Cysteine

Renal Impairment Monitor patients with impaired renal function receiving PN solutions containing the recommended dosage of ELCYS ® with frequent clinical evaluation and laboratory tests to assess renal function, including serum electrolytes and fluid balance [see Dosage and Administration, Warnings and Precautions].

Hepatic Impairment Monitor patients with impaired liver function receiving PN solutions containing the recommended dosage of ELCYS ® with frequent clinical evaluation and laboratory tests to assess liver function, such as bilirubin and liver function parameters [see Dosage and Administration, Warnings and Precautions].

Important Administration Information Prior to administration, ELCYS® must be diluted and used as an admixture in PN solutions. ELCYS® is not for direct intravenous infusion. 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] . ELCYS ® is supplied as a pharmacy bulk package, and consists of one pharmacy bulk vial which must be diluted prior to intravenous administration [see Dosage andAdministration]. As a pharmacy bulk vial, ELCYS ® is intended for dispensing of single doses to many patients.

Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. Do not administer ELCYS ® as a direct, undiluted intravenous injection.

Preparation and Administration Instructions Prior to administration, ELCYS® must be diluted and used as an admixture in PN solutions. ELCYS® is not for direct intravenous infusion.

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.

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

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.