Pill Identifier App

Label Changes for:

Extraneal (icodextrin) Peritoneal Dialysis Solution

April 2009

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

Sections Modified

Summary of Changes to Contraindications and Warnings

BOXED WARNING (New)

Dangerous Drug-Device Interaction

  • Blood glucose measurement in patients receiving Extraneal (icodextrin) must be done with a glucose specific method (monitor and test strips).
  • Blood glucose monitoring devices using glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ-) or glucose-dye-oxidoreductase (GDO)-based methods must not be used in patients receiving Extraneal (icodextrin).

CONTRAINDICATIONS

  • Extraneal (icodextrin) is contraindicated
    • ...in patients with maltose or isomaltose intolerance...
    • ...and in patients with pre-existing severe lactic acidosis

WARNINGS

  • Dangerous drug- device interaction
    • Only use glucose-specific monitors and test strips to measure blood glucose levels in patients using Extraneal...
    • Use of GDH-POO or GDO-based glucose monitors and test strips has resulted in falsely elevated glucose reading...and has 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...
  • Not for intravenous injection.
  • Encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy...
  • If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results...
  • Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions...
  • When prescribing the solution to be used for an individĂșal patient, consideration should be given to the potential interaction between...

PRECAUTIONS
General

  • Peritoneal Dialysis- Related
    • The following conditions may predispose to adverse reactions to peritoneal dialysis
      procedures...
    • 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

Laboratory Tests

  • In situations where there is -
    a normal serum potassium level or hypokalemia, addition of potassium chloride (up to a
    concentration of 4 mEqlL) 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 beused.

ADVERSE REACTIONS

  • Post-Marketing
    • 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.
Hide
(web2)