Lupifil-P Special Precautions

The safety and efficacy of pegfilgrastim has not been investigated in patients receiving high dose chemotherapy.
Pegfilgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Clinical data suggest that the effect on time of recovery of severe neutropenia between pegfilgrastim and filgrastim is comparable in patients with de novo acute myeloid leukemia. However, the long term effect of pegfilgrastim has not been established in acute myeloid leukemia (AML) therefore, it should be used with caution in this patient population. The safety and efficacy of pegfilgrastim has not been investigated in patients with myelocysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients. The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. Lupifil-P (pegfilgrastim) contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. White blood cell (WBC) counts of 100 x 10⁹/L or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis have been reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of pegfilgrastim. Consistent with the clinical effects of pegfilgrastim and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 x 10⁹/L after the expected nadir, pegfilgrastim should be discontinued immediately.
Splenic Rupture is seen in very rare cases, in some cases fatal, have been reported following the administration of pegfilgrastim. Spleen size should be carefully monitored. Patients receiving pegfilgrastim who report left upper abdominal and/or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS) can occur in patients receiving pegfilgrastim. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving pegfilgrastim, for ARDS. Discontinue pegfilgrastim in patients with ARDS.
Serious Allergic Reactions including anaphylaxis, can occur in patients receiving pegfilgrastim. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue pegfilgrastim in patients with serious allergic reactions. Do not administer pegfilgrastim to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Severe Sickle Cell Crises can occur in patients with sickle cell disorders receiving pegfilgrastim. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte-colony stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim can act as a growth factor for certain tumor type including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved cannot be excluded.
Renal Impairment: Pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: There are insufficient data to recommend the use of pegfilgrastim in children and adolescents under 18 years of age.
Use in the Elderly: No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.