Several months have passed since I began taking Gilenya on May 5. Today I’m focusing on the drug’s possible side effects and how I have personally been affected. The good news is that I seem to be mostly fine so far. In spite of this year’s gloomy start with 2 separate attacks within it’s first few months, I have had no attacks since beginning this treatment. In hindsight I really do feel that Rebif, and probably interferons in general, are truly just not right for my body.

With my Gilenya followup appointment looming in a couple of weeks, I’ll soon find out if Gilenya suits me in the long run. As you can see, I do have my fingers crossed!

There are some known serious side effects of Gilenya and probably some yet to be discovered. Nothing is yet known about the effect of Gilenya use during pregnancy. We do know that the following side effects are possible :

• slowed heartrate for up to 1 month after beginning treatment
• decreased lymphocytes (white blood cells) leading to an increase in the risk of infections
• macular edema (swelling on or under the retina) – this primarily leads to blurry vision and blind spots (risk begins at 3 months)
• shortness of breath
• liver problems (or potential failure)
• high blood pressure

If you have read my other posts about MS, you have probably learned that Rebif affected my liver. After approximately 2.5 years of use, I ceased Rebif on the day my doctor let me see test results that showed liver enzymes in my blood were approximately 7x the acceptable limit for normal people. My neurologist considers this to be about 3x the acceptable limit for his patients with MS. This was the first time I was allowed to see test results and along with some other events this has convinced me I should always get copies of my test results to personally review. More on that in future posts.

Reviewing the list above, one would definitely have concerns. During the first few weeks, I could tell that my heart rate was slower, but it did normalize in about one month. So far, I’ve certainly noticed a slight change in my breath, but the change is very mild. Blood pressure is always high for me due to constant pain and muscle spasms – it has been controlled for the last 2 years and has not changed with this new medication. My optometrist has cleared me, for the moment, of any signs of macular edema. And finally, last week I had the necessary blood tests done to check my liver enzymes, my lymphocyte count, and various other stats that seem irrelevant to me. I will learn the results in 2 about 2 weeks.

Having recently joined Facebook, I am part of the Gilenya (Fingolimod) Users Support Group. I heartily recommend this to new and potential users. The discussion is largely about side effects, tips, etc. Learning that I am not alone in a few changes I experienced after starting usage, I want to add a couple of unofficial side effects to the list above based on my experience with Gilenya.

• Insomnia – For the first couple of months after beginning Gilenya, I only slept for about 3 to 4 hours per night, even with the futile use of Ambien. I can say with certainty now that I have not had insomnia for weeks, and my sleep has never been better. Before my diagnosis I seemed to always have insomnia. On interferon my sleep was often interrupted by the flu-like symptoms that tend to occur for most of us for several hours following a dose.  On Gilenya, having survived the initial insomnia, I usually sleep like a baby. This seems very common among other users – many of which began taking Gilenya in the morning rather than at night and used Sleepytime Tea by Celestial Seasonings to lull them into unconsciousness.
• Changes To The Skin – My skin has been brutally dry since the first week of treatment. Many others seem to experience this, but others have developed acne instead. Personally I may buy stock in the wonderful and expensive moisturizer I’ve started using to combat my issue. Regarding those who have acne instead – I wish you luck. I never figured that out in my teens and I doubt I could now.
• Increased Muscle And Nerve Pain – My spasticity and flexibility have noticeably  worsened, and it seems that others have also noticed this. Generally speaking, I am in more pain on a daily basis. Some patients take the drug at night to attempt to sleep through this.

Combined with work stress, this issue with spasticity and flexibility has kickstarted a yoga habit for my husband and myself. We aspire to work up to a daily routine (we use DVDs at home – we will never have time to fit classes into our irregular schedules). Doing yoga more frequently opened our eyes to the fact that our yoga equipment sucked. Having paper-thin mats on hardwood floors meant painful ankles and backs and an inability to complete all the poses. Poor straps and blocks meant we really weren’t using them. So we have officially overhauled our yoga gear and are loving the new stuff. This is now our current setup :

• Aurorae Northern Lights Yoga Mats
• GOGO Yoga Mat Harness
• Hugger Mugger Bamboo Yoga Block
• Yoga Strap With End Loops

This is certainly not the best gear for everyone, but it’s the best we’ve found for us. While I may not bend quite like the folks on the TV screen, I can now dwell on this in contorted positions while being in less pain than before. And that is fantastic.

