Product Overview
[Drug Name]
Generic Name: Vericigum Tablets
Trade Name: Vicotong Vericigum Tablets 2.5mg x 14 Tablets
[Main Ingredients]
The main ingredient of this product is Vericigum. Chemical Name: Methyl {4,6-diamino-2-[5-fluoro-1-[(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl)carbamate. Molecular Formula:
C₁₆H₁₆F₂N₁₆O₂. Molecular Weight: 426.39 g/mol
[Properties]
This product is a round, biconvex white film-coated tablet (2.5mg), brownish-red film-coated tablet (5mg), or orange-yellow film-coated tablet (10mg). One side is engraved with "2.5," "5," or "10," respectively, and the other side is engraved with "VC." The tablet appears white or off-white after removal of the coating.
[Indications/Main Functions]
Indicated for use in adult patients with symptomatic chronic heart failure (HF) with reduced ejection fraction (EF <45%) who have recently decompensated HF and whose condition has stabilized on intravenous therapy, to reduce the risk of hospitalization for HF or the need for emergency intravenous diuretic therapy.
[Specifications]
2.5 mg x 14 tablets
[Dosage and Administration]
The recommended starting dose is 2.5 mg once daily, taken with food. Double the dose approximately every two weeks and adjust to an appropriate maintenance dose based on patient tolerance. The maximum maintenance dose should not exceed 10 mg once daily. If patients experience tolerability issues (symptomatic hypotension or SBP <90 mmHg), a temporary dose reduction or discontinuation of Vericipaguat is recommended. For patients who are unable to swallow the tablet whole, crush the tablet and mix with water before taking immediately. Before starting treatment with Vericipaguat, perform a pregnancy test on females of childbearing potential (see [Warnings]). If a dose is missed, it should be taken as soon as the patient remembers on the day of the missed dose. Patients should not take two doses of Vericipiguat tablets on the same day. Eligible patients should be selected for treatment with this product based on information from the international multicenter study (VICTORIA) under the Clinical Trials section of the labeling.
[Contraindications]
This product is contraindicated in patients taking other soluble guanylate cyclase (sGC) stimulators (see Drug Interactions). This product is contraindicated in pregnant women (see Warnings).
[Precautions]
Vericipiguat may cause symptomatic hypotension (see Adverse Reactions). Studies have not been conducted in patients with an SBP < 100 mmHg at the start of treatment or with pre-existing symptomatic hypotension. The possibility of symptomatic hypotension should be considered in patients with hypovolemia, severe left ventricular outflow tract obstruction, resting hypotension, autonomic dysfunction, a history of hypotension, or concomitant treatment with antihypertensive drugs or organic nitrates (see Drug Interactions). If patients experience tolerability issues (symptomatic hypotension or SBP <90 mmHg), a temporary dose reduction or discontinuation of Vericipigat is recommended (see [Dosage and Administration]). Vericipigat has not been studied in combination with phosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil) in patients with heart failure and is not recommended in such patients due to the potential increased risk of symptomatic hypotension (see [Drug Interactions]). Renal Impairment: Vericipigat has not been studied in patients with an eGFR <15 mL/min/1.73 m2 at initiation of treatment or those on dialysis; therefore, treatment with Vericipigat is not recommended in these patients (see [Pharmacokinetics]). Hepatic Impairment: Vericipigat has not been studied in patients with severe hepatic impairment; therefore, treatment with Vericipigat is not recommended in these patients (see [Pharmacokinetics]). Excipient: Lactose: This product contains lactose. Patients with the rare congenital conditions of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use this product. Sodium: The sodium content in each tablet of this product is <1mmol (23mg), which means it is basically "sodium-free".
