Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Filgrastim
Drug ID BADD_D00897
Description Chemotherapy-induced neutropenia (CIN) is a common and serious complication of myelosuppressive chemotherapy. It is associated with significant morbidity and mortality and can increase the cost of cancer therapy. In these cases, colony stimulating factor is necessary to restore important cells for immune function [A35591]. For over twenty years, granulocyte colony-stimulating factors (G-CSFs; filgrastims) have been a pillar of treatment and prevention of CIN, and have been found to reduce the risk of neutropenia across various patient settings, decrease the incidence of febrile neutropenia, reduce the incidence of infection, reduce the requirement for treatment with antibiotics, and accelerate neutrophil recovery [A35591]. Filgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analog. It is marketed as the brand name _Neupogen_ by Amgen (initially approved in 1998) and as _Nivestym_, a biosimilar agent by Pfizer. Nivestym was approved by the FDA on July 20th, 2018 [L3735]. Between 1998 and the present, Neupogen/filgrastim has been approved for various indications [L3744]. _Tbo-filgrastim_, which is marketed by Sicor Biotech and FDA approved on August 29, 2012, contains the same active ingredient as Neupogen and is biologically similar, but it is formulated to be short-acting [F719]. On March 6, 2015, the FDA approved the biosimilar Zarxio (filgrastim-sndz) and is indicated for use in the same conditions as Neupogen. Zarxio is marketed by Sandoz [L3742].
Indications and Usage Filgrastim is used in patients with acute myeloid leukemia receiving induction or consolidation chemotherapy. It is also used in cancer patients receiving bone marrow transplant. In general, filgrastim increases neutrophil counts in order to decrease the risk of infection or duration of neutropenia in the aforementioned patient populations. Infection and neutropenia are adverse events associated with chemotherapy. Furthermore, filgrastim is also indicated for patients with severe chronic neutropenia. It mobilizes hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis to allow for a more rapid engraftment. Tbo-filgrastim has a narrower indication profile than Neupogen - it is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies.
Marketing Status Prescription
ATC Code L03AA02
DrugBank ID DB00099
KEGG ID D03235
MeSH ID D000069585
PubChem ID Not Available
TTD Drug ID D09WDK
NDC Product Code 70121-1569; 70121-1568; 55513-924; 55513-530; 55513-546; 55513-209; 70121-1571; 70121-1570; 71861-0001
Synonyms Filgrastim | Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor | Recombinant Methionyl Human Granulocyte Colony Stimulating Factor | G-CSF Recombinant, Human Methionyl | G CSF Recombinant, Human Methionyl | R-metHuG-CSF | R metHuG CSF | Zarxio | Filgrastim-sndz | Tbo-Filgrastim | Tbo Filgrastim | Granix | Topneuter | Neupogen
Chemical Information
Molecular Formula Not Available
CAS Registry Number 121181-53-1
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.006--Not Available
Acute respiratory distress syndrome22.01.03.001--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Bone pain15.02.01.001--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Constipation07.02.02.001--
Cough22.02.03.001--
Cutaneous vasculitis24.05.02.004; 23.06.02.001; 10.02.02.003--Not Available
Diarrhoea07.02.01.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Epistaxis22.04.03.001; 24.07.01.005--
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.007--
Haematuria20.02.01.006; 24.07.01.047--
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Headache17.14.01.001--
Hepatomegaly09.01.05.001--Not Available
Hypertension24.08.02.001--
Injection site reaction12.07.03.015; 08.02.03.014--
Mucosal inflammation08.01.06.002--Not Available
Nausea07.01.07.001--
Osteoporosis15.02.03.002; 14.04.04.002--
Pain08.01.08.004--
Peritonitis11.01.07.007; 07.19.05.004--
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
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