Velphoro Adverse Reactions

Summary of the safety profile: The current safety profile of Sucroferric Oxyhydroxide (Velphoro) is based on a total of 778 patients on haemodialysis and 57 patients on peritoneal dialysis, who received Sucroferric Oxyhydroxide (Velphoro) treatment of up to 55 weeks.
In these clinical trials, approximately 43 % of the patients experienced at least one adverse reaction during Sucroferric Oxyhydroxide (Velphoro) treatment, and 0.36 % of the adverse reactions were reported as serious. The majority of the adverse drug reactions (ADRs) reported from trials were gastrointestinal disorders, with the most frequently reported ADRs 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 ADR profile of Sucroferric Oxyhydroxide (Velphoro).
Tabulated list of adverse reactions: ADRs reported from the use of Sucroferric Oxyhydroxide (Velphoro) at doses from 250 mg iron/day to 3,000 mg iron/day in these patients (n=835) are listed in Table. (See table.)

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Pediatric Population: The safety profile of Velphoro in pediatric (2 to <18 years of age) and adult patients was comparable. The adverse reactions most frequently reported were gastrointestinal disorders including diarrhea (very common, 16.7%), vomiting (common, 6.1%), gastritis (common, 3.0%) and discolored feces (common, 3.0%).
ADR Reporting Statement: 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.