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VERQUVO is a brand name for Vericiguat, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VERQUVO (vericiguat) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or intravenous diuretic therapy. VERQUVO should be used in combination with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • VERQUVO should be initiated under the supervision of a healthcare professional who is experienced in the management of heart failure (HF). • Before starting VERQUVO, patients must be clinically stabilized and managed with standard of care HF therapies after their HF decompensation event (see 14 CLINICAL TRIALS).
Particularly, care should be taken to optimize volume status and diuretic therapy, and provide a sufficient stabilization period in order to maximize benefit from VERQUVO (see 7 WARNINGS AND PRECAUTIONS, General). • Treatment should not be initiated in patients with systolic blood pressure <100 mmHg (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
VERQUVO® (vericiguat) Page 5 of 31 • Careful consideration should be given whether to initiate VERQUVO in patients with markedly elevated NT-proBNP levels (see 7 WARNINGS AND PRECAUTIONS, General). 2 Breast-feeding). 3 Pharmacokinetics, Absorption).
• Double the dose of VERQUVO approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. 5 mg interrupt treatment. • The maximum recommended dose of VERQUVO is 10 mg once daily. 1 Pediatrics).
3 Pharmacokinetics, Special Populations and Conditions). 73m2 (without dialysis). 3 Pharmacokinetics - Special Populations and Conditions, Renal Insufficiency). Hepatic Impairment No dose adjustment of VERQUVO is required in patients with mild or moderate hepatic impairment.
3 Pharmacokinetics - Special Populations and Conditions, Hepatic Insufficiency). 4 Administration For oral use, one tablet per day, at approximately the same time each day. VERQUVO should be taken with food. 3 Pharmacokinetics, Absorption).
VERQUVO® (vericiguat) Page 6 of 31 Information about excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take VERQUVO. Sodium VERQUVO contains less than 25 mg of sodium per tablet, which is considered low sodium and suitable for restricted sodium diets.
5 Missed Dose If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose. Patients should not take two doses of VERQUVO on the same day.
1 Adverse Reaction Overview The safety of VERQUVO in adult patients with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event was evaluated in one pivotal phase 3 study (VICTORIA).
8% of patients receiving placebo in the VICTORIA trial. 2 Clinical Trial Adverse Reactions). 6% of patients receiving VERQUVO vs. 7% of patients receiving VERQUVO vs. 0% of patients receiving placebo). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The safety population of the VICTORIA study, a phase 3 randomized, placebo-controlled, double-blind, clinical trial in adult patients with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event, included a total of 2,519 patients treated with VERQUVO (up to 10 mg once-daily) and 2,515 patients treated with matching placebo (see 14 CLINICAL TRIALS).
6 years. Table 2 lists adverse drug reactions occurring ≥ 1% in patients treated with VERQUVO and greater than placebo in VICTORIA. 1% of placebo-treated patients. Events were generally manageable and rarely led to treatment discontinuation.
A greater proportion of hematocrit and hemoglobin decrease was observed in patients receiving VERQUVO treatment compared to placebo (Table 3). 9% of patients receiving placebo. 0% in patients receiving placebo. 5% of placebo-treated patients.
Event rates were highest during the first 4 months following treatment initiation. In patients receiving VERQUVO, hypotension events were mostly mild or moderate in intensity and generally manageable. 3% in patients receiving placebo.
, General). • Treatment should not be initiated in patients with systolic blood pressure <100 mmHg (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). VERQUVO® (vericiguat) Page 5 of 31 • Careful consideration should be given whether to initiate VERQUVO in patients with markedly elevated NT-proBNP levels (see 7 WARNINGS AND PRECAUTIONS, General).
2 Breast-feeding). 3 Pharmacokinetics, Absorption). • Double the dose of VERQUVO approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. 5 mg interrupt treatment. • The maximum recommended dose of VERQUVO is 10 mg once daily.
1 Pediatrics). 3 Pharmacokinetics, Special Populations and Conditions). 73m2 (without dialysis). 3 Pharmacokinetics - Special Populations and Conditions, Renal Insufficiency). Hepatic Impairment No dose adjustment of VERQUVO is required in patients with mild or moderate hepatic impairment.
3 Pharmacokinetics - Special Populations and Conditions, Hepatic Insufficiency). 4 Administration For oral use, one tablet per day, at approximately the same time each day. VERQUVO should be taken with food. 3 Pharmacokinetics, Absorption).
VERQUVO® (vericiguat) Page 6 of 31 Information about excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take VERQUVO. Sodium VERQUVO contains less than 25 mg of sodium per tablet, which is considered low sodium and suitable for restricted sodium diets.
5 Missed Dose If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose. Patients should not take two doses of VERQUVO on the same day. 5 OVERDOSAGE Limited data are available with regard to overdosage in patients treated with VERQUVO.
In VICTORIA, doses up to 10 mg have been studied. In the event of an overdose, hypotension may result. Symptomatic treatment should be provided. VERQUVO is unlikely to be removed by hemodialysis because of high protein binding. For management of a suspected drug overdose, contact your regional poison control centre.
1 Serious Drug Interactions). • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Events associated with hypotension such as dizziness and syncope were more frequent in patients receiving VERQUVO in comparison to placebo. However, falls and subsequent fractures, showed no difference between the treatment groups. 3 Less Common Clinical Trial Adverse Reactions In the VICTORIA study, adverse events referring to hepatic disorders (regardless of causality) were observed with a frequency of less than 1% and at a higher frequency in the VERQUVO arm compared to placebo.
1% placebo). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Table 3 shows laboratory test abnormalities reported in ≥ 1% of patients treated with VERQUVO. 5 Post-Market Adverse Reactions Not applicable.
5” on one side and “VC” on the other side. VERQUVO 5 mg film-coated tablets Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, debossed with “5” on one side and “VC” on the other side. VERQUVO 10 mg film-coated tablets Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, debossed with “10” on one side and “VC” on the other side.
VERQUVO is available in blisters of 14, 28, or 98 tablets. 5 mg, 5 mg, 10 mg Tablets: cellulose microcrystalline, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, and sodium laurilsulfate. Film coating: hypromellose, talc, and titanium dioxide (E171).
The film-coat for the 5 mg tablet also contains ferric oxide red (E172). The film- coat for the 10 mg tablet also contains ferric oxide yellow (E172). 1 Dosing Considerations), particularly patients with markedly elevated NT- proBNP levels.
Among VICTORIA trial patients who were hospitalized as part of their HF worsening index event, a greater reduction of cardiovascular death risk was associated with longer stabilization periods between index event and start of VERQUVO therapy.
Patients with markedly elevated NT-proBNP Predefined subgroup analyzes of the VICTORIA clinical trial suggest that treatment with VERQUVO increases cardiovascular mortality and the risk of hospitalization for heart failure if initiated in patients with markedly elevated NT-proBNP levels (see 14 CLINICAL TRIALS).
Cardiovascular Symptomatic Hypotension VERQUVO may cause symptomatic hypotension. 2 Clinical Trial Adverse Reactions). VERQUVO has not been studied in patients with systolic blood pressure (SBP) less than 100 mmHg or symptomatic […]