TABLE 1.

Key prescribing information for vericiguat and differences amongst global health authorities (the FDA, the EMA, and the PMDA).

Topic	FDA Label	EMA Label	PMDA Label	Comment
Indication	To reduce the risk of cardiovascular death and HF hospitalization, following a hospitalization for HF or need for outpatient i.v. diuretics, in adults with symptomatic chronic HF and ejection fraction <45%	Treatment of symptomatic chronic HF in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring i.v.	Chronic HF (only in patients who are receiving standard treatment for chronic HF)	FDA label specifies ejection fraction <45% EMA label mentions target patient population to have been stabilized after decompensation events PMDA label is more general in terms of target population
Contraindications	Use of other sGC stimulators Pregnancy	Any medicine that contains another sGC stimulator	During treatment with any sGC stimulator	All three labels contraindicate concomitant use of other sGC stimulators. FDA label also specifies contraindication in pregnancy.
Dosage and administration	The recommended starting dose is 2.5 mg orally once daily with food. Double the dose every 2 weeks to reach the maintenance dose of 10 mg once daily, as tolerated by the patient.	Before starting vericiguat, optimize volume status and diuretic therapy to stabilize patients after a decompensation event, particularly in patients with very high NT‐proBNP levels. Treatment should not be initiated in patients with SBP <100 mmHg. If patients experience symptomatic hypotension or SBP <90 mmHg, temporary down‐titration or discontinuation is recommended.	The dose should be increased stepwise every 2 weeks to 5 mg, and then 10 mg once daily. Dose should be decreased as appropriate according to the patient's condition(s), such as blood pressure. In case of SBP <90 mmHg with hypotensive symptoms, dose should be interrupted.	EMA and PMDA labels mention down‐titration or dose interruption in case of hypotension; EMA label is very specific about not initiating therapy in patients with low SBP.
Warning and precautions	Embryo‐fetal toxicity	Healthcare provider should be consulted before taking vericiguat if patients have: Low blood pressure with symptoms like dizziness or light‐headedness Severe kidney problems or are on dialysis Severe liver problems	Hypotension is an important identified risk	FDA label focuses on potential reproductive harm, while PMDA and EMA labels focus on blood pressure‐related issues
Other	Not recommended for co‐administration with PDE5 inhibitors.	Not recommended for co‐administration with PDE5 inhibitors; not recommended in severe renal‐ or hepatic‐impaired patients	Administration of vericiguat should be judged carefully for severe hepatic‐ or renal‐impaired patients	FDA and PMDA labels do not explicitly discourage use in severe hepatic‐ or renal‐impaired patients

Abbreviations: EMA, European Medicines Agency; FDA, U.S. Food and Drug Administration; HF, heart failure; i.v., intravenous; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; PDE5, phosphodiesterase type 5; PMDA, Pharmaceuticals and Medical Devices Agency; SBP, systolic blood pressure; sGC, soluble guanylate cyclase.