HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use UDENYCA safely and effectively. See full prescribing
information for UDENYCA.
UDENYCATM(pegfilgrastim-cbqv)injection, for subcutaneous
use
INITIAL U.S. APPROVAL: 2018
UDENYCA (pegfilgrastim-cbqv) is biosimilar* to Neulasta
(pegfilgrastim) for the indications listed. (1)
INDICATIONS AND USAGE
UDENYCA is a leukocyte growth factor indicated to decrease theincidence of infection, as manifested by febrile neutropenia, inpatients with non-myeloid malignancies receivingmyelosuppressive anti-cancer drugs associated with aclinically significant incidence of febrile neutropenia. (1)
Limitations of Use
UDENYCA is not indicated for the mobilization of peripheralblood progenitor cells for hematopoietic stem cell transplantation.
DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy
•6 mg administered subcutaneously once per chemotherapycycle. (2.1)
•Do not administer between 14 days before and 24 hours afteradministration of cytotoxic chemotherapy. (2.1)
•Use weight based dosing for pediatric patients weighing lessthan 45 kg; refer to Table 1. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL in a single-dose prefilled syringe formanual use only. (3)
CONTRAINDICATIONS
Patients with a history of serious allergic reaction to humangranulocyte colony-stimulating factors such as pegfilgrastim orfilgrastim products. (4)
WARNINGS AND PRECAUTIONS
•Fatal splenic rupture: eva luate patients who report left upperabdominal or shoulder pain for an enlarged spleen or splenicrupture (5.1)
•Acute respiratory distress syndrome (ARDS): eva luatepatients who develop fever, lung infiltrates, or respiratorydistress. Discontinue UDENYCA in patients with ARDS.
•Serious allergic reactions, including anaphylaxis:Permanently discontinue UDENYCA in patients with seriousallergic reactions. (5.3)
•Fatal sickle cell crises: Have occurred. (5.4)
•Glomerulonephritis: eva luate and consider dose-reduction orinterruption of UDENYCA if causality is likely. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5% difference in incidencecompared to placebo) are bone pain and pain in extremity. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contactCoherus Biosciences 1-800-4UDENYCA (1-800-483-3692) orFDA at 1-800-FDA-1088 or www.fda.gov/medwatchSee 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.
* Biosimilar means that the biological product is approved basedon data demonstrating that it is highly similar to an FDA-approvedbiological product, known as a reference product, and that there areno clinically meaningful differences between the biosimilarproduct and the reference product. Biosimilarity of UDENYCA
has been demonstrated for the condition(s) of use (e.g.indication(s), dosing regimen(s), strength(s), dosage form(s), androute(s) of administration) described in its Full PrescribingInformation.
Revised: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS**
FULL PRESCRIBING INFORMATION 2
1 INDICATIONS AND USAGE 2
2 DOSAGE AND ADMINISTRATION 2
2.1 Patients with Cancer Receiving Myelosuppressive
Chemotherapy 2
2.2 Administration 2
3 DOSAGE FORMS AND STRENGTHS 3
4 CONTRAINDICATIONS 3
5 WARNINGS AND PRECAUTIONS 3
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