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Blood clots, neutropenia (dose-limiting), thrombocytopenia (dose-limiting), anaemia, infection, hypotension, hypokalaemia, hypothyroidism, Stevens–Johnson syndrome, toxic epidermal necrolysis, angioedema, pneumonitis, hepatotoxicity and secondary malignancies (mostly myelodysplastic syndrome and acute myeloid leukaemia).
The Food and Drugs Administration (FDA) first approved filgrastim on February 20, 1991 marketed by Amgen with the brand name Neupogen. [31] It was innitially approved to reduce the risk of infection in patients with non-myeloid malignancies who are taking myelosuppressive anti-cancer drugs associated with febrile neutropenia with fever. [31]
Neutropenia itself is a rare entity, but can be clinically common in oncology [35] and immunocompromised individuals as a result of chemotherapy (drug-induced neutropenia). Additionally, acute neutropenia can be commonly seen from people recovering from a viral infection or in a post-viral state.
In 2015, Sandoz's filgrastim-sndz (Zarxio), obtained the approval of the US Food and Drug Administration (FDA) as a biosimilar. [ 11 ] [ 27 ] [ 28 ] 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 . [ 11 ]
Efbemalenograstim alfa can cause fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, sickle cell crises in patients with sickle cell disorders, glomerulonephritis, thrombocytopenia, capillary leak syndrome, and myelodysplastic syndrome and acute myeloid leukemia in people with breast and lung cancer.
Neutropenia indicates a deficiency of neutrophils (the most common granulocyte cell) only. [citation needed] To be precise, neutropenia is the term normally used to describe absolute neutrophil counts (ANCs) of less than 500 cells per microlitre, whereas agranulocytosis is reserved for cases with ANCs of less than 100 cells per microlitre.
Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute ...
Drug induced immune mediated hemolytic anemia Penicillin (high dose) Methyldopa; Hemoglobinopathies (where these is an unstable or crystalline hemoglobin) Paroxysmal nocturnal hemoglobinuria (rare acquired clonal disorder of red blood cell surface proteins) Direct physical damage to RBCs Microangiopathic hemolytic anemia