From the FDA Drug Label
Lung problems. VERZENIO may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death If you develop lung problems during treatment with VERZENIO, your healthcare provider may tell you to temporarily stop taking VERZENIO, decrease your dose, or stop your treatment. Tell your healthcare provider right away if you have any new or worsening symptoms, including: – trouble breathing or shortness of breath – cough with or without mucus – chest pain (ILD) (includes pneumonitis, radiation pneumonitis, interstitial lung disease, pulmonary fibrosis, organizing pneumonia, radiation fibrosis – lung, lung opacity, sarcoidosis)
Pulmonary complications of Verzenio include:
- Severe or life-threatening inflammation of the lungs
- Interstitial lung disease (ILD)
- Pneumonitis
- Pulmonary fibrosis
- Organizing pneumonia Patients should be monitored for new or worsening symptoms, such as trouble breathing, shortness of breath, cough, or chest pain. If lung problems occur, the healthcare provider may need to temporarily stop or decrease the dose of Verzenio, or stop treatment altogether 1.
From the Research
Verzenio (abemaciclib) can cause serious pulmonary complications, most notably interstitial lung disease (ILD) and pneumonitis, which occur in approximately 5.0% of patients, as reported in the most recent study 2. These complications typically present as new or worsening respiratory symptoms including dyspnea, cough, and fever, often accompanied by radiographic findings such as ground-glass opacities or infiltrates on chest imaging. Patients on Verzenio should be monitored regularly for pulmonary symptoms, and if respiratory symptoms develop or worsen, the medication should be interrupted immediately pending evaluation. If ILD/pneumonitis is confirmed, Verzenio should be permanently discontinued in severe cases (Grade 3-4), while dose reduction may be considered for milder cases after resolution of symptoms. Some key points to consider in managing patients on Verzenio include:
- Risk factors for developing pulmonary complications include prior lung disease, concurrent radiation therapy, and use of other medications with pulmonary toxicity, as well as Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 and a past medical history of interstitial pneumonia (IP) 2.
- Healthcare providers should perform baseline pulmonary function assessment before starting Verzenio and educate patients to report any breathing difficulties promptly.
- The mechanism behind Verzenio-induced lung toxicity is not fully understood but may involve direct cytotoxic effects on pneumocytes or immune-mediated inflammation.
- A study using transbronchial lung cryobiopsy found that abemaciclib-induced ILD can present with fibrosing organizing pneumonia, which may be responsive to corticosteroids 3.
- Another study found that the incidence of abemaciclib-induced ILD was 7.4%, with most cases being grade 1/2, and all cases ultimately being confirmed to be in remission or cured 4. Overall, careful monitoring and prompt evaluation of respiratory symptoms are crucial in managing patients on Verzenio to minimize the risk of pulmonary complications.