16.3 Special Handling
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-4

17 PATIENT COUNSELING INFORMATION
• Peripheral neuropathy

Advise patients that ADCETRIS can cause a peripheral neuropathy. They should be advised to report to their health care provider any numbness or tingling of the hands or feet or any muscle weakness [see Warnings and Precautions (5.1)].

• Fever/Neutropenia
Advise patients to contact their health care provider if a fever of 100.5˚F or greater or other evidence of potential infection such as chills, cough, or pain on urination develops [see Warnings and Precautions (5.3)].

• Infusion reactions

Advise patients to contact their health care provider if they experience signs and symptoms of infusion reactions including fever, chills, rash, or breathing problems within 24 hours of infusion [see Warnings and Precautions (5.2)].

• Pregnancy and Nursing

ADCETRIS can cause fetal harm. Advise women receiving ADCETRIS to avoid pregnancy. Advise patients to report pregnancy immediately [see Warnings and Precautions (5.7)]. Advise patients to avoid nursing while receiving ADCETRIS [see Use in Specific Populations (8.3)].

Manufactured by:
Seattle Genetics, Inc.
Bothell, WA 98021
1-855-473-2436
U.S. License 1853

ADCETRIS is a trademark and Seattle Genetics andare US registered trademarks of Seattle Genetics, Inc.

August 2011

PACKAGE LABEL

NDC 51144-050-01

ADCETRIS™

(brentuximab vedotin) FOR INJECTION

50 mg/vial

Single-use vial.

Discard unused portion.

Reconstitution and dilution required

For intravenous use only

Rx Only

SeattleGenetics®
ADCETRIS
brentuximab vedotin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51144-050
Route of Administration INTRAVENOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Brentuximab Vedotin (Brentuximab Vedotin)  Brentuximab Vedotin 50mg in10.5mL
 
Inactive Ingredients
Ingredient Name Strength
Trehalose Dihydrate 
Trisodium Citrate Dihydrate 
Citric Acid Monohydrate 
Polysorbate 80 
 
Product Characteristics
Color WHITE (off-white)  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51144-050-01 1 VIAL, SINGLE-DOSE ( VIAL) in 1 BOX contains a VIAL, SINGLE-DOSE
1  10.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX(51144-050-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125388 08/25/2011 
Labeler -Seattle Genetics, Inc. (028484371) 
Establishment
Name Address ID/FEI Operations
Seattle Genetics, Inc.  028484371 MANUFACTURE
Establishment
Name Address ID/FEI Operations
PIRAMAL HEALTHCARE UK LTD  215586998 MANUFACTURE
Establishme