Iron sucrose Pregnancy and Breastfeeding Warnings

Iron sucrose is also known as: Venofer

Iron sucrose Pregnancy Warnings

Patients with gestational iron-deficiency anemia that was refractive to oral iron replacement therapy were randomly assigned to receive intravenously administered iron sucrose or iron sucrose plus recombinant human erythropoietin in a Swiss study. Forty patients were randomized to the two treatment arms. Erythropoietin 300 units/kg plus iron sucrose 200 mg administered intravenously were given twice a week to one group of 20 women and iron sucrose only to the other. The therapy was continued until patients reached target hemoglobin values of 11.0 g/dL or until 4 weeks of therapy had been completed. Women receiving the combination therapy reached target hemoglobin levels in an average of 18 days as opposed to 25 days in the single agent group. One woman in the combination group and 5 women in the other group had not reached the target value after 4 weeks of therapy. The therapy was well tolerated with no serious side effects noted. All red blood cell indices and clinical parameters were normal in all neonates. Fifty patients with gestational iron-deficiency anemia involved in a random, prospective, open study were divided into two equal groups. Each group was administered either iron sucrose intraveneously or oral iron therapy. The hemoglobin level at 6-month gestational ranged between 8 and 10 g/dL for all participants. The IV group received 6 doses of weight based iron sucrose using the formula: pre-pregnancy weight x (target hemoglobin - actual hemoglobin) x 0.24 + 500 mg, rounded up to the nearest 100 mg. Doses were administered days 1, 4, 8, 12, 15, and 21. The oral group received iron sulfate 80 mg three times a day plus folic acid 15 mg daily for four weeks. Forty-seven patients completed the study. The 3 patients who did not complete the study did so for reasons unrelated to iron administration. All participants reached target hemoglobin level by day 30. The IV group showed a change in hemoglobin from 9.6 +/- 0.79 g/dL to 11.11 +/- 1.3 g/dL on day 30. The oral group showed a change in hemoglobin from 9.7 +/- 0.5 g/dL to 11 +/- 1.25 g/dL on day 30. The therapies were well tolerated with no serious side effects noted. Birth weight, hemoglobin, and ferritin level were normal for all neonates.

Iron sucrose has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There is minimal controlled data in human pregnancy. Iron sucrose should only be given during pregnancy when the need has been clearly established. The use of iron sucrose with and without recombinant human erythropoietin has been studied in the treatment of gestational iron-deficiency anemia.

Iron sucrose Breastfeeding Warnings

There are no data on the excretion of iron sucrose into human milk. Caution is recommended by the manufacturer when administering iron sucrose to nursing women.

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