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Extraneal

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Extraneal

Extraneal

WARNINGS

Dangerous Drug-Device Interaction

(See Boxed Warning)

Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal (icodextrin) Peritoneal Dialysis Solution. Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods must not be used. In addition, some blood glucose monitoring systems using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based methods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and test strips has resulted in falsely elevated glucose readings (due to the presence of maltose, see Drug/Laboratory Test Interactions). Falsely elevated glucose readings have led patients or health care providers to withhold treatment of hypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognized hypoglycemia, which has led to loss of consciousness, coma, permanent neurological damage, and death. Plasma levels of Extraneal (icodextrin) and its metabolites return to baseline within approximately 14 days following cessation of Extraneal (icodextrin) administration. Therefore falsely elevated glucose levels may be measured up to two weeks following cessation of Extraneal (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors and test strips are used.

Because GDH-PQQ, GDO, and GDH-FAD-based blood glucose monitors may be used in hospital settings, it is important that the health care providers of peritoneal dialysis patients using Extraneal (icodextrin) carefully review the product information of the blood glucose testing system, including that of test strips, to determine if the system is appropriate for use with Extraneal (icodextrin).

To avoid improper insulin administration, educate patients to alert health care providers of this interaction whenever they are admitted to the hospital.

The manufacturers) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose readings. For a list of toll free numbers for glucose monitor and test strip manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visit www.glucosesafety.com.

Extraneal (icodextrin peritoneal dialysis solution) is intended for intraperitoneal administration only. Not for intravenous injection.

Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including Extraneal (icodextrin). Infrequent but fatal outcomes have been reported.

If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to the identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Rarely, serious hypersensitivity reactions to Extraneal (icodextrin peritoneal dialysis solution) have been reported such as toxic epidermal necrolysis, angioedema, serum sickness, erythema multiforme and leukocytoclastic vasculitis. If a serious reaction is suspected, discontinue Extraneal (icodextrin peritoneal dialysis solution) and institute appropriate treatment as clinically indicated.

Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions (See CONTRAINDICATIONS). It is recommended that patients with conditions known to increase the risk of lactic acidosis [e.g., acute renal failure, inborn errors of metabolism, treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.

When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides. For example, rapid potassium removal may create arrhythmias in cardiac patients using digitalis or similar drugs; digitalis toxicity may be masked by hyperkalemia, hypermagnesemia, or hypocalcemia. Correction of electrolytes by dialysis may precipitate signs and symptoms of digitalis excess. Conversely, toxicity may occur at suboptimal dosages of digitalis if potassium is low or calcium high.

PRECAUTIONS

General

Peritoneal Dialysis-Related

The following conditions may predispose to adverse reactions to peritoneal dialysis procedures: abdominal conditions, including uncorrectable mechanical defects that prevent effective PD or increase the risk of infection, disruption of the peritoneal membrane and diaphragm by surgery, congenital anomalies or trauma prior to complete healing, abdominal tumors, abdominal wall infections, hernias, fecal fistula, colostomies or ileostomies, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity, such as documented loss of peritoneal function or extensive adhesions that compromise peritoneal function. Conditions that preclude normal nutrition, impaired respiratory function, recent aortic graft placement, and potassium deficiency may also predispose to complications of peritoneal dialysis.

Aseptic technique should be employed throughout the peritoneal dialysis procedure to reduce the possibility of infection.

Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

Overinfusion of peritoneal dialysis solution volume into the peritoneal cavity may be characterized by abdominal distention, feeling of fullness and/or shortness of breath. Treatment of overinfusion is to drain the peritoneal dialysis solution from the peritoneal cavity.

Need for Trained Physician

Treatment should be initiated and monitored under the supervision of a physician knowledgeable in the management of patients with renal failure.

A patient's volume status should be carefully monitored to avoid hyper- or hypovolemia and potentially severe consequences including congestive heart failure, volume depletion and hypovolemic shock. An accurate fluid balance record must be kept and the patient's body weight monitored.

