Icodextrin Peritoneal Dialysis Solution

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Extraneal (icodextrin peritoneal dialysis solution) was originally studied in controlled clinical trials of 493 patients with end-stage renal disease who received a single daily exchange of Extraneal (icodextrin peritoneal dialysis solution) for the long dwell (8-to 16- hours). There were 215 patients exposed for at least 6 months and 155 patients exposed for at least one year. The population was 18-83 years of age, 56% male and 44% female, 73% Caucasian, 18% Black, 4% Asian, 3% Hispanic, and it included patients with the following comorbid conditions: 27% diabetes, 49% hypertension and 23% hypertensive nephropathy.

Rash was the most frequently occurring Extraneal (icodextrin peritoneal dialysis solution) -related adverse event (5.5%, Extraneal (icodextrin peritoneal dialysis solution) ; 1.7% Control). Seven patients on Extraneal (icodextrin peritoneal dialysis solution) discontinued treatment due to rash, and one patient on Extraneal (icodextrin peritoneal dialysis solution) discontinued due to exfoliative dermatitis. The rash typically appeared within the first three weeks of treatment and resolved with treatment discontinuation or, in some patients, with continued treatment.

Female patients reported a higher incidence of skin events, including rash, in both Extraneal (icodextrin peritoneal dialysis solution) and dextrose control treatment groups.

Table 1 shows the adverse events reported in these clinical studies, regardless of causality, occurring in ≥ 5% of patients and more common on Extraneal (icodextrin peritoneal dialysis solution) than control.

Table 1 - Adverse Experiences in ≥ 5 % of Patients and More Common on EXTRANEAL (icodextrin peritoneal dialysis solution)

Adverse reactions reported with an incidence of > 5% and at least as common on dextrose control included pain, asthenia, exit site infection, infection, back pain, hypotension, diarrhea, vomiting, nausea/vomiting, anemia, peripheral edema, hypokalemia, hyperphosphatemia, hypoproteinemia, hypervolemia, arthralgia, dizziness, dyspnea, skin disorder, pruritis.

Additional adverse events occurring at an incidence of < 5% and that may or may not have been related to Extraneal (icodextrin peritoneal dialysis solution) include: pain on infusion, abdominal enlargement, cloudy effluent, ultrafiltration decrease, postural hypotension, heart failure, hyponatremia, hypochloremia, hypercalcemia, hypoglycemia, alkaline phosphatase increase, SGPT increase, SGOT increase, cramping, confusion, lung edema, facial edema, exfoliative dermatitis, eczema, vesicobullous rash, maculopapular rash, erythema multiforme. All reported events are included in the list except those already listed in Table 1 or the following two paragraphs, those not plausibly associated with Extraneal (icodextrin peritoneal dialysis solution) , and those that were associated with the condition being treated or related to the dialysis procedure.

Extraneal (icodextrin peritoneal dialysis solution) was additionally studied in a subpopulation of 92 high average/high transporter APD patients in a two-week controlled clinical trial where patients received a single daily exchange of Extraneal (icodextrin peritoneal dialysis solution) (n=47) or dextrose control (n=45) for the long dwell (14 ±2 hours). Consistent with the data reported in the original trials of Extraneal (icodextrin peritoneal dialysis solution) , rash was the most frequently occurring event.

Adverse events common to the peritoneal dialysis, including peritonitis, infection around the catheter, fluid and electrolyte imbalance, and pain, were observed at a similar frequency with Extraneal and Controls (See PRECAUTIONS).

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

Decreases in serum sodium and chloride have been observed in patients using Extraneal (icodextrin peritoneal dialysis solution) . 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 patients' serum electrolyte levels as part of routine blood chemistry testing is recommended.

Post-Marketing

The following adverse reactions have been identified during post-approval use of Extraneal (icodextrin peritoneal dialysis solution) . Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse reactions are listed by MedDRA System Order Class (SOC), followed by Preferred Term in order of severity.

INFECTIONS AND INFESTATIONS: Fungal peritonitis, Peritonitis bacterial, Catheter site infection, Catheter related infection

BLOOD AND LYMPHATIC SYSTEM DISORDERS: Thrombocytopenia, Leukopenia, Leukocytosis

IMMUNE SYSTEM DISORDERS: Leukocytoclastic vasculitis, Serum sickness, Hypersensitivity

METABOLISM AND NUTRITION DISORDERS: Shock hypoglycemia, Fluid overload, Dehydration, Fluid imbalance

