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New Xeljanz Warning - Heads Up!

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Posted 2/28/2019 6:31 PM (GMT 0)
For those on the 2x 10mg dose: https://www.medscape.com/viewarticle/909551

Note: they *are* saying this relates to RA patients on the UC induction dose, but it’s unclear whether the increased risk of pulmonary embolism is because of something specific to RA, or the 10mg twice daily dosing for anyone who takes it.
Posted 2/28/2019 7:01 PM (GMT 0)
Thanks for flagging this up. I could not access the above link but found an alternative:
https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm
I noticed the RA trial was only on people over 50, may be significant.
Posted 2/28/2019 7:04 PM (GMT 0)
Agree. Interesting: I met with my GI last week and he said he’s hesitant to use Xeljanz for longer than six months at a time in younger patients. This is based on observations of their patient population at Mass General’s Crohn’s & Colitis Center. He feels that safer small molecule drugs (like Filgotinib, maybe?) will be an option fairly soon, so he prefers to use Xeljanz as a bridging medication unless the patient is truly out of options.
Posted 2/28/2019 7:05 PM (GMT 0)
Interesting. I do know we have an increased risk of clotting, big veins especially. That would make pulmonary embolism and DVTs higher for us in general, regardless of meds we're on...
Posted 2/28/2019 7:40 PM (GMT 0)

Fletch10 said...
Agree. Interesting: I met with my GI last week and he said he’s hesitant to use Xeljanz for longer than six months at a time in younger patients. This is based on observations of their patient population at Mass General’s Crohn’s & Colitis Center. He feels that safer small molecule drugs (like Filgotinib, maybe?) will be an option fairly soon, so he prefers to use Xeljanz as a bridging medication unless the patient is truly out of options.

My GI is also really excited about small molecule drugs. He's responsible for the IBD clinical studies at the hospital that I go to.

Stelara is working well for me; I was planning on using Xeljanz in the future if necessary but when I said this to my GI he told me that he's really excited about the small molecule drugs and wasn't so happy with Xeljanz. He's not a fan of Entyvio either.

I'm not interested in risking taking a drug that might be very dangerous to me just so I can poop better. I was once offered Tysabri and before he could finish his sentence I stopped him and told him no way would I take it.
Posted 2/28/2019 7:41 PM (GMT 0)
Yes! My GI said they are liking Stelara more and more, even off label for UC patients.
Posted 2/28/2019 7:46 PM (GMT 0)

Fletch10 said...
He feels that safer small molecule drugs (like Filgotinib, maybe?) will be an option fairly soon, so he prefers to use Xeljanz as a bridging medication unless the patient is truly out of options.

ks1905 said...


My GI is also really excited about small molecule drugs. He's responsible for the IBD clinical studies at the hospital that I go to.

I'm not interested in risking taking a drug that might be very dangerous to me just so I can poop better. I was once offered Tysabri and before he could finish his sentence I stopped him and told him no way would I take it.

What's so special about the "small molecule drugs"?

I thought Tysabri was used for Crohn's; not for UC?
Posted 2/28/2019 8:04 PM (GMT 0)

xy123 said...

Fletch10 said...
He feels that safer small molecule drugs (like Filgotinib, maybe?) will be an option fairly soon, so he prefers to use Xeljanz as a bridging medication unless the patient is truly out of options.

ks1905 said...


My GI is also really excited about small molecule drugs. He's responsible for the IBD clinical studies at the hospital that I go to.

I'm not interested in risking taking a drug that might be very dangerous to me just so I can poop better. I was once offered Tysabri and before he could finish his sentence I stopped him and told him no way would I take it.

What's so special about the "small molecule drugs"?

I thought Tysabri was used for Crohn's; not for UC?

Tysabri was for offlabel use. I started Stelara 3 years ago as off label use.

My GI has always been willing to write off label scripts and fight with the insurance company for me. Over the years I’ve upgraded to better insurance just so they cover the stuff that I needed like Stelara. I switched from an HMO to a PPO.
Posted 2/28/2019 8:18 PM (GMT 0)
I am truly out of options so i will stick with xeljanz for now smile

Birth control pills also come with the risk of embolism

it all depends on the size of the risk how willing i would be to take a drug.

Xeljanz is also a small molecule drug, filgotinib and upadacitinib are the same class of drug only more targeted (it's something like xeljanz/tofacitinib is a jak1 and jak3 inhibitor and the other two are jak1 inhibitors only)
Posted 3/1/2019 12:53 AM (GMT 0)

iPoop said...
Interesting. I do know we have an increased risk of clotting, big veins especially. That would make pulmonary embolism and DVTs higher for us in general, regardless of meds we're on...

That's what I was thinking too. We are already at an increased risk, and I am a migraine sufferer. I am happy I don't have to think much about these potential consequences at the moment. The last thing I want is a PE.
Posted 3/1/2019 5:42 AM (GMT 0)
Do these risks apply only to the time you’re taking the drug or after you’ve stopped taking them?
Wondering not just for xeljanz but for UC drugs in general.
Posted 3/1/2019 6:08 AM (GMT 0)

iPoop said...
Interesting. I do know we have an increased risk of clotting, big veins especially. That would make pulmonary embolism and DVTs higher for us in general, regardless of meds we're on...


Is that at all times or only during disease activity? I know during my last major flare i wasn't allowed to do long haul flights because the nurse said the inflammation gives an increased risk of a blood clot.

RA patients in general have an increased risk of pulmonary thrombosis by an extra ~2-3 per 1000 people (just googling it now)
Posted 3/1/2019 1:16 PM (GMT 0)
By the way, for those not familiar with xeljanz: 2 x 10mg per day is the "induction" dose, ideally for 8 weeks. After remission the guidelines are to switch to a maintenance dose of 2x 5mg per day, which does not carry the same risks in terms of side effects. I write this as I don't want people to be unduly deterred from taking xeljanz.
Posted 3/1/2019 1:21 PM (GMT 0)
Our increased blood clotting risks apply with or without meds, and are at their very highest when we are flaring severely and sedentary as a consequence thereof. In fact, if you are hospital-inpatient during a flare they immediately put you on blood thinners during your stay.

I'm in a remission now, and when I look at my bloodwork (Complete Bloodcell Count), I see an above range (but not anemic) MCV and MCH result, which is something many of us would share, if you take a look at your results. That means our bloodcells are bigger than normal, and therefore more prone to clotting. That's great if you get a small cut, it clots fast and we stop bleeding sooner than most. However, if you're talking blood vessels clogging then it isn't a good thing and things like DVTs (big veins in legs) and PEs (lungs) which can be serious.

The takeaway, is be mindful of this increased risk make sure you get at least some light exercise in a given day to mitigate that risk. If you are going to be sitting for long periods of time (office worker, or sitting for a long distance flight/bus/train trip) then find excuses to get up and do do brief walks and/or stretches every so often. When we're flaring we're at highest risk, so try and move around and do some light exercise within the bounds of what is possible (short walks, stretches, yoga, etc).

Post Edited (iPoop) : 3/1/2019 6:25:21 AM (GMT-7)

Posted 3/1/2019 2:37 PM (GMT 0)

iPoop said...
Our increased blood clotting risks apply with or without meds, and are at their very highest when we are flaring severely and sedentary as a consequence thereof. In fact, if you are hospital-inpatient during a flare they immediately put you on blood thinners during your stay.

During my two stays for flares with Cyclosporine I do not remember being put on blood thinners. I was also in my 20's at the time.

Even during my 3 surgeries I do not remember being on blood thinners for very long. As soon as I was up and walking a good amount they stopped the blood thinners. I did A LOT of walking.

During my hip surgery I refused blood thinners, they gave me special boots to take home for two weeks which reduced blood clotting risks. Doc said they had similar statistics as Heparin in preventing blood clots. The orthopedic surgeon operates on many RA patients.
Posted 3/1/2019 3:01 PM (GMT 0)

ks1905 said...

Stelara is working well for me; I was planning on using Xeljanz in the future if necessary but when I said this to my GI he told me that he's really excited about the small molecule drugs and wasn't so happy with Xeljanz. He's not a fan of Entyvio either.

Out of curiosity, what's his beef with Entyvio?
Posted 3/1/2019 4:37 PM (GMT 0)

Butthurt said...

ks1905 said...

Stelara is working well for me; I was planning on using Xeljanz in the future if necessary but when I said this to my GI he told me that he's really excited about the small molecule drugs and wasn't so happy with Xeljanz. He's not a fan of Entyvio either.

Out of curiosity, what's his beef with Entyvio?

I have two GI, one is my IBD GI and the other is my primary care doctor who is also a GI. They both aren't fans of Entyvio because it is slow acting and not as effective as their experiences with Remicade with their UC patients. I'm also in this limbo where I "might have" crohns so my IBD guy is even less thrilled with Entyvio for CD. My PCP one time said to me "if Entyvio works" and he really emphasized the IF. That's not to say that it doesn't work some UC patients but it's not their first choice in medication for their patients.

My IBD guy really likes Stelara. I've had very good results with it.
Posted 3/1/2019 4:47 PM (GMT 0)
Yeah cautions with blood thinners undoubtedly varies by location and such. A reasonable precaution, I think.

My new gasteroenteroligist seemed to have a beef with xeljanz (small molecule biologics are new and he questioned how it worked), and favored entyvio over it. I didn't ultimately need to switch from remicade, but he/I had a brief conversation about them, just in case. So I think you're going to see lots of different opinions. Whatever works best for you is the best choice, of course but hard to say which that'll be.

