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Extraneal

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Extraneal

Extraneal Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Extraneal (icodextrin) is a peritoneal dialysis solution used in peritoneal dialysis that lasts 8 hours or longer (also called the long dwell exchange). Common side effects include stomach pain, nausea, headache, or new or worsening cough.

The dose of Extraneal is individualized. It should be administered only as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8- to 16- hours. Extraneal may interact with adefovir, blood pressure medications, digoxin, entecavir, insulin, metformin, or HIV or AIDS medications. Tell your doctor all medications and supplements you use. During pregnancy, Extraneal should be used only if prescribed. It is unknown if this drug will harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Extraneal (icodextrin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Extraneal in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using icodextrin and call your doctor at once if you have a serious side effect such as:

  • fever, stomach pain, redness, or cloudy drained fluid;
  • flu symptoms;
  • chest pain;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild stomach pain, nausea;
  • headache; or
  • new or worsening cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Extraneal (Icodextrin Peritoneal Dialysis Solution) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Extraneal FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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)

  EXTRANEAL Control
N = 493 N = 347
Peritonitis 26% 25%
Upper respiratory infection 15% 13%
Hypertension 13% 8%
Rash 10% 5%
Headache 9% 7%
Abdominal pain 8% 6%
Flu syndrome 7% 6%
Nausea 7% 5%
Cough increase 7% 4%
Edema 6% 5%
Accidental injury 6% 4%
Chest Pain 5% 4%
Dyspepsia 5% 4%
Hyperglycemia 5% 4%

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.

Peritoneal Dialysis-Related

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).

Changes in Alkaline Phosphatase and Serum Electrolytes

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) .

Read the entire FDA prescribing information for Extraneal (Icodextrin Peritoneal Dialysis Solution) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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