NERVOUS SYSTEM DISORDERS: Hypoglycemic coma, Burning sensation

EYE DISORDERS: Vision blurred

RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Stridor

GASTROINTESTINAL DISORDERS: Sclerosing encapsulating peritonitis, Aseptic peritonitis, Peritoneal cloudy effluent, Ileus, Ascites, Inguinal hernia, Abdominal discomfort

SKIN AND SUBCUTANEOUS DISORDERS: Toxic epidermal necrolysis, Erythema multiforme, Angioedema, Urticaria generalized, Toxic skin eruption, Swelling face, Periorbital edema, Exfoliative rash, Skin exfoliation, Prurigo, Rash (including macular, papular, erythematous, exfoliative), Dermatitis (including allergic and contact), Drug eruption, Erythema, Onychomadesis, Dry skin, Skin chapped, Blister

MUSCULOSKELETAL, CONNECTIVE TISSUE DISORDERS: Arthralgia, Back pain, Musculoskeletal pain

REPRODUCTIVE SYSTEM AND BREAST DISORDERS: Penile edema, Scrotal edema

GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS: Discomfort, Pyrexia, Chills, Malaise, Drug effect decreased, Drug ineffective, Catheter site erythema, Catheter site inflammation, Infusion related reaction (including Infusion site pain, Instillation site pain)

Drug Abuse And Dependence

There has been no observed potential of drug abuse or dependence with Extraneal (icodextrin peritoneal dialysis solution) .

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.

No data are available on experiences of overdosage with Extraneal (icodextrin peritoneal dialysis solution) . Overdosage of Extraneal would be expected to result in higher levels of serum icodextrin and metabolites, but it is not known what signs or symptoms might be caused by exposure in excess of the exposures used in clinical trials. In the event of overdosage with Extraneal (icodextrin peritoneal dialysis solution) , continued peritoneal dialysis with glucose-based solutions should be provided.

Mechanism of Action

Extraneal (icodextrin peritoneal dialysis solution) is an isosmotic peritoneal dialysis solution containing glucose polymers (icodextrin) as the primary osmotic agent. Icodextrin functions as a colloid osmotic agent to achieve

ultrafiltration during long peritoneal dialysis dwells. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, Extraneal (icodextrin peritoneal dialysis solution) also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status.

Pharmacokinetics of Icodextrin

Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. In a single-dose pharmacokinetic study using Extraneal (icodextrin), a median of 40% (60 g) of the instilled icodextrin was absorbed from the peritoneal solution during a 12-hour dwell. Plasma levels of icodextrin rose during the dwell and declined after the dwell was drained. Peak plasma levels of icodextrin plus its metabolites (median Cpeak 2.2g/L) were observed at the end of the long dwell exchange (median T^ = 13 hours).

At steady-state, the mean plasma level of icodextrin plus its metabolites was about 5 g/L. In multidose studies, steady-state levels of icodextrin were achieved within one week. Plasma levels of icodextrin and metabolites return to baseline values within approximately two weeks following cessation of icodextrin administration.

Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization (DP), including maltose (DP2), maltotriose (DPS), maltotetraose (DP4), and higher molecular weight species. In a single dose study, DP2, DPS and DP4 showed a progressive rise in plasma concentrations with a profile similar to that for total icodextrin, with peak values reached by the end of the dwell and declining thereafter. Only very small increases in blood levels of larger polymers were observed. Steady-state plasma levels of icodextrin metabolites were achieved within one week and stable plasma levels were observed during long-term administration.

Some degree of metabolism of icodextrin occurs intraperitoneally with a progressive rise in the concentration of the smaller polymers in the dialysate during the 12-hour dwell.

Icodextrin undergoes renal elimination in direct proportion to the level of residual renal function. Diffusion of the smaller icodextrin metabolites from plasma into the peritoneal cavity is also possible after systemic absorption and metabolism of icodextrin.

Special Populations

The influence of age on the pharmacokinetics of icodextrin and its metabolites was not assessed.

The influence of gender and race on the pharmacokinetics of icodextrin and its metabolites was not assessed.

Clinical Studies

Extraneal (icodextrin peritoneal dialysis solution) has demonstrated efficacy as a peritoneal dialysis solution in clinical trials of approximately 480 patients studied with end-stage renal disease (ESRD).

In the active-controlled trials of one to six months in duration, described below, Extraneal (icodextrin peritoneal dialysis solution) used once-daily for the long dwell in either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) therapy resulted in higher net ultrafiltration than 1.5% and 2.5% dextrose solutions, and higher creatinine and urea nitrogen clearances than 2.5% dextrose. Net ultrafiltration was similar to 4.25% dextrose across all patients in these studies. Effects were generally similar in CAPD and APD.

