Rx Item-Fulphila 6 Mg/0.6Ml Syg 0.6ml By Biocon Biologics

These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA® (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA® (pegfilgrastim-jmdb) is biosimilar* to NEULASTA® (pegfilgrastim). (1) RECENT MAJOR CHANGES Warnings and Precautions, Thrombocytopenia (5.7) 03/2021 Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (5.10) 03/2021 INDICATIONS AND USAGE Fulphila 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 Fulphila 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 Fulphila in patients with ARDS. (5.2) • Serious allergic reactions, including anaphylaxis: Permanently discontinue Fulphila in patients with serious allergic reactions. (5.3) • Fatal sickle cell crises: Discontinue Fulphila if sickle cell crisis occurs. (5.4) • Glomerulonephritis: Evaluate and consider dose-reduction or interruption of Fulphila 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 Fulphila 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 Biocon Biologics Inc. at 1-833-986-1468 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *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 Fulphila 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. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2023

Fulphila 6 Mg/0.6Ml Syg 0.6ml
Fulphila 6 Mg/0.6Ml Syg 0.6ml By Biocon Biologics Fulphila biosimilar to Neulasta Sy 6Mg/0.6Ml 0.6Ml Item No.:RX720240 NDC No.RX83257-0005-41 83257-005-41 83257000541 8325700541 UPC No.: 3-83257-0

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