Verquvo Vericiguat Film-coated Tablets

1. Indications and Usage
Chronic Heart Failure (HF): Indicated for the treatment of adult patients with symptomatic chronic heart failure and a left ventricular ejection fraction (LVEF) of less than 45%.
It is used to reduce the risk of cardiovascular death and hospitalization for heart failure.
It is applicable to adult patients with symptomatic chronic heart failure who have recently experienced decompensated heart failure and have a stable condition after intravenous treatment with reduced ejection fraction (LVEF <45%), in order to reduce the risk of hospitalization for heart failure or the need for emergency intravenous diuretic treatment.
2. Dosage and Administration
Administration: Oral administration. Must be taken with food to ensure adequate absorption (bioavailability) .
Starting Dose: 2.5 mg once daily.
Titration: Increase the dose approximately every 2 weeks based on tolerability (blood pressure and clinical status) to the target maintenance dose.
Target Maintenance Dose: 10 mg once daily.
Missed Dose: Take as soon as possible on the same day with food. Do not take two doses on the same day. If a dose is missed, resume the normal schedule the next day.
Swallowing: Tablets may be crushed and mixed with water for patients who have difficulty swallowing .
3. Mechanism of Action
sGC Stimulator: Vericiguat is a soluble guanylate cyclase (sGC) stimulator.
Pathway: It directly stimulates sGC, independent of nitric oxide (NO), and also sensitizes sGC to endogenous NO. This leads to an increase in intracellular cyclic guanosine monophosphate (cGMP) levels.
Effect: Increased cGMP results in smooth muscle relaxation and vasodilation, as well as inhibition of vascular smooth muscle cell proliferation and hypertrophy .
4. Safety and Warnings
Hypotension: Symptomatic hypotension may occur. Monitor blood pressure, especially during dose titration. Not recommended for use with long-acting nitrates or PDE-5 inhibitors due to additive hypotensive effects 。
Embryo-Fetal Toxicity: Vericiguat may cause fetal harm. It is contraindicated in pregnancy. Women of childbearing potential must use effective contraception during treatment and for at least one month after the last dose 。
Contraindications:
Pregnancy.
Concomitant use with other sGC stimulators (e.g., riociguat, priciguat) .
5. Adverse Reactions
Most Common (≥5%): Hypotension and Anaemia .
Other Common Reactions: Dizziness, Headache, Nausea, Dyspepsia, Vomiting .
6. Drug Interactions
sGC Stimulators: Contraindicated with other sGC stimulators .
PDE-5 Inhibitors: Not recommended for concomitant use (e.g., sildenafil, tadalafil) due to the risk of severe hypotension 。
Long-acting Nitrates: Not recommended for concomitant use .
7. Pharmaceutical Information
Chemical Name: Methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzoyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}carbamate .
Molecular Formula: C19H16FN5O3 .
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep container tightly closed .