Table 2.
Cytokine based immunomodulators approved by US FDA
| Name | Approval year | Category | Therapeutic use | Route of administration | Trade name |
|---|---|---|---|---|---|
| Aldesleukin (rhIL-2) | 1992 | Human recombinant interleukin-2 product | Metastatic renal cell carcinoma | Intravenous infusion | PROLEUKIN |
| Oprelvekin (rhIL-11) | 1997 | Recombinant interleukin eleven (IL-11), a thrombopoietic growth factor | Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy | NEUMEGA® | |
| Filgrastim | 1991 | Leukocyte growth factor | To decrease the incidence of infection as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs | Injection, for subcutaneous or intravenous use | NEUPOGEN® |
| Tbo-filgrastim (rhG-CSF) | 2012 | Leukocyte growth factor | Reduction in 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 | Injection, for subcutaneous use | GRANIX® |
| Sargramostim(rhGM-CSF) | 1991 | Leukocyte growth factor | To accelerate bone marrow recovery in diverse settings of bone marrow failure | Injection, for subcutaneous or intravenous use | LEUKINE® |
| Metreleptin (rh-leptin) | 2014 | Leptin analog | As adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy | Injection for subcutaneous use | MYALEPTTM |
| Epoetin alfa | 1989 | Erythropoiesis-stimulating agent | Treatment of anemia due to- chronic kidney disease (CKD) and Zidovudine treated HIV infected patients | For intravenous or subcutaneous use | EPOGEN® |
| Darbepoietin alfa | 2001 | Erythropoiesis-stimulating agent | Treatment of anemia due to: chronic kidney disease (CKD) and concomitant myelosuppressive chemotherapy | For intravenous or subcutaneous use | ARANESP® |
| Interferon alfa-2b | 1986 | Alpha interferon | Hairy Cell Leukemia, Malignant Melanoma, Follicular Lymphoma, Condylomata Acuminata, AIDS-Related Kaposi's Sarcoma and Chronic Hepatitis C and B | Intramuscular, subcutaneous, intralesional, or intravenous Injection | INTRON® A |
| Interferon beta-1 | 1996 | Glycoprotein | Treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. | Intramuscular injection | AVONEX , Betaseron® |
| Interferon gamma-1 | 1990 | Interferon gamma | Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) and Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO) | Subcutaneous use | ACTIMMUNE® |
| Palifermin(rhKGF) | 2004 | Mucocutaneous epithelial human growth factor | To decrease the incidence and duration of severe oral mucositis inpatients with hematologic malignancies receiving myelotoxic therapy | Intravenous use | KEPIVANCE® |
| Becaplermin (rhPDGF) | 2005 | Recombinant human platelet-derived growth factor (rhPDGF-BB) | Treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply | Gel | REGRANEX® |
| RhBMP-2 | 2002 | Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) | Treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. | Bone graft | INFUSE® |
| Pegademase bovine | 1990 | (monomethoxypolyethylene glycol succinimidyl) 11-17adenosine deaminase. It is a conjugate of numerous strands of monomethoxypolyethylene glycol (PEG) | Severe adenosine deaminase (ADA) deficiency with immunodeficiency disease (SCID). | Intramuscular injection | ADAGEN® |
| Pegfilgrastim | 2002 | Covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol | To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia | Subcutaneous use | NEULASTA® |
| Peginterferon alfa-2b | 2011 | Covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG) | Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy | For injection, for subcutaneous use | SYLATRON™ |