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).
- Extraneal (icodextrin) is contraindicated
- ...in patients with maltose or isomaltose intolerance...
- ...and in patients with pre-existing severe lactic acidosis
- 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 individúal patient, consideration should be given to the potential interaction between...
- Peritoneal Dialysis- Related
- The following conditions may predispose to adverse reactions to peritoneal dialysis
- 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
- 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.
- 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.