Efficacy and Safety of Pegfilgrastim in Indian Patients.
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Date
2013-06
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Abstract
Context: Pegfilgrastim, a pegylated recombinant
granulocyte colony stimulating factor, promotes the
hematopoietic recovery after cytotoxic chemotherapy and
is marketed in India as PegstimTM. Aims: This post
marketing surveillance study was undertaken to evaluate
the efficacy and safety of PegstimTM in clinical practice in
Indian patients. Material and Methods: Investigators
participating in this post marketing surveillance were asked
to capture data of all the patients who were given PegstimTM
along with cytotoxic chemotherapy for their underlying
malignancy. PegstimTM was given as a single subcutaneous
dose approximately 24 hours after administration of
cytotoxic chemotherapy and patients were followed up for
14 days with blood counts at baseline and every alternate
day. Each cycle of chemotherapy in which PegstimTM was
administered was considered as a distinct patient entity for
efficacy and safety analysis. Results: PegstimTM injections
were used in 213 patients and led to an increase in Absolute
Neutrophil Count (ANC) as early as 2 days after
administration of the drug with mean percent increase in
ANC of 129.8 ± 210.9% at the end of 14 days. The overall
incidence of moderate-severe (grade III/IV) febrile
neutropenia in the total population studied was 6.1% (13
patients). Intravenous antibiotics were used in 10 (4.7%)
patients while 4 (1.9%) patients required hospitalization. A
total of 57 adverse events were reported in 32 patients during
the entire course of the study, the most common being
musculoskeletal pain in 22 (10.3%) patients. Conclusions:
The results from this post marketing surveillance study
support the efficacy and tolerability of PegstimTM used for
preventing neutropenia across various tumor types and
regimens in Indian patients.
Description
Keywords
pegfilgrastim, post marketing surveillance, febrile neutropenia, cytotoxic chemotherapy
Citation
Sanmukhani Jayesh J, Mittal Ravindra, Pawar Prafulla. Efficacy and Safety of Pegfilgrastim in Indian Patients. Indian Medical Gazette. 2013 Jul ; 147 (6): 230-235.