Interstitial Lung Disease (ILD) and Pneumonitis

ILD and pneumonitis, including fatal cases, have been reported with ENHERTU; monitor patients and initiate management at first sign of ILD1*

  • Severe, life-threatening, or fatal ILD, including pneumonitis can occur in patients treated with ENHERTU1
  • In clinical studies, of the 234 patients with HER2+ unresectable or mBC treated with ENHERTU, ILD occurred in 9% of patients (n=22/234)1
    • Majority of ILD events were Grade 2 (n=12/22)2
    • Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients1
  • Median time to first onset was 4.1 months (range: 1.2-8.3)1

*ILD includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis.1

HER2, human epidermal growth factor receptor 2; mBC, metastatic breast cancer.

ENHERTU Prescribing Information management recommendations for ILD/pneumonitis, including corticosteroid recommendations, were based on experience in the clinical trials and developed in collaboration with an external ILD expert panel comprised of oncologists, pulmonologists, and radiologists

It could be more than a cough

Identification of the signs and symptoms of ILD, including cough, dyspnea, fever,
and worsening respiratory symptoms, can help inform patient management.1

Promptly investigate evidence of ILD/pneumonitis

  • Evaluate patients with suspected ILD by radiographic imaging1
  • Consider consultation with a pulmonologist1
  • Investigation may be prompted by incidental findings on routine scans when checking for progression or symptomatic findings
    • ILD is a diagnosis of exclusion. Rule out other potential causes

For asymptomatic ILD (Grade 1)1

  • Consider corticosteroid treatment (e.g., ≥0.5 mg/kg prednisolone or equivalent)
  • Interrupt ENHERTU until resolved to Grade 0, then:

For symptomatic ILD (Grade 2 or greater)1

  • Promptly initiate corticosteroid treatment (e.g., ≥1 mg/kg prednisolone or equivalent)
  • Upon improvement, follow by gradual taper (e.g., 4 weeks)
  • Permanently discontinue ENHERTU in patients who are diagnosed with any symptomatic ILD
*ILD includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis.1

ILD identification1,3

Severity Description (NCI-CTCAEa grading)
Grade 1 Asymptomatic, clinical or diagnostic observations only
Grade 2 Symptomatic, limiting instrumental activities of daily living
Grade 3 Severe symptoms, limiting self-care activities of daily living; oxygen indicated
Grade 4 Life-threatening respiratory compromise
Grade 5 Death
aToxicity grades are in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v.4.03).

Symptom identification is key to ILD/pneumonitis diagnosis

Monitor patients for and promptly investigate the signs and symptoms of ILD, which may include1:

  • Cough
  • Dyspnea
  • Fever
  • New or worsening respiratory symptoms

Talk to your patients to raise awareness and help identify symptoms1

  • Advise patients to contact their healthcare provider immediately for any of the symptoms shown above
  • Inform patients of the risks of severe, life-threatening, or fatal ILD
  • Advise patients to read the FDA-approved patient labeling:
    download the Medication Guide

Potential questions to ask your patients to help early identification of ILD4,5

  • Have you been coughing recently? Is it a dry cough?
  • Have you had any shortness of breath, especially during or after physical activity?
  • Have you experienced any new breathing or respiratory problems?
  • If you already have respiratory problems, have they gotten worse?
  • Have you had a fever?
  • Have you been feeling tired?
  • Have you lost weight?

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ENHERTU Dosage & Administration and Recommendations for Adverse Reactions Guide
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