Pregnancy Cat

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Pegfilgrastim should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.Nursing Mothers: It is not known whether Pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.

Precautions

Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in patients with left upper abdominal or shoulder pain.
Acute Respiratory Distress Syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Pegfilgrastim in patients with ARDS.
Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Pegfilgrastim in patients with serious allergic reactions.

Overdose Effects

The maximum amount of Pegfilgrastim that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum Absolute Neutrophil Count (ANC) of 55x109/L, with a corresponding mean maximum WBC of 67x109/L. The absolute maximum ANC observed was 96x109/L with a corresponding absolute maximum WBC observed of 120x109/L.

Drug Classes

Hematopoietic drug

Storage Conditions

Pegfilgrastim should be stored in a refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light

Composition

n/a

Mode Of Action

Pegfilgrastim, a Granulocyte Colony-Stimulating Factor (G-CSF) is a pegylated glycoprotein that regulates the production and release of functional neutrophils from bone marrow. Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (Filgrastim) and monomethoxy polyethylene glycol. Filgrastim is a water soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD) and a 20 kD monomethoxy polyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

Reconstitution

n/a