Administration of NEUTROMAX at the recommended dosage is frequently associated with musculoskeletal pain which is usually mild or moderate and generally controlled with analgesics. Its intensity is rarely severe.
Less frequent adverse events include urinary abnormalities (predominantly mild or moderate dysuria).
Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase, alkaline phosphatase, serum uric acid, and gamma-glutamyl transpeptidase may frequently occur.
White blood cell 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), though no apparent complications were reported.
NEUTROMAX does not increase the incidence of clinical side effects associated with cytotoxic chemotherapy.
Frequency of side effects reported in patients treated with Filgrastim/chemotherapy and placebo/chemotherapy was similar and included nausea and vomiting, alopecia, diarrhea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalized weakness, sore throat, constipation and unspecified pain. Vascular disorders (e.g. veno-occlusive disease and fluid volume disturbances) have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation, although the causal association with Filgrastim has not been established. Symptoms suggestive of allergic-type reactions have been reported in rare cases, approximately half of these were associated with the initial dose. Overall, reports were more common after i.v. administration. In some cases, rechallenge resulted in a recurrence of symptoms. Rare and sometimes fatal cases of interstitial pneumonia have been described with the use of NEUTROMAX after chemotherapy, particularly with regimens containing bleomycin, although no casual connection has been established.
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