For my readers who are contemplating what treatment to begin or who are not interested in Gilenya, I have discovered a valuable resource. The MSAA (The Multiple Sclerosis Association Of America) has developed a program to assist with choosing the best treatment for you from all available options. This program is called S.E.A.R.C.H. – http://www.msassociation.org/programs/search/ This looks like a great service for someone making a change in treatment and for those who are newly diagnosed. Considering the wealth of new drugs and their varied risks working their way through the FDA pipeline, I believe this will soon be even more useful than it is now.

In two weeks, if my test results prevent my continued use of Gilenya I may even need it for my next step forward. For now – I’m just hopeful.

meh.

I have looked forward to buying Star Wars on blu-ray for Will for a very long time. Unfortunately, we just found out the original versions of the movies aren’t included at all, and the HD versions aren’t even in widescreen. We’ve gone ahead and cancelled our pre-order and will just wait until an acceptable box set comes out. I’m sure there will eventually be 10 different box set versions and plenty of people will pay for them all. This is so disappointing. What to include in this set should have been a no-brainer.

That said, I’m really excited about Legend finally on blu-ray (and with the director’s cut), the Stanley Kubrick blu-ray box set,, and (finally) the real Lord Of The Rings blu-ray box set (the previous one was missing footage). I’m not a nut for the LOTR movies, but they are a lot of fun. Will and I both really admire Kubrick, and I am kind of nuts for Legend.

On the MS front, Gilenya has been going well as a treatment. Downsides are that I’m a bit drowsy sometimes and a bit cold (both seem so random). Sleep is difficult. My skin is definitely more sensitive than usual, especially to sunlight which I didn’t think was possible. I have no idea if it’s healing any damage considering how badly I react to heat and summer has been brutal. In approximately 3 months I will have more information about whether or not the drug is affecting my eyes or my liver. Right now I’m chalking up random bruises to Pye going crazy at night and beating me awake with bags of treats.

I learned yesterday that acknowledging that my heart rate lowered during my first dose during my followup phone call was construed as lodging a complaint that required me to go in and pay for a completely unnecessary neurology appointment to fill out the “complaint” paperwork.

I’m happy on the drug but having to use my weekday weekend (I worked Sunday) to go to my doc and pay for a visit to fill out unnecessary paperwork following a completely misconstrued phone call is unacceptable on all sides. Not the least of which is that a lowered heart rate is expected – hence having to be monitored for your first dose(s) in a doctor’s office.

Lesson learned – never bother explaining symptoms to a pharmaceutical company, or to my doctor who thinks I’m an over-reporter. The truth is, and I assume this is true for most MS patients, that for every symptom I divulge there are at least 10 others that I keep to myself. I won’t think of myself as an over-reporter until I buy stock in ink and paper then keep a log of it all. I thought I only reported the significantly painful symptoms or when I developed muscle weakness or paralysis as a result of an exacerbation. How inconvenient of me.

As I said, lesson learned. Now if only George Lucas would learn one.

Gilenya: The Pill Of Things To Come

Will and I spent most of last night in a smoky club in Charlotte called The Milestone not being able to hear Young Widows because the place was tiny with awful acoustics and the bands had huge equipment. The mold is all that keeps the place from going up in flames everytime someone puts out a cigarette on the floor. The audience there seemed like great people who all seemed to know each other. I truly wish more great shows would come to Greenville or that we had a similar scene of seemingly good people who just love music. Also, apparently since seeing Blonde Redhead a few months ago at Variety Playhouse in Atlanta, they have come out with extra big PBR (this appears to be a requirement).

Getting to bed at about 4:30 am was probably a mistake. Although it was really great getting to see our friends Jon & Britty and they introduced us to Vietnamese food for the very first time.

This was probably not the best way to spend the evening before my first dose of Gilenya. I spent the whole day in the neurologist’s office hooked up to heart monitors and trying to stay awake. I finally finished a book I’ve been meaning to read by Wendy Rose and got a few other things done as well. For the most part, it went alright.

