LAKE ZURICH, Ill., May 7, 2020 – Fresenius Kabi announced today the immediate availability in the United States of Potassium Phosphates Injection, USP in the following presentations: 15 mM per 5 mL, 45 mM per 15 mL and 150 mM per 50 mL.
Potassium Phosphates Injection, USP is indicated as a source of phosphate for addition to large-volume intravenous fluids to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. In its use to treat potassium and phosphorus deficiencies, Potassium Phosphates Injection, USP is often administered in conjunction with parenteral nutrition treatments.
“Fresenius Kabi is pleased to offer health care providers flexibility and choice with the introduction of three FDA-approved presentations of Potassium Phosphates Injection to support their clinical needs,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are proud to continue to supply the widest array of Potassium Phosphates Injection dosage options among all NDA-approved suppliers.”
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.
About Potassium Phosphates Injection, USP
Potassium Phosphates Injection, USP is a phosphorus replacement product indicated as a source of phosphorus:
- In intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated
- For parental nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated
Important Safety Information
Administer intravenously only after dilution or admixing in a larger volume of fluid. Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). Potassium Phosphates Injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL; otherwise, use an alternative source of phosphorus. Monitor serum phosphorus, potassium, calcium, and magnesium concentrations.
Potassium Phosphates Injection is contraindicated in patients with hyperkalemia, hyperphosphatemia, hypercalcemia or significant hypocalcemia and severe renal impairment (eGFR less than 30 mL/min/1.73m2) or end stage renal disease.
Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration: Administer only after dilution or admixing; do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion.
Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
Hyperkalemia: Increased risk in patients with renal impairment, severe adrenal insufficiency, or treated concurrently with other drugs that increase potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin, or the immunosuppressants tacrolimus and cyclosporine). Patients with cardiac disease may be more susceptible to the effects of hyperkalemia. Do not exceed the maximum age-appropriate recommended daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion.
Hyperphosphatemia and Hypocalcemia: Obtain serum calcium concentration prior to administration. Monitor serum phosphorus and calcium concentrations during and following infusion.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
Hypomagnesemia: Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.
Vein Damage and Thrombosis: Potassium Phosphates Injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition. It is not for direct intravenous infusion. If thrombophlebitis develops, remove the catheter as soon as possible and initiate appropriate medical treatment.
Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.
Drug Interactions: Use of other medications that increase potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin, or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia. Avoid use of Potassium Phosphates Injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.
This Important Safety Information does not include all the information needed to use Potassium Phosphates Injection safely and effectively. Please see accompanying full prescribing information for Potassium Phosphates Injection. Full prescribing information is also available at www.fresenius-kabi.com/us.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Potassium Phosphate Injection safely and effectively. Please see the full prescribing information for Potassium Phosphate Injection at https://tinyurl.com/y76c6eor.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.