Active Ingredient: Lipegfilgrastim
Lipegfilgrastim is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 6 milligrams lipegfilgrastim, one dose.
The recommended dose is 6 mg of lipegfilgrastim for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
In clinical studies with a limited number of elderly patients, there was no relevant age-related difference with regard to the efficacy or safety profiles of lipegfilgrastim. Therefore, no adjustment of the dose is necessary for elderly patients.
The lipegfilgrastim solution is to be injected subcutaneously (SC). The injection should be given into the abdomen, upper arm or thigh.
For:
Regimen A, in the case that patient age in years is ≥ 2 and patient weight is < 10 kg :
Subcutaneous, 0.6 milligrams lipegfilgrastim, one dose.
Regimen B, in the case that patient age in years is ≥ 2 and patient weight is ≥ 10 kg and patient weight is < 20 kg :
Subcutaneous, 1.5 milligrams lipegfilgrastim, one dose.
Regimen C, in the case that patient age in years is ≥ 2 and patient weight is ≥ 20 kg and patient weight is < 30 kg :
Subcutaneous, 2.5 milligrams lipegfilgrastim, one dose.
Regimen D, in the case that patient age in years is ≥ 2 and patient weight is ≥ 30 kg and patient weight is < 45 kg :
Subcutaneous, 4 milligrams lipegfilgrastim, one dose.
Regimen E, in the case that patient age in years is ≥ 2 and patient weight is ≥ 45 kg :
Subcutaneous, 6 milligrams lipegfilgrastim, one dose.
The recommended dose of lipegfilgrastim for paediatric patients is based on body weight according to the table below:
Recommended dose in children 2 years of age and older:
| Body weight (kg) | Dose (for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy) |
| <10 | 0.6 mg (0.06 ml) |
| ≥10 to <20 | 1.5 mg (0.15 ml) |
| ≥20 to <30 | 2.5 mg (0.25 ml) |
| ≥30 to <45 | 4.0 mg (0.40 ml) |
| ≥45 | 6.0 mg (0.60 ml) |
The lipegfilgrastim solution is to be injected subcutaneously (SC). The injection should be given into the abdomen, upper arm or thigh.
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