Cysteine

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. ELCYS ® is a sulfur-containing amino acid indicated 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.

Endogenous cysteine is synthesized from methionine by the enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. ELCYS ® provides cysteine to the systemic circulation of patients who require PN and cannot synthesize adequate quantities of cysteine due to insufficient or deficient cystathionase activity.

• ELCYS ® is for admixing use only. Not for direct intravenous infusion. • PHARMACY BULK PACKAGE: Dispense single-doses to many patients in a pharmacy admixture program. Use within 4 hours of puncture. • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in pediatric patients and adults.

ELCYS ® is contraindicated in: • Patients with known hypersensitivity to one or more amino acids. • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output. • Hypersensitivity to one or more amino acids. • Inborn errors of amino acid metabolism. • Pulmonary edema or acidosis due to low cardiac output

• Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. • Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter. • Increased blood urea nitrogen (BUN): Monitor laboratory parameters and discontinue if exceeds normal postprandial limits and continues to increase. • Acid-Base Imbalance: Monitor laboratory parameters and supplement with electrolytes as needed. • Hepatobiliary Disorders: Monitor liver function parameters and ammonia levels. • Hyperammonemia: Neurocognitive delay possible in infants, monitor blood ammonia levels. • Aluminium Toxicity: Increased risk in patients with renal impairment, including preterm infants.

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Pulmonary embolism due to pulmonary vascular precipitates • Vein damage and thrombosis • Increased BUN • Acid-base imbalance • Hepatobiliary disorders • Hyperammonemia • Aluminum toxicity Adverse reactions with the use of cysteine hydrochloride injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Store at 20°C to 25°C (68°F to 77°F). Protect from freezing. For storage of admixed solution see Dosage and Administration.