atric patients weighing less than 10 kg, administer 0.1 mg/kg (0.01 mL/kg) of UDENYCA
3 DOSAGE FORMS AND STRENGTHSInjection: 6 mg/0.6 mL clear, colorless, preservative-free solution in a single-dose prefilled syringe for manual useonly.
4 CONTRAINDICATIONS
UDENYCA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products orfilgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture
Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. eva luate foran enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receivingUDENYCA.
5.2 Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products.
eva luatepatients who develop fever and lung infiltrates orrespiratory distress after receiving UDENYCA for ARDS.
Discontinue UDENYCA in patients with ARDS.
5.3 Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products.
Themajority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recurwithin days after the discontinuation of initial anti-allergic treatment.
Permanently discontinue UDENYCA inpatients with serious allergic reactions. Do not administer UDENYCA to patients with a history of serious allergicreactions to pegfilgrastim products or filgrastim products.
5.4 Use in Patients with Sickle Cell Disorders
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastimproducts. Discontinue UDENYCA if sickle cell crisis occurs.
5.5 Glomerulonephritis
Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based uponazotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events ofglomerulonephritis resolved after dose reduction or discontinuation of pegfilgrastim products. If glomerulonephritis
is suspected, eva luate for cause. If causality is likely, consider dose-reduction or interruption of UDENYCA.
5.6 Leukocytosis
White blood cell (WBC) counts of 100 x109 /L or greater have been observed in patients receiving pegfilgrastimproducts. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
5.7 Capillary Leak Syndrome
Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and ischaracterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency,severity and may be life-threatening if treatment is delayed.
Patients who develop symptoms of capillary leaksyndrome should be closely monitored and receive standard symptomatic treatment, which may include a need forintensive care.
5.8 Potential for Tumor Growth Stimulatory Effects on Malignant Cells
The granulocyte colony-stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastimproducts act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor forany tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products arenot appr |
