Gilenya information center
We'd like to share with you some safety-related information about Gilenya (fingolimod).
Gilenya Safety information update: April 13, 2012
Please find below a statement on a confirmed case of progressive multifocal leukoencephalopathy (PML) in a JCV antibody positive, multiple sclerosis (MS) patient treated with natalizumab for approximately 3.5 years prior to starting Gilenya.
Reported multiple sclerosis (MS) deaths of patients on Gilenya (fingolimod) from any cause
Please find below some information about reported multiple sclerosis (MS) deaths of patients on Gilenya from any cause through December 13, 2011.
Frequently asked questions
View the FAQ below or download it as a PDF.
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Why have you communicated reported multiple sclerosis (MS) patient deaths from any cause for Gilenya from May 12, 2003 through Dec 13, 2011?
- Novartis has communicated this information publically with the goal of eliminating any confusion in the MS community.
- On January 20, 2012, the European Medicines Agency (EMA) announced a review of Gilenya citing 11 deaths as being of potential interest. However, as noted by the EMA, currently it is not clear if these deaths were caused by Gilenya or not and the exact cause of death in the one patient who died within 24 hours of taking Gilenya is still unexplained.
- In January 2012 Novartis communicated fingolimod patient deaths from any cause in MS clinical trials and in the post-marketing setting from May 12, 2003 to December 13, 2011 that were reported to Novartis.
- To date, approximately 30,000 MS patients have been treated with fingolimod.
- From May 12, 2003 through December 13, 2011 there were a total of 31 deaths reported to Novartis from any cause in people with MS who have taken fingolimod in clinical trials and post-approval.
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Why is December 13, 2011 the cut-off date for the information communicated about reported Gilenya MS patient deaths?
- December 13, 2011 was the cut-off date for the submission of safety data by Novartis to the European Medicines Agency (EMA) in the context of a preliminary safety data assessment by the agency following the first reported death within 24 hours of first dose.
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What can you tell us about the 11 deaths that are cited by the European Medicines Agency (EMA)?
- 11 deaths were cited by the EMA in its January 20, 2012 public communication:
- One of the deaths occurred within 24 hours after taking the first dose of Gilenya. This is the case that occurred in November 2011 and the cause of death is not established at this time.
- o All of these deaths were reported to the health authorities in accordance with regulations, and we regularly assess new safety data in the context of potential causality and background rates.
- As noted by the EMA, currently it is not clear if these 11 deaths were caused by Gilenya or not and the exact cause of death in the one patient who died within 24 hours of taking Gilenya is still unexplained.
- The complete EMA press release and Q&A issued on January 20, 2012 announcing its initiation of a review of Gilenya can be accessed here.
- Based on information received by Novartis, following is a breakdown of these 11 death cases1:
- 3 cases of complications of advanced MS
- 3 cases of myocardial infarction
- 2 cases of drowning
- 2 cases of unexplained death during sleep (including the November 2011 case)
- 1 case of hypertensive cardiovascular disease
- 11 deaths were cited by the EMA in its January 20, 2012 public communication:
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What are the EMA’s interim recommendations for healthcare professionals in the European Union during its review of Gilenya?
- On January 20, 2012, the EMA made the following interim recommendations:
- While the review is ongoing, the EMA's Committee for Medicinal Products for Human Use (CHMP) is advising doctors to increase their level of monitoring of patients around the first dose of the medicine.
- Before starting treatment with Gilenya, all patients should have their heart checked by electrocardiogram (ECG or EKG), a test that measures the electrical activity of the heart.
- After receiving the first dose of Gilenya, all patients should have their heart function continuously monitored by ECG for six hours.
- All patients should also have their blood pressure and heart rate checked every hour for six hours after the first dose.
- If patients develop any clinically relevant heart problem (such as bradycardia or atrioventricular block), doctors are advised to consider extending the monitoring period until it is resolved.