Unfortunately, I didn’t think to remove my dark nail polish before this so they had to send someone out to buy nail polish remover before I could begin. There is nothing like the shock on a man’s face when he realizes that nail polish remover actually removes nail polish. The doctor went over my starter kit with me just to see what was in it. I will never understand why pharmaceutical companies waste so much money and marketing on useless things like pens people will never use, tote bags they don’t want, etc etc. And then there was maybe one valid bit of literature with it. Mostly there were packets of word puzzles (the words of course were things like lesions, myelin, etc), how to do exercises like lifting your toes, etc… Obviously we all need instructions on toe-lifting.

Two weeks worth of medication were also included. Gilenya has strange packaging. You pinch one side of the box and pull on the other. When I received my first month supply from Curascript the boxes did not work right at all. It was a wrestling match. These, however, worked perfectly. I was ready for a fight but the thing just opened correctly and I took my first dose.

Having had little sleep caused a problem. When we came home last night all smoky clothes went into the washer before we showered and went to bed. So today I stole Will’s jacket. After they hooked up all the wires and left me in a sleep study room so they could watch me with cameras, I covered up with Will’s jacket and started reading poetry. So, obviously, pretty soon the tech came in and woke me up shaking me and just stuck a blanket over me. He said, however that my heart rate was within the normal range.

So I tried to stay awake, I really did. But now here I have Will’s jacket to prop up on, music on my iPhone, a blanket, and poetry on 3.5 hours sleep. So at some later point he woke me up again. Heart rate is too low – time to take a walk. I’m not sure he knew why I was there. He seemed suspicious that the medication was making me favor my left side, and make sharp turns clumsily. Also, he really needed a cigarette. After I explained that I was there taking MS medication and had muscle weakness and knotted muscles on my right side I think he got it. Not much I could do about all of that. Adding Valium to the mix today seemed like a bad idea so I had avoided that.

Back to bed, determined to stay awake, I did fairly well. They brought me a Firehouse Subs sandwich which was the first time I’ve had anything from there. I had the Italian. It was awesome – especially once I got someone to bring me a napkin. Then the heart rate went down too low again. I finished my Wendy Rose book walking in place (although I preferred Bone Dance to Now Poof She Is Gone) and read about half of the The Bell Jar. Which is about time, because Sylvia Plath’s Ariel has always just been one of my favorite things. I even gave a copy to my 12 year old niece recently. I’m assuming either the genetic link will make her love it, or the fact that she’s 12 and it’s Sylvia Plath poetry will make her hate it.  Who knows.

Eventually my heart rate rose enough again and I was able to sit back down. The rest of my first dose went without incident. According to the literature, I’m allowed to continue taking it if I can keep my heart rate above 55. The lowest I got without exercise was 58, but it stayed at that for about 20 to 30 minutes even with exercise. Over the next month my body should adapt. In the meantime I’m mostly just cold and sleepy.

The first dose should be the most difficult and tomorrow will probably be about the same, maybe a little better. I’m not too worried. Now I just have to keep a check on my vision and liver enzymes.

Milk Thistle - Don't worry - I take it in pill form.

Maybe it’s silly, but for hundreds of years many people have used Milk Thistle to protect and heal their livers. I’m adding that in with my medication. It can’t hurt, surely.

I learned today that my neurologist favors socialized healthcare (smart man) and that he likes Atlas Shrugged (the book, not the movie – don’t get me started about this – Ayn Rand could create some inspiring heroes, but she is seriously screwed up and what is with all the rape in her books). I also asked him how many MS patients he had (about 30) and if any had ever asked him about medical marijuana (no, but now 1 had). He saw it as a medicine that will be difficult to really peg by the FDA to regulate as medication, was aware that THC wasn’t the useful component for treatment (even though it is available in legal pill form), and doubted that South Carolina will legalize it anytime soon.

