KADCYLA side effects and safety profile

Most common severe adverse reactions (ARs) in the EMILIA trial

  • Overall incidence of ARs Grades ≥3 was lower with the T-DM1, KADCYLA: 43% vs 59% with lapatinib + capecitabine1
  • Most common (>2%) severe ARs (Grades ≥3) with KADCYLA were thrombocytopenia, increased transaminases, anemia, hypokalemia, fatigue, and peripheral neuropathy1
  • 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 KADCYLA1,3
EMILIA most common severe adverse reactions

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

The following clinically relevant ARs were reported in <10% of patients in the KADCYLA-treated group in EMILIA: dyspepsia (9%), urinary tract infection (9%), chills (8%), dysgeusia (8%), neutropenia (7%), peripheral edema (7%), pruritus (6%), hypertension (5%), blood alkaline phosphatase increased (4.7%), vision blurred (4.5%), conjunctivitis (3.9%), dry eye (3.9%), lacrimation increased (3.3%), drug hypersensitivity (2.2%), left ventricular dysfunction (1.8%), infusion-related reaction (1.4%), pneumonitis (1.2%), nodular regenerative hyperplasia (0.4%), portal hypertension (0.4%).1

Incidence of interstitial lung disease (ILD) across MBC trials1

  • Cases of ILD, including pneumonitis, some leading to acute respiratory distress syndrome or fatal outcome have been reported in clinical trials with KADCYLA
  • In patients with MBC, pneumonitis was reported at an incidence of 0.8% (7 out of 884 treated patients), with one case of Grade 3 pneumonitis
  • In the EMILIA trial, pneumonitis was reported at an incidence of 1.2% (6 out of 490 KADCYLA-treated patients), with no pneumonitis-related deaths1,6

KADCYLA patients had fewer dose modifications and treatment discontinuations1

EMILIA rate of dose modifications and treatment discontinuation
  • The most frequent adverse events leading to dose reduction of KADCYLA (in ≥1% of patients) included thrombocytopenia, increased transaminases, and peripheral neuropathy1
  • The most common adverse events leading to KADCYLA withdrawal were thrombocytopenia and increased transaminases1
  • Incidence of dose delays was lower for KADCYLA (24%) compared with lapatinib (37%) or capecitabine (44%)1,9
    • The most frequent adverse events leading to a dose delay of KADCYLA (in ≥1% of patients) were neutropenia, thrombocytopenia, leukopenia, fatigue, increased transaminases, and pyrexia1

Dosing for KADCYLA in MBC

See the efficacy results