Eflapegrastim-Xnst (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: SUBCUTANEOUS.
Brand Names
- ROLVEDON
Indications and Usage
Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Contraindications
Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products. Reactions may include anaphylaxis [see Warnings and Precautions (5.3)].
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)] •Sickle cell crisis in patients with sickle cell disorders [see Warnings and Precautions (5.4)] •Glomerulonephritis [see Warnings and Precautions ( 5.5 )] •Leukocytosis [see Warnings and Precautions (5.6)] •Thrombocytopenia [see Warnings and Precautions (5.7)] •Capillary leak syndrome [see Warnings and Precautions (5.8)] •Potential for tumor growth stimulatory effects on malignant cells [see Warnings and Precautions (5.9)] •Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer [see Warnings and Precautions (5.10)] •Aortitis [see Warnings and Precautions (5.11)] •Nuclear Imaging [see Warnings and Precautions (5.12)]
Mechanism of Action
Eflapegrastim-xnst is a recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.
Overdosage
Overdose of Rolvedon may result in leukocytosis and bone pain. In the event of overdose, general supportive measures should be instituted as necessary. Monitor the patient for adverse reactions [see Adverse Reactions (6)].