ts by laboratories with demonstrated proficiency. (5.8)
ADVERSE REACTIONS
The most common adverse drug reactions (frequency > 25%) with KADCYLA (n=884 treated patients) were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
• Nursing Mothers: Discontinue nursing or discontinue KADCYLA taking into consideration the importance of the drug to the mother. (8.3)
• Females of Reproductive Potential: Counsel females on pregnancy prevention and planning. Encourage patient participation in the MotHER Pregnancy Registry by contacting 1-800-690-6720). (5.3, 8.1, 8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 02/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Doses and Schedules
2.2 Dose Modifications
2.3 Preparation for Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hepatotoxicity
5.2 Left Ventricular Dysfunction
5.3 Embryo-Fetal Toxicity
5.4 Pulmonary Toxicity
5.5 Infusion-Related Reactions, Hypersensitivity Reactions
5.6 Thrombocytopenia
5.7 Neurotoxicity
5.8 HER2 Testing
5.9 Extravasation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Females of Reproductive Potential
8.7 Renal Impairment
8.8 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.6 Cardiac Electrophysiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Metastatic Breast Cancer
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied/Storage
16.2 Special Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
Do Not Substitute KADCYLA for or with Trastuzumab
WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY
•Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin. (2.2, 5.1)
•Cardiac Toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). eva luate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function. (2.2, 5.2)
•Embryo-Fetal Toxicity: Exposure to KADCYLA can result in embryo-fetal death or birth defects. Advise patients
