Dosage and Administration

OPSYNVI^® Contains 2 Proven Therapies in 1 Tablet^1,2

OPSYNVI^® reduces pill count and may help reduce costs compared with separate ERA and PDE5i prescriptions^1-7

With a once-daily tablet, OPSYNVI^® (macitentan/tadalafil) delivers guideline-recommended macitentan and tadalafil.^1,2

How many tablets do you think patients may take in a single week with separate ERA and PDE5i prescriptions?

UP TO

0PILLS

PER DAYPER WEEK

ERA + sildenafil 20 mg

4 to 13 tablets daily, in 3 divided doses^3,4

UP TO13PILLS

UP TO91PILLS

ERA + tadalafil 20 mg

3 tablets, once daily^3,5

UP TO3PILLS

UP TO21PILLS

OPSYNVI® maintenance dose—

1 once-daily macitentan 10 mg/tadalafil 40 mg tablet¹

UP TO1PILL

UP TO7PILLS

OPSYNVI® is priced the same as OPSUMIT® (macitentan)^6*†

Avoid the added cost of a separate PDE5i prescription⁷

Combination therapy with a single prescription

OPSYNVI® is the first and only US FDA-approved single-tablet combination of 2 recommended treatments for PAH^1,8

For females of reproductive potential, exclude pregnancy prior to initiation of therapy and ensure use of effective contraceptive methods prior to the initiation of treatment, during treatment, and for 1 month after discontinuation¹
1 once-daily tablet
- OPSYNVI® can be administered with or without food¹
- Tablets should not be cut, crushed, or chewed¹
- If the patient misses a dose of OPSYNVI®, tell the patient to take it as soon as possible and then take the next dose at the regularly scheduled time. Tell the patient not to take 2 doses at the same time if a dose has been missed¹
The use of OPSYNVI® is not recommended in patients undergoing dialysis. Avoid use of OPSYNVI® in patients with severe renal impairment¹
OPSYNVI® was not studied in patients with severe hepatic impairment. OPSYNVI® must not be initiated in patients with severe hepatic cirrhosis (Child-Pugh class C) or clinically significant elevated hepatic aminotransferases (>3 x ULN)¹

Medication¹

Effect¹

Nitrates

Administration of nitrates within 48 hours after the last dose of OPSYNVI^® is contraindicated

Strong inducers of CYP3A4 (eg, rifampin)

Strong CYP3A4 inhibitors (eg, ritonavir, ketoconazole, and itraconazole)

Increase macitentan and tadalafil exposure
Avoid concomitant use of OPSYNVI^® with strong CYP3A4 inhibitors such as ritonavir, ketoconazole, and itraconazole
Use other PAH treatment options when strong CYP3A4 inhibitors are needed

Moderate dual or combined inhibitors of CYP3A4 and CYP2C9 (eg, fluconazole and amiodarone)

Predicted to increase macitentan exposure 4-fold
Concomitant use of OPSYNVI^® with moderate dual inhibitors of CYP3A4 and CYP2C9 should be avoided
Concomitant use of OPSYNVI^® with both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor should also be avoided

Alpha-blockers

PDE5 inhibitors, including tadalafil and alpha-blockers, are both vasodilators with blood pressure–lowering effects
Concomitant administration of alpha-blockers and tadalafil may lead to symptomatic hypotension
Combination of OPSYNVI^® with doxazosin is not recommended

Antihypertensives

PDE5 inhibitors, including tadalafil, are mild systemic vasodilators with blood pressure–lowering effects
In pharmacology studies, small reductions in blood pressure occurred following coadministration of tadalafil with selected antihypertensive medications‡ vs placebo

Alcohol

Mild vasodilator, like tadalafil
When taken in combination, blood pressure-lowering effects of each individual compound may increase
Substantial consumption of alcohol (ie, ≥5 units) in combination with OPSYNVI^® can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache
Tadalafil (10 mg or 20 mg) did not affect alcohol plasma concentrations, and alcohol did not affect tadalafil plasma concentrations

Explore the A DUE trial

and how OPSYNVI® offered greater reductions in PVR vs monotherapy¹