resence 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. 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
IMMUNE SYSTEM DISORDERS: Serum sickness, Hypersensitivity
METABOLISM AND NUTRITION DISORDERS: Shock hypoglycemia, Fluid overload, 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, 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.
OVERDOSAGE
No data are available on experiences of overdosage with EXTRANEAL. 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, continued peritoneal dialysis with glucose-based solutions should be provided.
DOSAGE AND ADMINISTRATION
EXTRANEAL is intended for intraperitoneal administration only. 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.
Not for intravenous injection.
Patients should be carefully monitored to avoid under- or over-hydration. An accurate fluid balance record must be kept and the patient’s body weight monitored to avoid potentially severe consequences including congestive heart failure, volume depletion, and hypovolemic shock.
Aseptic technique should be used throughout t
