Novartis says it has updated prescribing data for multiple sclerosis therapy Gilenya (Fingolimod) after a review by the Food and Drug Administration (FDA). The prescribing information includes new parameters for selecting patients, based on specific cardiovascular considerations. Novartis emphasizes that the prescribing information does not alter treatment management of MS patients currently taking Gilenya, unless treatment is stopped, and then a need to reinitiate occurs.

Gilenya (fingolimod) is an oral medication, taken once a day, which has been proven to reduce relapse numbers, as well as slowing down disability progression in patients with relapsing forms of MS (multiple sclerosis). Fingolimod, a sphingosine 1-phosphate receptor modulator, sequesters lymphocytes in lymph nodes, stopping them from becoming involved in an autoimmune reaction.

The prescribing information (PI) changes follow an FDA review, announced in December 2011.

The updated PI advises doctors to have patients who are being considered for Gilenya therapy to undergo an ECG (electrocardiogram) beforehand, and at the end of the six-hour observation period, as well as hourly heart rate and blood pressure measurements.

Novartis reiterates that patients currently already on Gilenya treatment are not affected by this update, unless they came off the medication and the doctor is considering restarting Gilenya therapy.

Novartis explains that new recommendations have been issued on how to reinitiate Gilenya therapy if it had been discontinued. If you are an MS patient, you should not make any changes to your current medication regime, even if you are on Gilenya, without checking with your doctor first.

The prescribing information also recommends that those with some pre-existing heart conditions, as well as patients on concomitant heart rate lowering drugs, be checked by a doctor before going on the first dose of Gilenya. If these patients then do go on to receiving Gilenya, they should be monitored overnight with continuous ECG in a clinic after the first dose. Novartis wrote on its US website today “Experience with the use of Gilenya in such patients is limited.”

The term contraindications refers to when a treatment is inadvisable. The updated PI includes new contraindications.

Gilenya therapy is contraindicated in those with the presence of, or a history of:

  • Heart attack (during the last six months)
  • Stroke (during the last six months)
  • 2nd and 3rd degree AV (atrioventricular) block
  • Other severe cardiac rhythm disturbances
  • As well as those taking certain anti-arrhythmic medications

Novartis informs that 36,000 patients globally have been treated with Gilenya in human studies in the post-marketing setting (as of February 2012).

Barry Singer, MD, Director, MS Center for Innovations in Care, Missouri Baptist Medical Center, said:

“Gilenya represents an important treatment option for relapsing forms of MS. Choosing appropriate patients for Gilenya therapy and patient safety is essential.”

Novartis says it will be informing US doctors and patients through established field force and patient communication channels. Updated data will be posted at www.gilenya.com. Doctors and patients may also contact Novartis at 1-888-NOW-NOVA.

In a communiqué online, Novartis wrote:

“Also today, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) confirmed a positive benefit-risk profile of Gilenya. The CHMP recommended updates to the product information in the European Union that provide further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients. Those recommendations apply only to use of Gilenya in European Union countries. “

Written by Christian Nordqvist