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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Autologous and Allogeneic Bone Marrow Transplantation

Acceleration of myeloid recovery in adults with non-Hodgkin’s lymphoma, acute lymphocytic (lymphoblastic) leukemia (ALL), or Hodgkin’s disease undergoing cytotoxic chemotherapy and autologous bone marrow transplantation (BMT).

Acceleration of myeloid recovery in patients undergoing allogeneic BMT from HLA-matched related donors.Also has been used to accelerate myeloid recovery in patients receiving allogeneic BMT from unrelated donors†.

Designated an orphan drug by FDA for use in BMT patients for the management of neutropenia associated with BMT and for the promotion of early engraftment.

Peripheral Blood Progenitor Cell Transplantation

Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

Acceleration of myeloid engraftment following autologous peripheral blood progenitor cell (PBPC) transplantation.

Bone Marrow Transplantation Failure or Engraftment Delay

Prolongation of survival in adults who have undergone allogeneic or autologous BMT and in whom engraftment is delayed or has failed. Designated an orphan drug by FDA for use in BMT patients for the treatment of delayed or failed engraftment.

Has been used in a limited number of patients to reduce the period of severe myelosuppression and the risk of infectious complications in patients with delayed engraftment following PBPC transplantation†.

Leukemias

Acceleration of neutrophil recovery and reduction of the incidence of severe and life-threatening infections following induction chemotherapy in adults ≥55 years of age with acute myelogenous leukemia (AML); safety and efficacy not established in individuals <55 years of age.

Designated an orphan drug by FDA for use in patients with AML to reduce neutropenia and leukopenia and to increase survival.

Use of biosynthetic GM-CSFs in patients with acute leukemia has been controversial, since results of in vitro studies indicate that certain leukemic cell lines have receptors for GM-CSF and that these drugs may have a stimulatory effect on leukemic blast cells in vitro. Some experts state that use of sargramostim in the treatment of myeloid leukemias should be considered investigational and undertaken with caution.

Myelodysplastic Syndromes and Aplastic Anemia

Has been used to increase leukocyte counts in adults with myelodysplastic syndrome† (MDS) classified as refractory anemia (RA), refractory anemia with excess blasts (RAEB), or refractory anemia with excess blasts in transformation (RAEB-T); however, it is unclear whether sargramostim will alter (either increase or decrease) the rate of progression to AML or alter the usually fatal outcome of the disease. Generally should be used under protocol conditions.

Has been used with some success to increase leukocyte counts in a limited number of adults and adolescents ≥15 years of age with moderate to severe aplastic anemia†. Generally should be used under protocol conditions.

Neutropenia Associated with HIV Infection and Antiretroviral Therapy

Treatment to correct or minimize HIV-associated neutropenia† or drug-induced neutropenia (e.g., neutropenia associated with use of zidovudine, interferon alfa, and/or cytotoxic chemotherapy) in HIV-infected patients†.

Congenital, Cyclic, and Idiopathic Neutropenias

Has been used with variable success in an effort to increase neutrophil counts in patients with various primary neutropenias, including congenital neutropenia†, acquired idiopathic neutropenia†, and glycogen storage disease type Ib†. Filgrastim may be more effective than sargramostim and other biosynthetic GM-CSFs, since filgrastim results in more consistent increases in neutrophil counts and does not cause eosinophilia.

Chemotherapy-induced Neutropenia

Treatment to increase neutrophil counts and decrease the risk of infectious complications† in patients with malignancies receiving myelosuppressive antineoplastic therapy. Has been used prophylactically in a limited number of children with refractory solid tumors receiving myelosuppressive therapy†.

Filgrastim has been used more extensively to date than biosynthetic GM-CSFs in patients with chemotherapy-induced neutropenia; intermittent low-grade fevers reported in a large proportion of patients receiving GM-CSF therapy but not in those receiving filgrastim therapy.