Nouress: Package Insert and Label Information (Page 2 of 2)

11 DESCRIPTION

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 C3 H7 NO2 S • HCI • H2 O and molecular weight is 175.63. The chemical structure of L-cysteine hydrochloride monohydrate is depicted below:

chemical structure

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.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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. 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.

15 REFERENCES

  1. Ayers P. et al. A.S.P.E.N. Parenteral Nutrition Handbook, 2nd ed. 2014 pg. 123 and 124.

16 HOW SUPPLIED/STORAGE AND HANDLING

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 76014-006-33), 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 (2.3).

17 PATIENT COUNSELING INFORMATION

Inform caregivers or home healthcare providers of the following risks of NOURESS:

  • 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)]
  • Aluminum toxicity [see Warnings and Precautions (5.6)]
  • Monitoring and laboratory tests [see Warnings and Precautions (5.7)]

Manufactured for:

Avadel Legacy Pharmaceuticals, LLC

Chesterfield, MO 63005

Rev. 12/19

PRINCIPAL DISPLAY PANEL — NDC: 76014-006-33 — Vial Label

Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 76014-006-05 — Carton Label

Carton Label
(click image for full-size original)

NOURESS
cysteine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76014-006
Route of Administration Intravenous DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYSTEINE HYDROCHLORIDE (CYSTEINE) CYSTEINE 34.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76014-006-05 5 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (76014-006-33)
1 NDC:76014-006-33 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (76014-006-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA212535 04/01/2020
Labeler — Avadel Legacy Pharmaceuticals, LLC (965538205)

Revised: 01/2020 Avadel Legacy Pharmaceuticals, LLC

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