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macitentan/tadalafil (Opsynvi)
Indications:
- pulmonary arterial hypertension
Contraindications:
- pregnancy
- lactation (do not breast feed)
- chronic renal failure stage 4 or 5
- severe hepatic impairment
*for all female patients, OPSYNVI is available only through Macitentan-Containing Products Risk Evaluation & Mitigation Strategy (REM), a restricted program.
Dosage:
- one tablet taken orally once daily with or without food
*
Tablets: 10 mg macitentan/20 mg tadalafil or 10 mg macitentan/40 mg tadalafil
Monitor:
- baseline serum transaminases & as clinically indicated
Adverse effects:
- most common >= 10%
- edema/fluid retention, anemia, headache/migraine
- macitentan
- hepatotoxicity
- decreased sperm count
- tadalafil
- hypotension
- non-arteritic ischemic optic neuropathy
- priapism
- hearing impairment
- other
- pulmonary edema due to pulmonary vaso-occlusive disease
Drug interactions:
- avoid use with other phosphodiesterase-5 inhibitors
- avoid use with strong CYP3A4 inhibitors & inducers
Mechanism of action:
- combination of macitentan, an endothelin receptor antagonist & tadalafil, a phosphodiesterase-5 inhibitor
- macitentan reduces risk of clinical worsening events & hospitalization
- tadalafil improves exercise ability
General
pharmacologic combination
References
- Lou N
Fixed-Dose Macitentan/Tadalafil Combo Gets FDA Approval for PAH.
Opsynvi puts two drugs commonly prescribed for pulmonary arterial hypertension
into one tablet.
MedPage Today March 25, 2024
https://www.medpagetoday.com/cardiology/prevention/109338
- HIGHLIGHTS OF PRESCRIBING INFORMATION
Opsynvi (macitentan and tadalafil) tablets, for oral use
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/OPSYNVI-pi.pdf
Components
macitentan (Opsumit)
tadalafil (Cialis, Adcirca, 'weekend Viagra')