I spent hours recently emailing everyone in the legislature about this. I received exactly two coherent replies

1. 1. From Chandra Dillard, whom I’ve met. She’s responsible for a great deal of what’s great about the West End of downtown Greenville. She spoke with us at a neighborhood meeting once a few years ago. She confessed that she needed to educate herself more on the matter. I confess, I really liked her a lot when I met her and have always voted for her since.
2. 2. From Senator Jim DeMint. It was even rational. He pointed out that regardless of what the states do, it’s still a federally regulated substance. But he said he would keep my opinion in mind if legislation ever came up regarding it.

All other replies were badly spelled and grammatically incorrect versions of “This ain’t my job.” Maybe they were just high when writing it. It inspired Will and I to come up with a better field sobriety test than walking in a straight line, etc. Try to get someone to do some division, multiplication, or add more than 3 numbers together. It will be both hilarious and less work. Most of our replies from government officials have always come back as if a D student in the 3rd grade wrote it. Nothing against 3rd grade D students, it just seems odd that they our politicians would use them for replying to consitutents’ letters.

Think South Carolina should make an effort to legalize “compassionate care” (aka medicinal cannabis) for patients who need it? Then go have fun harassing our government. Good luck navigating those crappy websites.

So, for now, I’m definitely on Gilenya, although future results might change that. Pollen and hope are in the air

Grey's Diagram Of The Body's Intercostal Muscles.

Lately my absence has been due to serious trouble with something frequently called the MS Hug or sometimes Girdle Pain or sometimes Girdle Band Sensation. There are a couple of theories  on what causes this. One theory is that it is just muscle spasms like all the other muscles spasms experienced by people like me. And by “muscle spasms” I mean awful unbearable crippling pain (although not always). The more popular theory is that the spasms are caused  by lesions on the spinal cord – I’ve never had an MRI on my spinal cord so I can’t tell you if that could be a factor here. It can be an exacerbation or a psuedoexacerbation. In my case I’m not sure. But I’m going to try to give you all the information I can about this abomination. Please remember, I work at a telecommunications company and have no medical background.

My first experiences with this were extremely painful, but slowly I determined that caffeine, stress, and heat were triggers for all of my muscle spasms, especially the ms hug. I cut out caffeine altogether, tried to use yoga and perspective to control my stress, and I try very hard to stay out of the heat. It can hurt for a few seconds to weeks. It can hurt a little or can be so painful that I end up in the ER because valium to the vein is my only hope. Sometimes, even that doesn’t help. The pain can be unreal. It can be unbearable. It can be so bad that you do not wish to live through it. My recent episode was the worst it has ever been and drove my blood pressure to incredible heights.

This particular episode lately was triggered immediately by the stress of Novartis telling me that my insurance company (and I work my ass off to make sure I stay in a job that keeps me in insurance) had refused to cover any multiple sclerosis medication due to cost. Just to be clear, we pay for the highest level of insurance just to make sure we have the maximum amount of coverage.

There are different types of pain. When I talk to Will, I refer to them as “flavors” of pain. But technically speaking, neurologists will usually call this a “parasthesia” which means that it’s an abnormal sensation caused by neuropathic pain. To me, this makes no sense. When I randomly feel like a grease fire is on my hand that is an abnormal sensation caused by my brain. The MS Hug, or perhaps let’s call it the “MS Grip Of F*cking Death” clearly involves pain that is caused by muscles gone nuts, even if they have gone nuts because there are wonky ass nerves between your brain and muscles.

My daily treatment, per doctor’s orders this round went something like 10 10mg of Valium per day, spread out over 5 doses of 2 pills each. Up to 6 7.5mg Loritab per day, sometimes 10mg Cyclobenzabrine, sometimes 0.125mg Hyoscyamine, sometimes 2mg Hydromorphone.  Between 2 ER visits I was given mostly Valium, Solumedrol, and Morphine. After finally believing I had beaten this episode of the hug, the pain would return and I would have to take pills again. When I finally really beat the hug, I went off the pills altogether. Normally, I can feel the hug coming on, take a couple Valium and it will go away. At worst, it comes on full force, I take some Loritab as well, or maybe Ambien and I’m better in the morning. Or perhaps I may be on a couple Valium a day for a few days in a row.

