is not recommended in patients undergoing dialysis. Avoid use of OPSYNVI® in patients with severe renal impairment because of increased tadalafil exposure (AUC), lack of clinical experience and the lack of ability to influence clearance by dialysis.

For patients with mild to moderate renal impairment, the recommended dose should be consistent with the adult dosing (see Dosage – Adults 18 years of age and older).

Hepatic impairment

OPSYNVI® was not studied in severe hepatic impairment patients defined as a Model for End-Stage Liver Disease score ≥19. OPSYNVI® is contraindicated in patients with severe hepatic impairment, with or without cirrhosis (Child-Pugh Class C), or clinically significant elevated hepatic aminotransferases greater than 3 times the Upper Limit of Normal (> 3 × ULN).

For patients with mild to moderate hepatic impairment (Child Pugh Class A or B), the recommended dose should be consistent with the adult dosing (see Dosage – Adults 18 years of age and older).

Missed dose

If a dose of OPSYNVI® is missed, the tablet should be taken as soon as the patient remembers. Otherwise, advise the patient to skip the dose and take the next dose at the regular time. The patient should be advised not to take 2 doses on the same day to make up for a missed dose.

Administration

OPSYNVI® should be taken orally once daily with or without food. The film-coated tablets must be swallowed whole, with water, and must not be chewed, divided or crushed.

Contraindications

Contraindications

OPSYNVI® is contraindicated:

• In women who are or may become pregnant.

• In breastfeeding women.

• In patients with severe hepatic impairment with or without cirrhosis (Child-Pugh Class C), or clinically significant elevated hepatic aminotransferases greater than 3 times the upper limit of normal (> 3×ULN).

• In patients who are hypersensitive to the active substance or to any of the excipients listed (see List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• In patients who had acute myocardial infarction within the last 90 days.

• In patients with severe hypotension (< 90/50 mmHg).

• In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of OPSYNVI® to patients who are using any form of organic nitrate is contraindicated.

• When co-administered with guanylate cyclase stimulators, such as riociguat, as it may potentially lead to symptomatic hypotension.

• In patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.