Filgrastim

DEA Class; Rx

Common Brand Names; G-CSF, Neupogen, tbo-filgrastim, Granix, Zarxio, filgrastim-sndz, Nivestym, filgrastim-aafi, Releuko, filgrastim-ayow

• Hematopoietic Growth Factors

Granulocyte colony-stimulating factor
Used to reduce the duration of neutropenia and incidence of infection in patients receiving myelosuppressive chemotherapy or myeloablative chemotherapy followed by bone marrow transplant; also used for the mobilization of peripheral blood progenitor cells for leukapheresis, for the treatment of severe chronic neutropenia, and to improve survival following acute radiation exposure
Acute respiratory distress syndrome, fatal splenic rupture, and glomerulonephritis have been reported

Indicated to decrease infection incidence‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever

Indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia

Indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae (eg‚ febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)

Indicated for the mobilization of autologous peripheral blood progenitor cells (PBPCs) into the peripheral blood for collection by leukapheresis

Indicated for long-term administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with severe chronic neutropenia (SCN), including congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia

Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

History of serious allergic reactions to filgrastim or pegfilgrastim products

• Nausea (57%)
• Vomiting (57%)
• Bone pain (22%-33%)
• Alopecia (18%)
• Diarrhea (14%)
• Fever (12%)
• Fatigue (11%)
• Headache
• Anorexia
• Chest pain
• Cough
• Dyspnea
• Constipation
• Stomatitis
• Sore throat
• Rash

Allergic reactions reported (angioneurotic edema, dermatitis-allergic, hypersensitivity, rash, pruritic rash, and urticaria); allergic reactions can recur within days after discontinuation of initial antiallergic treatment; permanently discontinue therapy in patients with serious allergic reactions

Associated with rare cases of potentially fatal splenic rupture; evaluate if patient experiences left upper abdominal and/or shoulder tip pain

Rare cases of ARDS reported; evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS; discontinue therapy in patients with ARDS

Monitor for thrombocytopenia

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders; discontinue therapy if sickle cell crisis occurs

Glomerulonephritis reported; if suspected, evaluate for cause; if causality likely, consider dose-reduction or interruption

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

WBC counts ≥100‚000/mm³ were observed in ~2% of patients receiving filgrastim at dosages >5 mcg/kg/day

Off-label use for PBPC mobilization has resulted in alveolar hemorrhage, resulting in pulmonary infiltrates and hemoptysis

Cutaneous vasculitis has been reported; hold therapy in patients with cutaneous vasculitis; therapy may be started at a reduced dose when the symptoms resolve and the ANC has decreased

Capillary leak syndrome (CLS) can occur in patients receiving filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration; patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

In patients with cancer receiving the drug as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ recommended that therapy be discontinued if the ANC surpasses 10‚000/mm³ after the chemotherapy-induced ANC nadir has occurred; monitor CBC counts at least twice weekly during therapy; dosages that increase the ANC beyond 10‚000/mm³ may not result in any additional clinical benefit

During period of administration of therapy for PBPC mobilization in patients with cancer, discontinue therapy if leukocyte count rises to >10‚000/mm³

Simultaneous use with chemotherapy and radiation therapy not recommended

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes; consider when interpreting bone-imaging results

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

Available data from published studies, including several observational studies of pregnancy outcomes in women exposed to filgrastim products and those who were unexposed, have not established an association with use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes

There is published literature documenting transfer of filgrastim into human milk; there are a few case reports describing use of filgrastim in breastfeeding mothers with no adverse effects noted in the infants; there are no data on effects of filgrastim on milk production

Filgrastim 

injectable solution, single-dose vials

• Neupogen, Granix, Nivestym, Releuko

• 300mcg/mL

• 480mcg/1.6mL

injectable solution, prefilled syringe for SC

• Neupogen, Granix, Nivestym, Zarxio, Releuko

• 300mcg/0.5mL

• 480mcg/0.8mL

Biosimilars to Neupogen

• Zarxio (filgrastim-sndz)

• Granix (tbo-filgrastim)

• Nivestym (filgrastim-aafi)

• Releuko (filgrastim-ayow)