VERARD
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VERARD (VERARD).
Verard (vericiguat) is a soluble guanylate cyclase (sGC) stimulator. It sensitizes sGC to endogenous nitric oxide (NO) and directly stimulates sGC independently of NO, thereby increasing cyclic guanosine monophosphate (cGMP) production, leading to vasodilation and anti-remodeling effects in the heart and vasculature.
| Metabolism | Primarily metabolized by UGT1A9 and to a lesser extent by UGT1A1; minor metabolism via CYP450 enzymes (CYP1A2, CYP2C8, CYP2C9, CYP3A4). |
| Excretion | Renal excretion (70% unchanged, 20% as inactive metabolites), biliary/fecal (10%). |
| Half-life | Terminal elimination half-life 12-15 hours; prolonged to 24-30 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | 95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8-1.2 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Oral: 60-70% (first-pass metabolism). |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 2-5 minutes. |
| Duration of Action | Oral: 8-12 hours; Intravenous: 4-6 hours. |
400 mg orally twice daily for 14 days
| Dosage form | UNKNOWN |
| Renal impairment | CrCl >=60 mL/min: 400 mg twice daily; CrCl 30-59 mL/min: 200 mg twice daily; CrCl 15-29 mL/min: 200 mg daily; CrCl <15 mL/min: not recommended |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B: 200 mg twice daily; Child-Pugh Class C: not recommended |
| Pediatric use | 2-12 years: 6 mg/kg orally twice daily for 14 days; >12 years: same as adult |
| Geriatric use | No specific adjustment required; monitor renal function and use lower end of dosing if CrCl <60 mL/min |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VERARD (VERARD).
| Breastfeeding | VERARD is excreted in human milk; M/P ratio = 0.85. Not recommended during breastfeeding due to potential adverse effects in the infant, including sedation and feeding difficulties. |
| Teratogenic Risk | VERARD (verardine) is contraindicated in pregnancy. First trimester: High risk of major congenital malformations, including neural tube defects and cardiac anomalies. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and neurodevelopmental impairment. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Concomitant use with phosphodiesterase-5 (PDE-5) inhibitors (e.g., sildenafil, tadalafil) due to risk of hypotension; concomitant use with soluble guanylate cyclase stimulators (e.g., riociguat); pregnancy (based on animal data).
| Precautions | Use not recommended in patients with severe renal impairment (eGFR <15 mL/min/1.73 m²) or on dialysis; monitor for hypotension, especially in patients with low systolic blood pressure or volume depletion; not recommended in patients with severe hepatic impairment (Child-Pugh C); contains lactose, avoid in patients with lactose intolerance. |
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| Monitor fetal growth by ultrasound every 4 weeks; assess amniotic fluid volume; conduct fetal heart rate monitoring after 28 weeks; maternal blood pressure and renal function monthly. |
| Fertility Effects | VERARD may impair female fertility by disrupting menstrual cycles and reducing ovarian reserve. Male fertility may be affected by decreased spermatogenesis. Reversible upon discontinuation. |