Gilenya experiences wanted!

Early this morning I received the following comment on my “Gilenya: Day 00” post from azcharli:

“I started Gelenya on December 19th. The very first 6 hour observation ended with me waking up in the ER with a heart rate of 34. The hospital wanted to keep me overnight for observation. As luck would have it my heart rate went up to 57 just in time for the nurse to tell the doctor and get me discharged. As soon as he saw it I unplugged the monitor and I was out of there.
My heart rate is still in the 40's and 50's.
Anyway 2 days later I had to go back to the ER with blood red eyes and terrible eye pain, oh and the horrible headaches. Not 1 person including my Neurologists assitant have ever heard of Gelenya. Needless to say they had to call poison control to find out about it.
I have been back twice with severe eye pain and headaches. The hospital told me it has nothing to do with Gelenya and sent me home. I just got back again tonight with the same thing. Severe eye pain when i look to one side or another which in turn makes my head pound. Once again they say it has nothing to with the drug. Bull... I have had MS for 17 years and have never had this before. I am curious to see how many others are in my situation. Honestly, I would rather be blind than go through one more day of pain and suffering.
Signed, Scared in Arizona.”

First, a disclaimer: I am not a doctor (and I don’t even play one on TV). The information that I share here is based upon my personal experiences as a patient and should be considered anecdotal. Before trying any recommendation or following any advice offered on this blog (by me or commenters) please discuss it with a medical professional who is fully aware of your medical history.

Sue, I am so sorry you are having this experience. MS is tough enough; we shouldn’t have to deal with all the medication-induced side-effects as well. OR have to put up with medical professionals who are unfamiliar with the drug but are certain that it is not what’s making you sick.

When I read this, my initial thought was that you have optic neuritis. Usually when I have optic neuritis I have excruciating pain whenever I move my eyes and I rub them so much that they get bloodshot. I also get a terrible headache from all the eye pain/stress. But I would suspect that after 17 years you would have had optic neuritis and know how it presents. If you’ve never had it (lucky you), that could be what’s going on. My neuro treats with IV steroids and it resolves.

Outside of that, I have never heard of anyone having this cluster of symptoms or this experience with Gilenya. BUT I know that doesn’t mean much when it comes to MS, side-effects, and drug interactions. And because Gilenya has been on the market for such a short time, I’m sure there are a lot of things that are still unknown about the drug. Frankly, we know that Gilenya can damage our vision, so I don’t understand why it is so far-fetched that it could cause eye pain!

I would suggest having your doctor call Novartis and inquire about your symptoms. It seems that with most drugs there are symptoms that are so rare that they don’t have to report them on the information sheets. With a simple phone call from a medical professional, the drug company will let you know if this is a side-effect of the drug. It is also good to share this information with them (especially with new medications) so they can keep record of the various side-effects. Who knows, maybe your experience isn’t so unique after all.

I’m gonna link to this post on my Twitter, Facebook, and Google+ accounts. I invite everyone to share their experiences with Gilenya in the comments. Just remember that these drugs work differently for each person, so check with your doctor before making any health-related decisions.

Gilenya: Days 02 - 07

Current medication: Diltiazem, Zyrtec, Vitamin D (high dose- taken on Wednesday), Gilenya, Ibuprofen, Baclofen, Lamotrigine, Tizanidine, Lyrica, Vicodin

Mood: Sad, frustrated.

Physical: right foot numbness, jaw pain, headache, nausea, chills, scratchy throat, tingling lips, cough, extreme fatigue, dizziness, sharp pain in right calf, stiffness in both legs, hypersensitivity in both legs, shadow-like presence in lower right quadrant of right eye, difficulty with balance.

Neurological: difficulty focusing/multi-tasking, occasional slurred speech/lazy tongue, confusion, difficulty saying certain words.

Sleep: On 7/18/11- 7 hours uninterrupted, 1 “sleep episodes” around 1:30 PM.

Other (falls, dropping items, etc): None

Aids: canes

Tests/Results: closely monitoring blood pressure-still slightly elevated.

Appointments: None

After seeing the NP last Tuesday, I went home to rest. Basically, she wanted to see me and make sure I was OK. They took my blood pressure, gave me ibuprofen, and monitored me for a half hour. I was released home and cleared to return to work on Wednesday. She also reminded me to take Zyrtec twice a day to relieve some of the discomfort (it isn’t working).

Since then, things haven’t changed. I am in a lot of pain and have increased all forms of pain management without much relief. The pain level makes every day tasks even more difficult than they were a few weeks ago and it is slowing me down immensely. I feel like my head is full of oatmeal. Not good.

