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
YesNo
Has the patient been evaluated by radiographic imaging?
YesNo
Has the patient consulted with a pulmonologist on other possible causes?
YesNo
Has the patient been dry-coughing recently?
YesNo
Has the patient experienced shortness of breath, especially during or after physical activity?
YesNo
Has the patient experienced any new breathing or respiratory problems?
YesNo
Have the patient’s current respiratory problems gotten worse?
YesNo
Has the patient experienced a fever?
YesNo
Has the patient felt fatigue at all?
YesNo
Has the patient lost any weight?
YesNo
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).