Assessment of the Efficacy of Intravenous Iron Therapy (Venofer®) in the Treatment of Iron Deficiency Anemia (IDA)

Patients with iron deficiency anemia (IDA) who need intravenous iron are normally treated with iron dextran. One of the major side effects of iron dextran is severe (sometimes fatal) anaphylactic reaction, which can develop in about 1% of patients. On the other hand, iron sucrose (Venofer®) another intravenous iron preparation that has improved safety and ease of administration. This preparation is being used in dialysis patients with very good results. But this has never been formally evaluated in non-dialysis-dependent patients. In view of these issues with iron dextran, some non-dialysis dependent patients in the Hematology/Oncology clinic at Coney Island hospital with IDA who needed parental iron therapy for IDA (due to intolerance or poor response to oral iron) were offered treatment with Venofer®^. Our study is done to assess the response of intravenous iron therapy Venofer® in non-dialysis dependent patients with IDA.

Consecutive patients who were treated with Venofer® for IDA in the Hematology/Oncology clinic in Coney Island Hospital, Brooklyn, New York, USA were obtained medical records. The number of cases included in the study was 42. Charts of these patients were reviewed and key data were collected before the start of treatment and weekly after starting the treatment. Response was defined as an increase in the hemoglobin level of 2 g/dl or greater after starting the treatment. At the same time, the reason for starting the IV iron therapy and the toxicity associated with treatment was evaluated. The paired t test was used to assess hemoglobin response.

Patients received 200 mg by of Venofer® by slow IV push every week. Analysis showed that 35 out of 42 patients (83.3%) received 4 doses. The mean increase in hemoglobin level after 4 doses was 1.65±0.98 g/dl (P=0.00002). 7 out of 35 patients achieved increase of 2 g/dl or greater in hemoglobin level (response rate of 20%). 13 out of 42 patients (30.9%) continued to receive Venofer® up to 8 doses. The mean increase in hemoglobin level after 8 doses of treatment was 2.66±1.73 g/dl (P=0.00001). 11 out of 13 patients who received 8 doses achieved a hemoglobin increase of 2 g/dl or greater (response rate of 84.6%). Indications for starting IV iron for 12 patients was intolerance to oral iron due to GI side effects, for 24 patients it was no response with oral therapy, for 3 patients it was general malabsorption and other 3 patients due to non-compliance. Among all the patients studied, none had any complications related to intravenous iron.

Our data showed that intravenous the iron prepration, Venofer®, which is currently not the standard of care for treatment of IDA in non-dialysis-dependent patients has very good response (response rate of 20% after 4 cycles and 84.6 % after 8 cycles). It is well tolerated and has no major side effects. More studies needs to be done with larger number of patients, with attention to both medical and economic impact, before this can become a stanadard of care for non-dialysis-dependent patients with IDA, who do not respond or have intolerance to oral iron preprations.

Off Label Use: Venofer® for iron deficiency anemia in non-dialysis dependent patients.