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Clinical data | |
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Trade names | Neupogen, others |
Other names | XM02 |
Biosimilars | filgrastim-aafi, [1] filgrastim-ayow, [2] filgrastim-sndz, filgrastim-txid [3] Accofil, Biograstim, Fraven Grastofil, Nivestim, [4] Nivestym, [5] Nypozi, [3] [6] Ratiograstim, Releuko, [2] Tevagrastim, Zarxio, [7] Zarzio [8] |
AHFS/Drugs.com | Monograph |
MedlinePlus | a692033 |
License data |
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Routes of administration | Intraveneous, subcutaneous |
Drug class | Hematopoietic agents, colony-stimulating factors |
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ChEMBL | |
ECHA InfoCard | 100.167.401 |
Chemical and physical data | |
Formula | C845H1343N223O243S9 |
Molar mass | 18802.90 g·mol−1 |
Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. [15] Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. [15] It may also be used to increase white blood cells for gathering during leukapheresis. [15] It is given either by injection into a vein or under the skin. [15] Filgrastim is a leukocyte growth factor. [14]
Common side effects include fever, cough, chest pain, joint pain, vomiting, and hair loss. [15] Severe side effects include splenic rupture and allergic reactions. [15] It is unclear if use in pregnancy is safe for the baby. [15] Filgrastim is a recombinant form of the naturally occurring granulocyte colony-stimulating factor (G-CSF). [15] It works by stimulating the body to increase neutrophil production. [15]
Filgrastim was approved for medical use in the United States in 1991. [15] It is on the World Health Organization's List of Essential Medicines. [16] [17] Filgrastim biosimilar medications are available. [15]
Filgrastim is used to treat neutropenia; [14] acute myeloid leukemia; [14] nonmyeloid malignancies; [14] leukapheresis; [14] congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; [14] and myelosuppressive doses of radiation. [14] [18]
Tbo-filgrastim (Granix) is indicated for reduction in the duration of severe neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. [19]
The most commonly observed adverse effect is mild bone pain after repeated administration, [20] and local skin reactions at the site of injection. [14] Other observed adverse effects include serious allergic reactions (including a rash over the whole body, [21] shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, and sweating), ruptured spleen (sometimes resulting in death), [22] alveolar hemorrhage, acute respiratory distress syndrome, and hemoptysis. [14] Severe sickle cell crises, in some cases resulting in death, have been associated with the use of filgrastim in people with sickle cell disorders. [14]
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes; this should be considered when interpreting bone-imaging results. [14]
G-CSF is a colony stimulating factor which has been shown to have minimal direct in vivo or in vitro effects on the production of other haematopoietic cell types. Neupogen (filgrastim) is the name for recombinant methionyl human granulocyte colony stimulating factor (r-metHuG-CSF). [14]
In 2015, Sandoz's filgrastim-sndz (Zarxio), obtained the approval of the US Food and Drug Administration (FDA) as a biosimilar. [7] [23] [24] This was the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as part of the Affordable Care Act. [7] Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. [24]
In 2018, filgrastim-aafi (Nivestym) was approved for use in the United States. [1]
In September 2008, Ratiograstim, Tevagrastim, Biograstim, and Filgrastim ratiopharm were approved for use in the European Union. [25] [26] [27] [28] Filgrastim ratiopharm was withdrawn in July 2011 and Biograstim was withdrawn in December 2016.
In February 2009, Filgrastim Hexal and Zarzio were approved for use in the European Union. [29] [8]
In June 2010, Nivestim was approved for use in the European Union. [4]
In October 2013, Grastofil was approved for use in the European Union. [30]
In September 2014, Accofil was approved for use in the European Union. [31]
In 2016, Fraven was approved for use by Republic of Turkey ministry of health. [32]
Nivestym was approved for medical use in Canada in April 2020. [5]
In October 2021, Nypozi was approved for medical use in Canada. [6]
In February 2022, filgrastim-ayow (Releuko) was approved for medical use in the United States. [2] [33]
In June 2024, filgrastim-txid (Nypozi) was approved for medical use in the United States. [3]
Shortly after it was introduced, analyses of whether filgrastim is a cost-effective way of preventing febrile neutropenia depended upon the clinical situation and the financial model used to pay for treatment. [34] The longer-acting pegfilgrastim may in some cases be more cost-effective. [35]
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.
Teriparatide, sold under the brand name Forteo, is a form of parathyroid hormone (PTH) consisting of the first (N-terminus) 34 amino acids, which is the bioactive portion of the hormone. It is an effective anabolic agent used in the treatment of some forms of osteoporosis. Teriparatide is a recombinant human parathyroid hormone analog. It has an identical sequence to the 34 N-terminal amino acids of the 84-amino acid human parathyroid hormone.
Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).
Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is injected just under the skin. Effects generally begin an hour after use.
Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).
Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.
Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related macular degeneration, diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.
Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23.
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab.
Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is delivered subcutaneously either by injection or from an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed.
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
Rilpivirine, sold under the brand names Edurant and Rekambys, is a medication, developed by Tibotec, used for the treatment of HIV/AIDS. It is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) with higher potency, longer half-life and reduced side-effect profile compared with older NNRTIs such as efavirenz.
Aflibercept, sold under the brand names Eylea and Zaltrap, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.
Cabotegravir, sold under the brand name Vocabria among others, is a antiretroviral medication used for the treatment of HIV/AIDS. It is available in the form of tablets and as an intramuscular injection, as well as in an injectable combination with rilpivirine under the brand name Cabenuva.
Polatuzumab vedotin, sold under the brand name Polivy, is a CD79b-directed antibody-drug conjugate medication used for the treatment of diffuse large B-cell lymphoma (cancer). It was developed by the Genentech subsidiary of Roche.
Eflapegrastim, sold under the brand name Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals. Eflapegrastim is a leukocyte growth factor. It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents.
Lipegfilgrastim, sold under the brand name Lonquex, is a medication used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults. It is given by injection under the skin in the abdomen, upper arm or thigh.
Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL-36R) antagonist. It is given via injection into a vein.
Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia. It is a leukocyte growth factor. It is given by subcutaneous injection.
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