Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

Contraindications

4 CONTRAINDICATIONS EXTRANEAL is contraindicated in patients with: • known hypersensitivity to icodextrin [see Warnings and Precautions ( 5.3 )] • maltose or isomaltose intolerance • glycogen storage disease • severe lactic acidosis, as EXTRANEAL contains lactate which may contribute to worsening acidosis if conversion to bicarbonate is impaired and may be associated with hyperventilation, lethargy, hypotension or irregular heart rhythms. • Known hypersensitivity to icodextrin • Maltose or isomaltose intolerance • Glycogen storage disease • Pre-existing severe lactic acidosis

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary EXTRANEAL is a pharmacologically inactive solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of EXTRANEAL with monitoring of hematology, blood chemistry, and fluid status is not expected to cause fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.