In an additional randomized, multicenter, active-controlled two-week study in high average/high transporter APD patients, Extraneal (icodextrin peritoneal dialysis solution) used once daily for the long dwell produced higher net ultrafiltration compared to 4.25% dextrose. Mean creatinine and urea nitrogen clearances were also greater with Extraneal (icodextrin peritoneal dialysis solution) and ultrafiltration efficiency was improved.

In 175 CAPD patients randomized to Extraneal (icodextrin peritoneal dialysis solution) (N=90) or 2.5% dextrose solution (N=85) for the 8-15 hour overnight dwell for one month, mean net ultrafiltration for the overnight dwell was significantly greater in the Extraneal (icodextrin peritoneal dialysis solution) group at weeks 2 and 4 (Figure 1). Mean creatinine and urea nitrogen clearances were also greater with Extraneal (icodextrin peritoneal dialysis solution) (Figure 2).

Figure 1 - Mean Net Ultrafiltration for the Overnight Dwell

Figure 2 - Mean Creatinine and Urea Nitrogen Clearance for the Overnight Dwell

In another study of 39 APD patients randomized to Extraneal (icodextrin peritoneal dialysis solution) or 2.5% dextrose solution for the long, daytime dwell (10-17 hours) for three months, the net ultrafiltration reported during the treatment period was (mean ± SD) 278 ± 192 mL for the Extraneal (icodextrin peritoneal dialysis solution) group and -138 ± 352 mL for the dextrose group (p < 0.001). Mean creatinine and urea nitrogen clearances were significantly greater for Extraneal (icodextrin peritoneal dialysis solution) than 2.5% dextrose at weeks 6 and 12 (p < 0.001).

In a six-month study in CAPD patients comparing Extraneal (icodextrin peritoneal dialysis solution) (n=28) with 4.25% dextrose (n=31), net ultrafiltration achieved during an 8-hour dwell averaged 510 mL for Extraneal (icodextrin peritoneal dialysis solution) and 556 mL for 4.25% dextrose. For 12-hour dwells, net ultrafiltration averaged 575 mL for Extraneal (icodextrin peritoneal dialysis solution) (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-hour D/D0 ratio < 0.34, as defined by the peritoneal equilibration test (PET)), comparing Extraneal (icodextrin peritoneal dialysis solution) (n=47) to 4.25% dextrose (n=45), after adjusting for baseline, the mean net ultrafiltration achieved during a 14 ± 2 hour dwell was significantly greater in the Extraneal (icodextrin peritoneal dialysis solution) group than the 4.25% dextrose group at weeks 1 and 2 (p < 0.001, see Figure 3). Consistent with increases in net ultrafiltration, there were also significantly greater creatinine and urea nitrogen clearances and ultrafiltration efficiency in the Extraneal (icodextrin peritoneal dialysis solution) group (p < 0.001, see Figure 3).

Figure 3 - Mean Net Ultrafiltration, Creatinine and Urea Nitrogen Clearances and Ultrafiltration Efficiency for the Long Dwell in High Average/High Transporter Patients

Peritoneal Membrane Transport Characteristics: After one year of treatment with Extraneal (icodextrin peritoneal dialysis solution) during the long dwell exchange, there were no differences in membrane 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 (icodextrin peritoneal dialysis solution) or 2.5% dextrose solution for the long dwell.

MEDICATION GUIDE

Extraneal
(X-tra-neel)
(icodextrin) Peritoneal Dialysis Solution

Read the Medication Guide that comes with Extraneal (icodextrin peritoneal dialysis solution) before you begin treatment and each time you receive a carton of Extraneal (icodextrin peritoneal dialysis solution) . There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about Extraneal?

Extraneal (icodextrin) contains maltose, which can react with certain blood glucose (blood sugar) monitors and test strips.

• Using Extraneal (icodextrin peritoneal dialysis solution) may cause a false (incorrect) high blood sugar reading or may hide a blood sugar reading that is actually very low. This can happen if you use a glucose monitor or test strips with glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase (GDO).
  This kind of false reading means that your blood sugar may really be too low even though the test says that it is normal or high. This can lead to dangerous side effects.
• You could accidentally wait too long to treat your low blood sugar if you have low blood sugar and do not use the right kind of monitor and test strips.
• You could accidentally take too much insulin if you have a false high blood sugar reading.
• Taking too much insulin or waiting too long to treat low blood sugar can cause you to have serious reactions including: loss of consciousness (passing out), coma, permanent neurological problems, or death.
• You must only use a specific glucose monitor and test strips if you have high blood sugar or diabetes and monitor your blood glucose.
• Do not use blood glucose monitors or test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ) or glucose-dye-oxidoreductase (GDO).
• You, or your nurse or doctor should call the manufacturer of your blood glucose monitor and test strips to make sure that the maltose in Extraneal (icodextrin) will not affect your blood sugar test results.
• If you are hospitalized or go to an emergency room, tell the hospital staff that you use Extraneal (icodextrin peritoneal dialysis solution) so that they use the right kind of blood sugar monitor and test strips for you.
• You can get information on glucose monitor and test strip methods from their manufacturers. For a list of toll free numbers for glucose monitor and test strip manufacturers, you can ask your doctor or go to www.glucosesafety.com.

