Interstitial lung disease (ILD) and Pneumonitis

ILD and pneumonitis, including Grade 5 cases, have been reported with ENHERTU 5.4 mg/kg (pooled clinical studies; N=984)1,a

The majority of events were Grade 1 or 2 (n=98/118)1,2

  • In patients with mBC and other solid tumors, ILD/pneumonitis occurred in 12% of patients (n=118/984); fatal outcomes due to ILD occurred in 1% of patients (n=10/984)
  • Median time to first onset was 5 months (range: 0.9-23) with ENHERTU
  • A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment

DESTINY-Breast04: incidence of ILD/pneumonitis3

Adjudicated as drug-related ILD, n (%) ENHERTU
5.4 mg/kg (n=371)
Chemotherapy
(n=172)
Grade 1 13 (3.5) 1 (0.6)
Grade 2 24 (6.5) 0
Grade 3 5 (1.3) 0
Grade 4 0 0
Grade 5 3 (0.8) 0
All Grades 45 (12.1) 1 (0.6)
  • Of the 371 patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12.1% of patients (n=45/371)3
    • Three Grade 5 adjudicated drug-related ILD/pneumonitis events were observed with ENHERTU3,a
    • 82% of the ILD cases were Grade 1 or 2 (37/45)3
  • In DESTINY-Breast04, median time to onset of first adjudicated drug-related ILD event was 129 days with ENHERTU and 60 days with chemotherapy2,3

aGrade 5=fatal cases.2

Symptom identification and investigation at the first sign of ILD/pneumonitis are key to diagnosis and monitoring1

Signs and symptoms of ILD/pneumonitis1

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

Promptly investigate evidence of ILD/pneumonitis4

  • 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 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 (Grade 1)1

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

For symptomatic ILD (Grade 2 or greater)1

  • Promptly initiate systemic corticosteroid treatment (eg, ≥1 mg/kg/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 ILD5,6

  • 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?

Review management information for these other potential treatment risks:

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CBC, complete blood count; CT, computed tomography; FDA, Food and Drug Administration; HCP, healthcare professional.