- On January 20, 2012, the EMA made the following interim recommendations:
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What information did FDA provide to healthcare professionals in the United States in its Drug Safety Communication?
- On December 20, 2012, The US Food and Drug Administration (FDA) issued a Drug Safety Communication following the first reported death of a patient within 24 hours of receiving their first dose of Gilenya.
- Consistent with the current US Prescribing Information which remains unchanged as of this time, FDA stated the following:
- If you prescribe Gilenya, carefully follow the recommendations in the Gilenya drug label.
- Observe all patients for signs and symptoms of bradycardia for 6 hours after the first dose.
- Obtain a baseline ECG before the first dose if one was not recently performed for those patients at higher risk of bradyarrhythmias.
- Gilenya has not been studied in patients with ischemic heart disease, congestive heart failure, second degree or higher conduction block, sick sinus syndrome, or prolonged QT interval. Gilenya has not been studied with concomitant use of Class Ia or Class III antiarrhythmic agents. These patients, as well as patients receiving beta blockers, calcium channel blockers, and those with a low heart rate or history of syncope, are at increased risk of developing bradycardia and conduction block. Carefully monitor these patients during initiation of therapy.
- If Gilenya therapy is discontinued for more than two weeks, the effects on heart rate and atrioventricular (AV) conduction may recur on reintroduction of Gilenya treatment and the same precautions and monitoring as for initial dosing should be followed.
- Make sure your patients know the signs and symptoms of bradycardia and when to seek care.
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What has the EMA advised for patients in the European Union?
- The EMA has advised the following for patients in the EU:
- Patients are advised to immediately report to their doctor any symptoms that could suggest they have a heart problem (such as chest pain, weakness or dizziness).
- Patients who have any questions should speak to their doctor or pharmacist.
- The EMA has advised the following for patients in the EU:
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What information did FDA provide to patients in the United States in its Drug Safety Communication?
- Consistent with the current US Prescribing Information which remains unchanged as of this time, FDA stated the following:
- Gilenya may cause serious side effects, such as slow heart rate (bradycardia), which may be related to slowed conduction of electrical impulses from the upper chambers of the heart to the lower chambers of the heart. These effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations.
- A slowing of the heart rate due to Gilenya mostly occurs after the first dose, and your heart rate usually returns to normal within 1 month after you start taking the drug.
- Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
- Call your healthcare professional and seek immediate care if you develop any signs or symptoms of slow heart rate such as dizziness, tiredness, slow or irregular heart beat or palpitations
- Discuss any questions or concerns about Gilenya with your healthcare professional.
- Report any side effects you experience to your healthcare professional and the FDA MedWatch program.
- Consistent with the current US Prescribing Information which remains unchanged as of this time, FDA stated the following:
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What can you tell us about the other 20 deaths?
- Approximately 30,000 MS patients have been treated with fingolimod to-date and there have been 31 deaths reported to Novartis due to any cause from May 12, 2003 through December 13, 2011. The other 20 deaths aside from the 11 EMA have cited include:
- 6 suicides
- 5 were off the drug for three months to three years at the time of death
- 4 complications of advanced MS
- 2 infections (1 disseminated herpes zoster, 1 herpes encephalitis)
- 1 traffic accident
- 2 others
- Approximately 30,000 MS patients have been treated with fingolimod to-date and there have been 31 deaths reported to Novartis due to any cause from May 12, 2003 through December 13, 2011. The other 20 deaths aside from the 11 EMA have cited include:
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Can you give an update on the patient death from November 2011?
- As the FDA indicated in its Drug Safety Communication:
- The patient was also treated with metoprolol (a beta blocker) and amlodipine (a calcium channel blocker).
- The patient had completed 6 hours of monitoring after the first dose without incident but died less than 24 hours after the first dose.
- The exact cause of death has not been established
- The complete FDA Drug Safety Communication issued on December 20, 2011 can be accessed here.
- As the FDA indicated in its Drug Safety Communication:
