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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.…
The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
…Discontinue fingolimod if significant hepatic injury or herpes meningoencephalitis is confirmed.…
…Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.…
Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
A summary of letters and drug alerts recently sent to healthcare professionals.
Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.
Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
Medicines and Healthcare products Regulatory Agency (MHRA) responses to freedom of information (FOI) requests for week commencing 15 February 2021
The Medicines and Healthcare products Regulatory Agency (MHRA) responses to freedom of information (FOI) requests for week commencing 29 August 2022.
Guidance used by UK Visas and Immigration to make decisions in asylum and human rights applications.
The Medicines and Healthcare products Regulatory Agency (MHRA) responses to freedom of information (FOI) requests for week commencing 18 July 2022
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