Indications
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.
It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ( 1 )
Contraindications
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 ( 4 )
- Inborn errors of amino acid metabolism ( 4 )
- Pulmonary edema or acidosis due to low cardiac output ( 4 )
Warnings and precautions
- Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 )
- Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsm/L or more must be infused through a central catheter. ( 2.1 , 5.2 )
- Increased blood urea nitrogen (BUN): Monitor laboratory parameters and discontinue if exceeds normal postprandial limits and continues to increase. ( 5.3 )
- Acid-Base Imbalance: Monitor laboratory parameters and supplement with electrolytes as needed. ( 5.4 )
- Hepatobiliary Disorders: Monitor liver function parameters and ammonia levels. ( 5.5 )
- Hyperammonemia: Neurocognitive delay possible in infants; monitor blood ammonia levels. ( 5.6 , 8.4 )
- Aluminium Toxicity: Increased risk in patients with renal impairment, including preterm infants. ( 5.7 , 8.4 )
- Monitoring and Laboratory Tests: Monitor fluid and electrolytes, serum osmolarity, blood glucose, kidney and liver function, blood count and coagulation parameters throughout treatment. ( 5.8 )
At a glance
- Brand name
- Elcys
- Active substance
- cysteine hydrochloride
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- Exela Pharma
- Status
- Prescription
- FDA approval
- 16 Apr 2019
- Application
- NDA210660-001
- RxCUI
- 2169277



