Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile

The current safety profile of Velphoro is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received sucroferric oxyhydroxide treatment of up to 55 weeks.

In these clinical trials, approximately 43% of the patients experienced at least one adverse reaction during Velphoro treatment, and 0.36% of the adverse reactions were reported as serious. The majority of the adverse reactions reported from trials were gastrointestinal disorders, with the most frequently reported adverse reactions being diarrhoea and discoloured faeces (very common). The vast majority of these gastrointestinal disorders occurred early during treatment and abated with time with continued dosing. No dose-dependent trends were observed in the adverse reactions profile of Velphoro.

Tabulated list of adverse reactions

Adverse reactions reported from the use of Velphoro at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table 1.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).


Table 1      Adverse reactions detected in clinical trials

System organ class              Very common                Common                   Uncommon 
Metabolism and nutrition                                                          Hypercalcaemia disorders                                                                         Hypocalcaemia Nervous system disorders                                                             Headache Respiratory, thoracic and                                                            Dyspnoea mediastinal disorders
Gastrointestinal disorders       Diarrhoea*                 Nausea              Abdominal distension Faeces                Constipation                  Gastritis discoloured               Vomiting            Abdominal discomfort
Dyspepsia                  Dysphagia
Abdominal pain           Gastro-oesophageal
Flatulence           reflux disease (GORD)
Tooth discolouration     Tongue discolouration
Skin and subcutaneous                                                                 Pruritus tissue disorders                                                                       Rash General disorders and                              Product taste abnormal              Fatigue administration site conditions

Description of selected adverse reactions

*Diarrhoea
Diarrhoea occurred in 11.6% of patients in clinical trials. In the 55 weeks long term studies, the majority of these diarrhoea adversereactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.

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/