DEFITELIO (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Hemorrhage: Advise patients and caregivers that DEFITELIO may increase the risk of bleeding (hemorrhage). Instruct patients to immediately report any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision) [see Warnings and Precautions (5.1)].
Hypersensitivity Reactions: Ask patients if they have been treated with defibrotide sodium previously. Instruct patients on the risk of allergic reactions, including anaphylaxis. Describe the symptoms of allergic reactions, including anaphylaxis, and instruct the patient to seek medical attention immediately if they experience such symptoms [see Warnings and Precautions (5.2)].

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

carton
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This product’s label may have been updated. For full prescribing information, please visit labels.fda.gov.

Distributed by:

Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304

DEFITELIO® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.
© 2016 Jazz Pharmaceuticals

DEFITELIO
defibrotide sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68727-800
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEFIBROTIDE SODIUM (DEFIBROTIDE FREE ACID) DEFIBROTIDE SODIUM 80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRISODIUM CITRATE DIHYDRATE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68727-800-01 2.5 mL in 1 VIAL None
2 NDC:68727-800-02 25 mL in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208114 03/30/2016
Labeler — Jazz Pharmaceuticals, Inc. (135926363)
Registrant — Jazz Pharmaceuticals, Inc. (135926363)
Establishment
Name Address ID/FEI Operations
Gentium S.r.L 432729114 API MANUFACTURE (68727-800), ANALYSIS (68727-800)
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. 434078638 MANUFACTURE (68727-800)
Establishment
Name Address ID/FEI Operations
Jazz Pharmaceuticals Ireland Limited 896650210 MANUFACTURE (68727-800)

Revised: 06/2021 Jazz Pharmaceuticals, Inc.

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