Antidote (Phosphate Binder)
PREGNANCY RECOMMENDATION: No Human Data—Animal Data Suggest Moderate Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of sevelamer in human pregnancy have been located. The limited animal data suggest a moderate risk of toxicity that may be partially due to a deficiency of fat-soluble vitamins, such as vitamin D. The effect of sevelamer on the absorption of vitamins in pregnant women has not been studied (1). However, supplementation with higher oral doses of vitamins, especially fat-soluble vitamins (except vitamin A), might be required or IV vitamins should be considered.
FETAL RISK SUMMARY
Sevelamer is a polymeric phosphate binder that is administered orally. It is used in patients with end-stage renal disease for the reduction of serum phosphorus. The drug inhibits intestinal phosphate absorption by binding phosphorus. Sevelamer is not absorbed into the systemic circulation (1).
Reproduction studies have been conducted in rats and rabbits. No evidence of impaired fertility was observed in male and female rats. In pregnant rats, doses about 15 times the human dose (HD) or higher caused reduced or irregular ossification of fetal bones. The toxicity was thought to be due to reduced absorption of vitamin D. In rabbits, a dose about 10 times the HD caused an increased incidence of early resorptions, resulting in a slight increase in prenatal mortality (1).
BREASTFEEDING SUMMARY
No reports describing the use of sevelamer during human lactation have been located. The drug is not absorbed into the systemic circulation, but it may cause vitamin deficiencies in the mother by preventing intestinal vitamin absorption, especially of fat-soluble vitamins. Because vitamins are excreted into breast milk, thereby further reducing maternal vitamin concentrations, women who are taking sevelamer might have to take higher oral doses of vitamins, especially fat-soluble vitamins (except vitamin A), or IV vitamin administration should be considered.
Reference
1.Product information. Renagel. Genzyme, 2004.