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 Thrombocytopenia

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.

2.3 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 emtansine) and not trastuzumab.

Administration:
•Administer KADCYLA as an intravenous infusion only with a 0.22 micron in-line non-protein adsorptive polyethersulfone (PES) filter. Do not administer as an intravenous push or bolus.
 •Do not mix KADCYLA, or administer as an infusion, with other medicinal products.
 •In order to improve traceability of biological medicinal products, the tradename of the administered product should be clearly recorded (or stated) in the patient file.

Reconst