Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Indication

KADCYLA® (ado-trastuzumab emtansine), 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.

Important Safety Information

Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO­FETAL TOXICITY

  • Do not substitute KADCYLA for or with trastuzumab
  • 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
  • Cardiac toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function
  • 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

The following additional serious adverse reactions have been reported in clinical trials with KADCYLA:

  • Interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatality: KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis
  • Infusion-related reactions (IRR), hypersensitivity: KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR
  • Hemorrhage: Fatal cases of hemorrhage occurred in clinical trials among patients with no known identified risk factors, as well as among patients with thrombocytopenia and those receiving anticoagulation and antiplatelet therapy
  • Thrombocytopenia: Monitor platelet counts prior to initiation of KADCYLA and prior to each dose. Institute dose modifications as appropriate
  • Peripheral neuropathy: KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ≤ Grade 2
  • Reactions secondary to extravasation: The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration

Additional Important Safety Information:

  • Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA therapy
  • Nursing mothers: Discontinue nursing or discontinue KADCYLA, taking into consideration the importance of the drug to the mother
  • The most common adverse drug reactions (frequency >25%) across clinical trials with KADCYLA were fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation, and epistaxis

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see click here for additional Important Safety Information and accompanying full Prescribing Information, including Boxed WARNINGS.