AL (n=28) with 4.25% dextrose (n=31), netultrafiltration achieved during an 8-hour dwell averaged 510 mL for EXTRANEAL and 556 mL for 4.25% dextrose.
For 12-hour dwells, net ultrafiltration averaged 575 mL for EXTRANEAL (n=29) and 476 mL for 4.25% dextrose(n=31). There was no significant difference between the two groups with respect to ultrafiltration.
In a two week study in high average/high transporter APD patients (4-hour D/P creatinine ratio >0.70 and a 4-hourD/D0 ratio <0.34, as defined by the peritoneal equilibration test (PET)), comparing EXTRANEAL (n=47) to 4.25%dextrose (n=45), after adjusting for baseline, the mean net ultrafiltration achieved during a 14 2 hour dwell wassignificantly greater in the EXTRANEAL group than the 4.25% dextrose group at weeks 1 and 2 (p<0.001, seeFigure 2). Consistent with increases in net ultrafiltration, there were also significantly greater creatinine and ureanitrogen clearances and ultrafiltration efficiency in the EXTRANEAL group (p<0.001, see Figure 2).
Figure 2 – Mean Net Ultrafiltration, Creatinine and Urea Nitrogen Clearances and Ultrafiltration Efficiencyfor the Long Dwell in High Average/High Transporter Patients
14.2 Peritoneal Membrane Transport Characteristics
After one year of treatment with EXTRANEAL during the long dwell exchange, there were no differences inmembrane transport characteristics for urea and creatinine. The mass transfer area coefficients (MTAC) for urea, creatinine, and glucose at one year were not different in patients receiving treatment with EXTRANEAL or 2.5%
dextrose solution for the long dwell.
16. HOW SUPPLIED/STORAGE AND HANDLING
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:
Container Fill Volume NDC
ULTRABAG 2 L NDC 0941-0679-52
ULTRABAG 2.5 L NDC 0941-0679-53
AMBU-FLEX II 2 L NDC 0941-0679-06
AMBU-FLEX II 2.5 L NDC 0941-0679-05
Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.
Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].
Protect from freezing.
Store in moisture barrier overwrap and in carton until ready to use.
17. PATIENT COUNSELING INFORMATION
See Medication Guide. A Patient Medication Guide is provided in each carton of EXTRANEAL.
Inform patients of the following:
Only use glucose-specific monitors and test strips [see Boxed Warning]. Use of non-specific blood glucosemonitors and test strips has resulted in falsely elevated blood glucose readings due to the presence ofmaltose. Falsely elevated blood glucose readings have led patients or health care providers to withholdtreatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted inunrecognized hypoglycemia, which has led to loss of consciousness, coma, neurological damage, anddeath.
Serious allergic reactions have been observed in patients using EXTRANEAL. Patients should call theirdoctor or get medical help if they experience any of these symptoms during treatment with EXTRANEAL:
swelling of the face, eyes, lips, tongue, or mouth; trouble swallowing or breathing; skin rash, hives, sores inthe mouth, on eyelids, or in the eyes; or, if skin blisters or peels.
Peritonitis is a common side effect of patients on peritoneal dialysi |
