Skip to Content

Label Changes for:

Prismasol and Phoxillum Renal Replacement Solution

July 2016

Changes have been made to the 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)

July 2016


  • PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.


Electrolyte and Volume Abnormalities (revised)
  • PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs and outputs, potassium, phosphorous, other electrolytes and acid-base balance throughout the procedure. Abnormalities may be corrected by changing the formulation of replacement solution and/or dialysate, supplementation, or adjusting flow rates appropriately.
  • PHOXILLUM replacement solutions contain hydrogen phosphate, a weak acid that may increase the risk of metabolic acidosis.


The following adverse reactions have been identified with other similar products and therefore, may occur with use of these products:

  • Metabolic acidosis
  • Hypotension
  • Acid-base disorders
  • Electrolyte imbalance
  • Hyperphosphatemia (for phosphate containing solutions)
  • Fluid imbalance


  • As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter.