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Targeted active surveillance of branded generic deferasirox in pediatric thalassemia patients in a tertiary care hospital of India: A pharmacovigilance study (Record no. 133106)

MARC details
000 -LEADER
fixed length control field 02695nam a2200157 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 251029b |||||||| |||| 00| 0 eng d
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Panigrahi
245 ## - TITLE STATEMENT
Title Targeted active surveillance of branded generic deferasirox in pediatric thalassemia patients in a tertiary care hospital of India: A pharmacovigilance study
300 ## - PHYSICAL DESCRIPTION
Extent p 77-82
520 ## - SUMMARY, ETC.
Summary, etc. biblio.abstract <br/>Permissions<br/>Research Article<br/>Targeted active surveillance of branded generic deferasirox in pediatric thalassemia patients in a tertiary care hospital of India: A pharmacovigilance study<br/>Panigrahi, Mousumee; Swain, Trupti Rekha1; Jena, Rabindra Kumar2; Panigrahi, Ashutosh3; Debta, Nishant4<br/>Author Information<br/>Indian Journal of Pharmacology 57(2):p 77-82, Mar–Apr 2025. | DOI: 10.4103/ijp.ijp_88_23<br/>Open<br/>Abstract<br/>INTRODUCTION: <br/>Deferasirox is a newer oral iron chelator which needs to be given for at least 1 year to see a significant decrease in serum ferritin level in thalassemia patients with chronic iron overload. This study aimed to assess the safety profile of branded generic deferasirox in pediatric thalassemia cases, as it has not been studied in eastern India, especially in real-world settings.<br/><br/>SUBJECTS AND METHODS: <br/>It was an observational hospital-based study in a government tertiary care teaching hospital where branded generic deferasirox is distributed free of cost to patients. One hundred and seventy-four patients were included. Safety assessment was done through active questioning about the symptoms starting after deferasirox therapy and through laboratory parameters and clinical examination.<br/><br/>RESULTS: <br/>Sixty percent of patients developed adverse drug reactions (ADRs) with deferasirox during the 1-year follow-up. ADRs were more common in males than females. The highest number of ADRs was related to the gastrointestinal and hepatobiliary system. The ADRs were either mild or moderate. Compliance and number of ADRs were found to be inversely correlated.<br/><br/>CONCLUSION: <br/>ADRs of deferasirox are acceptable looking at the benefits. Regular monitoring and management of ADRs will facilitate patient compliance. However, healthcare professionals need to be alert while prescribing this drug and report any ADR, even if it is not labeled. This study found increased serum lipase and mouth ulcer as adverse effects, which are not yet labeled. These can be signals for further analysis by regulatory authorities.
654 ## - SUBJECT ADDED ENTRY--FACETED TOPICAL TERMS
Subject <a href="Blood transfusion">Blood transfusion</a>
-- <a href="chelation therapy">chelation therapy</a>
-- <a href="drug-related side effects and adverse reactions">drug-related side effects and adverse reactions</a>
-- <a href="ICL670">ICL670</a>
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Mousumee
773 0# - HOST ITEM ENTRY
Host Biblionumber 125270
Host Itemnumber 114201
Place, publisher, and date of publication Mumbai Wolters Kluwer India
Title Indian Journal of Pharmacology
International Standard Serial Number 0253-7613
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
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Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Location (home branch) Sublocation or collection (holding branch) Date acquired Koha issues (times borrowed) Piece designation (barcode) Koha date last seen Price effective from Koha item type
    Dewey Decimal Classification     SNDT Juhu SNDT Juhu 29/10/2025   JP984.2 29/10/2025 29/10/2025 Journal Article