These highlights do not include all the information needed to use FYLNETRA safely and effectively. See full prescribing information for FYLNETRA.
FYLNETRA® (pegfilgrastim-pbbk) injection, for subcutaneous use.
Initial U.S. Approval: 2022
FYLNETRA (pegfilgrastim-pbbk) is biosimilar* to NEULASTA (pegfilgrastim)
INDICATIONS AND USAGE
FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1)
Limitations of Use
FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy
6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. (2.1)
Use weight based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. (3)
CONTRAINDICATIONS
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. (4)
WARNINGS AND PRECAUTIONS
Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.(5.1)
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue FYLNETRA in patients with ARDS. (5.2)
Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions. (5.3)
Fatal sickle cell crises: Discontinue FYLNETRA if sickle cell crisis occurs. (5.4)
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of FYLNETRA if causality is likely. (5.5)
Thrombocytopenia: Monitor platelet counts. (5.7)
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. (5.10)
ADVERSE REACTIONS
Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835 5472, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
* Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of FYLNETRA® has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration) described in its Full Prescribing Information. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2022
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Table of Contents
Table of Contents
1 INDICATIONS AND USAGE
1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy - FYLNETRA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid ...
2 DOSAGE AND ADMINISTRATION
2.1 Patients with Cancer Receiving - Myelosuppressive Chemotherapy - The recommended dosage of FYLNETRA is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For ...
3 DOSAGE FORMS AND STRENGTHS
FYLNETRA is a clear, colorless to slightly yellow, preservative-free solution available as: Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
4 CONTRAINDICATIONS
FYLNETRA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and ...
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture - Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who ...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1)] Acute Respiratory ...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy - Risk Summary - Although available data with FYLNETRA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major ...
10 OVERDOSAGE
Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim ...
11 DESCRIPTION
Pegfilgrastim-pbbk is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with ...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action - Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation ...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim products. Pegfilgrastim did not affect reproductive ...
14 CLINICAL STUDIES
14.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy - Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled ...
16 HOW SUPPLIED/STORAGE AND HANDLING
FYLNETRA single-dose prefilled syringe for manual use - FYLNETRA (pegfilgrastim-pbbk) injection is a clear, colorless to slightly yellow, preservative-free solution supplied in a prefilled ...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Advise patients of the following risks and potential risks with FYLNETRA: Splenic ...
PATIENT INFORMATION
FYLNETRA® (fil-ne-trah) (pegfilgrastim-pbbk) injection - Single-Dose Prefilled Syringe - What is FYLNETRA? FYLNETRA is a man-made form of granulocyte colony-stimulating factor ...
Instructions for Use
Instructions for Use - FYLNETRA® (fil-ne-trah) (pegfilgrastim-pbbk) Injection, for subcutaneous use - Single-Dose Prefilled Syringe - Guide to parts - Important: The needle is covered by ...
PRINCIPAL DISPLAY PANEL
carton ...
INGREDIENTS AND APPEARANCE
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