I was not prepared for the fact that I would have to go through opiate withdrawal from this episode. It has been extremely difficult, to say the least. It brings back the darkest parts of my life in full color or just leaves me with the blackest possible mood for no reason. Every stupid thing I have done, everything I have done to ever feel guilty about haunts me – from fights with my family to being hurtful to former boyfriends. Every instance where I’ve let a friend take advantage of me or abuse me replays over and over. After a few weeks, I think I’m finally past it and hope to never, ever have to go through either the hug or the withdrawal again. Let me reiterate – the withdrawal has been TERRIBLE.

So, what is this MS Hug thing? A lot of what follows is probably ripped off the internet because I was an English major who dropped out of college to pay rent rather than going to med school.

The MS Hug involves some or all of the intercostal muscles going into spasm – these muscles hold your ribs together and make your torso flexible. The image at the top of the blog post shows these muscles – the most important thing to remember is that they are located around the abdomen and are largely in between the ribs. Maybe this is different for everyone, but for me it typically starts on one side and at worst ends up wrapping completely around me from just underneath my breasts to the top of my hips. My muscles often feel like river pebbles to the touch. Clothes get tight because the muscles push out, but the muscles also push in, so vomiting ensues and I can barely breathe more than small gasps of air. You may ask if this is a stabbing, throbbing, etc etc pain. It’s all of the above. The most common description is that you’re being squeezed or crushed to death.

The intercostal muscles fill up the spaces between the adjacent ribs. They are arranged in three sets, external, internal and innermost internal, eleven pairs of each.

There are three principal layers;

1. External intercostal muscles, which aid in quiet and forced inhalation. They originate on ribs 1-11 and have their insertion on ribs 2-12. The external intercostals are responsible for the elevation of the ribs, and expanding the transverse dimensions of the thoracic cavity.
2. Internal intercostal muscles, which aid in forced expiration (quiet expiration is a passive process). They originate on ribs 2-12 and have their insertions on ribs 1-11. The internal intercostals are responsible for the depression of the ribs decreasing the transverse dimensions of the thoracic cavity.
3. Innermost intercostal muscle, the deep layers of the internal intercostal muscles which are separated from them by the neurovascular bundle.

Both the external and internal muscles are innervated by the intercostal nerves and are provided by the intercostal arteries and intercostal veins. Their fibres run in opposite directions

All muscles are in a constant state of readiness (tonus). Although muscles work in pairs and groups to create movement a muscle can only contract (pull) while the opposing muscle relaxes. However, tension is always maintained in both muscle pairs (tonus) to maintain stability.  Tension maintained in the relaxing muscle prevents the contracting muscle from overreacting. When the nerve impulse to the muscle, or muscle group are interrupted the relaxing muscle or muscle group receiving the nerve impulse to maintain its opposing tension will no longer work to maintain the equalizing balance and its opposite partner will then over-react causing the symptoms known as MS Hug.

Here are some ideas for alternative therapies to end the pain from an active hug (and my take on them) from what I personally believe to probably be most effective to least :

• Loosen Your Clothing (Hell yeah. Or just lose it altogether. Seriously. With over 75% of MSers being women, I’m just gonna say take off your bra, hands-down. Men reading this will probably agree, but not necessarily for the same reason)
• Warmth (A heating pad helps, except when the cats demand it back and I wake up with cat scratches all over my stomach. A hot bath helps sometimes, and sometimes not.)
• Fluids (Maybe – I’ll just throw it right back up. Better than dry heaves? Although if the pain is not too bad, it’s sweet when Will makes hot chocolate for me – it’s like a heating pad on the inside)
• Pressure Or Massage To  The Affected Areas (I can usually only tolerate this on my back – the pain is too great anywhere else.)
• Ibuprofen (HAHAHAHA – no. This started for me when I was already on 80 mg of Baclofen per day for spasticity, so that never helped me. Valium (Diazapam), sometimes mixed with Loritab (Hydrocodone) is my only solution. Unless you’re very much not like me at all. I have Lyrica, but I haven’t had a chance to try it yet. I have also heard of Lorazepam, Xanaflex, and Neurontin. Botox is a newly approved treatment. Anecdotal evidence suggests that marijuana helps with all muscle pain, other pain, and lots of other MS problems. I’m researching this now and I will try to make this my next post.)
• Analgesic Creams: (This sounds like a joke, but who knows.)
• Deep Breaths Through The Nose, Exhaled Through The Mouth (Who can breathe deeply when you can’t breathe deeply?)
• Creative Visualizations: Pretend It’s Not Happening Or Is Being Relieved However You Wish (OK – whatever – I started going into shock last time and only stopped shaking for about 20 minutes while the morphine worked – feel free to give it a try though!)

