Hepatotoxicity [see Warnings and Precautions (5.1)]

A reduction in the dose of Kadcyla is recommended in the case of hepatotoxicity exhibited as increases in serum transaminases and/or hyperbilirubinemia (see Tables 2 and 3).

Table 2 Dose Modification Guidelines for Increased Serum Transaminases (AST/ALT) Grade 2
(> 2.5 to ≤ 5 × ULN) Grade 3
(> 5 to ≤ 20 × ULN) Grade 4
(> 20 × ULN)
ALT = alanine transaminase; AST = aspartate transaminase; ULN = upper limit of normal.
Treat at same dose level. Do not administer Kadcyla until AST/ALT recovers to Grade ≤ 2, and then reduce one dose level. Permanently discontinue Kadcyla.
Table 3 Dose Modification Guidelines for Hyperbilirubinemia Grade 2
(> 1.5 to ≤ 3 × ULN) Grade 3
(> 3 to ≤ 10 × ULN) Grade 4
(> 10 × ULN)
Do not administer Kadcyla until total bilirubin recovers to Grade ≤ 1, and then treat at same dose level. Do not administer Kadcyla until total bilirubin recovers to Grade ≤ 1, and then reduce one dose level. Permanently discontinue Kadcyla.

Permanently discontinue Kadcyla treatment in patients with serum transaminases > 3 × ULN and concomitant total bilirubin > 2 × ULN.

Permanently discontinue Kadcyla in patients diagnosed with nodular regenerative hyperplasia (NRH).

Left Ventricular Dysfunction [see Warnings and Precautions (5.2)]

Table 4 Dose Modifications for Left Ventricular Dysfunction Symptomatic CHF LVEF < 40% LVEF 40% to ≤ 45% and decrease is ≥ 10% points from baseline LVEF 40% to ≤ 45% and decrease is < 10% points from baseline LVEF > 45%
CHF = Congestive Heart Failure; LVEF = Left Ventricular Ejection Fraction
Discontinue Kadcyla Do not administer Kadcyla. Do not administer Kadcyla. Continue treatment with Kadcyla. Continue treatment with Kadcyla.
  Repeat LVEF assessment within 3 weeks. If LVEF < 40% is confirmed, discontinue Kadcyla. Repeat LVEF assessment within 3 weeks. If the LVEF has not recovered to within 10% points from baseline, discontinue Kadcyla. Repeat LVEF assessment within 3 weeks.

Thrombocytopenia [see Warnings and Precautions (5.6)]

A reduction in dose is recommended in the case of Grade 4 thrombocytopenia (platelets < 25,000/mm3) (see Table 5).

Table 5 Dose Modification Guidelines for Thro
Grade 3 Grade 4
PLT 25,000/mm3 to < 50,000/mm3 PLT < 25,000/mm3
PLT = Platelets
Do not administer Kadcyla until platelet count recovers to ≤ Grade 1 (≥ 75,000/mm3), and then treat at same dose level. Do not administer Kadcyla until platelet count recovers to ≤ Grade 1 (≥ 75,000/mm3), and then reduce one dose level.

Pulmonary Toxicity [see Warnings and Precautions (5.4)]

Kadcyla should be permanently discontinued in patients diagnosed with interstitial lung disease (ILD) or pneumonitis.

Peripheral Neuropathy [see Warnings and Precautions (5.7)]

Kadcyla should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ≤ Grade 2.

Preparation for Administration
​In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Kadcyla (ado-trastuzumab emtan