Interstitial Lung Disease (ILD) and Pneumonitis

ILD and pneumonitis, including Grade 5 cases, have been reported with ENHERTU; monitor patients and initiate management at first sign of ILD1,a,b

  • ILD and pneumonitis, including fatal cases, have been reported with ENHERTU

In DESTINY-Gastric01

  • 10% of patients (n=12/125) in the ENHERTU arm experienced ILD/pneumonitis of any grade1,c
  • The majority of ILD/pneumonitis cases in previously treated patients with HER2+ aGC who received ENHERTU were Grade 1 or 22
    • 2.4% of patients (n=3/125) experienced Grade 1 events
    • 4.8% of patients (n=6/125) experienced Grade 2 events
    • 1.6% of patients (n=2/125) experienced Grade 3 events
    • 0.8% of patients (n=1/125) experienced a Grade 4 event
  • Median time to first onset was 2.8 months (range: 1.2-21.0)1

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

bGrade 5=fatal cases.

cPercentages of ILD/pneumonitis events by grade may not add up to 10% due to rounding.

Symptom identification and investigation at the first sign of ILD/pneumonitis are key to diagnosis and monitoring

Signs and symptoms of ILD/pneumonitis1

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

Promptly investigate evidence of ILD/pneumonitis3

  • Diagnosis of ILD/pneumonitis requires exclusion of other causes
  • Evaluation may include:
    • High-resolution CT
    • Pulmonologist consultation
    • Blood culture and CBC
  • All events of ILD/pneumonitis, regardless of severity or seriousness, should be followed until resolution, including after drug discontinuation
  • Advise patients of the potential benefits and risks of treatment and to contact their HCP immediately to report any of these symptoms

Monitor patients with moderate renal impairment more frequently; a higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in these patients1

Investigation may be prompted by incidental findings on routine scans when checking for progression or symptomatic findings

For asymptomatic ILD/pneumonitis (Grade 1)1

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

For symptomatic ILD/pneumonitis (Grade 2 or greater)1

  • Promptly initiate systemic corticosteroid treatment (eg, ≥1 mg/kg per day prednisolone or equivalent)
    • Continue for at least 14 days followed by gradual taper for at least 4 weeks
  • Permanently discontinue ENHERTU in patients who are diagnosed with any symptomatic ILD/pneumonitis

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 with 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?
Ready to learn more about ENHERTU?

aGC, advanced gastric cancer; HER2, human epidermal growth factor receptor 2.