Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PEGFILGRASTIM (UNII: 3A58010674) (PEGFILGRASTIM - UNII:3A58010674)
Pfizer Laboratories Div Pfizer Inc
SUBCUTANEOUS
PRESCRIPTION DRUG
NYVEPRIA is 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 [see Clinical Studies (14)] . Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)] . Risk Summary Although available data with NYVEPRIA or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. These studies have not establishe
NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard. The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex. NYVEPRIA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01). NYVEPRIA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe. Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
Biologic Licensing Application
NYVEPRIA- PEGFILGRASTIM-APGF INJECTION, SOLUTION PFIZER LABORATORIES DIV PFIZER INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NYVEPRIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NYVEPRIA. NYVEPRIA™ (PEGFILGRASTIM-APGF) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2020 NYVEPRIA (pegfilgrastim-apgf) is biosimilar* to NEULASTA (pegfilgrastim) (1) RECENT MAJOR CHANGES Warnings and Precautions, Thrombocytopenia (5.7) 04/2021 Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (5.10) 04/2021 INDICATIONS AND USAGE NYVEPRIA 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) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (1) DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy • • • 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 • • • • • • • 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 PFIZER INC. AT 1-800-438-1985 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 6 mg administered subcutaneously once per chemotherapy cycle. (2.1) Do not administer between 14 days before and 24 hours afte Lesen Sie das vollständige Dokument