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DOSING AND ADMINISTRATION

OPSYNVI® Contains 2 Proven Therapies in 1 Tablet1-3

Titrating OPSYNVI® (macitentan/tadalafil)1

For patients who are treatment naïve to any PAH therapy or transitioning from ERA monotherapy1

Starting dose:

1 OPSYNVI® 10 mg/20 mg tablet

once daily for 1 week

If tolerated, up-titrate to

1 OPSYNVI® 10 mg/40 mg tablet

once daily

For patients who are transitioning from a stable-dose PDE5i monotherapy or ERA + PDE5i loose-dose combinations1

No titration needed

Start with

1 OPSYNVI® 10 mg/40 mg tablet

once daily

  • Obtain a pregnancy test in females of reproductive potential prior to OPSYNVI® treatment, monthly during treatment, and one month after stopping OPSYNVI®. Initiate treatment with OPSYNVI® in females of reproductive potential only after a negative pregnancy test

1 once-daily tablet

  • OPSYNVI® can be administered with or without food
  • Tablets should not be cut, crushed, or chewed
  • 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 missed
  • The use of OPSYNVI® is not recommended in patients undergoing dialysis. Avoid use of OPSYNVI® in patients with severe renal impairment
  • 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)

Drug Interactions1

MedicationEffect
Nitrates
  • Administration of nitrates within 48 hours after the last dose of OPSYNVI® is contraindicated
Strong inducers of CYP3A4 (eg, rifampin)
  • Significantly reduce macitentan exposure
  • Use of OPSYNVI® with strong CYP3A4 inducers should be avoided
Strong CYP3A4 inhibitors (eg, ketoconazole)
  • 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)
  • 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
  • PDE5i, including tadalafil, are mild systemic vasodilators
  • In pharmacology studies, small reductions in blood pressure occurred following coadministration of tadalafil with selected antihypertensive medications* vs placebo
Alcohol
  • Both alcohol and tadalafil are mild vasodilators
  • 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
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*

Selected antihypertensive medications include amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol.

CYP=cytochrome P450; ERA=endothelin receptor antagonist; PAH=pulmonary arterial hypertension; PDE5i=phosphodiesterase type 5 inhibitor; ULN=upper limit of normal.

References: 1. OPSYNVI® (macitentan/tadalafil) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Galie N, Brundage BH, Ghofrani HA, et al; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009;119(22):2894-2903. 3. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818 and suppl 1-21. doi:10.1056/NEJMoa1213917

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To report suspected adverse reactions, contact Johnson & Johnson at 1-800-526-7736,
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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