videothumbnail The ENHERTU View
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Listen to medical experts discuss the efficacy and safety of ENHERTU from DESTINY-Breast 01, including their experience treating these patients with ENHERTU.

Left Ventricular Dysfunction

Management of left ventricular ejection fraction (LVEF) decrease with ENHERTU1

    Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. LVEF decrease has been observed with anti-HER2 therapies, including ENHERTU.

  • In the 234 patients with unresectable or metastatic HER2+ breast cancer who received ENHERTU 5.4 mg/kg, two cases (0.9%) of asymptomatic LVEF decrease were reported. No decreases of LVEF to <40% were observed
  • Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated
  • Manage through treatment interruption or discontinuation

Dose modifications for decreased LVEF1

Severity Treatment Modification
LVEF greater than 45% and absolute decrease from baseline is 10% to 20%
  • Continue treatment with ENHERTU
LVEF
40%
to 45%
And absolute decrease from baseline is less than 10%
  • Continue treatment with ENHERTU
  • Repeat LVEF assessment within 3 weeks
And absolute decrease from baseline is 10% to 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF has not recovered to within 10% from baseline,
    permanently discontinue ENHERTU
  • If LVEF recovers to within 10% of baseline, resume treatment with ENHERTU at the same dose
LVEF less than 40% or absolute decrease from baseline is greater than 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF of less than 40% or absolute decrease from baseline of greater than 20% is confirmed, permanently discontinue ENHERTU
Symptomatic congestive heart failure (CHF)
  • Permanently discontinue ENHERTU
Toxicity grades are in accordance with the National Cancer Institute—Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v.4.03).

Review information for these other potential treatment risks:

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ENHERTU Dosage & Administration and Recommendations for Adverse Reactions Guide
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HER2, human epidermal growth factor receptor 2.