Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile

The most frequently reported adverse reaction under treatment with vericiguat was hypotension (16.4%).

Tabulated list of adverse reactions

The safety of vericiguat was evaluated in a phase III study (VICTORIA) which included a total of 2,519 patients treated with vericiguat (up to 10 mg once daily) (see section 5.1). The mean duration of vericiguat exposure was 1 year and the maximum duration was 2.6 years.

The adverse reactions reported with vericiguat obtained from clinical studies are listed in the table below by MedDRA system organ class and by frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000).

Table 1: Adverse reactions

MedDRA                       Very common                         Common system organ class
Blood and lymphatic                                              Anaemia system disorders
Nervous system                                                   Dizziness disorders                                                        Headache Vascular disorders           Hypotension
Gastrointestinal                                                 Nausea disorders                                                        Dyspepsia Vomiting
Gastro-oesophageal reflux disease

Description of selected adverse reactions

Hypotension
Over the course of the VICTORIA study, the mean reduction in systolic blood pressure was approximately 1 to 2 mmHg greater in patients who received vericiguat compared with placebo. In VICTORIA, hypotension was reported in 16.4% of vericiguat-treated patients compared with 14.9% of placebo-treated patients. This includes also orthostatic hypotension that was reported in 1.3% of vericiguat-treated patients compared with 1.0% of placebo-treated patients. Symptomatic hypotension was reported in 9.1% of vericiguat-treated and 7.9% of placebo-treated patients, and was considered as a serious adverse event in 1.2% of vericiguat-treated patients and 1.5% of placebo-treated patients (see section 4.4).



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Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/