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Sevelamer Pregnancy and Breastfeeding Warnings

Sevelamer is also known as: Renagel, Renvela

Sevelamer Pregnancy Warnings

Recommended for use during pregnancy when benefit outweighs risk AU TGA pregnancy category: B3 US FDA pregnancy category: C

In rabbit studies, a slight increase in early resorptions occurred at doses approximately twice the maximal clinical trial dose based on body surface area (BSA). In rats, reduced or irregular ossification of fetal bones occurred probably due to a reduced absorption of fat-soluble vitamin D. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Sevelamer Breastfeeding Warnings

The non-absorbed nature of this drug makes its excretion in human breast milk unlikely. No adequate and controlled studies have been conducted in nursing mothers.

Benefit should outweigh risk Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Renvela (sevelamer)." Genzyme Corporation, Cambridge, MA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Renagel (sevelamer)." Genzyme Corporation, Cambridge, MA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Renvela (sevelamer)." Genzyme Corporation, Cambridge, MA.
  2. "Product Information. Renagel (sevelamer)." Genzyme Corporation, Cambridge, MA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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