FDA Approves Preservative-Free, Single-Dose Potassium Phosphates IV Injection Bags

The FDA approved the first presentation of preservative-free potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use bags, streamlining treatment administration to eliminate compounding steps, reduce preparation time, and enhance safety for clinicians. This approval represents a significant advancement in the field of phosphorus replacement therapy and marks the expansion of new formulation for phosphorus replacement therapy that improves overall pharmacy efficiency in clinical settings. By simplifying the administration process, reducing preparation time, and enhancing safety, this new formulation not only benefits clinicians but also improves the quality of care provided to patients.

Phosphate is vital for bone mineralization, nerve function, muscle contraction, and various cellular processes, including glycolysis and ATP production. Image Credit: © faizan muhammad - stock.adobe.com

Hypophosphatemia is characterized by a low level of phosphate in the blood and can be either a short-term (acute) or chronic condition, with varying degrees of severity. Phosphate is an essential electrolyte that plays a critical role in several physiological processes. It is vital for bone mineralization, nerve function, muscle contraction, and various cellular processes, including glycolysis and ATP production. The importance of phosphate extends to maintaining the structural integrity of bones and teeth, as well as supporting cellular energy metabolism. In cases of hypophosphatemia, low phosphate levels can lead to a range of symptoms, including muscle pain, weakness, and, in severe instances, complications such as respiratory or heart failure. Early detection and appropriate management are crucial to prevent these potentially serious outcomes.^1,2

Standard of care treatment for hypophosphatemia typically involves oral phosphate replacement medication to correct phosphate levels in the blood. This approach is often complemented by dietary recommendations, encouraging the intake of foods rich in phosphorus, such as dairy products, meats, and nuts. In many cases, oral supplements are effective in managing mild to moderate hypophosphatemia. However, when the condition is more severe or when patients cannot tolerate oral intake, intravenous phosphate replacement becomes necessary.¹

Phosphate replacement through an IV is generally reserved for severe cases of hypophosphatemia. It is especially indicated for patients exhibiting severe symptoms or when rapid correction of phosphate levels is required. Intravenous administration allows for controlled, immediate delivery of phosphate, which is essential in critical situations where timely intervention can prevent further complications.¹

Potassium phosphates in sodium chloride injection is a phosphorous replacement formulated to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement methods are not feasible. It is available as a single-dose infusion bag and can be stored at room temperature, simplifying the administration process and enhancing convenience for clinicians. Additionally, the formulation is latex- and preservative-free, making it a suitable option for individuals with sensitivities or allergies to these substances.^1,3

“We are pleased to offer this new differentiated injectable product to hospitals,” said Andy Boyer, executive vice president, chief commercial officer of Generics, in a press release. “This new IV parenteral infusion bag is preservative-free and can be stored at room temperature. With the addition of new 505(b)(2) injectables, we are meaningfully expanding our injectables portfolio.”³

REFERENCES

1. Hypophosphatemia. Cleveland Clinic. March 11, 2024. Accessed July 30, 2024. https://my.clevelandclinic.org/health/diseases/24040-hypophosphatemia

2. Physiology, phosphate. National Library of Medicine. August 28, 2023. Accessed July 30, 2024. https://www.ncbi.nlm.nih.gov/books/NBK560925/#:~:text=Cellular%20functions%3A%20In%20the%20cells,%2C%20e.g.%2C%20glycolysis%20and%20ammoniagenesis.

3. Amneal receives u.s. fda approval for potassium phosphates injection iv bags. Business Wire. July 29, 2024. Accessed July 30, 2024. https://www.businesswire.com/news/home/20240729345025/en/Amneal-Receives-U.S.-FDA-Approval-for-Potassium-Phosphates-Injection-IV-Bags