vised: 12/2016
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING
FROM DRUG-DEVICE INTERACTION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
2.2 Directions for Use
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Allergy to Cornstarch or Icodextrin
4.2 Metabolic Diseases
4.3 Severe Lactic Acidosis
5 WARNINGS AND PRECAUTIONS
5.1 Unrecognized Hypoglycemia Resulting From Drug-Device
Interaction
5.2 REMS Program for EXTRANEAL
5.3 Peritonitis and Encapsulating Peritoneal Sclerosis
5.4 Hypersensitivity Reactions
5.5 Lactic Acidosis
5.6 Overinfusion
5.7 Electrolyte, Fluid, and Nutrition Imbalances
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Ultrafiltration, Urea and Creatinine Clearance
14.2 Peritoneal Membrane Transport Characteristics
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information arenot listed.
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FULL PRESCRIBING INFORMATION
WARNING: UNRECOGNIZED HYPOGLYCEMIA RESULTING FROM DRUG-DEVICE INTERACTION
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 dehydrogenasepyrroloquinolinequinone (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 (GDHFAD)-basedmethods must not be used. Use of GDH-PQQ, GDO, and GDH-FAD-based glucose monitors and teststrips has resulted in falsely elevated glucose readings (due to the presence of maltose) [see Warnings and Precautions(5.1)].
Falsely elevated glucose readings have led patients or health care providers to withhold treatment ofhypoglycemia or to administer insulin inappropriately. Both of these situations have resulted in unrecognizedhypoglycemia, 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 twoweeks following cessation of EXTRANEAL (icodextrin) therapy when GDH-PQQ, GDO, and GDH-FAD-based blood
glucose monitors and test strips are used.
To avoid improper insulin administration, educate all patients to alert health care providers of this interactionparticularly in hospital settings.
The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causesinterference or falsel |
