• White blood cell disorders

Udenyca Generic Name & Formulations

General Description

Pegfilgrastim-cbqv 6mg/0.6mL; soln for SC inj; preservative-free.

Pharmacological Class

Granulocyte colony stimulating factor.

How Supplied

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



Generic Availability


Mechanism of Action

Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Udenyca Indications


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.

Udenyca Dosage and Administration

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 Contraindications

Not Applicable

Udenyca Boxed Warnings

Not Applicable

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 Pharmacokinetics


Half-life: 15–80 hours.

Udenyca Interactions

Not Applicable

Udenyca Adverse Reactions

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).

Udenyca Clinical Trials

See Literature

Udenyca Note

Not Applicable

Udenyca Patient Counseling

See Literature