oblems, chest pain, tachycardia, and urticaria following infusion.
Rapid weight gain, edema, and orthostatic hypotension following infusion. Instruct patients to weigh themselves daily.
Visual loss, including loss of color vision.
Manufactured and Distributed by:
Eisai Inc.
Woodcliff Lake, NJ 07677
US License No. 1862
PRINCIPAL DISPLAY PANEL
NDC 62856-603-01
ONTAK®
(denileukin diftitox)
300mcg/2mL
Sterile Solution-No Preservatives
Rx Only-For I.V. Use Only
Single-Use Vial
Store frozen at or below -10°C (14°F).
ONTAK
denileukin diftitox injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-603
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DENILEUKIN DIFTITOX (DENILEUKIN DIFTITOX) DENILEUKIN DIFTITOX 300ug in2mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETIC ACID
POLYSORBATE 20
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62856-603-01 6 VIAL ( VIAL) in 1 PACKAGE contains a VIAL
1 2 mL in 1 VIAL This package is contained within the PACKAGE(62856-603-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103767 10/15/2008
Labeler -Eisai, Inc (831600833)
Establishment
Name Address ID/FEI Operations
Eisai Inc. 624009093 manufacture
