Renvela Use In Pregnancy & Lactation





DCH Auriga - Healthcare
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data from the use of sevelamer in pregnant women. Animal studies have shown some reproductive toxicity when sevelamer was administered to rats at high doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see Pharmacology: Toxicology: Preclinical safety data under Actions and Precautions). The potential risk to humans is unknown. Renvela should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Breast-feeding: It is unknown whether sevelamer/metabolites are excreted in human milk. The non-absorbed nature of sevelamer indicates that excretion of sevelamer in breast milk is unlikely. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Renvela should be made taking into account the benefit of breast-feeding to the child and the benefit of Renvela therapy to the woman.
Fertility: There are no data from the effect of sevelamer on fertility in humans. Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative body surface area.
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