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NOURESS
(cysteine hydrochloride) Injection
NOURESS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use supplied as 500 mg/10 mL cysteine hydrochloride, USP in a single-dose vial.
Each mL of NOURESS contains 50 mg of cysteine hydrochloride, (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH. The pH range of NOURESS is 1.0 to 1.5.
The active ingredient is cysteine hydrochloride. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate. Its molecular formula is C3H7NO2S •HCI • H2O and molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is depicted below:
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Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine is a sulfur-containing amino acid and is prone to oxidation when exposed to air in aqueous solution, which may convert cysteine to insoluble cystine resulting in precipitation over time.
NOURESS contains no more than 145 mcg/L of aluminum.
NOURESS (cysteine hydrochloride injection) is a sterile, nonpyrogenic solution for intravenous use supplied as 500 mg/10 mL cysteine hydrochloride, USP in a single-dose vial.
Each mL of NOURESS contains 50 mg of cysteine hydrochloride, (equivalent to 34.5 mg of cysteine), and 0.006 mL of hydrochloric acid (6M) in water for injection. Sodium hydroxide and/or hydrochloric acid are used as needed to adjust the pH. The pH range of NOURESS is 1.0 to 1.5.
The active ingredient is cysteine hydrochloride. The chemical name of cysteine hydrochloride is L-cysteine hydrochloride monohydrate. Its molecular formula is C3H7NO2S •HCI • H2O and molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is depicted below:
|
Cysteine hydrochloride is a white crystalline powder soluble in water. Cysteine is a sulfur-containing amino acid and is prone to oxidation when exposed to air in aqueous solution, which may convert cysteine to insoluble cystine resulting in precipitation over time.
NOURESS contains no more than 145 mcg/L of aluminum.
NOURESS is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition.
NOURESS is for intravenous infusion after dilution and admixing use only. Prior to administration, NOURESS must be diluted and used as an admixture in parenteral nutrition 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].
The dosage of the final parenteral nutrition solution containing NOURESS must be based on the concentrations of all components in the solution and the recommended nutritional requirements [see DOSAGE AND ADMINISTRATION]. Consult the prescribing information of all added components to determine the recommended nutritional requirements.
The dosage of NOURESS 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, and complete blood count.
Prior to administration of parenteral nutrition solution containing NOURESS, correct severe fluid, electrolyte and acid-base disorders.
The recommended dosage and volume of NOURESS is based upon the recommended daily protein (amino acid) requirements.
Table 1: Recommended Daily Dosage of NOURESS in Neonates (Preterm and Term Infants Less Than One Month of Age)
| Dosage | Proteina Requirement (g Amino Acids/kg/day)1 | Dosage (mg NOURESS/g Amino Acids) | Volume (mL NOURESS/g Amino Acids) |
| Neonates | 3 to 4 | 22 | 0.44 |
| a Protein is provided as amino acids. | |||
NOURESS contains 50 mg/mL of cysteine hydrochloride (equivalent to 34.5 mg/mL of cysteine). Therefore, the recommended dosage of NOURESS provides 15 mg cysteine/gram of amino acids for neonates.
NOURESS (cysteine hydrochloride injection) is a clear, colorless, sterile and nonpyrogenic solution supplied as follows: 500 mg/10 mL (50 mg/mL) of cysteine hydrochloride, USP in single-dose vials (NDC 76014006-05), packaged as 5 vials per carton (NDC 76014-006-05)
Store NOURESS at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Avoid excessive heat. Protect from freezing. If accidentally frozen, discard the vial.
Vial stoppers are not made with natural rubber latex.
For storage of admixed solution see DOSAGE AND ADMINISTRATION
Injection: 500 mg/10 mL (50 mg/mL) cysteine hydrochloride, USP as a clear, colorless, sterile solution in a single-dose vial.
REFERENCES
1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123 and 124.
Manufactured for: Avadel Legacy Pharmaceuticals, LLC Chesterfield, MO 63005. Â Revised: Dec 2019
Included as part of the PRECAUTIONS section.
Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some fatal cases, pulmonary embolism occurred as a result of calcium phosphate precipitates. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the solution [see DOSAGE AND ADMINISTRATION], the infusion set and catheter should also periodically be checked for precipitates.
NOURESS must be diluted and used as an admixture in parenteral nutrition solutions. Solutions with an osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see DOSAGE AND ADMINISTRATION]. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.
Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.
Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.
Administration of NOURESS may result in metabolic acidosis in neonates.
Administration of amino acid solutions to a patient with hepatic impairment may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of acid-base balance during parenteral nutrition therapy. Significant deviations from normal concentrations may require the use of additional electrolyte supplements.
Hepatobiliary disorders are known to develop in some patients, including neonates, without preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients.
Instances of asymptomatic hyperammonemia have been reported in patients receiving parenteral nutrition without overt liver dysfunction. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function [see CONTRAINDICATIONS, Use In Specific Populations]
Hyperammonemia is of special significance in infants, as it can result in neurocognitive delays. Monitor liver function parameters and ammonia levels during treatment with NOURESS. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.
NOURESS contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Neonates and preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which also contain aluminum.
Patients with renal impairment including neonates and preterm infants, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Exposure to aluminum from NOURESS is not more than 0.25 mcg/kg/day when preterm and term neonates are administered the recommended maximum dosage of NOURESS (22 mg cysteine hydrochloride/g of amino acids and 4 g of amino acids/kg/day) [see DOSAGE AND ADMINISTRATION]. When prescribing NOURESS for use in parenteral nutrition containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use In Specific Populations].
Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, ammonia levels, blood count and coagulation parameters throughout treatment [see DOSAGE AND ADMINISTRATION].
NOURESS for use as an additive to amino acid solutions to meet nutritional requirements is not indicated for use in adults. Appropriate administration of NOURESS is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with cysteine hydrochloride.
NOURESS is used as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition and is not indicated for use in adults. There are no data on the presence of cysteine hydrochloride in human or animal milk or the effects on milk production. Data available on the effects of cysteine hydrochloride on infants, either directly or through breastmilk, do not suggest a significant risk of adverse reactions from exposure.
NOURESS is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of neonates, including preterm infants, requiring total parenteral nutrition. The safety profile for NOURESS use in neonates includes risks of acid-base imbalance and hepatobiliary dysfunction.
Acid-base imbalance, including metabolic acidosis, and liver dysfunction may occur with NOURESS administration in preterm infants. Frequent clinical and laboratory assessments are necessary to monitor and manage fluid balance, electrolyte concentrations, liver tests, and acid-base balance during parenteral nutrition therapy [see WARNINGS AND PRECAUTIONS].
Hyperammonemia is of special significance in neonates. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured during treatment [see WARNINGS AND PRECAUTIONS].
Because of immature renal function, neonates including preterm infants, receiving prolonged parenteral nutrition with NOURESS may be at higher risk of aluminum toxicity [see WARNINGS AND PRECAUTIONS].
In the event of over hydration or solute overload, re-evaluate the patient and institute appropriate corrective measures [see WARNINGS AND PRECAUTIONS].
NOURESS is contraindicated in:
Endogenous cysteine is synthesized from methionine by the enzyme, cystathionase, via the transsulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. NOURESS provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities of cysteine due to deficient cystathionase activity.
Inform caregivers or home healthcare providers of the following risks of NOURESS:
