American Regent Introduces Potassium Phosphates, USP; FDA-Approved and "AP" Rated¹

2023-10-19

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SHIRLEY, N.Y., Oct. 19, 2023 /PRNewswire/ -- American Regent announces the launch and availability of Potassium Phosphates Injection, USP, which is FDA-approved and therapeutically equivalent to Potassium Phosphates

.1 Potassium Phosphates Injection, USP is 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 parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated

American Regent Introduces Potassium Phosphates, USP; FDA-Approved and "AP" Rated¹

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来源: PRNewswire

Potassium Phosphates Injection, USP is available in three presentations

"An important part of our company's mission is to assist in mitigating shortages and ensuring supply of critical medications whenever possible. To that end, we are pleased to add Potassium Phosphates Injection, USP to our robust line of products that are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc.

This product is available for immediate shipment. Customers can order

Potassium Phosphates Injection, USP,

through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.

Potassium Phosphates Injection, USP is supplied as follows:

See the following Important Safety Information, in addition to the product's Full Prescribing Information.

For additional information, please visit www.americanregent.com.

Potassium Phosphates Injection, USP

For intravenous use

INDICATIONS

AND

USAGE

Potassium Phosphates Injection is 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 parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Potassium Phosphates Injection is contraindicated in patients with: hyperkalemia; hyperphosphatemia; hypercalcemia or significant hypocalcemia; severe renal impairment (eGFR less than 30 mL/min/1.73m2) or end stage renal disease.

WARNINGS AND PRECAUTIONS

Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration

: Intravenous administration of potassium phosphates to correct hypophosphatemia in single doses of phosphorus 50 mmol and greater and/or at rapid infusion rates (over 1 to 3 hours) in intravenous fluids has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, and seizures. In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death. 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

: Pulmonary vascular emboli and pulmonary distress related to precipitates in the pulmonary vasculature have been described in patients receiving admixed products containing calcium and phosphate or parenteral nutrition. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.

Hyperkalemia

: Potassium Phosphates Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses, undiluted or by rapid intravenous infusion. 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: Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment. Hyperphosphatemia can cause the formation of insoluble calcium phosphorus products with consequent hypocalcemia, neurological irritability with tetany, nephrocalcinosis with acute kidney injury and more rarely, cardiac irritability with arrhythmias. Monitor serum phosphorus and calcium concentrations during and following infusion.

Aluminum Toxicity

: Potassium Phosphates Injection contains aluminum that may be toxic. Patients with renal impairment, including preterm infants, can accumulate aluminum at levels associated with central nervous system and bone toxicity.

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. The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.

Laboratory Monitoring

Monitor serum phosphorus, potassium, calcium and magnesium concentrations during treatment.

ADVERSE

REACTIONS

Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.

The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity; Hypomagnesemia; Vein Damage and Thrombosis

DRUG

INTERACTIONS

Other Products that Increase Serum Potassium - Administration of Potassium Phosphates Injection to patients treated concurrently or recently with products that increase serum potassium 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.

USES IN SPECIFIC POPULATIONS

Lactation

- Phosphorus and potassium are present in human milk. Administration of the recommended dose of Potassium Phosphates Injection is not expected to cause harm to a breastfed infant. There is no information on the effects of potassium phosphates on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Phosphates Injection and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric

Use - Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Potassium Phosphates Injection may be at higher risk of aluminum toxicity.

Geriatric Use - Dose selection of Potassium Phosphates Injection for an elderly patient should be cautious, starting at the low end of the dosing range. It may be useful to monitor renal function during treatment.

Renal Impairment - Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to Potassium Phosphates Injection may be greater in patients with impaired renal function. Use is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or end stage renal disease. In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2 to 2), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations.

OVERDOSAGE

Hyperphosphatemia - Administration of excessive doses of intravenous potassium phosphates in intravenous fluids and/or at rapid infusion rates has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, seizures, and tetany.

Hyperkalemia - Excessive administration of phosphates given as potassium salts may also cause hyperkalemia. Manifestations of hyperkalemia include: disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation; hypotension; muscle weakness including paresthesia, muscular and respiratory paralysis.

Management - In the event of overdosage, discontinue infusions containing potassium phosphates immediately and institute general supportive measures, including ECG monitoring, laboratory monitoring, and correction of serum electrolyte concentrations, especially potassium, phosphorus, calcium, and magnesium.

For additional safety information, please see Full Prescribing Information.

You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch

or calling 1-800-FDA-1088.

REF-2383 2/2022

You are encouraged to report adverse drug events (ADEs) to American Regent:

T 1.800.734.9236;

E [email protected];

F 1.610.650.0170

ADEs may also be reported to the FDA:

1.800.FDA.1088

or www.fda.gov/medwatch

Medical Information:

T 1.888.354.4855

(9:00 am–5:00 pm Eastern Time, Monday–Friday)

www.americanregent.com/medical-affairs

For medical information outside of normal business hours

that cannot wait until the next business day, please call 1.877.845.6371

About American Regent

American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy.

American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future.

Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.

For more information, please visit www.americanregent.com.

About Daiichi Sankyo Group

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society."

For more information, please visit: www.daiichisankyo.com.

All trademarks are the property of their respective owners.

Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. Accessed September 19, 2023. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=216274#327

PP-PO-US-0008

SOURCE American Regent, Inc.