Safety and efficacy of iron sucrose in patients sensitive to iron dextran:North American Clinical Trial

Sensitivity to iron dextran is a potent obstacle to maintaining optimum iro n status in patients with dialysis-associated anemia. As part of the North American clinical trials for iron sucrose injection, we examined the effect of intravenous (IV) iron sucrose in 23 hemodialysis patients with document ed sensitivity to iron dextran, ongoing epoetin alfa therapy, and below-tar get-range hemoglobin (Hgb) levels (<11.0 g/dL), We assigned patients to tre atment groups according to whether reactions they had experienced to iron d extran were judged to be mild (n = 16; group A) or severe (n = 7; group B). We prospectively examined adverse events and vital signs after administeri ng 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment s essions and compared results with those recorded in each of three consecuti ve dialysis sessions without iron treatment. We administered iron sucrose b y IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients. We did not admini ster a test dose. Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose (184 doses by IV push, 39 doses by IV in fusion). Intradialytic blood pressure changes after IV iron sucrose injecti on did not differ from those recorded during dialysis sessions without trea tment. An increase in values for Hgb, hematocrit, transferrin saturation, a nd ferritin, coupled with no significant change in epoetin dose and a decre ase in total iron-binding capacity, confirmed the efficacy of iron sucrose injection in managing anemia. We conclude that iron sucrose injection is sa fe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion. (C) 2000 by the National Kidney Foundation, Inc.