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Medical information request
Medical information request


Progressive multifocal leukoencephalopathy 

  • Cases of PML have occurred in patients with MS who received fingolimod in the post-marketing setting1
  • The overall incidence of PML under fingolimod therapy not attributed to previous natalizumab treatment is very rare and the risk remains low
  • Beyond the known risk factors for developing PML*, no specific risk factors have yet been established in fingolimod-treated patients 
Progressive multifocal leukoencephalopathy(PML)_V2.jpg
*human polyomavirus JC virus infection, immunsuppresion, immunosenescence etc
**exposure includes both clinical trials and postmarketing experience; postmarketing patient exposure is estimated based on worldwide sales volume
^Cumulative number of patients with non-post natalizumab exposure, post-natalizumab exposure where causal relation with fingolimod cannot be ruled out and insufficient information regarding natalizumab exposure

 

Case details of 64 patients who developed PML under fingolimod

  • Mean age at the time of PML diagnosis was 49 (range 29 - 71) years (56 patients)
  • Treatment duration with fingolimod was approximately 5 years (range: 18 to 144 months)
  • Based on available ALC information, none exhibited sustained grade 4 lymphopenia (<200 cells/ul)
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About PML

About PML

  • Progressive multifocal leukoencephalopathy is caused by reactivation of the JC virus, a ubiquitous human papovavirus that is typically acquired during childhood and remains latent in the kidneys and possibly other sites (eg, mononuclear cells, CNS)
  • Increasingly, PML is occurring as a complication of immunomodulatory therapy
  • Common symptoms/signs include clumsiness, hemiparesis, aphasia, dysarthria, hemianopia and cognitive impairment
  • PML is suspected in patients with unexplained progressive brain dysfunction, particularly in those with depressed cell-mediated immunity
  • CSF is analyzed for JC viral DNA using PCR; a positive result with compatible neuroimaging findings is nearly pathognomonic
  • Supportive management and management of underlying disorders are helpful in managing PML
     

Suspected or confirmed PML: Get Novartis support

Novartis support

  • Novartis can help physicians with the assessment of a suspected PML case, after the adverse event has been reported to the company via standard pharmacovigilance processes
  • Subsequently, there is access to an external expert MRI service and Novartis has constituted an external PML adjudication panel for case evaluation
  • If a second opinion on an MRI with atypical findings/suspicion of PML is requested, Novartis can support obtaining this through a MRI expert center (MIAC), University Hospital Basel, Switzerland. Novartis will not have access to the MRI and will only receive a report
  • In addition, Novartis can support logistics for shipment of CSF samples for testing for presence of JCV DNA (PCR) by Unilabs A/S, Denmark and by Quest in the US. In this case, both the physician and Novartis receives the report
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Last updated: November 2023. The page will be updated once a year.

Abbreviations
ALC, absolute lymphocyte count; CI, confidence interval; CNS, central nervous system; CSF, cerebrospinal fluid; DNA, deoxyribonucleic acid; JC, John Cunningham; MRI, magnetic resonance imaging; MIAC, Medical Image Analysis Centre; PCR, polymerase chain reaction; PML, progressive multifocal leukoencephalopathy
References
1. Data on File, cutoff date February 2023, Novartis Pharma AG. 2. Data on File, Novartis Pharma AG.
* Indication wording varies in different countries. The current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of fingolimod in the individual country.