Table 1.
Biologic | Type | Indications | Immune-related safety warnings |
---|---|---|---|
Aldesleukin | Recombinant human IL-2 | Metastatic renal cell carcinoma, metastatic melanoma |
• Boxed warnings for capillary leak syndrome and infection • Risk of hypersensitivity reported169 |
Filgrastim | Recombinant methionyl human G-CSF | AML, bone marrow transplant in cancer, blood progenitor cell collection and therapy, chronic neutropaenia |
• No boxed or product label warnings issued • Risk of splenic rupture and ARDS indicated in product label • Additional monitoring required by the MHRA |
Interferon alpha | Recombinant human IFNα | Chronic hepatitis C, hairy cell leukaemia, AIDS-related Kaposi's sarcoma, CML |
• Boxed warnings for autoimmune reactions and infections • Risk of cytopaenia indicated in product label • Risk of immunogenicity reported170 |
Interferon beta-1a | Recombinant human IFNβ1a | Relapsing–remitting multiple sclerosis |
• No boxed or product label warnings issued • Anaphylaxis reported post-approval • Immunogenicity reported170 |
Interferon beta-1b | Recombinant human IFNβ1b | Relapsing–remitting multiple sclerosis |
• No boxed warnings issued • Lymphopaenia risk indicated in product label • Risk of immunogenicity reported170 |
Interferon gamma | Recombinant human IFNγ | Chronic granulomatous disease, malignant osteopetrosis | • No boxed or product label warnings issued |
Peginterferon alfa-2a | Pegylated recombinant human IFNα2a | Chronic hepatitis C |
• Boxed warnings issued for autoimmune reactions and infections • Risk of cytopaenia indicated in product label |
Peginterferon alfa-2b | Pegylated recombinant human IFNα2b | Chronic hepatitis C |
• Boxed warnings issued for autoimmune reactions and infections • Risk of cytopaenia indicated in product label |
Sargramostim | Recombinant human GM-CSF | AML, non-Hodgkin's lymphoma, bone marrow transplant | • No boxed or product label warnings issued |
AML, acute myeloid leukaemia; ARDS, acute respiratory distress syndrome; CML, chronic myeloid leukaemia; G-CSF, granulocyte colony-stimulating factor; GM-CSF, granulocyte–macrophage CSF; IFNα, interferon-α; IL-2, interleukin-2; MHRA, Medicines and Healthcare products Regulatory Agency (UK). |