Left Ventricular Ejection Fraction (LVEF)

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

  • Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated
  • Manage through treatment interruption or discontinuation
  • LVEF decrease has been observed with anti-HER2 therapies. 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

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%
And absolute decrease from baseline is 10% to 20%
  • Continue treatment with ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • 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).

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ENHERTU Dosage & Administration and Recommendations for Adverse Reactions Guide
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