ELCYS

ELCYS- cysteine hydrochloride injection, solution
Exela Pharma Sciences, LLC

1 INDICATIONS AND USAGE

ELCYS is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants

requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have

impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete

profile of amino acids for protein synthesis.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

ELCYS is for admixing use only. It is not for direct intravenous infusion. Prior to administration, ELCYS must be diluted

and used as an admixture in parenteral nutrition (PN) solutions.

The resulting solution is for intravenous infusion into a central or peripheral vein. The choice of a central or peripheral

venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater

must be infused through a central catheter [see Warnings and Precautions (5.2)].

2.2 Preparation and Administration Instructions

ELCYS is not for direct intravenous infusion. Prior to administration, ELCYS must be diluted and used as anadmixture in PN solutions.
ELCYS is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
ELCYS is for addition to amino acid solutions prior to further admixing with dextrose injection using a PN container.
Use a dedicated line for PN solutions.
Intravenous lipid emulsions can be infused concurrently into the same vein as ELCYS containing amino acid and dextrose solutions by a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps.
For administration without lipid emulsion, use a 0.22 micron in-line filter.
To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry.
If infused with lipid emulsion, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
Visually inspect the diluted PN solution containing ELCYS for particulate matter before admixing, after admixing, and prior to administration. The solution should be clear and there should be no precipitates. A slight yellow color does not alter the quality and efficacy of this product.

2.3 Preparation Instructions for Admixing Using a Parenteral Nutrition (PN) Container

Remove ELCYS vial from the carton and inspect for particulate matter.
Transfer the required amount of ELCYS to an amino acid solution using strict aseptic techniques to avoid microbial contamination.
The amino acid solution containing ELCYS can then be used to prepare admixtures in the PN container using strict aseptic techniques.
Amino acids solution containing ELCYS may be mixed with dextrose injection. The following proper mixing sequence must be followed to minimize pH related problems:
Transfer dextrose injection to the parental nutrition pooling container
Transfer phosphate salt
Transfer ELCYS-containing amino acid solution
Transfer electrolytes
Transfer trace elements
Use gentle agitation during admixing to minimize localized concentration effects; shake containers gently after each addition.
For automated compounding, refer to Instructions for Use of the applicable compounder.
Because additives may be incompatible, evaluate all additions to the PN container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Questions about compatibility may be directed to Exela Pharma Sciences, LLC. If it is deemed advisable to introduce additives to the PN container, use aseptic technique.
Inspect the final PN solution containing ELCYS to ensure that precipitates have not formed during mixing or addition on additives. Discard if any precipitates are observed.

Stability and Storage

For single use only. Discard used container of ELCYS.
Use of ELCYS for admixing should be limited to up to 4 hours at room temperature (25ºC/77ºF) after the container closure has been penetrated. Discard any remaining drug.
Use PN solution containing ELCYS promptly after mixing. Any storage of the admixture should be under refrigeration and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Discard any remaining admixture.
Protect PN solution from light.

2.4 Dosing Considerations

The dosage of the final PN solution containing ELCYS must be based on the concentrations of all components in the solution and the recommended nutritional requirements [see Dosage and Administration (2.5)]. Consult the prescribing information of all added components to determine the recommended nutritional requirements for dextrose and lipid emulsion, as applicable.
The dosage of ELCYS should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to initiating parenteral nutrition, the following patient information should be reviewed: review of all medications, gastrointestinal function and laboratory data (such as electrolytes (including magnesium, calcium, and phosphorus), glucose, urea/creatinine, liver panel, complete blood count and triglyceride level (if adding lipid emulsion).
Prior to administration of PN solution containing ELCYS, correct severe fluid, electrolyte and acid-base disorders.

2.5 Recommended Dosage in Pediatric Patients and Adults

The recommended dosage and volume of ELCYS is shown in Table 1 and is based upon the recommended daily protein

(amino acids) requirement. For pediatric patients from birth to less than 12 years of age, the recommended dosage of

ELCYS is 22 mg/gram of amino acids. For adults and pediatric patients 12 years of age and older, the recommended

dosage of ELCYS is 7 mg/gram of amino acids.

Table 1. Recommended Daily Dosage of ELCYS in Pediatric Patients and Adults

Age
Recommended Proteina Requirement
(g AA/kg/day)1
Recommended Dosage
(mg ELCYS/g AA)
Recommended Volume
(mL ELCYS/g AA)

Preterm and term infants less than 1 month of age

3 to 4
22
0.44

Pediatric patients 1 month to less than 1 year of age

2 to 3
22
0.44

Pediatric patients 1 year to 11 years of age

1 to 2
22
0.44

Pediatric patients 12 years to 17 years of age

0.8 to 1.5
7
0.14

Adults: Stable Patients

0.8 to 1
7
0.14

Adults: Critically Ill Patientsb

1.5 to 2
7
0.14

AA = Amino Acid

a Protein is provided as amino acids (AA).

b Includes patients requiring more than 2 to 3 days in the intensive care unit with organ failure, sepsis or postoperative major surgery. Do not use in patients with

conditions that are contraindicated [see Contraindications (4)]

ELCYS contains 50 mg/mL of cysteine hydrochloride (equivalent to 34.5 mg/mL of cysteine). Therefore, the ELCYS

dosages in Table 1 provide:

15 mg cysteine/gram of amino acids for pediatric patients less than 12 years of age
5 mg cysteine/gram of amino acids for adults and pediatric patients 12 years of age and older
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