Neutromax Special Precautions

Malignant Cell Growth: Granulocyte-colony stimulating factor can promote growth of myeloid cells and some­ non-myeloid cells in vitro. The safety and efficacy of NEUTROMAX administration in patients with myelodysplasia, acute myelogenous leukemia and chronic myelogenous leukemia have not been established. Therefore because of the possibility of tumor growth, NEUTROMAX is not indicated in any malignancy with myeloid-characteristics. Clinical trials have not yet established whether NEUTROMAX influences the progression of myelodysplastic syndrome to acute myeloblastic leukemia. Therefore, NEUTROMAX is not indicated in any pre-malignant myeloid condition.
Leukocytosis: White blood cells counts of 100 x 10⁹/L or greater have been observed in less than 5% of patients receiving NEUTROMAX at doses above 0.3 M I.U./kg/day (3 µg/kg/day), although no other complication or side effects were reported. However, in view of the potential risks associated with severe leukocytosis, white blood cells counts should be performed at regular intervals during NEUTROMAX therapy. If leukocyte counts exceed 50 x 10⁹/L after the expected nadir, NEUTROMAX should be discontinued immediately.
Risks associated with increased doses of chemotherapy: Special caution should be used when treating patients with high dose chemotherapy, because improved therapeutic responses have not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurological and dermato­logical effects (please, refer to the prescribing information of the specific chemotherapy agents used).
Treatment with NEUTROMAX does not preclude thrombocytopenia and anaemia due to myelosuppressive chemotherapy. Because of the potential risks that result from the use of higher doses of chemotherapy during NEUTROMAX therapy (e.g. full doses of the prescribed schedule), the patient may be at greater risk of thrombocytopenia and anaemia.
Regular monitoring of platelet count and hematocrit is recommended, especially when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Other special precautions: Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with NEUTROMAX for more than 6 months.
Studies have not been performed with NEUTROMAX in patients with severe impairment of renal or hepatic functions and therefore its use in this patients group cannot be recommended. Likewise, the effects of NEUTROMAX in patients with substantially reduced myeloid progenitors have not been studied. NEUTROMAX acts primarily on neutrophil precursors to exert its effect in elevating neutrophil counts. Therefore, in patients with reduced precursors (such as those treated with extensive radiotherapy or chemotherapy), neutrophil response may be diminished.