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.

Limitations of Use:

Not for mobilization of peripheral blood progenitor cells for HSCT.

Adults and Children:

See full labeling. Do not give between 14 days before and 24 hours after chemotherapy. ≥45kg: 6mg SC once per chemotherapy cycle. 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.

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 CBC during therapy. Discontinue if aortitis is suspected. Myeloid malignancies. Myelodysplasia. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.

Pharmacologic Class:

Granulocyte colony stimulating factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—1

Pricing for UDENYCA

6mg/0.6ml syringe (Qty: 1)
Appx. price $4139
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