Here’s hoping that if you experience this, that this post will help you understand it better. Or if a loved one is experiencing this, you will understand better what they are going through. The pain can be unbearable, and the treatment can be dangerous.

If your treatment involves narcotics, perhaps your experience will be different than mine. Be cautious. Ask questions. Almost all of the drugs that I was on for this episode noticeably affected my ability to breathe even when I was unaffected by the hug.

Be careful.

Good luck to all.

UPDATE

I had meant to write this initially, but I have heard that Oprah had Dr. Oz and Montel Williams on a show at some point and spoke about the MS Hug.  On the show (which I did not watch) allegedly Dr. Oz said that the leading cause of death from MS was suffocation due to the MS Hug. This is not true. I have yet to find any evidence of a single death due to the hug, no matter how much you may feel like it. Can the MS Hug kill you? I don’t think so, but in a serious episode of it you will face very high blood pressure from pain and you may hyperventilate. Suffocation? No. Feeling like it? Yes.

Today I received my first phone call from Gilenya / Novartis, one month and three days after submitting forms to them. Nurses are specifically assigned as case managers to patients and stay with them at least through the process of getting started on the drug.

The call mostly consisted of me answering questions about my health history and current doctors. How long have I been diagnosed with Multiple Sclerosis, have I had recent vaccinations, etc. We went over the tests I would need to complete before the first dose, and she told me that they were still undergoing a “benefits investigation” to determine if I was eligible to receive the drug.

The nurse was extremely nice and sounded knowledgable, at least pertinent to the contents of the conversation. I wish I’d had the forethought to prepare any questions I might come up with ahead of time – I had begun to doubt that I would have any direct contact with the company again.

She did tell me a few things that I did not know before this call :

• There is a “two week rule” for Gilenya. If a person on Gilenya stops using the drug for two weeks, that person is required to undergo the entire approval process again to restart it – vision tests, EKG, blood tests galore, monitored doses in a doc office, etc…
• Although Will and I don’t intend to have children, it will probably interest anyone who is thinking of starting the drug that if a pregnancy occurs while on Gilenya / Fingolimod there is a registry they want you to join so that they can follow your progress. (PS – You should really try to NOT get pregnant on it)
• Any vaccinations must be cleared with a neurologist to ensure that no live virus vaccinations are administered (viral infections usually trigger MS attacks).

Finally, I have permission to contact Gilenya / Novartis and proceed with all the tests necessary to start the drug.

Pâté

There is some good news in my quest to start Gilenya – and it really is starting to feel like I’m seeking the holy grail. On the day I ceased Rebif I also saw a gastroenterologist for my elevated liver enzymes. The tally so far is $800 for the consult, $600 for the results, and forthcoming bills for some blood tests and an abdomenal ultrasound. Results are that I am clear of all liver diseases – he seemed disappointed.

In hindsight, I should have just waited to see the GI. After almost a month of being off Rebif, new blood tests reveal that my liver function is almost back to normal. Previous tests actually showed my enzymes at about 6 to 7 times the high limit for normal, which was worse than I had known. Now I am only a few points out of bounds. Time should take care of the rest.

A lot of relief came with this news. Also, I can’t stress enough the lack of stress that comes with knowing that I don’t have to take a shot every other day. So, now that my liver is suitable for sustaining human life again I’m hoping that I also won’t have to switch to the daily Copaxone injection.

Unfortunately, all that I’ve heard from Gilenya is that they would have someone return my call about a week ago. Which hasn’t happened. However, apparently they have been calling my doctor. So, while they won’t speak to me (the patient), I have heard through the grapevine that they are in the process of negotiating with my insurance company. Perhaps this is why the insurance company has started sending me packets notifying me that they have assigned an advocate for my “complex health issues.” While I appreciate the advocate, it does sting a bit that the insurance company has to hire nurses to fight them for my healthcare.

