Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer vericiguat to a pregnant female because it may cause fetal harm.
Heart failure with reduced ejection fraction (adjunctive agent):
Note: May be considered for additional therapy in patients who are persistently symptomatic despite an optimal medical regimen for heart failure with reduced ejection fraction. In the clinical trial, patients who were concurrently using or anticipated to use long-acting nitrates or a PDE-5 inhibitor (eg, sildenafil) were excluded due to potential for additive hypotensive effects (Armstrong 2020).
Oral: Initial: 2.5 mg once daily with food; double the dose every ≥2 weeks to a target maintenance dose of 10 mg once daily as tolerated based on BP and clinical symptoms (Armstrong 2020). The following can be used as a guide for upward and downward titration:
Systolic BP ≥100 mm Hg: Consider dose up-titration if not already on 10 mg target dose; maintain dose if already on 10 mg target dose (Armstrong 2020).
Systolic BP ≥90 and <100 mm Hg: Maintain current dose (Armstrong 2020).
Systolic BP <90 mm Hg: Decrease dose (eg, if current dose is 5 or 10 mg) or interrupt therapy (eg, if current dose is 2.5 mg or if patient has symptomatic hypotension) (Armstrong 2020).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR ≥15 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <15 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild to moderate hepatic impairment (Child-Pugh class A and B): No dosage adjustment necessary.
Severe hepatic impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Verquvo: 2.5 mg, 5 mg, 10 mg
No
Oral: Administer with food; for patients unable to swallow, tablets may be crushed and mixed with water immediately before administration.
Heart failure with reduced ejection fraction: To reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic heart failure and ejection fraction <45%.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Cardiovascular: Hypotension (16%)
1% to 10%:
Gastrointestinal: Dyspepsia (3%) (Armstrong 2020), nausea (4%) (Armstrong 2020)
Hematologic & oncologic: Anemia (10%)
Concomitant use of other soluble guanylate cyclase stimulators (eg, riociguat); pregnancy.
Concurrent drug therapy issues:
• Nitrates: In the clinical trial for heart failure with reduced ejection fraction, patients who had concurrent or anticipated use of long-acting nitrates (eg, isosorbide mononitrate, isosorbide dinitrate, transdermal nitroglycerin) were excluded. Coadministration of short-acting nitrates (eg, SL nitroglycerin spray for angina attacks) was allowed (Armstrong 2020).
• PDE-5 inhibitors: In the clinical trial for heart failure with reduced ejection fraction, patients who had concurrent or anticipated use of a PDE-5 inhibitor (eg, sildenafil) were excluded (Armstrong 2020).
Dosage form specific issues:
• Lactose: Formulation may contain lactose.
Substrate of BCRP/ABCG2, P-glycoprotein/ABCB1 (minor), UGT1A1, UGT1A9; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: Vericiguat may enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Riociguat: May enhance the adverse/toxic effect of Soluble Guanylate Cyclase Stimulators. Risk X: Avoid combination
Soluble Guanylate Cyclase Stimulators: May enhance the adverse/toxic effect of Vericiguat. Risk X: Avoid combination
Bioavailability is increased when taken with food. Management: Administer with food.
[US Boxed Warning]: Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for 1 month after stopping treatment.
Based on data from animal reproduction studies, in utero exposure to vericiguat may cause fetal harm.
[US Boxed Warning]: Do not administer vericiguat to a pregnant female because it may cause fetal harm. Use is contraindicated during pregnancy.
Health care providers should notify the manufacturer of pregnancies exposed to vericiguat (1-877-888-4231).
It is not known if vericiguat is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.
Daily weights, BP; negative pregnancy test prior to starting treatment.
Vericiguat enhances production of cyclic guanosine monophosphate (cGMP) by directly stimulating soluble guanylate cyclase (sGC) independent of nitric oxide (NO) and enhances sGC sensitivity to endogenous NO, thereby increasing cGMP production. Increased levels of cGMP lead to smooth muscle relaxation and vasodilation.
Distribution: Vd: ~44 L.
Protein binding: ~98%.
Metabolism: Primarily undergoes glucuronidation by UGT1A9 and, to a lesser extent, by UGT1A1, to form an inactive N-glucuronide metabolite.
Bioavailability: 93% when taken with food.
Half-life elimination: 30 hours.
Time to peak: 4 hours (with food); 1 hour (fasting state).
Excretion: Urine: ~53%; feces: 45% (primarily as unchanged drug).
Clearance: 1.6 L/hour.
Tablets (Verquvo Oral)
2.5 mg (per each): $24.48
5 mg (per each): $24.48
10 mg (per each): $24.48
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