5.1 Splenic Rupture 3
5.2 Acute Respiratory Distress Syndrome 3
5.3 Serious Allergic Reactions 3
5.4 Use in Patients with Sickle Cell Disorders 3
5.5 Glomerulonephritis 3
5.6 Leukocytosis 3
5.7 Capillary Leak Syndrome 3
5.8 Potential for Tumor Growth Stimulatory Effects
on Malignant Cells 4
5.9 Aortitis 4
5.10 Nuclear Imaging 4
6 ADVERSE REACTIONS 4
6.1 Clinical Trials Experience 4
6.2 Immunogenicity 5
6.3 Postmarketing Experience 5
8 USE IN SPECIFIC POPULATIONS 6
8.1 Pregnancy 6
8.2 Lactation 6
8.4 Pediatric Use 7
8.5 Geriatric Use 7
10 OVERDOSAGE 7
11 DESCRIPTION 7
12 CLINICAL PHARMACOLOGY 7
12.1 Mechanism of Action 7
12.2 Pharmacodynamics 7
12.3 Pharmacokinetics 8
13 NONCLINICAL TOXICOLOGY 8
14 CLINICAL STUDIES 8
16 HOW SUPPLIED/STORAGE AND HANDLING 9
17 PATIENT COUNSELING INFORMATION 9
**Sections or subsections omitted from the full prescribinginformation are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
UDENYCA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients withnon-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significantincidence of febrile neutropenia [see Clinical Studies (14)].
Limitations of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem celltransplantation.
2 DOSAGE AND ADMINISTRATION
2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
The recommended dosage of UDENYCA is a single subcutaneous injection of 6 mg administered once perchemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1. Do not administerUDENYCA between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
2.2 Administration
UDENYCA is administered subcutaneously via a single-dose prefilled syringe for manual use.Prior to use‚ remove the carton from the refrigerator and allow the UDENYCAprefilled syringe to reach roomtemperature for a minimum of 30 minutes. Discard any prefilled syringe left at room temperature for greater than 48hours.
Visually inspect parenteral drug products (prefilled syringe) for particulate matter and discoloration prior toadministration, whenever solution and container permit. Do not administer UDENYCA if discoloration or
particulates are observed.
The needle cap on the prefilled syringe is not made with natural rubber latex.
Pediatric Patients weighing less than 45 kg
The UDENYCA prefilled syringe is not designed to allow for direct administration of doses less than 0.6 mL (6mg). The syringe does not bear graduation marks which are necessary to accurately measure doses of UDENYCAless than 0.6 mL (6 mg) for direct administration to patients. Thus, the direct administration to patients requiring
dosing of less than 0.6 mL (6 mg) is not recommended due to the potential for dosing errors. Refer to Table 1.
Table 1. Dosing of UDENYCA for pediatric patients weighing less than 45 kg
Body Weight UDENYCA Dose Volume to Administer
Less than 10 kg* See below* See below*
10 – 20 kg 1.5 mg 0.15 mL
21 – 30 kg 2.5 mg 0.25 mL
31 – 44 kg 4 mg 0.4 mL
*For pedi |
