{"id":"tbo-filgrastim","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":["6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Allergic Reactions [see Warnings and Precautions (5.3) ] Sickle Cell Disorders [see Warnings and Precautions (5.4) ] Glomerulonephritis [see Warnings and Precautions (5.5) ] Capillary Leak Syndrome [see Warnings and Precautions (5.6) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.7) ] Myelodysplastic Syndrome and Acute Myeloid Leukemia [see Warnings and Precautions (5.8) ] Leukocytosis [ see Warnings and Precautions ( 5.9 ) ] Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended [see Warnings and Precautions ( 5.10 ) ] Aortitis [see Warnings and Precautions ( 5.12 ) ] Alveolar Hemorrhage [see Warnings and Precautions (5.13) ] Most common adverse reaction (≥1%) to GRANIX is bone pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1 ‑ 866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Adult Patients GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-U.S.-approved filgrastim product were used as controls. Both GRANIX and the non-U.S.-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 10 6 /L after nadir was reached. Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-U.S.-approved filgrastim product). Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 10 6 /L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies. Additional Adverse Reactions Other adverse reactions known to occur following administration of filgrastim products include myalgia, headache, vomiting, cutaneous vasculitis and thrombocytopenia. Adverse Reactions in Pediatric Patients GRANIX clinical trials safety data in pediatric patients are based upon the results of one single-arm clinical trial in 50 pediatric patients who received myelosuppressive chemotherapy for treatment of solid tumors without marrow involvement [see Use in Special Populations ( 8.4 )] . In this study, GRANIX was administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy. The most common (>5%) adverse reactions included thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%). 6.2 Postmarketing Experience The following adverse reactions have"],"contraindications":["4 CONTRAINDICATIONS GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [ see Warnings and Precautions (5.3) ]. Patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products. ( 4 )"]},"status":"discontinued","trials":["NCT00005589","NCT00002791","NCT00006578","NCT05780879","NCT00003958","NCT01766934","NCT01329900","NCT00416598","NCT00058292","NCT00981799","NCT00002526","NCT00007982","NCT01572662","NCT07376460","NCT01110135","NCT00004089","NCT00004231","NCT00863434","NCT00906945","NCT00306111","NCT00030719","NCT02177695","NCT00003812","NCT01164475","NCT03922724","NCT00025259","NCT00003631","NCT01987596","NCT03136146","NCT00005959","NCT00003846","NCT00193973","NCT01105273","NCT00005796","NCT07186179","NCT00017355","NCT02221492","NCT00004899","NCT00025558","NCT04606082","NCT07107217","NCT01553214","NCT00001048","NCT00002831","NCT00004853","NCT00002675","NCT04959175","NCT01523678","NCT00880815","NCT01413178"],"aliases":["Filgrastim Biosimilar Tbo-filgrastim","Filgrastim XM02","Granix","XM02"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"tbo-filgrastim","companyId":"teva-branded-pharmaceutical-products-r-d-inc","ecosystem":[],"mechanism":{"drugClass":"Leukocyte Growth Factor [EPC]","explanation":"1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older 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. ( 1 )","oneSentence":"12.1 Mechanism of Action Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity."},"commercial":null,"references":[],"biosimilars":[],"companyName":"Teva Branded Pharmaceutical Products R&D, Inc.","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"tbo-filgrastim","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00005589","phase":"Phase 3","title":"Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy","status":"COMPLETED","sponsor":"EBMT Solid Tumors Working Party","isPivotal":true,"enrollment":460,"indication":"Lymphoma","completionDate":"2013-04"},{"nctId":"NCT00002791","phase":"Phase 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Phase II Pilot Study","status":"COMPLETED","sponsor":"Northwestern University","isPivotal":false,"enrollment":0,"indication":"Leukemia, Myelodysplastic Syndromes","completionDate":"2004-08"},{"nctId":"NCT00025558","phase":"Phase 1","title":"Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease","status":"COMPLETED","sponsor":"NYU Langone Health","isPivotal":false,"enrollment":0,"indication":"Brain and Central Nervous System Tumors","completionDate":""},{"nctId":"NCT04606082","phase":"NA","title":"Intra Uterine Injection of Human Chorionic Gonadotropin Versus Granulocyte Colony Stimulating Factor at Ovum Pick up Day Significantly Increase Implantation Rate and Pregnancy Rate in Intra Cytoplasmi","status":"UNKNOWN","sponsor":"Al-Azhar University","isPivotal":false,"enrollment":200,"indication":"Fertility Disorders","completionDate":"2021-01-10"},{"nctId":"NCT07107217","phase":"Phase 2","title":"Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Blokhin's Russian Cancer Research Center","isPivotal":false,"enrollment":40,"indication":"Breast Cancer","completionDate":"2027-12"},{"nctId":"NCT01553214","phase":"Phase 4","title":"Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone","status":"RECRUITING","sponsor":"National Institutes of Health Clinical Center (CC)","isPivotal":false,"enrollment":1000,"indication":"Allogeneic Granulocyte Donation","completionDate":"2032-01-01"},{"nctId":"NCT00001048","phase":"Phase 2","title":"A Phase II Multicenter Study Comparing Antiretroviral Therapy Alone to Antiretroviral Therapy Plus Cytosine Arabinoside (Cytarabine; Ara-C) for the Treatment of Progressive Multifocal Leukoencephalopa","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":false,"enrollment":90,"indication":"HIV Infections, Leukoencephalopathy, Progressive Multifocal","completionDate":"1997-04"},{"nctId":"NCT00002831","phase":"Phase 1","title":"A Phase I/II Study of High-Dose Deoxyazacytidine, Busulfan, and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":24,"indication":"Leukemia","completionDate":"2002-12-31"},{"nctId":"NCT00004853","phase":"Phase 1","title":"A Randomized Trial of Filgrastim-SD/01 vs. Filgrastim in Newly Diagnosed Children and Young Adults With Sarcoma Treated With Dose-Intensive Chemotherapy","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":34,"indication":"Ewing's Sarcoma, Rhabdomyosarcoma","completionDate":"2009-05-20"},{"nctId":"NCT00002675","phase":"Phase 2","title":"A TRIAL OF ADJUVANT CHEMOTHERAPY IN PATIENTS WITH INTRAOCULAR RETINOBLASTOMA","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","isPivotal":false,"enrollment":50,"indication":"Retinoblastoma","completionDate":"2001-01"},{"nctId":"NCT04959175","phase":"Phase 1","title":"Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","isPivotal":false,"enrollment":320,"indication":"Hematologic Neoplasms","completionDate":"2027-04-30"},{"nctId":"NCT01523678","phase":"Phase 2","title":"Phase II Study of Weekly Paclitaxel/Carboplatin in Combination With Prophylactic G-CSF in the Treatment of Gynaecological Cancers","status":"COMPLETED","sponsor":"Belgian Gynaecological Oncology Group","isPivotal":false,"enrollment":108,"indication":"Ovarian Cancer, Endometrial Cancer","completionDate":"2018-08-14"},{"nctId":"NCT00880815","phase":"Phase 1","title":"Fludarabine, Bendamustine, and Rituximab (FBR) Non-Myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":60,"indication":"CD20 Positive, Chronic Lymphocytic Leukemia","completionDate":"2019-05-28"},{"nctId":"NCT01413178","phase":"Phase 3","title":"A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","isPivotal":true,"enrollment":205,"indication":"Myeloma","completionDate":"2019-03-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"SUBCUTANEOUS","dosage_text":"2 DOSAGE AND ADMINISTRATION Recommended dose: 5 mcg/kg per day administered as a subcutaneous injection Administer the first dose no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer within 24 hours prior to chemotherapy ( 2.1 ) 2.1 Recommended Dosage The recommended dose of GRANIX is 5 mcg/kg per day administered as a subcutaneous injection. Administer the first dose of GRANIX no earlier than 24 hours following myelosuppressive chemotherapy. Do not administer GRANIX within 24 hours prior to chemotherapy. Daily dosing with GRANIX should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. Monitor complete blood count (CBC) prior to chemotherapy and twice per week until recovery. 2.2 General Considerations for Administration GRANIX may be administered by either a healthcare professional, a patient or caregiver. Before a decision is made to allow GRANIX to be administered by a patient or caregiver, ensure that the patient is an appropriate candidate for self-administration or administration by a caregiver. Proper training on storage, preparation, and administration technique should be provided. If a patient or caregiver is not an appropriate candidate for any reason, then in such patients, GRANIX should be administered by a healthcare professional. Dispense only the prefilled syringe without a safety needle guard device to patient or caregiver. Instruct patients and caregivers to follow the Instructions for Use provided with the GRANIX prefilled syringe to properly administer an injection after training by a healthcare professional. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Do not administer GRANIX if discoloration or particulates are observed. The prefilled syringe and vial are for single-dose only. Discard unused portions. GRANIX and all its components are not made with natural rubber latex. Recommended sites for subcutaneous GRANIX injections include the abdomen (except for the two-inch area around the navel), the front of the middle thighs, the upper outer areas of the buttocks, or the upper back portion of the upper arms. The injection site should be varied daily. GRANIX should not be injected into an area that is tender, red, bruised, or hard, or that has scars or stretch marks. 2.3 Important Administration Instructions for Healthcare Professionals Hold the syringe assembly by the open sides of the device and remove the needle shield. Expel any extra volume depending on dose needed. Inject GRANIX subcutaneously as recommended [ see Dosage and Administration (2.2) ]. Push the plunger as far as it will go to inject all the medication. Injection of the entire prefilled syringe contents is necessary to activate the needle guard. With the plunger still pressed all the way down, remove the needle from the skin. Slowly let go of the plunger and allow the empty syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers. needle image 1 needle image 2 needle image 3 needle image 4 needle image 5 needleimage 6"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"Tbo-filgrastim, also known as Leucostim, is a medication used to treat various conditions, including low neutrophil count, which may occur due to HIV/AIDS, chemotherapy, radiation poisoning, or unknown causes. It works by acting as a granulocyte colony-stimulating factor receptor agonist, stimulating the production of white blood cells.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-08-29T00:00:00.000Z","mah":"SICOR BIOTECH","brand_name_local":"GRANIX","application_number":"BLA125294"}],"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}