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,a
- 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 5.4 mg/kg, ILD occurred in 9% of patients (n=22/234)1,2
- 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
aILD includes events that were adjudicated as ILD: pneumonitis, interstitial lung disease, respiratory failure, organizing pneumonia, acute respiratory failure, lung infiltration, lymphangitis, alveolitis.1
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/pneumonitis1
- 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
- Diagnosis of ILD requires exclusion of other causes
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:
- If resolved in 28 days or less from date of onset, maintain dose
- If resolved in greater than 28 days from date of onset, reduce dose one level (see Recommended dose reductions for ENHERTU for adverse reactions)
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
|Severity||Description (NCI-CTCAEb 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|
Symptom identification is key to ILD/pneumonitis diagnosis
Monitor patients for and promptly investigate the signs and symptoms of ILD, which may include1:
- 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 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?