Safety and tolerability profile
PrVELPHORO® has a well-established safety and tolerability profile
Treatment-related treatment-emergent adverse events (TR-TEAEs) with incidence >5% in combined data from 6-week and 55-week pivotal studies1
- The majority of the ADRs reported from trials were gastrointestinal disorders.
- Diarrhea was also very common; however, the majority of these events were mild and transient, occurring soon after initiation of treatment and resolving with continued treatment.
- As expected with oral preparations containing iron, discoloured feces were very common.
- Changes in iron parameters during treatment with VELPHORO were consistent with a minimal level of iron absorption.
- No safety signals were detected with respect to clinical chemistry, hematological, or vitamin levels.
- Patients with peritonitis, significant gastric disorders and patients who have had major gastrointestinal surgery were not included in clinical studies with VELPHORO. VELPHORO should only be used in these patients if the benefits outweigh the risks.
- VELPHORO can cause discoloured (black) stool, which may visually mask gastrointestinal bleeding.
- Reference:
- 1. VELPHORO Product Monograph. Otsuka Canada Pharmaceutical Inc.