CMP Pharma issued the following announcement on Feb. 27.
Specialty pharmaceutical company CMP Pharma, Inc. announced today that its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019. This will provide Health Care Providers, for the first time, an FDA approved potassium phosphates injection. The availability of this product will help alleviate supply concerns from previous market shortages of this critical phosphate repletion treatment. CMP Pharma's Potassium Phosphates Injection will be available from National and Regional wholesalers.
Potassium Phosphates Injection is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. Additionally, it is indicated as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
For more information, contact CMP Pharma at 252-753-7111.
About this Product
CMP's Potassium Phosphates Injection provides a stable, reliable, and easy-to-dose therapeutic option to healthcare professionals. Many practitioners and pharmacists are unaware that all current potassium phosphates formulations on the market today are products that have not been approved by the FDA. These unapproved products have not undergone FDA's review process for quality, safety and efficacy and therefore can expose patients, as well as physicians, to unknown risks.
A major concern with the unapproved potassium phosphates formulations is aluminum toxicity. The FDA has established allowable limits for aluminum in injectable products, and current unapproved potassium phosphates injectable products on the market significantly exceed these limits.
CMP's Potassium Phosphates Injection will help address the critical demand for potassium phosphates while providing physicians and their patients with a product that meets FDA standards for quality, safety and efficacy.
Important Safety Information
INDICATIONS AND USAGE
POTASSIUM PHOSPHATES INJECTION is a phosphorus replacement product indicated as a source of phosphorus:
- in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.
- for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.
- Limitations of Use: Safety has not been established for parenteral nutrition in adults weighing less than 45 kg or pediatric patients less than 12 years of age or weighing less than 40 kg due to the risk of aluminum toxicity.
- hyperkalemia
- hyperphosphatemia
- hypercalcemia or significant hypocalcemia
- severe renal impairment (eGFR less than 30 mL/min/1.73m2) and 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 with drugs that increase potassium. Patients with cardiac disease may be more susceptible. Do not exceed the maximum daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion.
- Hyperphosphatemia and Hypocalcemia: 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: Infuse concentrated or hypertonic solutions through a central catheter.
Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.
DOSAGE AND ADMINISTRATION
- Administer intravenously only after dilution or admixing in a larger volume of fluid.
- POTASSIUM PHOSPHATES INJECTION provides phosphorus 3 mmol/mL (potassium 4.7 mEq/mL).
- Monitor serum phosphorus, potassium, calcium, and magnesium concentrations.
- See full prescribing information for instructions on preparation and administration.
Adverse reactions are hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia.
To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About CMP Pharma, Inc.
CMP Pharma is a specialty pharmaceutical company that addresses critical needs for niche markets by developing and manufacturing a portfolio of high value pharmaceutical products, including liquids and semi-solids. CMP Pharma combines decades of experience in pharmaceutical development and manufacturing to provide medicines to fill the unmet medical needs of many patients.
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