Lemtrada Screening & Most Common Side Effects (per Genzyme)

[Marco]

If you search this, or a few other, MS sites, you will quickly learn that I was not cheering the approval of Lemtrada. Now, I am actively cheering for the best outcomes of all Lemtrada patients. While I believe Lemtrada has the chance to be a miracle to many patients, it will also be problematic for other patients. Now that it is approved, I can only hope and pray for Lemtrada patients, that they will see the benefits without any negative effects. I believe the media, and many others, promote treatments without fully explaining potential risks. This morning I was sent a link to the Lemtrada prescribing information and I want to share that information with you. I have attempted to provide an unbiased summary of Genzyme's document about pre & post infusion testing and the most common side effects. I will refrain from any commentary, but will reply to specific comments or questions asked.

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For patients, that previously received Lemtrada did all of the above testing or information get conveyed to you?

For patients considering Lemtrada, has your doctor followed the complete safety protocol as briefly outlined below?
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Pre & Post Treatment Monitoring
- Were you screened for tuberculosis, HBV and HCV? Did they check your last screening of HPV?
- Was your thyroid tested? Your thyroids should be retested every 3 months, for 4 years after your final infusion.
- Did you have a screening MRI for PML? Did your doctor cover the signs & symptoms of PML and discuss what should happen if you develop new PML signs?
- Did any of you have a immunization, (flu, shingles or other) in the past 6 weeks?
- Did you get a CBC w/differential? Urinalysis? These tests should be repeated every month for 4 years after the last treatment.
- Did anyone have an active infection? This is grounds for considering a delay in Lemtrada treatment.
- Are any of you on the recommended anti-viral prophylaxis?
- Were any of you "stable" on your current medication, if so, do you realize Lemtrada was NOT recommended?
- Did you realize that you signed up for follow up testing and screenings for 4 years after your final dose?
- Are you, or are you considering, getting pregnant? In the next 16 months after the intial dose? Sixty percent of pregnancies reported between Cycle 1 and Cycle 2 were spontaneously or electively aborted. Of the remaining forty percent, 2 had preterm pregnancies, 14 had spontaneous abortions, 5 had elective abortions, 1 still birth and 11 pregnancies had unknown outcomes. All that said, Lemtrada is not recommended for pregnant women, or for 4 months after your last dose.
- It is not known whether Lemtrada is excreted in human milk.
- In addition to the birth issues, pregnant women had special risks of Immune, Autommune and/or Thyroid Disorders.
- It is not known if patients 65 years or older, have any, similar or increased risks than other patients.

Side Effects
Like all medicines, LEMTRADA can cause side effects.

Very common side effects (reported in at least 10% of clinical trials patients) which often occur during or shortly after a single infusion or treatment course include:

• Headache
• Dizziness
• Rash, Hives, Itching
• Fever
• Nausea, vomiting
• Difficulty sleeping
• Back pain, joint pain, pain in arms or legs
• Upper respiratory tract infection/cough, cold
• Urinary tract infection
• Chills
• Sore throat or mouth pain
• Feeling tired
• Bruising
• Tingling sensation
• Diarrhea

Other common side effects (reported between 5-10% of clinical trial patients) include:

• Decrease of white blood cells (lymphocytes)
• Fast or irregular heartbeat (palpitations), chest discomfort
• Indigestion (heartburn), stomach pain, constipation
• Flu, flu-like illness
• Muscular pain, muscular weakness, muscle spasms, neck pain
• Swelling of the arms and/or legs
• Weakness
• Oral herpes
• Altered taste, numbness, blurred vision
• Depression, anxiety
• Cough, difficulty breathing or shortness of breath
• Bronchitis
• Body rash, redness of the skin
• Reddening of the face and neck
• Under-active thyroid gland
• Nose bleeds

Information extracted directly from the Genzyme here article located here: http://www.genzyme.ca/thera/docs/ca_...lemtradapi.pdf.

[Mable]

Yeah, it's nasty stuff.

[Marco]

Lemtrada can also put MS on "pause" for 5, even 10 years. So like most of our medications, bigger risk can lead to bigger rewards. The larger the Lemtrada population, the more likely some of the uglier side effects will be realized. It also becomes more likely that some neurologist, nurse, or patient does not keep all the safety protocols. I don't want to dissuade anyone from taking Lemtrada, but I do hope they follow every safety protocols.

[spacedive]

For me, after 2.5 weeks any issues I had went away and I felt like a new born baby! I am very happy I got Lemtrada

-Harold

[Mable]

I'm am just so torn about it.

Lemtrada is new, has lots of bad side effects, and is scary. But I like the idea of stopping my disease, and maybe even undoing a little of it. I'm very tempted by the promise of stopping any excess brain atrophy too.

On the other hand, if I'm JC-, wouldn't I get basically the same results with Tysabri, buying myself some time until we know more about Lemtrada, or something safer comes out?

I don't swallow pills well, and I'm having breakthrough disease with Copaxone. So, I think when I see my neuro at the end of December, I'll end up on one or the other.

I'm leaning toward Lemtrada, if my neuro hasn't changed his mind about letting me have it.

[ru4cats]

Thanks, Marco. Some of these are down right scary! I'll stick with Tysabri since I'm JC-. No side effects at all for me.

[pb909]

Marco - Thanks for posting the info.

How did the Disability results show for the trial compared to other drugs?

I'm on the "progressive" path so my Neuro is trying to slowdown my disability the best he can (I've gone from Tysabri to Aubagio now).

