Pegfilgrastim-Apgf (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- NYVEPRIA
Indications and Usage
Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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 Dosage and Administration (2.1) and Clinical Studies (14)].
Contraindications
NYVEPRIA is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included 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 Hypersensitivity Reactions [see Warnings and Precautions (5.3)] •Use 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 [see Warnings and Precautions (5.10)] •Acute Myeloid Leukemia [see Warnings and Precautions (5.10)] •Aortitis [see Warnings and Precautions (5.11)]
Mechanism of Action
Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
Overdosage
Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions [see Adverse Reactions (6)]. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.