Significant losses of protein, amino acids, water-soluble vitamins and other medicines may occur during peritoneal dialysis. The patient's nutritional status should be monitored and replacement therapy should be provided as necessary.

In patients with hypercalcemia, particularly in those on low-calcium peritoneal dialysis solutions, consideration should be given to the fact that Extraneal (icodextrin peritoneal dialysis solution) 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 (icodextrin peritoneal dialysis solution) . Appropriate monitoring of blood glucose should be performed and insulin dosage adjusted if needed (See WARNINGS; 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 (icodextrin peritoneal dialysis solution) . 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 (icodextrin peritoneal dialysis solution) interferes with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ), glucose-dye-oxidoreductase (GDO), and some glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD)-based blood glucose measurements, patients must be instructed to use only glucose-specific glucose monitors and test strips (See WARNINGS; Drug/Laboratory Test Interactions).

A Patient Medication Guide is provided in each carton of Extraneal (icodextrin peritoneal dialysis solution) .

Laboratory Tests

Serum Electrolytes

Decreases in serum sodium and chloride have been observed in patients using Extraneal (icodextrin peritoneal dialysis solution) . The mean change in serum sodium from baseline to the last study visit was -2.8 mmol/L for patients on Extraneal (icodextrin peritoneal dialysis solution) and -0.3 mmol/L for patients on control solution. Four Extraneal (icodextrin peritoneal dialysis solution) 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 (icodextrin peritoneal dialysis solution) 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 (icodextrin peritoneal dialysis solution) does not contain potassium. Evaluate 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 evaluation of serum and total body potassium, and only under the direction of a physician.

Fluid, hematology, blood chemistry, electrolyte concentrations, and bicarbonate should be monitored periodically. If serum magnesium levels are low, magnesium supplements may be used.

Alkaline Phosphatase

An increase in mean serum alkaline phosphatase has been observed in clinical studies of ESPJ) patients receiving Extraneal (icodextrin peritoneal dialysis solution) . No associated increases in liver function tests were observed. Serum alkaline phosphatase levels did not show evidence of progressive increase over a 12-month study period. Levels returned to normal approximately two weeks after discontinuation of Extraneal (icodextrin peritoneal dialysis solution) .

There were individual cases where increased alkaline phosphatase was associated with elevated AST (SGOT), but neither elevation was considered causally related to treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Icodextrin did not demonstrate evidence of genotoxicity potential in in vitro bacterial cell reverse mutation assay (Ames test); in vitro mammalian cell chromosomal aberration assay (CHO cell assay); and in the in vivo micronucleus assay in rats. Long-term animal studies to evaluate the carcinogenic potential of Extraneal or icodextrin have not been conducted. Icodextrin is derived from maltodextrin, a common food ingredient.

A fertility study in rats where males and females were treated for four and two weeks, respectively, prior to mating and until day 17 of gestation at up to 1.5 g/kg/day (1/3 the human exposure on a mg/m2 basis) revealed slightly low epididymal weights in parental males in the high dose group as compared to Control. Toxicological significance of this finding was not evident as no other reproductive organs were affected and all males were of proven fertility. The study demonstrated no effects of treatment with icodextrin on mating performance, fertility, litter response, embryo-fetal survival, or fetal growth and development.

Pregnancy

Pregnancy Category C

Complete animal reproduction studies including in utero embryofetal development at appreciable multiples of human exposure have not been conducted with Extraneal or icodextrin. Thus it is not known whether icodextrin or Extraneal (icodextrin peritoneal dialysis solution) solution can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Extraneal (icodextrin peritoneal dialysis solution) should only be utilized in pregnant women when the need outweighs the potential risks.

Nursing Mothers

It is not known whether icodextrin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Extraneal (icodextrin peritoneal dialysis solution) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No formal studies were specifically carried out in the geriatric population. However, 140 of the patients in clinical studies of Extraneal (icodextrin peritoneal dialysis solution) were age 65 or older, with 28 of the patients age 75 or older. No overall differences in safety or effectiveness were observed between these patients and patients under age 65. Although clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.

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