Drug updated on 4/15/2024
| 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.
Summary
- Tbo-filgrastim (Granix) is indicated for the reduction of duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. This is applicable to both adult and pediatric patients 1 month and older.
- Two studies were reviewed which compared Granix's effectiveness against other granulocyte colony-stimulating factor (G-CSF) drugs in treating neutropenia in cancer patients undergoing myelosuppressive therapy.
- The first study reported that tbo-filgrastim significantly reduces the risk of febrile neutropenia compared to placebo or no treatment, while showing similar efficacy and safety profiles when compared to pegfilgrastim. Adverse events such as bone pain were also comparable across these treatments.
- The second study's Bayesian network meta-analysis findings indicated that tbo-filgrastim showed a higher risk of febrile neutropenia occurrence than pegfilgrastim but was less effective than mecapegfilgrastim, lipegfilgrastim, and balugrastim at reducing this condition. These latter three drugs also demonstrated better tolerability by causing fewer instances of bone pain.
- Both studies focused on cancer patients receiving myelosuppressive anticancer drugs without providing specific subgroup analyses like age groups or types of cancer.
- In terms of safety and efficacy, tbo-filgrastim’s most common side effect was bone pain, similar to its counterparts. However, certain alternatives like mecapegfilgrastim displayed superior tolerance profiles. While Granix effectively reduced the duration of severe neutropenia, it may be outperformed by newer medications such as mecapegfilgrastim according to their ability to reduce occurrences of febrile neutropenia.
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 |