In patients with hypercalcemia, particularly in those on low-calcium peritoneal dialysis solutions, consideration should be given to the fact that EXTRANEAL is not provided in a low-calcium electrolyte solution.

Solutions that are cloudy, contain particulate matter, or show evidence of leakage should not be used.

Insulin-dependent diabetes mellitus
Patients with insulin-dependent diabetes may require modification of insulin dosage following initiation of treatment with EXTRANEAL. Appropriate monitoring of blood glucose should be performed and insulin dosage adjusted if needed (See WARNINGS; PRECAUTIONS, Drug/Laboratory Test Interactions).

Information for Patients
Patients should be instructed not to use solutions if they are cloudy, discolored, contain visible particulate matter, or if they show evidence of leaking containers.

Aseptic technique should be employed throughout the procedure.

To reduce possible discomfort during administration, patients should be instructed that solutions may be warmed to 37°C (98°F) prior to use. Only dry heat should be used. It is best to warm solutions within the overwrap using a heating pad. To avoid contamination, solutions should not be immersed in water for warming. Do not use a microwave oven to warm EXTRANEAL. Heating the solution above 40°C (104°F) may be detrimental to the solution. (See DOSAGE AND ADMINISTRATION, Directions for Use).

Because the use of EXTRANEAL interferes with glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) and glucose-dye-oxidoreductase based blood glucose measurements, patients should be instructed to use only glucose-specific glucose monitors and test strips. (See WARNINGS; PRECAUTIONS, Drug/Laboratory Test Interactions).

A Patient Medication Guide is provided in each carton of EXTRANEAL.

Laboratory Tests

Serum Electrolytes
Decreases in serum sodium and chloride have been observed in patients using EXTRANEAL. The mean change in serum sodium from baseline to the last study visit was –2.8 mmol/L for patients on EXTRANEAL and –0.3 mmol/L for patients on control solution. Four EXTRANEAL patients and two control patients developed serum sodium < 125 mmol/L. The mean change in serum chloride from baseline to last study visit was –2.0 mmol/L for EXTRANEAL patients and + 0.6 mmol/L for control patients. Similar changes in serum chemistries were observed in an additional clinical study in a subpopulation of high average/high transporter patients. The declines in serum sodium and chloride may be related to dilution resulting from the presence of icodextrin metabolites in plasma. Although these decreases have been small and clinically unimportant, monitoring of the patients’ serum electrolyte levels as part of routine blood chemistry testing is recommended.

EXTRANEAL does not contain potassium. eva luate serum potassium prior to administering potassium chloride to the patient. In situations where there is a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a concentration of 4 mEq/L) to the solution may be necessary to prevent severe hypokalemia. This should be made under careful eva luation of serum and to