Velphoro Adverse Reactions

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 Velphoro 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 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 Velphoro.
Tabulated list of adverse reactions: ADRs reported from use of Velphoro at doses from 250mg iron/day to 3,000mg iron/day in these patients (n=835) are listed in Table 2.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). (See Table 2.)

Click on icon to see table/diagram/image

Post-marketing Experience: The safety profile of Velphoro has been confirmed in the post-authorisation safety study (PASS) VERIFIE (see Pharmacology: Pharmacodynamics under Actions).