`
`August 2017
`
`P.O. Box 818, 1245 Blowing Rock Blvd., Lenoir, NC 28645
`Tel: (828) 758 5474; Fax: (828) 757 7888
`
`IMPORTANT DRUG WARNING
`
`Dear Health Care Provider:
`
`RISK OF POTENTIAL ALUMINUM TOXICITY WITH USE OF POTASSIUM ACETATE 40
`Re:
`
`
`MEQ/20 ML INJECTION PARTICULARLY IN NEONATAL PATIENTS AND PATIENTS WITH RENAL
`IMPAIRMENT
`
`The purpose of this letter is to inform you of important safety information for Potassium Acetate
`40 mEq/20 mL (2 mEq/mL) Injection (NDC 51754-2001-4), manufactured and supplied by Exela Pharma
`Sciences, LLC (“Exela”). The current carton and vial labels for Exela’s Potassium Acetate 40 mEq/20 mL
`(2 mEq/mL) Injection indicate the product contains an aluminum level of not more than 200 mcg/L. We
`have determined that the actual aluminum level in some instances may exceed 200 mcg/L in the product.
`
`Potassium acetate injection is a source of potassium, for addition to large volume intravenous fluids, to
`prevent or correct hypokalemia in patients with restricted or no oral intake, or to prepare IV fluids when
`the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The labeling for the
`product contains the following warning about aluminum:
`
`WARNING: This product contains aluminum that may be toxic. Aluminum may
`reach toxic levels with prolonged parenteral administration if kidney function is
`impaired. Premature neonates are particularly at risk because their kidneys are
`immature, and they require large amounts of calcium and phosphate solutions,
`which contain aluminum.
`Research indicates that patients with impaired kidney function, including
`premature neonates, who receive parenteral levels of aluminum at greater than
`4 to 5 mcg/kg/day accumulate aluminum at levels associated with central
`nervous system and bone toxicity. Tissue loading may occur at even lower rates
`of administration.
`
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`Potassium acetate lots already in distribution may have aluminum levels that may exceed 200 mcg/L. To
`prevent an immediate shortage of potassium acetate, Exela, in coordination with the FDA, is releasing
`potassium acetate with an aluminum content that may exceed the amount stated on the product’s labels.
`
`Due to the potential for serious aluminum toxicity concerns in vulnerable patient populations,
`specifically in premature neonates, Exela urges the Health Care Provider to follow the guidance
`provided below under Health Care Provider Action and use the product only if the total aluminum level
`
`of the entire infusion is acceptable.
`
`
`
`HEALTH CARE PROVIDER ACTION
`
`Health Care Providers administering the drug should calculate a patient’s total
`aluminum exposure from multiple parenteral sources and make appropriate substitutions
`to prepare “low aluminum” parenteral solutions for use in patients who are in high risk
`groups. Such high risk groups include premature neonates and patients with renal
`impairment. For purposes of the calculation, the Provider should assume that the
`aluminum content of Exela’s Potassium Acetate 40 mEq/20 mL (2 mEq/mL) is
`
`500 mcg/L or 10 mcg/20 mL vial (or 0.5 mcg/mL).
`
`The labeling for Exela’s Potassium Acetate Injection provides the following dosing recommendation:
`
`The dose and rate of administration are dependent upon the individual needs of the
`patient. ECG and serum potassium should be monitored as a guide to dosage. Using
`aseptic technique, all or part of the contents of one or more vials may be added to
`other intravenous fluids to provide any desired number of milliequivalents (mEq) of
`potassium (K+) with an equal number of milliequivalents of acetate (CH3COO-).
`
`Normal daily requirements:
`
`Newborn: 2-6 mEq/kg/24 hr.
`Children: 2-3 mEq/kg/24 hr.
`Adult: 40-80 mEq/24 hr.
`
`Assuming that providing maximum normal daily requirement (i.e., 6 mEq/kg/24 hr) for a newborn
`patient is the intended objective, at the suggested aluminum content of 500 mcg/L in Exela’s product, the
`amount of aluminum delivered to the patient would be (500 mcg/L * (6 mEq/kg/24 hr)/2 mEq/mL)
`1.5mcg/kg/24 hr. Parenteral levels of aluminum greater than 4 to 5 mcg/kg/day, particularly in patients
`with impaired kidney function and in premature neonates, have been associated with central nervous
`system and bone toxicities due to aluminum accumulation. By itself, the Exela’s Potassium Acetate
`40 mEq/20 mL Injection product should not pose health risk at the recommended administration level.
`However, when this product is used in parenteral solutions containing other sources of aluminum, the
`product may significantly contribute to a patient’s total daily aluminum exposure in excess of the
`maximum normal daily requirement.
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`Reporting Adverse Events
`
`Health care providers and patients should report adverse events in patients taking Potassium Acetate
`40 mEq/20 mL (2 mEq/mL) Injection to Exela Pharma Sciences, LLC at 1-888-451-4321.
`
`Adverse events or quality problems experienced with the use of this product may also be
`reported to the FDA’s MedWatch Adverse Event Reporting Program either online, or regular
`mail, or by fax:
`Complete and submit the report Online: www.fda.gov/medwatch/report.htm
`(cid:120)(cid:3)
`Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
`1-800-332-1088 to request a reporting form, then complete and return to the address
`on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
`
`(cid:120)(cid:3)
`
`You may also contact our medical information department at 1-888-451-4321 or our agent, Propharma
`Group, at 1-877-443-0226 if you have any questions about the information contained in this letter or
`the safe and effective use of Potassium Acetate 40 mEq/20 mL (2 mEq/mL) Injection.
`
`This letter is not intended as a complete description of the benefits and risks related to the use of
`Potassium Acetate 40 mEq/20 mL (2 mEq/mL) Injection. Please refer to the enclosed full prescribing
`information.
`
`Sincerely,
`
`Digitally signed by Phanesh Koneru
`DN: cn=Phanesh Koneru, l=US, o=Exela
`Pharma Sciences, LLC,
`email=pkoneru@exela.us, c=United States,
`givenName=Phanesh Koneru
`Date: 2017.08.02 17:24:57 -04'00'
`
`Phanesh
`Koneru
`Phanesh Koneru, Ph.D., LL.M.
`President & CEO
`
`Enclosure(s): Potassium Acetate 40 mEq/20 mL (2 mEq/mL) Injection Full Prescribing Information
`
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