What is Extraneal (icodextrin peritoneal dialysis solution) ?

Extraneal (icodextrin peritoneal dialysis solution) is a prescription peritoneal dialysis solution. Extraneal (icodextrin peritoneal dialysis solution) draws fluid and wastes from your bloodstream into your peritoneal cavity (the space inside your abdomen). The fluids and wastes are removed from your body when the Extraneal (icodextrin peritoneal dialysis solution) solution is drained.

Extraneal (icodextrin peritoneal dialysis solution) is for the long dwell exchange (8 hours to 16 hours) in peritoneal dialysis. The long dwell is the exchange that lasts 8 hours or more:

• the nighttime exchange if you are on continuous ambulatory peritoneal dialysis (CAPD)
• the daytime exchange if you are using a cycler

Extraneal (icodextrin peritoneal dialysis solution) is not for intravenous injection (injection into a vein). It is not known if Extraneal (icodextrin peritoneal dialysis solution) is safe and works in children.

Who should not use Extraneal (icodextrin peritoneal dialysis solution) ?

Do not use Extraneal (icodextrin peritoneal dialysis solution) if:

• you have a glycogen storage disease
• you do not tolerate maltose or isomaltose
• you have severe lactic acidosis
• you are allergic to cornstarch or icodextrin

What should I tell my doctor before using Extraneal (icodextrin peritoneal dialysis solution) ?

Extraneal (icodextrin peritoneal dialysis solution) may not be right for you. Before using Extraneal (icodextrin peritoneal dialysis solution) , tell your doctor about all your medical conditions, including if you:

• have a condition that affects your nutrition, or you are not able to eat well
• have a lung or breathing problem
• have low potassium levels in your blood
• have high calcium levels in your blood
• have low magnesium levels in your blood
• have had recent aortic graft surgery
• have had stomach area (abdomen):
  • surgery in the past 30 days
  • tumors
  • open wounds
  • hernia
  • infection
• are pregnant or plan to become pregnant. It is not known if Extraneal (icodextrin peritoneal dialysis solution) will harm your unborn baby.
• are breast-feeding. It is not known if Extraneal (icodextrin peritoneal dialysis solution) passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. The dose of certain medicines may need to be changed when you use Extraneal (icodextrin peritoneal dialysis solution) . Especially tell your doctor if you take:

• insulin
• blood pressure medicine
• digoxin (Lanoxicaps, Lanoxin, Lanoxin Pediatric)

Know the medicines you take. Keep a list of them and show your doctor and pharmacist when you get a new medicine.

How should I use Extraneal (icodextrin peritoneal dialysis solution) ?

• Use Extraneal (icodextrin peritoneal dialysis solution) exactly as prescribed by your doctor.
• Use Extraneal (icodextrin peritoneal dialysis solution) only for your long dwell exchange, and not more than 1 exchange in 24 hours.

Follow the steps that you learned in your peritoneal dialysis training to do your Extraneal (icodextrin peritoneal dialysis solution) exchange.