My optometrist completed all necessary vision tests last week. My neurologist has ordered some additional blood tests and an EKG. Then I will plan to spend 2 days in his office to be monitored for my first 2 doses in April, assuming that insurance approval has completed. The process must be difficult for everyone involved — my neurologist’s office staff look as though their blood pressure skyrockets every time “Fingolimod” is uttered. However, finally, everything looks to be in order. Unless, of course, you consider that no one at Novartis seems willing to speak to me (actually, I was sent a mailer today with their phone number if that counts).

Their general silence has begun to shatter my confidence in the drug. Are they just overwhelmed and have no time for new orders? Have they just hired employees who are still getting used to the process (of using a phone?)? Or, more importantly, are they intentionally slowing Gilenya’s introduction to the market for fear of discovering new side effects or higher occurrences of known side effects?

Let’s hope they’re just overrun with orders. Optimism remains… for now….

Tick Tock, Gilenya, Tick Tock

Almost two weeks ago I posted that  I was in the process of switching to Gilenya. Not so fast, I suppose. My neurologist’s office staff was eager for me to let Gilenya set up all of my doctor appointments for me to undergo the necessary tests. By their accounts they faxed in my information the morning I was in their office, and then a few days later when they hadn’t heard anything back. And then again when I called them after a very unproductive phone call with Gilenya.

Several months ago I switched positions within the company to work in a 24/7 network surveillance group. We rotate weekends, leaving me with a “weekend” during the week for a month here and there. I had hoped that I could use these days to get through all of my doctor appointments this month. But the opportunity to accomplish that is rapidly vanishing.

When I gave up on hearing from Gilenya, I called them. I was not in their system and was told either the doctor had not sent anything or that it can take a couple of weeks for someone to process the fax from my doctor. The representatives also advised me that I should just setup all appointments with doctors and for tests myself as it would take a long time if I relied on them to do it. They then told me that they also would not order the tests, that my neurologist had to do that anyway.

At this point, I wanted to cut Gilenya-The-Company out of the process of getting to Gilenya-The-Drug. I called my neurologist and asked them to help order the tests from my primary care physician so that I could get started without waiting for Gilenya. This is when I discovered that they rely on Gilenya to negotiate approval with my insurance company.

So, with no tests ordered and no response from Gilenya I am simply waiting to see what happens.

There’s no denying the dual frustration of having to wait for faceless others somewhere to get around to my file while I effectively become unprotected by any DMD having already stopped interferon treatment. Hopefully my next post will be good news rather than more of nothing.

Gilenya (Fingolimod)

As it turns out, similarly to my father’s results with Avonex, Rebif has caused my liver enzymes to shoot up to about 3X the upper limit of normal in the span of slightly less than 2 years. My options?

1) Tysabri : the risk of PML is too severe for me to brave this drug – reputed to be a risk of death or severe disability as high as 1 in 200 for some individuals and 1 in 2000 for others
2) Copaxone : statistically slightly less effective than interferons – works great for my father but I truly don’t want to do a daily injection except as a last resort
3) Gilenya : aka Fingolimod – when this was first approved by the FDA I wrote a blog post to summarize all the information I could find – it is the only oral disease modifying drug for multiple sclerosis – DING! DING! DING!

I have chosen to switch to Gilenya.

My neurologist says I will be his third patient to begin the process. In order to be approved I have to go through a handful of doctor appointments. The process reminds me a little of Scott Pilgrim vs. The World and so far has involved about the same volume of blood. I’ve seen a GI for my liver enzymes and he has put me through a round of blood tests and is checking for tumors just to be certain that the interferon was the sole cause of elevated enzymes. My optometrist will have to check a few more things than in a typical exam. My heart will need to be evaluated due to the risk of heart issues during the first dose. Saving the best for last – I have to lower my liver enzymes before starting the drug by ceasing interferon (no more shots!). The first time I take Gilenya I will have to spend the day in my neurologist’s office — if my heart rate drops I have to run in place to bring it up.

