ELCYS 10 mg/mL
Cysteine Hydrochloride · INJECTION, SOLUTION · Exela Pharma Sciences, LLC
ELCYS is a injection, solution containing cysteine hydrochloride at 10 mg/mL, taken intravenous. Manufactured by Exela Pharma Sciences, LLC.
Key Facts
- Brand Name
- ELCYS
- Generic Name
- Cysteine Hydrochloride
- NDC Code (Product)
51754-1007- Manufacturer
- Exela Pharma Sciences, LLC
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA210660
- Marketing Start
- 05/28/2019
Recall History
Exela Pharma Sciences LLC
Presence of Particulate Matter: Silicone
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • ELCYS ® is for admixing use only. Not for direct intravenous infusion . ( 2.1 ) • PHARMACY BULK PACKAGE: Dispense single-doses to many patients in a pharmacy admixture program. Use within 4 hours of puncture. ( 2.1 ) • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in pediatric patients and adults. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) 2.1 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 ( 5.2 )] . 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 ( 2.3 )]. As a pharmacy bulk vial, ELCYS ® is …
Contraindications
4 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 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Increased BUN [see Warnings and Precautions ( 5.3 )] • Acid-base imbalance [see Warnings and Precautions ( 5.4 )] • Hepatobiliary disorders [see Warnings and Precautions ( 5.5 )] • Hyperammonemia [see Warnings and Precautions ( 5.6 )] • Aluminum toxicity [see Warnings and Precautions ( 5.7 )] 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. • Local infusion site reactions, including a warm sensation, erythema, phlebitis and thrombosis at the infusion site • Generalized flushing, fever and nausea Most common adverse reactions are local reactions (warm sensation, erythema, phlebitis and thromb…
Frequently Asked Questions
What is ELCYS used for?
ELCYS contains Cysteine Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is ELCYS a controlled substance?
ELCYS is not classified as a controlled substance by the DEA.
What is the generic name for ELCYS?
The generic name for ELCYS is Cysteine Hydrochloride. There are 1 other brand versions of Cysteine Hydrochloride.
What is the NDC code for ELCYS 10 mg/mL?
The NDC (National Drug Code) for ELCYS 10 mg/mL is 51754-1007, listed by Exela Pharma Sciences, LLC.