Udenyca Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringe—1; Single-dose prefilled autoinjector—1; On-body injector (co-packaged w. single-dose prefilled syringe)—1
Manufacturer
Generic Availability
Mechanism of Action
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
Udenyca Dosage and Administration
Adults and Children
See full labeling. For autoinjector: not suitable for pediatrics weighing <45kg. For autoinjector, syringe: administer into abdomen, thighs, back of upper arm, or upper outer area of buttocks; rotate inj sites. For on-body injector (OBI): not recommended for hematopoietic subsyndrome of acute radiation syndrome and not studied in pediatric patients; health care provider must use only the co-packaged prefilled syringe and apply OBI to abdomen or back of upper arm. ≥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.
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. On-body injector: allergies to acrylic adhesive. Pregnancy. Nursing mothers.
Udenyca Pharmacokinetics
Elimination
Udenyca Interactions
Not Applicable
Udenyca Adverse Reactions
Adverse Reactions
Udenyca Clinical Trials
See Literature
Udenyca Note
Not Applicable
Udenyca Patient Counseling
See Literature