• To open Extraneal (icodextrin peritoneal dialysis solution) , tear the overwrap at the slit and remove the bag of solution.
• Before using Extraneal (icodextrin peritoneal dialysis solution) , always check to make sure:
• the bag does not leak. A small amount of moisture inside the overwrap is normal. Firmly squeeze the bag to check for small leaks.
• the expiration date has not passed. Do not use Extraneal (icodextrin peritoneal dialysis solution) after the expiration date shown on the carton and product label.
• Look at the bag to make sure the solution is clear and does not contain particles. Do not use a bag of Extraneal (icodextrin peritoneal dialysis solution) if it is cloudy or contains particles.
• Before using Extraneal (icodextrin peritoneal dialysis solution) , you may warm the bag in the overpouch, to make it more comfortable. Only use dry heat, such as a heating pad, to warm the Extraneal (icodextrin peritoneal dialysis solution) solution to 98.6° F (37 °C).
• Do not microwave Extraneal (icodextrin peritoneal dialysis solution) . You can damage the solution if it gets hotter than 104°F (40°C).
• To avoid an increased risk of infection, do not put Extraneal (icodextrin peritoneal dialysis solution) in water to heat the bag.
• To prevent a serious infection, you must:
  • clean (disinfect) your work surface (where you set your PD supplies) before starting your exchange.
  • use the technique that you were shown in your peritoneal dialysis training to prevent contamination with bacteria (aseptic technique), when making connections.
• If you use a manual method of peritoneal dialysis (CAPD), infuse Extraneal (icodextrin peritoneal dialysis solution) over 10 to 20 minutes at a rate that is comfortable for you
• When you drain the fluid after the dwell, check the drained fluid for cloudiness or fibrin. Fibrin looks like clumps or stringy material in the drained solution. Cloudy drained fluid or fibrin may mean that you have an infection. Call your doctor if your drained fluid is cloudy or contains fibrin.
• Regularly check and write down your fluid balance and weight to avoid having too much or too little fluid in your body (over-hydration or dehydration). This can help lessen the chance of serious side effects, such as heart failure and shock.
• Call your dialysis center or doctor if you need more help or have any questions. . If you infuse too much Extraneal (icodextrin peritoneal dialysis solution) , your stomach area (abdomen) may look large, and you may feel “full” or feel short of breath. If this happens, drain the Extraneal (icodextrin peritoneal dialysis solution) solution from your peritoneal cavity.
• Talk to your doctor before adding any other medicines to Extraneal (icodextrin peritoneal dialysis solution) .
• Throw away any unused Extraneal (icodextrin peritoneal dialysis solution) . Do not use your Extraneal (icodextrin peritoneal dialysis solution) solution more than one time.

What are possible side effects of Extraneal (icodextrin peritoneal dialysis solution) ?

See “What is the most important information I should know about Extraneal (icodextrin peritoneal dialysis solution) ?”

Common side effects of Extraneal (icodextrin peritoneal dialysis solution) include:

• rash. Rash usually happens during the first 3 weeks of treatment and may go away when treatment stops. Rash is more common in women.
• infection in the peritoneal cavity (peritonitis). Peritonitis is common in people on peritoneal dialysis. Tell your doctor right away if you have any pain, redness, fever, or cloudy drained fluid.
• high blood pressure
• headache
• stomach area (abdomen) pain
• increased cough
• flu-like symptoms
• nausea
• swelling
• chest pain
• upset stomach
• high blood sugar

These are not all the possible side effects of Extraneal (icodextrin peritoneal dialysis solution) . For more information, ask your doctor or dialysis center.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Extraneal (icodextrin peritoneal dialysis solution) ?

• Store Extraneal (icodextrin peritoneal dialysis solution) at 68°F to 77°F (20° to 25°C).
• Keep Extraneal (icodextrin peritoneal dialysis solution) in the moisture barrier overpouch in the carton until ready to use.
• Do not warm Extraneal (icodextrin peritoneal dialysis solution) above 104°F (40°C).
• Do not freeze Extraneal (icodextrin peritoneal dialysis solution) .

General information about Extraneal (icodextrin peritoneal dialysis solution)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Extraneal (icodextrin peritoneal dialysis solution) for a condition for which it was not prescribed. Do not give Extraneal (icodextrin peritoneal dialysis solution) to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Extraneal (icodextrin peritoneal dialysis solution) . If you would like more information, talk with your doctor. You can ask your doctor for information about Extraneal (icodextrin peritoneal dialysis solution) that is written for healthcare professionals. You can also find out more about Extraneal (icodextrin peritoneal dialysis solution) by calling your doctor or visiting the website www.renalinfo.com.

You should not use this medication if you are allergic to icodextrin or cornstarch, or if you have:

• maltose or isomaltose intolerance;
• severe lactic acidosis; or
• a glycogen storage disease (an inherited metabolic disorder).

If you have diabetes and you test your blood sugar using a glucose monitor and test strips, ask a doctor or pharmacist about the best type to use. Certain glucose monitors and test strips must not be used while you are being treated with icodextrin. Tell any doctor who treats you that you are using icodextrin.

Before using icodextrin, tell your doctor if any of the following conditions have recently affected your stomach area: surgery, tumors, hernia, infection, or open wounds.

To make sure you can safely use icodextrin, tell your doctor if you have any of these other conditions:

• a breathing disorder;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood;)
• high levels of calcium in your blood;
• high blood pressure, congestive heart failure;
• a stomach or intestinal condition such as inflammatory bowel disease, diverticulitis, or if you have a colostomy or ileostomy;
• if you are malnourished or cannot eat; or
• if you have recently had aortic graft surgery.

FDA pregnancy category C. It is not known whether icodextrin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether icodextrin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.