Hello, Gilenya!

Thursday, August 29, 2013, I started a new MS medication – Gilenya.

So far, the most annoying part of being on the once-a-day drug is that it required an initial observation period.  During your first dose, for your safety, you must be monitored for 6 hours.  For me, that meant being at the University of Chicago Medical Center infusion suite at 8 a.m. By 8:30, I had taken my first dose, and was sitting around waiting for anything to happen… anything at all.  Every hour, the nurses ran my vitals to make sure that my pulse wasn’t dropping to a worrisome level. The whole time I was at the hospital, my pulse stayed between 90 and 99 and my blood pressure remained in that annoying place where it tends to stay — just high enough to be considered high, despite taking medication, but not high enough to cause any concerns. By 3 p.m., Adam and I were back on the road to get home.

A few hours after Adam and I left the hospital, we went to the gym to do our regular Thursday afternoon cardio session. We both figured that if nothing had changed at the hospital, there was no good reason to take the day off from our physical fitness routine. Despite that hope, I started feeling really awful about 5 minutes into my usually 20 minute long jog on the elliptical trainer.  When Adam saw how hard I was pushing just to stay on the machine, he called it a day.  We went home and checked my pulse with the blood pressure wrist cuff… 68.  Now, 68 is a totally healthy pulse to have. It just happened to be 30 beats per minute less than what my regular resting heart rate was, so it made sense that I was dizzy and very tired. The Gilenya literature had let us know that pulse slowing could occur up to 24 hours after taking the first dose, so we followed the procedure we’d been given.

Adam called the Gilenya Go! program help line for me, and the nurse said to call my doctor… so we called. We were connected with the neurology resident that was on-call and were told that if my pulse dropped to close to 50 to call them back.  Thankfully, the lowest that my heart rate got that evening was 59.

Since that first night, I haven’t had any problems to speak of. My “normal” resting heart rate is now in the low 70s, and I figure that’s probably better for my body overall.  I haven’t had any other side effects that I can think of, and I’ve been enjoying having a medication for my MS that doesn’t appear to be negatively affecting me at all.

Of course, nothing in life can be totally simple… the Universe had to spice it up.

FDA warns of PML case connected to Gilenya

It was literally the same day that I started this drug that a warning came out from the FDA that Gilenya may cause PML, a rare and often lethal brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin.

PML had previously only been associated with Tysabri, because developing PML is a known risk of taking the drug, and 2,582 Tysabri patients have been recorded as developing the infection.

Fortunately, Novartis, the maker of Gilenya, does not believe that the diagnosis of PML occurred because of the patient’s use of Gilenya. In a quote from MedPageToday.com, Novartis said “‘MRI reviewers’ had examined brain scans taken before the patient started on fingolimod and determined that the patient might already have had PML, [prior to starting Gilenya] because lesions seen in the scans were “atypical” in MS.”

So, I’m not worried about developing PML.

Side Effects?

Gilenya has some serious potential side effects: slowed heart rate, increased risk of serious infections, macular edema, breathing problems, liver problems, and increases in blood pressure. The most common side effects of Gilenya are headache, flu, diarrhea, back pain, abnormal liver tests, and cough.

So far, for me, I’ve only experienced a slowed heart rate. It makes working out a little more difficult, but overall, it seems benign.  The only thing I’m actually worried about is increased blood pressure, since I’m already hypertensive.

I’ll be sure to keep everyone in the loop and let you know if anything changes, but for right now, Gilenya seems great. 🙂