I am still moving forward with Gilenya. I received my first 28-day shipment today and didn’t panic or freak out. That’s good right?!?! Yes, let’s take our victories as they come.

Now I just need my body to work better so I can cut that list of meds down again. I was doing to so well for months without such a long list. My budget will thank me, too.

Gilenya: Day 01

(This covers the time from the last post until 11 AM today.)

Current medication: Gilenya, Ibuprofen, Baclofen, Lamotrigine, Tizanidine, Lyrica, Vicodin

Mood: Anxious, sad, afraid.

Physical: terrible headache (7 out of 10), nausea, scratchy throat, tingling lips, cough, extreme fatigue, dizziness, sharp pain in right calf, throbbing-ache in both legs, stiffness in both legs, hypersensitivity in both legs, right eye pain with movement, shadow-like presence in lower right quadrant of right eye, difficulty with balance.

Neurological: difficulty focusing/multi-tasking, occasional slurred speech/lazy tongue, confusion, difficulty saying certain words.

Sleep: 2 hour nap then 5 hours uninterrupted, no “sleep episodes” today.

Other (falls, dropping items, etc): Extremely high blood pressure

Aids: canes

Tests/Results: Pre-Gilenya skin check clear, high blood pressure throughout the day before and after gilenya

Appointments: 07/12/2011 11:30 AM with NP to discuss side-effects, scheduled to see PCP on 07/15/2011 at 10:45 AM

Started Gilenya today. Shortly after the first dose I began feeling a scratchy throat and tingling lips. After 1 hour, by blood pressure spiked dangerously high in response to the medication, but there were no other cardiac symptoms so we just waited for it to return to normal on its own. As the day progressed, I developed a cough, headache, and felt numbness/tingling in lips. When released at the end of the observation period, the NP suggested I return for observation the next day but I refused and promised to check-in the following morning. When I came home I was exhausted and took a nap and an anti-inflammatory. I felt very cold and shivered the whole time, but didn’t have a fever. After the nap I sat up for 30 minutes or so then returned to bed for the night. It took about 90 minutes to fall asleep because I couldn’t get warm, but once I was sleeping, I stayed asleep until my alarm rang. I woke up feeling much worse. The headache was almost unbearable. I took the second dose of Gilenya at 6:10 AM and about 30 minutes later the scratchiness and tingling returned. My energy was low, but I went to work. I checked-in with the neuro’s office around 10:45 AM and after reporting my symptoms they wanted to see me immediately. I left work and headed to the office.

Gilenya: Day 00

(This is the first post in a series I'm hoping will document the changes that occur while I take Gilenya. The details of each post will cover anything that happens from the time of the last post to the time of the current post unless otherwise specified (versus a 12:00 AM-11:59 PM schedule). Every 4 weeks I will do a retrospective/summary entry using the same format.)

Current medication: Baclofen, Lamotrigine, Tizanidine, Lyrica, Vicodin

Mood: Anxious, hopeful.

Physical: sharp pain in right calf, throbbing-ache in both legs, stiffness in both legs, hypersensitivity in both legs, right eye pain with movement, shadow-like presence in lower right quadrant of right eye, slight blurry vision helped with reading glasses, difficulty with balance, headache, mild fatigue, sleepiness.

Sleep: 6 hours, woke up approximately 5 times (momentarily) during the night, no “sleep episodes” today.

Neurological: difficulty focusing/multi-tasking, occasional slurred speech/lazy tongue.

Other (falls, dropping items, etc): None.

Aids: cane

Tests/Results: None

Appointments: 07/11/2011 8:30 AM with NP to start Gilenya

In general, I feel “normal.” Most of the things going on have been constant for some time. The eye pain started nearly 3 weeks ago and was checked by Dr. C. She thinks it will resolve in time, I disagree. The visual presence is similar to what happens after you stare at a bright light or light bulb then look away. It started last Wednesday night and has not gone away. I will speak to the NP while in the office today and ask her if there is any cause for concern.

Gilenya.

My last post was titled “It’s Been Awhile,” but who knew it would take me 15 months to get back into the groove of writing. I’m hoping to update more often because I have quite a lot to say.

In the past 15 months a lot has happened. I started working full-time, started taking Betaseron, stopped taking Betaseron, started Tysabri, stopped Tysabri, had flare-ups roughly every 3 months, developed 3 new lesions, and decided to start Gilenya, or as Dr. C calls it, The Pill.

