White blood cell disorders:

Indications for: UDENYCA

To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia. To increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Limitations of Use:

Not for mobilization of peripheral blood progenitor cells for HSCT.

Adults and Children:

See full labeling. ≥45kg: On myelosuppressive chemotherapy: 6mg SC once per chemotherapy cycle. Do not give between 14 days before and 24 hours after chemotherapy. Hematopoietic subsyndrome of acute radiation syndrome:  6mg SC each for 2 doses, given 1 week apart. Administer the 1st dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy). Both: Pediatrics (31–44kg): 4mg; (21–30kg): 2.5mg; (10–20kg): 1.5mg; (<10kg): 0.1mg/kg. Direct administration of prefilled syringe with doses <6mg is not recommended. Prefilled autoinjector: not suitable for use in pediatrics <45kg.

UDENYCA Warnings/Precautions:

Monitor for splenomegaly, splenic rupture, acute respiratory distress syndrome (ARDS); evaluate if fever, lung infiltrates, or respiratory distress occurs; discontinue if ARDS diagnosed. Monitor for glomerulonephritis; consider dose reduction or interruption if treatment-related. Permanently discontinue if serious allergic reactions develop. Sickle cell disorders. Monitor CBCs, platelet counts during therapy. Discontinue if aortitis is suspected. Myeloid malignancies. Myelodysplasia. Monitor for MDS/AML in those with breast or lung cancer. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.

UDENYCA Classification:

Granulocyte colony stimulating factor.

Adverse Reactions:

Bone or extremity pain; anaphylaxis, ARDS, splenic rupture, aortitis, sickle cell crisis (discontinue if occurs), glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome (monitor closely if occurs).

Drug Elimination:

Half-life: 15–80 hours.

Generic Drug Availability:


How Supplied:

Single-dose prefilled syringe—1; Single-dose prefilled autoinjector—1