Drug updated on 11/1/2024
| 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.
Latest News
Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Tbo-filgrastim effectively reduces the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, showing similar efficacy to Neupogen across three phase III studies involving 677 patients with breast cancer, lung cancer, and non-Hodgkin lymphoma.
- ASCO (American Society of Clinical Oncology) guidelines support the prophylactic use of tbo-filgrastim to reduce febrile neutropenia risk in cases where the anticipated risk is approximately 20% or higher, in the absence of an equally effective and safe alternative. 4. 93.5% of patients experienced treatment-emergent adverse events (AEs), primarily due to chemotherapy; 27.3% had drug-related AEs.
- Severe drug-related AEs occurred in 2.8% of patients, with serious drug-related AEs in 0.7%, and 0.9% of patients discontinued due to drug-related AEs.
- 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, Inc., Parsippany, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor | 2016 | Supportive Care in Cancer |
| Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update | 2015 | Journal of Clinical Oncology |
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 |