Gilenya (First Oral Drug)

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Sept. 22, 2010 — The FDA today approved Novartis’ Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel.

Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised.

In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph node door.

Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections. Novartis will set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer-term use.

Gilenya was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.

Even at this dosage, Gilenya can have severe toxicity. In clinical trials, side effects linked to Gilenya included:

Two fatal herpes infections occurred in MS patients treated with Gilenya at 2.5 times the FDA-approved 0.5 mg dose. Novartis is not seeking approval for higher dosages.

Overall, the drug’s benefits outweighed its risks among the more than 2,600 MS patients who took the drug in clinical trials.

 

April 25, 2012

New Prescribing Information for Gilenya

On April 20, 2012, Novartis announced changes to the prescribing information for Gilenya™ (fingolimod) in the treatment of relapsing forms of multiple sclerosis (MS). This new prescribing information is applicable only to individuals who have not been given a first dose of Gilenya or for those who have stopped and will be restarting the drug. These changes do not affect any guidelines for individuals who are currently taking Gilenya.

The new parameters will appear on the labeling for Gilenya and were put in place by the United States Food and Drug Administration (FDA), following a review of the drug and its potential effects on the heart. These effects – such as a slowed heart rate (bradycardia) and changes in the conduction of electricity in the heart (atrioventricular [AV] block) – are temporary and usually occur during the first six hours after taking the first dose of Glienya. Rarely, a patient’s heart function may not return to normal until after the first six hours (and for up to 24 hours).

The FDA was reviewing this drug following the death of a patient within 24 hours after taking a first dose of Gilenya in November 2011. Investigators have not yet determined if Gilenya was involved in this tragic event.

This week (beginning April 23, 2012) the results of a two-year, Phase III extension trial with 1,080 participants (FREEDOMS II) were presented at the American Academy of Neurology’s annual meeting. In terms of safety, no new or unexpected adverse events were reported.

The new prescribing information increases the parameters for selecting individuals who may be prescribed Gilenya, and also increases the monitoring of patients when taking their first dose. As mentioned earlier, the labeling changes do not affect any guidelines for individuals who are already taking the drug.

The following is a summary of the new prescribing information:

  • All patients need to be screened in advance with an electrocardiogram (ECG) to determine any underlying heart conditions and to establish a baseline reading.
  • Any individuals with no pre-existing heart conditions may be given their first dose at a monitoring facility (presently 220 sites in the United States are registered to give an initial dose).
  • The normal protocol is to monitor a patient’s vitals (pulse, blood pressure, etc.) for six hours following the first dose. If the individual’s heart rate has returned to normal within those six hours and shows no other signs of a problem, he or she is given another ECG and is allowed to go home if the readings are normal.
  • Reactions are rare and only those who experience heart issues that do not resolve within the first six hours will need to be monitored until their heart rate or AV block returns to normal.
  • Contraindications (i.e., conditions that would present a higher risk of adverse events for someone to be started on Gilenya) include a heart attack, unstable angina (chest pain caused by reduced blood flow to the heart), stroke or warning stroke — any of which occurring within the past six months. Those with contraindications, as well as individuals who have an irregular or abnormal heartbeat (arrhythmia), or who take medicine to slow or alter the rhythm of their heart, are advised not to take Gilenya.
  • Individuals with risk factors (such as a heart problem or who are on heart medication) who are evaluated and deemed able to be prescribed the medication, will need to be given their first dose of Gilenya in a hospital and are to be monitored overnight with a continuous ECG. They may not be released until the next day when any heart issues have been resolved.

The European Medicines Agency (EMA) was also re-evaluating the risks and benefits of Gilenya. They determined that the benefits outweigh the risks for individuals with relapsing forms of MS. Their recommendations are very similar to the changes in prescribing information from the FDA.

In their press release dated April 20, 2012, the EMA states:

“Following a review of the latest evidence of the safety of the medicine, the Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends that doctors should not prescribe Gilenya to patients with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication. However, when treatment with Gilenya is considered necessary in these patients, their heart activity should be monitored at least overnight following the first dose of Gilenya and doctors should seek advice from a cardiologist on appropriate monitoring.

“The CHMP also recommends that all patients starting treatment with Gilenya should have their heart activity monitored before receiving the first dose of the medicine and continuously for at least six hours after. Monitoring should be extended for at least two hours in patients whose heart rate is lowest six hours after receiving the first dose of Gilenya. In patients who develop clinically significant heart problems such as bradycardia (a slow heart rate) or atrioventricular (AV) block (a problem with the conduction of electricity in the heart) monitoring should continue at least overnight and until the problems have been resolved.”

For more information, individuals may contact Novartis at (888) NOW-NOVA (888-669-6682) or call MSAA’s Helpline at (800) 532-7667. Information on this new prescribing information is also available by visiting www.gilenya.com.

Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer