Oprelvekin - Contraindications and Precautions

Contraindications and Precautions

• Patients with known hypersensitivity to Oprelvekin itself or any other ingredient.

• Patients with severe or decompensated heart failure should not be treated, because Oprelvekin may cause excessive fluid retention with edema and cardiac decompensation. Patients with compensated heart disease should be treated with caution and under permanent clinical supervision.

• Neumega is not indicated following myeloablative chemotherapy (increased likelihood of severe side-effects) and in pediatric patients.

• Renal impairment : Neumega is excreted renally. No differences of pharmakinetic parameters and clinical differences have been seen in mild to moderate impairment. Severe impairment has led to an increased number of patients with reduced hemoglobin due to dilutional anemia. Patients with severely disturbed renal function should be monitored very closely.

• The efficacy of Oprelvekin has not been systematically studied in patients receiving chemotherapy regimes of more than 5 days duration/each cycle or in those regimes containing agents that induce delayed thrombocytopenia (e.g. nitrosoureas, mitomycin C. Neumega should not be given in these cases.