ADR that result in revision of patient information
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| Canada: Information Update - Multiple sclerosis drug Gilenya (fingolimod): Safety information on the risk of skin cancer and a rare brain infection |
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Health Canada is informing Canadians that the drug label (product monograph) for the multiple sclerosis drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML).
Gilenya is a prescription drug used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability. It is specifically used when other MS treatments have not been effective or cannot be tolerated.
Gilenya works by modifying the body's immune system and reducing the access of certain immune cells (white blood cells known as lymphocytes) to the brain and spinal cord, which may reduce the damage that happens in these areas in MS and the frequency of MS relapses. A Health Canada safety review found that Gilenya, like other drugs that suppress the immune system, may increase the risk of lymphomas (lymphocyte cancer) and other cancers, particularly of the skin.
Medicines that suppress the immune system are also known to reduce the body's ability to fight infections. Cases of PML, a rare infection caused by the John Cunningham (JC) virus, have been reported with Gilenya use - including in patients who were not currently taking and had not previously taken other medications that suppress or change the immune system. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems. In severe cases, it can lead to disability or death.
Gilenya labelling in Canada already contained information on the possible risk of lymphoma, and warnings about how this drug reduces the body's ability to fight infection. It has been updated to include the risk of skin cancer and PML specifically, and to advise that patients and health professionals be vigilant for symptoms.
Additional information for healthcare professionals:
• Physicians should be vigilant for skin cancer.
• Physicians should be vigilant for clinical symptoms or MRI findings that may be suggestive of PML. MRI signs of PML may be apparent before clinical symptoms develop.
• If PML is suspected, suspend Gilenya treatment until PML has been ruled out.
Information for consumers:
• Early detection and treatment of skin cancers is important. If you already have moles or open sores before starting Gilenya, pay attention for changes in the size, shape or color of moles, or if open sores don't heal within weeks of starting treatment. These may be signs of skin cancer that you should talk to your doctor about.
• Basal cell carcinoma (BCC), a common form of skin cancer, is the type most often reported with Gilenya use. Talk to your doctor if you notice signs of BCC, including any skin nodules (e.g. shiny pearly nodules), patches or open sores that do not heal within weeks.
• Talk to your doctor as soon as possible if you think your MS is getting worse because these may be signs of PML. Signs may include new or worsening weakness; trouble using your arms or legs; or changes in thinking, memory, eyesight or balance.
• You should not use other medications and treatments that suppress or change how the immune system works at the same time as using Gilenya because this can increase your risk of infection and PML.
• Talk to your doctor if you have any questions or concerns about your MS treatment. Do not stop taking Gilenya without first consulting your doctor.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../55160a-eng.php
In Hong Kong, Gilenya Hard Capsules 0.5mg (HK-61192) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Ltd (Novartis), and is a prescription-only medicine. Related news on risk of PML has been released by the US FDA, and was posted on the Drug office website on 30 August 2013 and 5 August 2015. Letters to inform local healthcare professionals of the risk of PML were issued on 5 August 2015. So far, the Department of Health (DH) has not received any adverse drug reaction case on fingolimod.
Novartis has applied to the DH to update the package insert of the product to include the relevant warning of PML and BCC (a kind of skin cancer), and the application is under evaluation. As previously reported, the matter concerning PML will be discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee).
In view of the Health Canada’s announcement on the risk of lymphomas (lymphocyte cancer) and other cancers, particularly of the skin, in addition to PML mentioned by the US FDA, letters to inform local healthcare professionals of the warning will be issued, and the information will also be forwarded to the Committee for consideration.
Ends/ Friday, October 02, 2015
Issued at HKT 14:00
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