My father tells me that I will feel fantastic after I have stopped taking interferon for a couple of weeks. This is believable for several reasons – a fully functioning liver is probably a good thing, having interferon and its resulting flu symptoms out of my system is bound to be great, and my relief at the moment my neurologist told me to stop the injections made me realize how stressful the constant looming injections have been.

There are more risks with Gilenya than with the interferons and Copaxone, but I think I will fare pretty well. If I develop macular edema (0.4% chance), it may be possible to reverse. Other significant and potentially life-threatening problems can result from cold sores (I don’t get them) and chicken pox (had it when I was 12).

It certainly isn’t completely safe, and it can raise my liver enzymes as well. If it does, hello Copaxone. In the meantime I am extremely optimistic even if everyone else seems apprehensive. The most recent edition of Momentum magazine outlines all the MS drugs currently in the pipeline. Some sound great, some sound dubious. Having traveled once with prefilled syringes, I hope that this medicine will work out and I won’t have to do that again. This isn’t all about convenience and pain, but there’s no denying that it plays a large part in the decision.

Having had an exacerbation a few weeks ago, followed by Solumedrol infusions and an MRI the next day, I do wonder if I’m as responsive to interferon as others might be. No drug will prevent all attacks, but it’s possible that Gilenya could be more effective for me than Rebif. If all goes well, and especially if all goes terribly, I’ll try to chronicle how things progress with Gilenya here on the blog for anyone who may be considering it. Certainly, anyone would prefer more research and anecdotal information before committing to a drug like this. But my liver says it’s time to switch and it really is one of those important organs. Wish me well!

UPDATE

Since this post I have fought my way through the insurance and approval battle and have begun the medication. Please feel free to see my additional posts regarding this.

Gilenya (fingolimod) By Novartis

This post is a little late, but there has been a huge breakthrough in MS treatment. An oral medication by Novartis, Gilenya (formerly fingolimod and FTY720), has finally been approved by the FDA to be available by prescription as a daily 0.5 mg capsule as a first line treatment in October.

It is an immunomodulatory drug called an S1P-receptor modulator, similar to cell surface receptors on white blood cells. The drug was initially created to prevent tissue rejection following kidney transplants, but the dosage required for success was so high as to be toxic. The recommended dose for MS treatment is 5 times lower than in this initial attempt.

Essentially, this drug strips out a chemical component forcing T cells to stay in the lymph nodes where they cannot attack the central nervous system. It may also enhance repair to damaged neurons, have neuroprotective effects, and reduce whole-brain atrophy. Most treatments for MS now reduce relapses by an average of 35%. A study of Gilenya suggests a 60% reduction in relapse rate and a 74% to 82% reduction in damage as measured by MRI.

The downside to this is that there are some possible adverse side effects such as headache, flu, diarrhea, back pain, abnormal liver tests and cough. The worst possibilities are a reduction in heart rate, infrequent transient AV conduction block of the heart, increases in blood pressure; macular edema, elevated liver enzymes; and increased infections such as bronchitis and herpes. No one knows the effect of the drug on pregnancy or breastfeeding, so contraception is suggested while taking this drug. Studies so far have suggested that white blood cells return to their normal rates approximately 2 months after cessation of the drug.

Prior to starting the drug, patients need to be evaluated for baseline data on the heart, lungs, liver, eyes and vision, blood pressure, pulse, and white-blood-cell count. Patients should not take the drug if they have recently been infected by or vaccinated against chicken pox. You should be monitored for a reduction in heart rate and other side effects for 6 hours at a medical facility after your first dose

The price for Gilenya is higher than that of existing medications – $48,000 annually. Most existing treatments max out at about $38,000 annually.

When I started researching all the available data about Gilenya to write this article I was frustrated by 2 things :

• It is virtually impossible to find all the pertinent information in any one location
• Gilenya will probably still have an adverse effect on my liver.

As it stands, I suppose if and when I go off of Rebif it will probably be to Copaxone, but I would love to give this drug a try.  Enough of the facts — I’m just so excited about this – the more treatment options we have available the closer we are to a cure!