Gilenya is the spark I needed to get my fingers back on the keyboard. I guess it’s the newness of the drug and all its big promises that has me ready to document the changes of my body in the hope of looking back in a few months and seeing actual improvement in my condition.

Over the next few days or weeks I will do more in-depth entries about the other occurrences, but this entry is about Gilenya.

First off, I’m terrified about starting a new drug. This feeling isn’t exclusive to Gilenya, but seems stronger because it’s not just new to me, but it’s new to everyone. Gilenya (fingolimod) was approved by the FDA in September 2010 and is the first oral disease-modifying treatment. It’s not a cure. However, it is designed to slow down the progression of the disease and reduce the number of flare-ups for folks with relapsing forms of the disease. It’s also believed to make day-to-day life easier, which is a major plus for the drug. Oh, and it’s a pill! Personally, I don’t miss the needles and I’m sure every person that has chosen to try Gilenya absolutely agrees.

But with all drugs, there are risks. According to the Gilenya.com Patient Medication Guide:

GILENYA may cause serious side effects, including:

· Slow Heart Rate (bradycardia or bradyarrhythmia) when you start taking GILENYA.

GILENYA can cause your heart rate to slow down, especially after you take the first dose. Your heart rate will usually slow down the most about 6 hours after you take your first dose of GILENYA. You might feel dizzy or tired or be aware of a slow or irregular heartbeat if you heart rate slows down. Usually, if you experience these types of symptoms due to the slowing down of your heart rate, they will occur during the first 6 hours after the first dose.

Your doctor will watch you for the first 6 hours after you take the first dose to see if you have any serious side effects. Your slow heart rate will usually return to normal within 1 month after you start taking GILENYA.

· Infections.

GILENYA can increase your risk of serious infections. GILENYA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment. Your doctor may do a blood test before you start taking GILENYA.

· A problem with your vision called macular edema.

Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). You may not notice any symptoms with macular edema. Macular edema usually starts in the first 3 to 4 months after you start taking GILENYA. Your doctor should test your vision before you start taking GILENYA and 3 to 4 months after you start taking GILENYA, or any time you notice vision changes during treatment with GILENYA. Your risk of macular edema may be higher if you have diabetes or have had an inflammation of your eye called uveitis.

· Breathing problems.

Some people who take GILENYA have shortness of breath. Call your doctor right away if you have trouble breathing.

· Liver problems.

GILENYA may cause liver problems. Your doctor should do blood tests to check your liver before you start taking GILENYA.

Evidence of these problems and minor side-effects include:

• dizziness

• tiredness

• a slow or irregular heartbeat

• fever

• tiredness

• body aches

• chills

• nausea

• vomiting

• blurriness or shadows in the center of your vision

• a blind spot in the center of your vision

• sensitivity to light

• unusually colored (tinted) vision

• nausea

• vomiting

• stomach pain

• loss of appetite

• tiredness

• your skin or the whites of your eyes turn yellow

• dark urine

• headache

• flu

• diarrhea

• back pain

• abnormal liver tests

• cough

With this very long list of (known) things that could possibly go wrong, I think I have every right to be terrified. Don’t I? I’m definitely going to start the medication tomorrow, but I’m still worried.

You see, I have a history of being allergic to or exhibiting rare side-effects of medications. In college I was prescribed a mood stabilizer that made me spontaneously burst into tears. No one believed it was the drug. Finally I convince my doctor to call the drug company and “spontaneous tearfulness” was one of the rare side-effects. It’s so rare that they didn’t have to list it in the prescribing information. Or, my weird allergies to gadolinium, Vioxx (this was before the recalls and both my parents and doctor told me that my symptoms were made up), Cymbalta, Avonex, and Tysabri. There are others of course, but these stand out because I was told that I wouldn’t have any real problems. Well, no significant problems, but I did.

So I’m terrified that Gilenya will join this group and leave me blind and unable to breathe.

However, I am going to my doctor’s office tomorrow morning and I’m going to swallow that little capsule. I’m gonna sit there for 6-7 hours, reading, writing, listening to music, and munching on snacks. Nothing is going to go wrong. I’m not going to be allergic, and this medication will work for me.

In spite of all my fears, I sincerely believe that Gilenya will make a positive difference in my life. I look forward to the changes and am excited to write about them here.

And that’s my plan. I’m going to do periodic posts titled “Gilenya: Day XX” that will include a list of medications, symptoms, mood, etc. I’d like to promise that I will post daily, but I’m aiming for at least weekly. Hopefully after a few weeks or months there will be definitive proof of the effect of Gilenya on my MS.

Fingers crossed.