American Regent Introduces Potassium Phosphates, USP FDA-Approved And AP Rated1

(MENAFN- PR Newswire) 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

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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:

Pack NDC#	Strength	Supplied as	Shelf pack
0517-2051-25	Phosphorus 15 mmol/5 mL and Potassium 22 mEq/5 mL	5 mL Single-dose, plastic vial	25
0517-2102-25	Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL	15 mL Single-dose, plastic vial	25
0517-2505-25	Phosphorus 150 mmol/50 mL and Potassium 220 mEq/50 mL	50 mL Pharmacy Bulk Package, plastic vial	25

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

For additional information, please visit .

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/12)
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
<
60
mL/min/1.73
m2),
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
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:
800.1088
or

Medical Information:
T
1.888.354.4855
(9:00 am–5:00 pm Eastern Time, Monday–Friday)

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 .

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: .

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.

PP-PO-US-0008

SOURCE American Regent, Inc.

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