Advice for healthcare professionals:
- Monitor all patients for signs and symptoms of heart failure (including dyspnoea, oedema, or rapid weight gain from fluid retention)
- Consider reducing the dose, or interrupting or stopping treatment if symptoms of heart failure occur
- Please continue to report suspected adverse drug reactions to crizotinib or any other medicines on a Yellow Card
Crizotinib (Xalkori▼) is licensed to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer.
Cases of cardiac failure
There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib. A review by European medicines regulators of data from clinical trials and reports from clinical practice has concluded that this side effect is common (ie, occurs in between 1 in 10 and 1 in 100 patients who take crizotinib).
Up to 25 February 2015, about 14,700 patients worldwide have received crizotinib since licensing. Forty cases of cardiac failure have been reported in the post-marketing setting. In most cases cardiac failure occurred within 1 month of starting treatment with crizotinib, and affected patients with or without pre-existing heart disorders. The reports included some cases with evidence of symptoms of cardiac failure resolving on stopping crizotinib, and cases with evidence of symptoms reoccurring when it was reintroduced.
In the UK, we have received 2 Yellow Card reports of suspected heart failure with crizotinib up to 3 November 2015, 1 of which was fatal. Suspected adverse reactions should be reported to us on a Yellow Card.
See Letter sent to healthcare professionals, 14 October 2015.
Article citation: Drug Safety Update vol 9 issue 3, November 2015: 1.
Published 12 November 2015