Elliotts B

ADVERSE REACTIONS Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration. (See product labeling for methotrexate sodium and cytarabine.) Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives. If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.

CONTRAINDICATIONS None known.

DESCRIPTION Elliotts B ® Solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts B Solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine. Each 10 mL of Elliotts B Solution contains: Sodium Chloride, USP 73 mg Sodium Bicarbonate, USP 19 mg Dextrose, USP 8 mg Magnesium Sulfate • 7H 2 O, USP 3 mg Potassium Chloride, USP 3 mg Calcium Chloride • 2H 2 O, USP 2 mg Sodium Phosphate, dibasic • 7H 2 O, USP 2 mg Water for Injection, USP qs 10 mL Concentration of Electrolytes: Sodium 149 mEq/liter Bicarbonate 22.6 mEq/liter Potassium 4.0 mEq/liter Chloride 132 mEq/liter Calcium 2.7 mEq/liter Sulfate 2.4 mEq/liter Magnesium 2.4 mEq/liter Phosphate 1.5 mEq/liter The formulae and molecular weights of the ingredients are: INGREDIENT MOLECULAR FORMULA MOLECULAR WEIGHT Sodium Chloride NaCl 58.44 Sodium Bicarbonate NaHCO 3 84.01 Dextrose C 6 H 12 O 6 180.16 Magnesium Sulfate • 7H 2 O Mg 2 SO 4 • 7H 2 O 246.48 Potassium Chloride KCl 74.55 Calcium Chloride • 2H 2 O CaCl 2 • 2H 2 O 147.01 Sodium Phosphate, dibasic • 7H 2 O Na 2 HPO 4 • 7H 2 O 268.07 The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).

DOSAGE AND ADMINISTRATION See product labeling for methotrexate sodium and cytarabine. Elliotts B Solution is intended for intrathecal administration only. Elliotts B Solution does not contain antibac­terial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation. A sterile filter-needle should be used to withdraw the contents of the ampule. Intrathecal drug products should be inspected visually for particulate matter and discoloration prior to admin­istration. Preparation and Administration Precautions Elliotts B Solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. Care should be exercised in the handling and preparation of infusion solutions with these products. (See product labeling for methotrexate sodium and cytarabine.)

INDICATIONS AND USAGE Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.

WARNINGS Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by per­sonnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.

DRUG ABUSE AND DEPENDENCE There is no potential for drug abuse or drug dependence.

OVERDOSAGE Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evalu­ate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)

CLINICAL PHARMACOLOGY Elliotts B Solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. It has been demonstrated that Elliotts B Solution is comparable to cere­brospinal fluid in pH, electrolyte composition, glucose content, and osmolarity: Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts B Solution and CSF Solution Na + mEq/L K + mEq/L Ca ++ mEq/L Mg ++ mEq/L HCO 3 - mEq/L Cl - mEq/L pH Phosphorus mg/dL Glucose mg/dL Cerebrospinal Fluid 117-137 2.3-4.6 2.2 2.2 22.9 113-127 7.31 1.2-2.1 45-80 Elliotts B Solution 149 4.0 2.7 2.4 22.6 132 6.0-7.5 2.3 80 The approximate buffer capacity of Elliotts B Solution is 1.1 X 10 -2 equivalents when the challenge solution is 0.01 N HCl and 7.8 X 10 -3 equivalents when the challenge solution is 0.01 N NaOH. 1 Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compati­ble with Elliotts B Solution.

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Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate sodium chloride sodium cation chloride ion sodium bicarbonate bicarbonate ion anhydrous dextrose anhydrous dextrose MAGNESIUM SULFATE, UNSPECIFIED MAGNESIUM CATION potassium chloride potassium cation calcium chloride calcium cation sodium phosphate phosphate ion Water

Carcinogenesis, Mutagenesis, Impairment of Fertility No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.

NDA020577

Elliotts B

sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate

55792-007

HUMAN PRESCRIPTION DRUG

INTRATHECAL

PACKAGING Ampule labeling: Box labeling: Ampule Labeling Box Labeling

REFERENCES: 1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate. American Journal of Hospital Pharmacy (1978); 35:402. Rev. 10/2015

Usage in Pregnancy All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.

HOW SUPPLIED NDC SIZE 55792-007-10 10 mL ampule Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box. Store at controlled room temperature, 20º-25ºC (68º-77ºF) [See USP]. Preservative Free. Discard unused portion. Use only if solution is clear and ampule is intact. Distributed by: Lukare Medical, LLC Scotch Plains, NJ 07076 1-855-752-9317 www.elliottsbsolution.com

General Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION .)

PRECAUTIONS General Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION .) Carcinogenesis, Mutagenesis, Impairment of Fertility No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution. Usage in Pregnancy All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.