PMID- 26780505 OWN - NLM STAT- MEDLINE DCOM- 20170529 LR - 20181202 IS - 1433-7339 (Electronic) IS - 0941-4355 (Linking) VI - 24 IP - 6 DP - 2016 Jun TI - Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor. PG - 2677-84 LID - 10.1007/s00520-015-3057-2 [doi] AB - The recombinant human granulocyte colony-stimulating factor (G-CSF) known as filgrastim (Tevagrastim((R)), Ratiograstim((R)), Biograstim((R))) in Europe (approved in 2008) and tbo-filgrastim (Granix((R))) in the USA (approved in 2012; Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel) is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This article presents pooled clinical data for tbo-filgrastim compared with Neupogen((R)) (Amgen, Thousand Oaks, CA, USA) as well as tbo-filgrastim post-marketing safety data. The safety and efficacy of tbo-filgrastim were evaluated in three phase III studies in 677 patients receiving myelosuppressive chemotherapy and study drug (348 patients with breast cancer, 237 with lung cancer, 92 with non-Hodgkin lymphoma). In each study, the efficacy of tbo-filgrastim was similar to that of Neupogen. Overall, 633 (93.5 %) patients receiving the study drug experienced 6093 treatment-emergent adverse events (AEs), most of which were related to chemotherapy. Adverse events related to the study drug (tbo-filgrastim or Neupogen) were experienced by 185 (27.3 %) patients; 19 (2.8 %) had severe drug-related AEs, 5 (0.7 %) had drug-related serious AEs, and 6 (0.9 %) discontinued the study due to drug-related AEs. Overall, the most common drug-related AEs were bone pain (7.1 %), myalgia (4.0 %), and asthenia (4.4 %). The post-marketing safety profile of tbo-filgrastim was consistent with that observed during the clinical studies. The availability of tbo-filgrastim, a G-CSF with safety and efficacy comparable to those of Neupogen, provides physicians with an alternative treatment option for supportive care of patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. FAU - Pettengell, Ruth AU - Pettengell R AD - Department of Haematology, St. George's Hospital, St. George's, University of London, Blackshaw Road, London, SW17 0RE, UK. rpetteng@sgul.ac.uk. FAU - Bias, Peter AU - Bias P AD - Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany. FAU - Mueller, Udo AU - Mueller U AD - Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany. FAU - Lang, Nicole AU - Lang N AD - Teva ratiopharm/Teva Pharmaceuticals, Inc., Ulm, Germany. LA - eng PT - Journal Article PT - Meta-Analysis DEP - 20160116 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Antineoplastic Agents) RN - 0 (Hematologic Agents) RN - 143011-72-7 (Granulocyte Colony-Stimulating Factor) RN - PVI5M0M1GW (Filgrastim) SB - IM MH - Adult MH - Antineoplastic Agents/*adverse effects MH - Drug-Related Side Effects and Adverse Reactions/*drug therapy MH - Female MH - Filgrastim/administration & dosage/*adverse effects MH - Granulocyte Colony-Stimulating Factor/therapeutic use MH - Hematologic Agents/administration & dosage/*adverse effects MH - Humans MH - Male MH - Neoplasms/*drug therapy MH - Neutropenia/*chemically induced/*drug therapy OTO - NOTNLM OT - Adverse drug event OT - Drug toxicity OT - Filgrastim OT - Granulocyte colony-stimulating factor OT - Neutropenia OT - Safety EDAT- 2016/01/19 06:00 MHDA- 2017/05/30 06:00 CRDT- 2016/01/19 06:00 PHST- 2015/05/26 00:00 [received] PHST- 2015/12/14 00:00 [accepted] PHST- 2016/01/19 06:00 [entrez] PHST- 2016/01/19 06:00 [pubmed] PHST- 2017/05/30 06:00 [medline] AID - 10.1007/s00520-015-3057-2 [pii] AID - 10.1007/s00520-015-3057-2 [doi] PST - ppublish SO - Support Care Cancer. 2016 Jun;24(6):2677-84. doi: 10.1007/s00520-015-3057-2. Epub 2016 Jan 16.