Duration of Objective Response (months)

  Number of patients with OR

173

120
 

  Median duration (95% CI)

12.6 (8.4, 20.8)

6.5 (5.5, 7.2)
 
Figure 1 Kaplan-Meier Curve of IRC-Assessed Progression-Free Survival for Study 1

Figure 2 Kaplan-Meier Curve of Overall Survival for Study 1

15 REFERENCES
 1.OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied/Storage
 
KADCYLA (ado-trastuzumab emtansine) is supplied as:

Carton Contents

NDC

One 100 mg vial, single use vial

NDC 50242-088-01

One 160 mg vial, single use vial

NDC 50242-087-01
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution. Do not freeze or shake.

16.2 Special Handling
 
Follow procedures for proper handling and disposal of anticancer drugs1.

17 PATIENT COUNSELING INFORMATION
 •Inform patients of the possibility of severe liver injury and advise patients to immediately seek medical attention if they experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, anorexia, etc. [see Warnings and Precautions (5.1)].
 •Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions (5.2)].
 •Advise pregnant women and females of reproductive potential that KADCYLA exposure can result in fetal harm, including embryo-fetal death or birth defects [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.6)].
 •Advise females of reproductive potential to use effective contraception while receiving KADCYLA and for 6 months following the last dose of KADCYLA [See Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].
 •Advise nursing mothers treated with KADCYLA to discontinue nursing or discontinue KADCYLA, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.3)].
 •Encourage women who are exposed to KADCYLA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].

KADCYLA™ [ado-trastuzumab emtansine]

4862200

Manufactured by:

Initial U.S. Approval: February 2013

Genentech, Inc.

A Member of the Roche Group

KADCYLA is a trademark of Genentech, Inc.

1 DNA Way

©2013 Genentech, Inc.

South San Francisco, CA 94080-4990

U.S. License No: 1048
Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL - 100 mg Vial Label

NDC 50242-088-01
 
Kadcyla™
(ado-trastuzumab
emtansine)
For Injection
 
100 mg per vial

For Intravenous Infusion Only
Reconstitute and Dilute prior
to administration
Single-Dose Vial –
Discard Unused Portion

KEEP REFRIGERATED