Tbo-filgrastim

(Granix®)

Granix®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 300 mcg/0.5 mL, 480 mcg/0.8 mL)
Drug ClassLeukocyte 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
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  • 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.
  • American Society of Clinical Oncology (ASCO) 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 TitleYearSource
Granix (tbo-filgrastim) Prescribing Information.2023Teva Pharmaceuticals USA, Inc., Parsippany, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines