LEUKERAN (Page 3 of 3)

Special Populations

Hepatic Impairment: Patients with hepatic impairment should be closely monitored for toxicity. As chlorambucil is primarily metabolized in the liver, dose reduction may be considered in patients with hepatic impairment when treated with LEUKERAN. However, there are insufficient data in patients with hepatic impairment to provide a specific dosing recommendation.

HOW SUPPLIED

LEUKERAN is supplied as brown, film-coated, round, biconvex tablets containing 2 mg chlorambucil in amber glass bottles with child-resistant closures. One side is engraved with “GX EG3” and the other side is engraved with an “L.”
Bottle of 25 (NDC 69784-610-25)

Store in a refrigerator, 2° to 8°C (36° to 46°F).

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193.

4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Mfd. by: Excella GmbH, Feucht, Germany

Distributed by:
Woodward Pharma Services LLC
Wixom, MI 48393 Rev. 04/22

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 69784-610-25

LEUKERAN®

(chlorambucil) Tablets

2 mg

25 Tablets

Each tablet contains 2 mg chlorambucil.

Rx Only.

carton
(click image for full-size original)

Leukeran 2mg 25 ct. Carton

label
(click image for full-size original)

Leukeran 2mg 25 ct. Label

LEUKERAN chlorambucil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69784-610
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORAMBUCIL (CHLORAMBUCIL) CHLORAMBUCIL 2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
ANHYDROUS LACTOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE RED
STEARIC ACID
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color brown Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GX;EG3;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69784-610-25 25 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA010669 06/30/2022
Labeler — Woodward Pharma Services LLC (080406260)

Revised: 04/2022 Woodward Pharma Services LLC

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