KADCYLA (trastuzumab emtansine) injection, powder, lyophilized, for solution
[Genentech, Inc.]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KADCYLA safely and effectively. See full prescribing information for KADCYLA.
KADCYLA™ (ado-trastuzumab emtansine) for injection, for intravenous use
Initial U.S. Approval: 2013
WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning
• Do not substitute KADCYLA for or with trastuzumab. (2.1)
• Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients. Monitor hepatic function prior to initiation and prior to each dose. Institute dose modifications or permanently discontinue as appropriate. (2.2, 5.1)
 • KADCYLA may lead to reductions in left ventricular ejection fraction (LVEF). Assess LVEF prior to initiation. Monitor and withhold dosing or discontinue as appropriate. (2.2, 5.2)
 • Can cause fetal harm. Advise women of potential risk to the fetus. (5.3, 8.1, 8.6)
INDICATIONS AND USAGE
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, 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. (1)
DOSAGE AND ADMINISTRATION
• For intravenous infusion only. Do not administer as an intravenous push or bolus. Do not use Dextrose (5%) solution. (2.3)
 • 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. (2.1)
 • Management of adverse events (infusion-related reactions, hepatotoxicity, left ventricular cardiac dysfunction, thrombocytopenia, pulmonary toxicity or peripheral neuropathy) may require temporary interruption, dose reduction, or treatment discontinuation of KADCYLA. (2.2)
DOSAGE FORMS AND STRENGTHS
Lyophilized powder in single-use vials containing 100 mg per vial or 160 mg per vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
• Pulmonary Toxicity: Permanently discontinue KADCYLA in patients diagnosed with interstitial lung disease or pneumonitis. (2.2, 5.4)
 • Infusion-Related Reactions, Hypersensitivity Reactions: Monitor for signs and symptoms during and after infusion. If significant infusion-related reactions or hypersensitivity reactions occur, slow or interrupt the infusion and administer appropriate medical therapies. Permanently discontinue KADCYLA for life threatening infusion-related reaction. (2.1, 2.2, 5.5)
 • Thrombocytopenia: Monitor platelet counts prior to each KADCYLA dose. Institute dose modifications as appropriate. (2.2, 5.6)
 • Neurotoxicity: Monitor for signs or symptoms. Withhold dosing temporarily for patients experiencing Grade 3 or 4 peripheral neuropathy. (2.2, 5.7, 13.2)
 • HER2 Testing: Perform using FDA-approved tes