Other safety alerts
|
| |
| The United Kingdom: Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections |
| |
The Medicines and Healthcare products Regulatory Agency (MHRA) announces that fingolimod has an immunosuppressive effect. A recent routine EU review recommended strengthened warnings for malignancies including skin cancers and lymphoma and serious opportunistic infections.
Regarding the risk of malignancy, basal cell carcinoma and lymphoma were already known to occur in patients taking fingolimod and annual skin screening was advised. The review identified post-marketing reports of T-cell lymphoma (mostly cutaneous) and other types of skin cancer, including malignant melanoma (uncommon; post-marketing frequency less than 1 in 100 patients), squamous cell carcinoma (rare; less than 1 in 1,000), Kaposi sarcoma (very rare; less than 1 in 10,000), and Merkel cell carcinoma (unknown frequency).
Regarding the risk of fatal fungal infections and reports of progressive multifocal leukoencephalopathy (PML), analysis of post-marketing reports suggest a higher risk of serious infections, including fatal fungal infections, than clinical trial data predicted. Although the exact frequency of these infections is not known, vigilance for serious opportunistic infections is recommended. The routine review identified 54 reports of opportunistic systemic fungal infections, including 9 fatal cases of cryptococcal meningitis, over 397,764 patient-years of exposure since marketing.
In Apr 2016, MHRA informed about reports of PML in patients taking fingolimod. Worldwide, PML has now been reported in 79 patients taking fingolimod post-marketing, including 22 cases attributable to fingolimod.
Healthcare professionals are advised to:
- re-assess the benefit-risk balance of fingolimod therapy in individual patients, particularly those with additional risk factors for malignancy
- examine all patients for skin lesions before starting fingolimod and closely monitor for skin cancers at least every 6 to 12 months
- advise patients to avoid exposure to UV radiation (including sunlight and phototherapy) and seek urgent medical advice if they notice any skin lesions
- advise patients to seek urgent medical attention if they develop any symptoms or signs consistent with an infection, including up to 2 months after the end of fingolimod therapy
- report all suspected adverse drug reactions with fingolimod, including after discontinuation, on a Yellow Card
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/fingolimod-gilenya-updated-advice-about-risk-of-cancers-and-serious-infections
In Hong Kong, Gilenya Hard Capsules 0.5mg (HK-61192) is a pharmaceutical product containing fingolimod which is registered by Novartis Pharmaceuticals (HK) Limited (Novartis), and is a prescription-only medicine. So far, the Department of Health (DH) has received one case of adverse drug reaction related to fingolimod, but it was not related to skin cancers and infections.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 30 Aug 2013, with the latest update posted on 19 Apr 2016. Letters to local healthcare professionals to draw their attention related to risk of cancers and serious infections were issued on 5 Aug 2015, 2 Oct 2015 and 19 Apr 2016. Novartis has submitted application to update the package insert of the product, the application is being reviewed and the updated package insert will contain the new warnings in the above MHRA’s announcement including skin cancers.
Ends/Friday, Dec 15, 2017
Issued at HKT 17:00
|
| |
|
