Gilenya Update

written by: Cherie C. Binns RN BS MSCN

April 4, 2011

I attended a patient education program on Gilenya today presented by a nurse educator from Novartis and two local neurologists.

We heard that in the 6 months since Gilenya went on the market, there are 500 persons currently taking it.

It impacts liver function tests more negatively than any of the interferons so if a person had to go off an interferon due to elevated liver function Tests (LFTs) they will probably not so well on Gilenya.

One can transition directly from one of the injectable medications to Gilenya without a waiting period.

Persons on Tysabri need a minimum of 3-6 months with no Tysabri or steroids before being considered to start Gilenya.

Persons taking monthly IVSM need to miss at least one dose prior to going on Gilenya (off two months from last dose)

Persons taking CellCept, Immuran, Methotrexate or Cytoxan will have to wait 3-6 months before being considered eligible for Gilenya.

If a patient has not had chickenpox, they must have the vaccine and wait one month after receiving it to start Gilenya.

EKG and Ophthalmic exam looking for Macular edema must be done prior to drug administration.

Person must take first dose in Dr. Office or infusion Center when they can have cardiac monitoring and hourly vital signs done as first degree heart block can happen with the initial dose.

A follow up Ophthalmic exam must be done at 4 months into dosing to rule out macular edema.

The drug costs $4000/month and most private insurances will pay for it but so far Medicare and Medicaid are not.   Novartis is offering up to $800/month to each person to help cover copays.   So if you have Blue Cross and your Copay for one of the injectables is $75/month, you will have your copay covered by Novartis.  Pre-approval is mandatory.

Because there is currently no approved medication on the market for progressive non-relapsing forms of MS, now that this drug is FDA approved, it might be tried on an individual basis if a patient's Dr. feels their condition warrants trying this drug.

Most patients (up to 90%) have headaches or GI disturbances with this medication (diarrhea or nausea).   Some have flu-like symptoms but they are less prominent with this medication than with the interferons.

You are free to post this information and have anyone with further questions contact their neurologist for answers that are specific to their needs.

Cherie C. Binns RN BS MSCN

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