Other safety alerts
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| The United Kingdom: CDK4／6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that cases of interstitial lung disease and pneumonitis have been reported with the use of CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib. There have also been reports of some fatal cases.
Following European reviews of safety data, the Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PILs) for these products have been updated to include warnings about these risks.
Frequency of interstitial lung disease and pneumonitis in clinical trials is as follow: For abemaciclib, the product information notes that 3.4% of participants treated in clinical trials (n=768) had interstitial lung disease or pneumonitis of any grades of severity. The frequency of grade 3 (severe) events was 0.4% and grade 4 (life-threatening) events was 0.1% of participants. For palbociclib, the product information notes that 1.4% of participants treated in clinical trials (n=872) had interstitial lung disease or pneumonitis of any grade. One grade 3 event was reported (0.1%) and no grade 4 events (although fatalities have been reported post-marketing). For ribociclib, the product information notes that interstitial lung disease (any grade 0.3%, including 0.1% grade 3) was reported in the ribociclib-treated group in clinical studies, with no cases in the placebo-treated group. Pneumonitis was reported in both the ribociclib and the placebo-treated groups (any grade 0.4%; with no grade 3 or 4 events in either group).
Since authorisation and up to 21 Jan 2021, the number of suspected adverse reports of interstitial lung disease, pneumonitis and related terms in the United Kingdom received by the Yellow Card scheme was 8 for abemaciclib (of which 4 were fatal), 18 for palbociclib (of which 7 were fatal), and one for ribociclib. In interpreting these data, caution should be exercised and comparisons not drawn between the medicines given different exposures and other factors unrelated to the inherent safety of the medicines that may affect the number of reports. Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the adverse drug reaction.
Advice for healthcare professionals:
- Abemaciclib, palbociclib, and ribociclib are indicated for some locally advanced or metastatic breast cancer.
- There have been reports of interstitial lung disease and pneumonitis with these medicines, in some cases severe or fatal.
- During clinic appointments, ask patients about pulmonary symptoms indicative of interstitial lung disease and pneumonitis, such as cough or dyspnoea, and advise them to seek advice right away if they occur.
- Evaluate patients with new or worsening respiratory symptoms, refer to the SmPC, and consider dose interruption, modification, or discontinuation according to the severity of the event.
- Ensure patients are provided with a copy of the PIL, which provides information about the medicine and explains the symptoms that patients should be aware of.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/cdk4-slash-6-inhibitors-abemaciclibv-palbociclibv-ribociclibv-reports-of-interstitial-lung-disease-and-pneumonitis-including-severe-cases
In Hong Kong, there are registered pharmaceutical products containing abemaciclib (3 products), palbociclib (6 products) and ribociclib (1 product). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction related to abemaciclib (2 cases), palbociclib (129 cases; of which 1 case is related to pneumonitis) and ribociclib (13 cases).
Related news on was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 16 Sep 2019. Letters to inform local healthcare professionals were issued by the DH on the same day. In Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of products containing abemaciclib, palbociclib and ribociclib should include the relevant safety information. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Jun 18, 2021
Issued at HKT 16:00
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