• In clinical studies, of the 234 patients with HER2+ unresectable or metastatic breast cancer treated, ILD occurred in 9% of patients (n=22/234)
    • Majority of ILD events were Grade 2 (n=12/22)
    • Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients
  • Median time to first onset was 4.1 months (range: 1.2-8.3)

 

Click Here when Beginning a Patient Discussion


Has the patient experienced any of the following since start of treatment?
  • Pneumonitis
  • Interstitial lung disease
  • Respiratory failure
  • Organizing pneumonia
  • Acute respiratory failure
  • Lung infiltration
  • Lymphangitis
  • Alveolitis
Yes No

Has the patient been evaluated by radiographic imaging?
Yes No
Has the patient consulted with a pulmonologist on other possible causes?
Yes No

Has the patient been dry-coughing recently?
Yes No

Has the patient experienced shortness of breath, especially during or after physical activity?
Yes No

Has the patient experienced any new breathing or respiratory problems?
Yes No

Have the patient’s current respiratory problems gotten worse?
Yes No

Has the patient experienced a fever?
Yes No
Has the patient felt fatigue at all?
Yes No
Has the patient lost any weight?
Yes No

Based on these factor(s):

Click on the Grade best matching the patient’s degree of adverse event

Based on the responses, grade is suggested

  • Interrupt dose until resolved to Grade 0, then:
    • if resolved in ≤28 days from date of onset, maintain dose.
    • If resolved in >28 days from date of onset, reduce dose one level.
      • Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg prednisolone or equivalent).
    • Dose Modifications:
      • *Do not re-escalate the ENHERTU dose after a dose reduction is made*
        • Dose reduction schedule (starting dose is 5.4 mg/kg)
        • First dose reduction 4.4 mg/kg
        • Second dose reduction 3.2 mg/kg
        • Requirement for further dose reduction: Discontinue treatment
    • If a planned dose is delayed or missed
      • Administer as soon as possible; do not wait until the next planned cycle
      • Adjust the schedule of administration to maintain a 3-week interval between doses
      • Administer the infusion at the dose and rate the patient tolerated in the most recent infusion
  • Permanently discontinue.
  • Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg prednisolone or equivalent). Upon improvement, follow by gradual taper (e.g., 4 weeks).

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