Pegfilgrastim-cbqv
Generic Name: pegfilgrastim-cbqv
Brand Names:
Udenyca
11 DESCRIPTION Pegfilgrastim-cbqv 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 a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene.
Overview
11 DESCRIPTION Pegfilgrastim-cbqv 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 a molecular weight of approximately 19 kilodaltons (kDa). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene.
Uses
1 INDICATIONS AND USAGE UDENYCA 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 UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Dosage
2 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 .
Side Effects
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 Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Allergies to Acrylics [see Warnings and Precautions ( 5.4 )] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.5 )] Glomerulonephritis [see Warnings and Precautions ( 5.6 )] Leukocytosis [see Warnings and Precautions ( 5.7 )] Thrombocytopenia [see Warnings and Precautions ( 5.8 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.9 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precau...
Warnings
5 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 UDENYCA in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions. ( 5.3 ) The on-body injector for UDENYCA uses acrylic adhesives. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. ( 5.4 ) Fatal sickle cell crises: Discontinue UDENYCA if sickle cell crisis occurs. 4 CONTRAINDICATIONS UDENYCA 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 )] . Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Although available data with UDENYCA 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 established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING UDENYCA single-dose prefilled syringe for manual use UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe containing 6 mg pegfilgrastim-cbqv, supplied with a 29-gauge, 1⁄2-inch needle with an UltraSafe Passive ™ Needle Guard.
Frequently Asked Questions
What is Pegfilgrastim-cbqv used for?▼
1 INDICATIONS AND USAGE UDENYCA 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 UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
What are the side effects of Pegfilgrastim-cbqv?▼
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 Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Allergies to Acrylics [see Warnings and Precautions ( 5.4 )] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.5 )] Glomerulonephritis [see Warnings and Precautions ( 5.6 )] Leukocytosis [see Warnings and Precautions ( 5.7 )] Thrombocytopenia [see Warnings and Precautions ( 5.8 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.9 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precau...
Can I take Pegfilgrastim-cbqv during pregnancy?▼
8.1 Pregnancy Risk Summary Although available data with UDENYCA 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 established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.
What are the important warnings for Pegfilgrastim-cbqv?▼
5 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 UDENYCA in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions. ( 5.3 ) The on-body injector for UDENYCA uses acrylic adhesives. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction. ( 5.4 ) Fatal sickle cell crises: Discontinue UDENYCA if sickle cell crisis occurs. 4 CONTRAINDICATIONS UDENYCA 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 )] . Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.