Udenyca

— THERAPEUTIC CATEGORIES —
  • White blood cell disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Udenyca Generic Name & Formulations

    Legal Class

    Rx

    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

     

    Manufacturer

    Coherus Biosciences

    Generic Availability

    NO

    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

    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

    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

    Elimination

    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

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