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
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 of these risks and the need for effective contraception. (5.3, 8.1, 8.6)
1 INDICATIONS AND USAGE
KADCYLA™, as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
•Received prior therapy for metastatic disease, or
•Developed disease recurrence during or within six months of completing adjuvant therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Doses and Schedules
The recommended dose of KADCYLA is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer KADCYLA at doses greater than 3.6 mg/kg. Do not substitute KADCYLA for or with trastuzumab.
Closely monitor the infusion site for possible subcutaneous infiltration during drug administration [see Warnings and Precautions (5.9)].
First infusion: Administer infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion-related reactions [see Warnings and Precautions (5.5)].
Subsequent infusions: Administer over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
2.2 Dose Modifications