[Goldfinch]

All: Your mileage may vary. As with all MS patients, MS may behave differently, so may the results from this treatment. That said, I am confident in my neurologist's assessment of the risks of this drug.

I was on Tysabri for over seven years. Length of time on Tysabri is a risk factor, as well as JC viral load levels. My JC virus levels were elevated, and that, combined with my time on Tysabri, created enough concern on the part of neurologist to take me off of Tysabri in December 2013.

So I chose to accept treatment with Gilenya. I loved not getting the needle every month, but the side effects I experienced with Gilenya were bothersome. I have felt like I am slowly drowning from increased levels of fluid in my lungs since my first dose. I stuck it out because to me that was less damaging than losing irreplaceable myelin and having relapses. However, this morning, he advised me that my last MRI from two days ago shows disease activity and he is convinced the Gilenya is not helping me. He offered Lemtrada and advised me to think about it and do some research on it.

Now, my neurologist is involved in research and clinical trials, and he is an MS specialist. I am lucky to have him. He's never steered me wrong, and he has always been consistent and responsive. He advocates an aggressive approach to treatment, as do I.

His mantra where MS treatment is concerned is: Time = Brain. I have the rest of the month's doses of Gilenya. He told me to keep taking them while I consider the switch, because while they might not be helping much, they aren't hurting. I also have the option of returning to Tysabri and being closely monitored for JC levels.

He specifically said that PML is not a concern with Lemtrada. Posts here suggest otherwise. I am aware of the other risks of Lemtrada: the thyroid involvement, the increased risk of cancers in future...I didn't get the impression my neuro was trying to sell me on Lemtrada, but he WAS holding up the risks of a fatal brain infection versus the risks of treatable complications, and THAT was probably what will sway my decision. Thoughts?

[montanagirl10]

I will be making the switch to Lemtrada in June. For me, it is inevitable. I have been on Tysabri for a combined 4 years with JC index of 2.28. I will continue on Ty for 6 more months, but only get an infusion every other month. I am reluctant to switch right now because of the unknowns of Lemtrada.

I met with my neuro yesterday, she is an ms specialist, to talk about the side effects and complications with Lemtrada. She seems to think that once more patients chose to go with Lemtrada there will PML with it as well. The patient info. On the drug also states if your are JC+ an MRI and/or a spinal tap is indicated to rule out PML before starting Lemtrada. My neuro said she would do both before moving me because once you are infused with Lemtrada there is no taking it back, cleaning the drug out of you blood is not possible, once it is infused you are down that road. With this drug there is great reward with great risk, but it is the only next step for me as all other MS meds do not work for me.

The staff at my MS center was just going through their training on Lemtrada with the drug rep. today, so it is hard to get to much info about how they are rolling out this drug and what copayment assistance and other pt. programs are available right now, especially with the monthly, quarterly,and annual monitoring. So another reason I am not making the switch right now. I am glad there are so many more options for treating MS now, albeit the risks seem to increase with each one.

[spacedive]

I tested JC+, but Lemtrada has been fine with me since 2008.

[Alpharetta]

Trying to switch to Lemtrada now, did 3 years copaxone, Avonex to Tecfidera back Avonex on to Gilyena now. I spoke to my Primary care doctor after my last blood series this month. He indicated that thyroid hormone in today's drugs mirrors the body's own, he said it is one the few that do.

If thyroid issues are the main problem, that can be remedied with today's drugs but as talked about, PML continues to be a question.

[notswedish1]

Went to Neuro today

Hello everyone

Went to My Neuro specialist today and Lemtrada and Tysabri are on the table. I have other health issues so Gilyenia and Aubagio are out for me.

Got oodles of blood tests today including HIV, HPV, HSV, Hep B and Hep C, CBC w/diff, JCV, onward.... My Doc is pretty much a guru in the PNW.

I am nervous. I don't need any advice but would like support to even start a new med. I have been dx for 11 years and have only taken a DMD for about 4 of those 11 years. Clearly, my disease has gotten worse. So, for someone who classically has issues with ANY western meds, it would be be great if ya'll could provide some good words.

Thank you and much light to you on your journey.

Inga

[Marco]

Inga,
I have not been on either Tysabri or Lemtrada, but Western medications have helped a great many people. Years ago, I was in a similar place, but I am now thrilled to be on a medication. My medication helped stabilize the disease and reduce my progression. I won't offer advice, since you did not ask for it, but if questions do come up please let us know.

It really sounds like your neurologist is doing everything in their power to help you. That is so important that you trust their proficiency. I would also take comfort that if they would take such care in trying to help, they would not suggest something they believed would hurt you. I do hope all of your tests come back favorably and I wish you well.

[normand44]

Have had MS for 16 years, never any real problems till March 2015 affecting my legs, cannot stand for more then 1 minute always have some kind of asst. love the scooters in the stores, I wish more store's had them. I am 52 years young, I have 3 daughters and 1 grandson they live in MD I moved to SC 1/1/2014 and in March my legs started this mess. I start Lemtrada 1/25/2016 I can't wait and hoping it helps me, Ty did nothing for me. I feel very lucky I have great friends and family.

[alk]

Marco, I got a question for you:
Lemtrada has been used in Europe for a number of years and has been in trials or used for alternate purposed since the late 90s.

Plus, Most other DMTs that aren't interferons are roughly the same age.

Why does the lack of information on Lemtrada scare you more? Is it really that much less than what we know about some of the pills or Tysabry?