KADCYLA side effects and safety profile

Adverse reactions and discontinuation rates from the EMILIA trial

EMILIA trial clinical safety profile: Most common severe adverse reactions (ARs)

  • Overall incidence of ARs Grades ≥3 was lower with KADCYLA: 43.1% vs 59.2% with lapatinib + capecitabine
  • Most common severe ARs (Grades ≥3) more frequently associated with KADCYLA than with lapatinib + capecitabine were thrombocytopenia, peripheral neuropathy, anemia, increased transaminases, musculoskeletal pain, hemorrhage, and constipation
    • Incidence of alopecia was low (<5%) in both treatment arms
  • Diarrhea, hypokalemia, vomiting, neutropenia, fatigue, nausea, stomatitis, and rash (Grades ≥3) were the most common severe ARs more frequently associated with lapatinib + capecitabine than with KADCYLA

*ARs categorized according to the National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 3).

Lower overall incidence of severe (Grades ≥3) ARs1

  • Overall incidence of ARs Grades ≥3 was 43.1% vs 59.2% with lapatinib + capecitabine
  • Most common severe ARs (Grades ≥3) more frequently associated with KADCYLA than with lapatinib + capecitabine were thrombocytopenia, peripheral neuropathy, anemia, increased transaminases, musculoskeletal pain, hemorrhage, and constipation
    • Incidence of alopecia was low (<5%) in both treatment arms9
  • Diarrhea, hypokalemia, vomiting, neutropenia, fatigue, nausea, stomatitis, and rash (Grades ≥3) were the most common severe ARs more frequently associated with lapatinib + capecitabine than with KADCYLA

KADCYLA patients had fewer dose modifications and treatment discontinuations1

  • The most common ARs leading to dose reduction of KADCYLA (in ≥1% of patients) included thrombocytopenia, increased transaminases, and peripheral neuropathy1
  • The most common ARs leading to discontinuation of KADCYLA were thrombocytopenia and increased AST1
  • Incidence of dose delays was lower for KADCYLA (23.7%) compared with lapatinib (36.9%) or capecitabine (43.9%)1,12
    • ARs most frequently associated with a KADCYLA dose delay (in ≥1% of patients) were neutropenia, thrombocytopenia, leukopenia, fatigue, increased transaminases, and pyrexia1

Results from the phase III EMILIA trial of KADCYLA vs lapatinib + capecitabine

ND=not determined.
*Nodular regenerative hyperplasia and portal hypertension occurred in the same patient.

Preparing and administering KADCYLA

Instructions for KADCYLA dose calculation, dose adjustments, storage, and more.

KADCYLA survival data

Learn how KADCYLA performed in clinical trials vs lapatinib + capecitabine.