Capazi Tablet

Capazi 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%.

Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, and cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

Recommended Starting Dose: The recommended starting dose of Vericiguat is 2.5 mg orally once daily with food. Double the dose of Vericiguat approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. For patients who are unable to swallow whole tablet, Vericiguat may be crushed and mixed with water immediately before administration or as directed by physician.

Geriatric Patients: No dosage adjustment of Vericiguat is required in geriatric patients. No overall differences in safety or efficacy of Vericiguat were observed between patients aged 65 years and older compared to younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: No dosage adjustment of Vericiguat is recommended in patients with mild or moderate hepatic impairment.

Renal Impairment: No dosage adjustment of Vericiguat is recommended in patients with estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m2 who are not on dialysis. Vericiguat has not been studied in patients with eGFR <15 mL/min/1.73m2 at treatment initiation or on dialysis.

Use in Children & Adolescents: Safety and effectiveness of Vericiguat have not been established in pediatric patients.

Other Soluble Guanylate Cyclase Stimulators: Capazi is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.

PDE-5 Inhibitors: Concomitant use of Capazi with PDE-5 inhibitors is not recommended because of the potential for hypotension.

With food & others: Capazi should be taken with food. The absolute bioavailability of Capazi is 93% when taken with food.

Vericiguat is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.

Common Side effects: The most common side effects of Capazi tablet include low blood pressure & low red blood cells (Anemia).

Pregnancy: Vericiguat is contraindicated in pregnancy because it may cause fetal harm. 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.

Nursing Mothers: There are no data on the presence of Vericiguat in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from Vericiguat, women should be advised not to breastfeed during treatment with Vericiguat.

Capazi should not be administered to a pregnant female because it may cause fetal harm. Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Capazi. Pregnancy should be excluded 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.

Limited data are available with regard to overdosage in human patients treated with Capazi. Doses up to 10 mg have been studied. In a study of patients with preserved ejection fraction heart failure (left ventricular ejection fraction ≥45%), multiple doses of Capazi 15 mg have been studied and were generally well tolerated. In the event of an overdose, hypotension may result. Symptomatic treatment should be provided. Capazi is unlikely to be removed by hemodialysis because of high protein binding.

Stimulator of soluble guanylate cyclase

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.