Pegfilgrastim

DEA Class; Rx

Common Brand Names; Neulasta, Fulphila, pegfilgrastim-jmdb, Udenyca, pegfilgrastim-cbqv, Ziextenzo, pegfilgrastim-bmez, pegfilgrastim-apgf, Nyvepria, Fylnetra, pegfilgrastim-pbbk, Stimufend, pegfilgrastim-fpgk

• Hematopoietic Growth Factors

Granulocyte colony-stimulating growth factor
Indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia and to increase survival in patients acutely exposed to myelosuppressive doses of radiation
Acute respiratory distress syndrome, fatal splenic rupture, and glomerulonephritis have been reported

Indicated for chemotherapy-induced neutropenia prophylaxis, to decrease the incidence of febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia.

For the treatment of acute radiation exposure, to increase survival, in patients who receive myelosuppressive doses of radiation.

History of serious allergic reactions to pegfilgrastim or filgrastim

• Bone pain (31%)
• Pain in extremity (9%)
• Leukocytosis (WBC counts >100 x 10^9/L)

Rare cases of splenic rupture may occur; evaluate if patient experiences left upper abdominal and/or shoulder tip pain

ARDS reported; evaluate symptoms, including fever, pulmonary infiltrates, or respiratory distress; discontinue if ARDS occurs

Serious allergic reactions (eg, anaphylaxis) can occur; majority of reported events occurred upon initial exposure; allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial antiallergic treatment; permanently discontinue treatment in patients with serious allergic reactions (see Contraindications)

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

Capillary leak syndrome may occur; may vary in frequency and severity; closely monitor patients who develop symptoms and provide standard symptomatic treatment, which may include a need for intensive care

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

Leukocytosis observed; monitoring CBC count during therapy recommended; higher counts reported

Pegfilgrastim may potentially act as growth factor for any tumor type, including myeloid malignancies and myelodysplasia

Missed or partial doses reported in patients receiving drug via OBI due to device not performing as intended; in event of missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if dose had been correctly delivered; instruct patients using OBI to notify their healthcare professional immediately in order to determine need for replacement dose if they suspect that device may not have performed as intended

Aortitis reported; it may occur as early as the first week after start of therapy; manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, C-reactive protein and white blood cell count); consider aortitis in patients who develop these signs and symptoms without known etiology; discontinue if aortitis is suspected

Increased hematopoietic activity of 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

Thrombocytopenia reported; monitor platelet counts

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) associated with use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer; monitor patients for signs and symptoms of MDS/AML in these settings

Insufficient data available on use in pregnant women to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Unknown whether pegfilgrastim is secreted in human milk

Pegfilgrastim

prefilled syringe, single-dose

• 6mg/0.6mL (Neulasta, Fulphila, Fylnetra, Udenyca, Ziextenzo, Stimufend)

prefilled syringe, single-dose copackaged with the on-body injector (OBI)

• 6mg/0.6mL (Neulasta Onpro kit)

Biosimilars to Neulasta

• Fulphila (pegfilgrastim-jmdb)
• Fylnetra (pegfilgrastim-pbbk)
• Udenyca (pegfilgrastim-cbqv)
• Ziextenzo (pegfilgrastim-bmez)
• Stimufend (pegfilgrastim-fpgk)