Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 300 mcg/0.5 mL, 480 mcg/0.8 mL) |
Drug Class | Leukocyte growth factors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia, in adult and pediatric patients 1 month and older.
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Summary
- Granix (tbo-filgrastim) is indicated for reducing the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia, in adult and pediatric patients 1 month and older.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Filgrastim reduced the risk of febrile neutropenia by 42% compared to placebo or no treatment, with a risk ratio of 0.58.
- No significant difference in the incidence of febrile neutropenia was observed between filgrastim and pegfilgrastim (risk ratio: 0.90) or between filgrastim and its biosimilars (risk ratio: 1.03).
- In a network meta-analysis, filgrastim had a higher risk of febrile neutropenia compared to pegfilgrastim (OR: 1.63), while mecapegfilgrastim, lipegfilgrastim, and balugrastim showed higher effectiveness, with cumulative probabilities of 58%, 15%, and 11%, respectively.
- The most commonly reported adverse event with filgrastim was bone pain. There was no significant difference in safety profiles between filgrastim and pegfilgrastim, and safety profiles were similar between filgrastim and biosimilar filgrastim.
- In the network meta-analysis, filgrastim was associated with a higher risk of bone pain compared to some other G-CSF drugs. Mecapegfilgrastim, balugrastim, lipegfilgrastim, and L-G-CSF biosimilar had the lowest risk of bone pain, while short-acting G-CSF biosimilar and lenograstim showed a higher risk compared to pegfilgrastim.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Granix (tbo-filgrastim) Prescribing Information. | 2023 | Teva Pharmaceuticals USA, North Wales, PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Prevention and Treatment of Chemotherapy-Induced Febrile Neutropenia in Adults. | 2023 | Oncology |
NCCN Guidelines Insights: Hematopoietic Growth Factors, Version 1.2020. | 2020 | Journal of the National Comprehensive Cancer Network |
Recent advances in the management of chemotherapy-induced neutropenia: biosimilar granulocyte colony-stimulating factor use in Italy. | 2020 | Future Oncology |
Clinical role of filgrastim in the management of patients at risk of prolonged severe neutropenia: An evidence-based review. | 2019 | International Journal of Clinical Practice |