Rx Item-Stimufend 6 Mg/0.6Ml Syg 0.6ml By Fresenius Pharma Gen Neulasta

Clinical Information Gen. Code and Des. 83790 pegfilgrastim-fpgk SUBCUT SYRINGE 6 MG/0.6ML GCN and Des. 52848 pegfilgrastim-fpgk SUBCUT SYRINGE 6 MG/0.6ML Strength 6MG Dose Form SYRINGE (ML) Product Category RX Pharmaceuticals Fine Line Class 850085008510 All Rx Products DEA Class NC OMP Family AHFS Class 20160000 HEMATOPOIETIC AGENTS Active Ingredients 19167 pegfilgrastim-fpgk Inactive Ingredients 2551 polysorbates 9005645 2599 sorbitol 50704 8921 latex These highlights do not include all the information needed to use STIMUFEND safely and effectively. See full prescribing information for STIMUFEND. STIMUFEND® (pegfilgrastim-fpgk) injection, for subcutaneous use Initial U.S. Approval: 2022 STIMUFEND (pegfilgrastim-fpgk) is biosimilar* to NEULASTA (pegfilgrastim) RECENT MAJOR CHANGES Indications and Usage, Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome (1.2) 9/2023 Dosage and Administration, Patients with Hematopoietic Subsyndrome of Acute radiation Syndrome (2.2) 9/2023 INDICATIONS AND USAGE Stimufend 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) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Stimufend 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. (2.3) Patients acutely exposed to myelosuppressive doses of radiation Two doses, 6 mg each, administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. (2.2) Use weight-based dosing for pediatric patients weighing less than 45 kg; refer to Table 1. (2.3) DOSAGE FORMS AND STRENGTHS Injection: 6 mg/0.6 mL solution in a single-dose pre-filled 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 Stimufend in patients with ARDS. (5.2) Serious allergic reactions, including anaphylaxis: Permanently discontinue Stimufend in patients with serious allergic reactions. (5.3) Fatal sickle cell crises: Discontinue Stimufend if sickle cell crisis occurs. (5.4) Glomerulonephritis: Evaluate and consider dose- reduction or interruption of Stimufend 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 Stimufend 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 Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. * 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 Stimufend 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. Revised: 9/2023

Stimufend 6 Mg/0.6Ml
NDC No.65219-0371-10 65219-371-10 65219037110 6521937110 UPC No.: 3-65219-37110-6 365219-371106 365219371106

Stimufend 6 Mg/0.6Ml
NDC No.65219-0371-10 65219-371-10 65219037110 6521937110 UPC No.: 3-65219-37110-6 365219-371106 365219371106

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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Fylnetra 6 Mg/0.6Ml Syg 0.6ml
NDC No.70121-1627-01 70121-1627-1 70121162701 7012116271 UPC No.: 3-70121-16271-1 370121162711 370121-162711

Fylnetra 6 Mg/0.6Ml Syg 0.6ml
NDC No.70121-1627-01 70121-1627-1 70121162701 7012116271 UPC No.: 3-70121-16271-1 370121162711 370121-162711

Nyvepria 6 Mg/0.6Ml Syg 0.6ml
NDC No.00069-0324-01 00069-324-01 00069032401 0006932401 UPC No.: 3-00069-32401-2 300069324012 300069324012

Nyvepria 6 Mg/0.6Ml Syg 0.6ml
NDC No.00069-0324-01 00069-324-01 00069032401 0006932401 UPC No.: 3-00069-32401-2 300069324012 300069324012