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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.
  • ADRs = adverse drug reactions.
  • Reference:
  • 1. VELPHORO Product Monograph. Otsuka Canada Pharmaceutical Inc.

Important Safety Information

MECHANISM OF ACTION

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EFFICACY DATA

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DOSING AND ADMINISTRATION

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Important Safety Information

  • Clinical use:
  • Efficacy and safety in pediatric population (<18 years of age) have not been evaluated.
  • No overall differences in safety or efficacy were observed between subjects ≥65 and younger subjects.
  • Contraindications:
  • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
  • Patients with hemochromatosis or any other iron accumulation disorders.
  • Relevant warnings and precautions:
  • Diabetes, hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase insufficiency
  • Caution in patients with gastrointestinal issues
  • VELPHORO may cause black stools which may mask gastrointestinal bleeding
  • Patients with hepatic/biliary/pancreatic disorders/disease
  • Monitoring and laboratory tests regarding serum phosphorus and iron
  • Pregnant or nursing women
  • Less common clinical trial or post-market adverse reactions:
  • In the 6-week and 55-week clinical studies, tooth discolouration and product taste were some of the less common (<1%), treatment-related treatment emergent adverse events reported in more than one patient.
  • Eosinophilic peritonitis has been listed in post-market spontaneous reports.
  • For more information:
  • Please consult the Product Monograph at http://velphoromonograph.ca for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-877-341-9245.
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  • All trademarks identified by a ® or a ™ are protected trademarks (registered or unregistered) of their owners or licensors.
  • For more information, please visit www.otsukacanadatm-mc.ca.
  • © Otsuka Canada Pharmaceutical Inc. All rights reserved.
  • OCPI-VPO-00210E
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