This Is MS Multiple Sclerosis Community: Knowledge & Support

A Canadians first dose: "Well unfortunately it did not go well. My blood pressure dropped so quickly, to 30 bpm they sent me to VGH and after, every Doctor and their dog came to see me, as they are unfamiliar with Gilenya.

They had to call Poison Control. That's where the ER Doctors had to get the info.

I spent 26 hours in the Cardiac Care Unit, I'm good now and home but they say I'm still at risk for the next 21 days! I still have to go get a portable monitor to wear.

Remember all people react differently, and I usually react well to drugs. i was unaware that 11 people had died, when I was told 2."

So, wait. HOW many have died? What is the source for "11 deaths?" My doctor is strongly urging that I start 'Gilenya,' because 'we are running out of options.'

When he first told me about it, I left the office just shy of tossing the info in the trash can on my way to the bus. Then I thought about it a few days, read some good posts, and now this afternoon I feel like I am reading nothing but negative reviews.

I'm pretty angry because in the 6 months I was on Tysabri, the instances/risk of PML went from 1:1,000 to 1:500. Now I am being tested for it.
Also wasn't told about the Rebound Effect.

So, seeing as there are quotes of "11 patients," and not 2, as I was told, can anyone site a source for this figure? Because I'm sick of not being told things that are so critical to my health/longevity.

Thanks!

The latest set of opinions from the European Medicines Agency has been dominated by the news that a safety review of the benefits and risks of Novartis' oral multiple sclerosis treatment Gilenya has begun.

The agency's Committee for Medicinal Products for Human Use (CHMP) has started the probe following reports of heart problems in patients taking Gilenya (fingolimod), as well as the death of one patient in the USA less than 24 hours after the first dose. The exact cause of death is still unexplained, the agency notes.

The EMA also cited six other unexplained deaths (including three cases of sudden death) that have been after starting treatment with Gilenya, plus three deaths due to heart attack and one due to disruption of the heart rhythm. Currently, "it is not clear if these were caused by Gilenya or not", it stressed.

MEDICATION GUIDE
GILENYA™ (je-LEN-yah) (fingolimod)
Read this Medication Guide before you start using GILENYA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about GILENYA?

GILENYA may cause serious side effects, including:
1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA.
GILENYA can cause your heart rate to slow down, especially after you take your first dose.You will have a test to check the electrical activity of your heart (ECG) before you take your first dose of GILENYA. You should stay in a medical facility for at least 6 hours after you take your first dose of GILENYA.

After you take your first dose of GILENYA:
• Your pulse and blood pressure should be checked every hour.
• You should be watched by a healthcare professional to see if you have any serious side
effects. If your heart rate slows down too much, you may have symptoms such as:
o dizziness
o tiredness
o feeling like your heart is beating slowly or skipping beats

• If you have any of the symptoms of slow heart rate, they will usually happen during
the first 6 hours after your first dose of GILENYA. Symptoms can happen up to 24
hours after you take your first GILENYA dose.

• 6 hours after you take your first dose of GILENYA you will have another ECG. If your
ECG shows any heart problems or if your heart rate is still too low or continues to
decrease, you will continue to be watched.

• If you have any serious side effects after your first dose of GILENYA, especially those
that require treatment with other medicines, you will stay in the medical facility to be
watched overnight. You will also be watched for any serious side effects for at least 6
hours after you take your second dose of GILENYA the next day.

• If you have certain types of heart problems, or if you are taking certain types of
medicines that can affect your heart, you will be watched overnight after you take your
first dose of GILENYA. Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA. Call your doctor or go to the nearest emergency room right away if you have any symptoms of slow heart rate.

Besides the sudden death side effect , my medical history hits a couple of the other warnings/precautions (macular edema, HIGH blood pressure), so Gilenya doesn't sound like it's for me. Although my neuro would love for me to take something. Anything. She doesn't care what I choose.

I follow a strict diet, and I exercise regularly. That helps a lot, but it helps MORE while I'm on something that works. I relapse a LOT (3-4/yr) otherwise, even though my nominal health is great.
Please don't wait too long. I'm very happy on Gilenya - it's way easier than copaxone or tysabri - but even if that's not your choice, start finding what DOES work for you.

As to the "sudden death"s - When you have thousands or tens-of-thousands of people in a trial, it happens sometimes that things happen to them unrelated to the drug.

6.1 Clinical Trials Experience
A total of 1703 patients on GILENYA (0.5 or 1.25 mg once daily) constituted the safety population in the 2 controlled studies in patients with relapsing remitting MS (RRMS) [see Clinical Studies (14)].

Study 1 was a 2-year placebo-controlled clinical study in 1272 MS patients treated with GILENYA 0.5 mg (n=425), GILENYA 1.25 mg (n=429) or placebo (n= 418).

Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, n=431) study including 849 patients with MS treated with fingolimod, were generally similar to those in Study 1.

Hi again, ariehs,

I hate to keep pounding on this topic, but I think it's important to give our TiMS readers the most accurate info possible when their lives are on the line. So... according to the actual prescribing information, here are the total numbers in the 2 fingolimod trials (now Gilenya) - 1,703 patients, not "thousands or tens-of-thousands of people". That's why they don't have a truly accurate safety profile until the drugs are distributed into the general population. Here's a quote: