Prescription Drug Information: Voraxaze (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

VORAXAZE (glucarpidase) for injection is supplied as a sterile, preservative-free white lyophilized powder in an individually packaged glass single-dose vial closed with a bromo butyl elastomeric stopper and blue flip-off seal.

1,000 Units of glucarpidase per vial (1 vial per carton) NDC 50633-210-11

Store VORAXAZE refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not use VORAXAZE after the expiration date on the vial.

17 PATIENT COUNSELING INFORMATION

Serious Hypersensitivity Reactions

Inform patients that hypersensitivity reactions, including potentially serious reactions, may occur following a dose of VORAXAZE and to immediately report any signs and symptoms of infusion reactions [see Warnings and Precautions (5.1)].

Administration

Inform patients of the importance of continued monitoring of plasma methotrexate concentration and renal function at the appropriate times after discharge from the hospital [see Warnings and Precautions (5.2)].

Manufactured and distributed by:
BTG International Inc.
West Conshohocken, PA 19428

U.S. license 1861

VORAXAZE® is a registered trademark of Protherics Medicines Development

Ltd. BTG and the BTG roundel logo are registered trademarks of BTG

International Ltd.

P21011D

Package Label — Principal Display Panel — VORAXAZE Vial

Package Label -- Principal Display Panel -- VORAXAZE Vial
(click image for full-size original)

Package Label — Principal Display Panel — VORAXAZE Carton

Package Label -- Principal Display Panel -- VORAXAZE Carton
(click image for full-size original)
VORAXAZE
glucarpidase injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50633-210
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLUCARPIDASE (GLUCARPIDASE) GLUCARPIDASE 1000 [USP’U]
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE 10 mg
ZINC ACETATE 0.002 mg
TROMETHAMINE HYDROCHLORIDE 0.6 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50633-210-11 1 VIAL in 1 CARTON contains a VIAL
1 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (50633-210-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125327 04/01/2012
Labeler — BTG International Inc. (617382395)
Registrant — BTG International Inc. (617382395)

Revised: 11/2022 BTG International Inc.

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