{ "query": "vericiguat", "ingredient": "vericiguat", "slug": "vericiguat", "rxcui": "2475830", "brands": [ "Verquvo" ], "names": [ "vericiguat" ], "classes": [], "alternatives": [], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 1 }, "boxed_warning": "WARNING: EMBRYO-FETAL TOXICITY 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 VERQUVO to a pregnant female because it may cause fetal harm [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Do not administer VERQUVO to a pregnant female because it may cause fetal harm. ( 4 , 5.1 , 8.1 ) 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. ( 2.2 , 5.1 , 8.3 )", "indications_and_usage": "\u00ae is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14) ] . VERQUVO is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. ( 1 )", "contraindications": "is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Drug Interactions (7.1) ] . VERQUVO is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. ( 4 , 7.1 ) Pregnancy ( 4 )", "warnings_and_cautions": "5.1 Embryo-Fetal Toxicity Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose [see Dosage and Administration (2.2) and Use in Specific Populations (8.1 , 8.3) ].", "warnings": "", "adverse_reactions": "Most common adverse reactions reported in \u22655% are hypotension and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VERQUVO was evaluated in VICTORIA, which included 2,519 patients treated with VERQUVO (up to 10 mg once daily). The mean duration of VERQUVO exposure was 1 year, and the maximum duration was 2.6 years [see Clinical Studies (14) ] . Table 1 lists adverse drug reactions occurring more commonly with VERQUVO than placebo and in \u22655% of patients treated with VERQUVO in VICTORIA. Table 1: Adverse Drug Reactions Occurring with VERQUVO in VICTORIA Adverse Drug Reaction VERQUVO % N = 2,519 Placebo % N = 2,515 Hypotension 16 15 Anemia 10 7 VELOCITY The safety and tolerability of VERQUVO 5 mg once daily as a starting dose was evaluated in VELOCITY, a single-arm, open-label, 2-week study ...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Dosage and Administration ( 2.1 ) 01/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Dosing Instructions 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. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for one month after the final dose [see Contraindications (4) , Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Pregnancy Advise women who are exposed to VERQUVO during pregnancy to report their pregnancy to their healthcare provider. Health care providers should report any prenatal exposure to VERQUVO by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. [See Use in Specific Populations (8.1) ]. Lactation Advise women not to breastfeed during treatment with VERQUVO [see Use in Specific Populations (8.2) ] .", "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 07/2023 MEDICATION GUIDE VERQUVO \u00ae (ver-KYU-voh) (vericiguat) tablets What is the most important information I should know about VERQUVO? VERQUVO may cause birth defects if taken during pregnancy. Females must not be pregnant when they start taking VERQUVO. Females who are able to get pregnant: Your healthcare provider will do a pregnancy test to make sure that you are not pregnant before you start taking VERQUVO. You must use effective forms of birth control during treatment and for 1 month after you stop treatment with VERQUVO. Talk to your healthcare provider about forms of birth control that you may use to prevent pregnancy during treatment with VERQUVO. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with VERQUVO. There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Patients should report any exposure to VERQUVO during pregnancy by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. What is VERQUVO? VERQUVO is a prescription medicine used in ad...", "clinical_studies": "was a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multi-center trial comparing VERQUVO and placebo in 5,050 adult patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) and left ventricular ejection fraction (LVEF) less than 45% following a worsening heart failure event. A worsening heart failure event was defined as heart failure hospitalization within 6 months before randomization or use of outpatient IV diuretics for heart failure within 3 months before randomization. Patients were randomized to receive VERQUVO 10 mg or matching placebo. VERQUVO was initiated at 2.5 mg once daily and increased at approximately 2 week intervals to 5 mg once daily and the target dose of 10 mg once daily, as tolerated. Placebo doses were similarly adjusted. After approximately 1 year, 90% of patients in both treatment groups were treated with the 10 mg target dose. The primary endpoint was a composite of time to first event of CV death or hospitalization for heart failure. The median follow-up for the primary endpoint was 11 months. The population was 64% Caucasian, 22% Asian, and 5% Black. The mean age was 67 years and 76% we...", "brand_name": "VERQUVO", "manufacturer": "Merck Sharp & Dohme LLC", "application_number": "NDA214377", "pharm_class_epc": [ "Soluble Guanylate Cyclase Stimulator [EPC]" ], "route": [ "ORAL" ], "effective_time": "20260121", "set_id": "17056d73-1b1b-4bf2-9c07-b7a9367f0d6d", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 961, "serious": 480, "death": 148, "hospitalization": 239, "primary_suspect": 958, "top_reactions": [ [ "Hypotension", 111 ], [ "Death", 95 ], [ "Cardiac Failure", 70 ], [ "Dizziness", 68 ], [ "Product Dose Omission Issue", 54 ], [ "No Adverse Event", 49 ], [ "Blood Pressure Decreased", 40 ], [ "Anaemia", 38 ], [ "Fatigue", 37 ], [ "Malaise", 34 ], [ "Dyspnoea", 33 ], [ "Nausea", 31 ], [ "Asthenia", 29 ], [ "Diarrhoea", 29 ], [ "Product Use Issue", 28 ] ], "by_year": { "2021": 114, "2022": 218, "2023": 213, "2024": 177, "2025": 181, "2026": 58 }, "by_year_primary": { "2021": 114, "2022": 218, "2023": 212, "2024": 176, "2025": 181, "2026": 57 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 3, "nda": 1, "anda": 0, "first_approval": "20210119", "rems": false, "rems_last": "", "labeling_supplements": 2, "labeling_recent": 2, "sponsors": [ "CHANGZHOU PHARMACEUTICAL FACTORY", "MSD", "TORRENT PHARMACEUTICALS LTD" ], "unapproved": false, "first_approval_fmt": "01/19/2021" }, "trials": { "total": 51, "completed": 27, "terminated": 0, "with_results": 8, "industry": 31, "phase3": 3, "results_share": 0.2962962962962963, "terminated_share": 0.0 }, "pubmed": { "rct": 37, "meta": 13, "recent_rct": 32, "cochrane": [] }, "payments": { "year": "2024", "usd": 1685873.51, "records": 40813, "by_name": [ [ "Verquvo", 1685873.51 ] ], "names_checked": [ "vericiguat", "Verquvo" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 49590, "beneficiaries": 11127, "spend": 49680166.72, "by_brand": [ { "brand": "Verquvo", "claims": 49590, "per_claim": 1001.818244, "is_generic": false } ], "per_claim": 1001.8182440008065 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 68, "letter": "C", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "Death appears in 1.7x the share of reports seen across all of FAERS (-2)" ], "weight": 0.35 }, "evidence": { "score": 34, "letter": "F", "why": [ "37 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 30% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 81, "letter": "B", "why": [ "No recalls on record since 2016", "2 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)", "Approved within the last 5 years: long-term safety is not yet known (-10)" ], "weight": 0.15 }, "conflict": { "score": 70, "letter": "C", "why": [ "Pharma paid doctors $1,685,874 tied to this drug last year (-30)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 40, "letter": "F", "why": [ "No generic version approved: brand-only pricing (-30)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 59, "grade": "D", "questions": [ "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are hypotension, death, cardiac failure, dizziness. How would we recognize and handle those?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }