Pegfilgrastim-Unne (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTION.
Routes of administration: SOLUTION.
Brand Names
- ARMLUPEG
Contraindications
Armlupeg 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 factor that acts 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.