The one thing I noticed about xeljanz is you cannot skip doses, as bad compliance with dosing could lead to a flare. Remic/stelara/entyvio stay in your body a long time. However, the small molecule xeljanz has a pretty fast clearance rate of about 24 hours. Getting lazy about taking xeljanz during a remission could really bite one in the behind, a cautionary note to those who are taking it to be religious about taking it.
Posted 3/1/2019 7:25 PM (GMT 0)

ks1905 said...

Butthurt said...

ks1905 said...



I have two GI, one is my IBD GI and the other is my primary care doctor who is also a GI. They both aren't fans of Entyvio because it is slow acting and not as effective as their experiences with Remicade with their UC patients. I'm also in this limbo where I "might have" crohns so my IBD guy is even less thrilled with Entyvio for CD. My PCP one time said to me "if Entyvio works" and he really emphasized the IF. That's not to say that it doesn't work some UC patients but it's not their first choice in medication for their patients.

My IBD guy really likes Stelara. I've had very good results with it.

Thanks for clarifying. Just wanted to make sure it wasn't a safety issue of which I was unaware. I happen to be among those for whom Entyvio does work, whereas Remicade was of no use and left me feeling like I had the bends. Joint pain so bad I could barely walk. Literally had to crawl up the stairs at home. Goes to show, we're all different.

Nice to hear of your success with Stelara. Could be something to try in the event the Entyvio craps out (no pun intended) at some point down the line.
Posted 3/1/2019 7:56 PM (GMT 0)
I am liking xeljanz so far. It took 4 weeks before i felt it was doing something. I don't know if it will be enough to keep me out of surgery but i am currently feeling better than I did on either of infliximab or entyvio (of these two, entyvio worked better for me).
Posted 3/1/2019 8:42 PM (GMT 0)

Butthurt said...

Thanks for clarifying. Just wanted to make sure it wasn't a safety issue of which I was unaware. I happen to be among those for whom Entyvio does work, whereas Remicade was of no use and left me feeling like I had the bends. Joint pain so bad I could barely walk. Literally had to crawl up the stairs at home. Goes to show, we're all different.

Nice to hear of your success with Stelara. Could be something to try in the event the Entyvio craps out (no pun intended) at some point down the line.

I ended up with serum sickness from Remicade after about 5 good years on it. I had similar side effects that you had.

Isn't Entyvio supposed to have some of the best safety profiles among all of the biologicals?
Posted 3/10/2019 7:45 AM (GMT 0)
One important thing to note is that a lot of these biologics are rushed to market now. The idea is to get the IBD population on a series, and by the time those drugs wear off there will be another on the market. The drugs are not that different from one another, not in the grand scheme, but they have enough molecular differences that they are "new" to the immune system.

This is how they keep stinging us along to buy their crappy drugs. They keep us alive through immune suppression and then when our immune system figures it out they have another crappy drug ready.

Each time they push a new drug to market, the population becomes a guinea big. Like, they didn't know about this RA problem before? Nope, because they only "discovered" it after the general IBD population started using it. There was a time when drugs would be trialed for many years before going to market. Not anymore.
Posted 3/10/2019 9:25 AM (GMT 0)
Xeljanz is not a biologic.

Xeljanz took over a decade to develop in the lab before they tried it on people, and pfizer nearly pulled the plug because it was so expensive for the company to do the research. It's extremely difficult, inefficent and expensive to develop new drugs and get them to market.

Xeljanz was licensed to treat RA 6 years before it was licensed for colitis. That means 6 years of data on a large population.

The dose at which pulmonary embolism becomes a risk is a high dose which, in the guidelines for colitis, should only be used short-term to induce remission, not to maintain it.

The study which found an increased risk of embolism was on a population of RA sufferers who were over 50 and already had another risk factor for embolism. The statistics for the increased risk is also not documented in the articles written for the general public (i.e. is it 1%, 0.1%??) which makes it hard to assess the risk.

When you have severe colitis you have to make tough choices. Surgery also comes with risks and those of us with a severe condition do have to make a choice whether to try these drugs or opt for surgery.

Xeljanz is the only drug which has helped me and I've worked through nearly all of them in succession during a highly miserable 3 years with no remission.

By all means make people aware of the risks and then they can make informed decisions.

Noone wants to take immunosuppressants. But UC can also be fatal if left untreated. 100 years ago the death rate was about 30%.

Post Edited (poopydoop) : 3/10/2019 3:32:59 AM (GMT-6)

Posted 3/11/2019 3:52 PM (GMT 0)
Hi i just talked with my (GI) dr about this as I had an appointment for a check-up. He said the statistics do show an increased incidence of pulmonary thrombosis in both RA and UC patients taking the high dose of xeljanz (2x10mg per day). However what's not yet clear is whether it's caused by xeljanz itself or the autoimmune condition itself, since people taking the higher dose generally have more severe inflammation. (And in any case the chance of PT is still small). Apart from that the only other significant risk factor with xeljanz is shingles. I asked about getting a vaccine but he was doubtful it would be effective when i am already under immunosuppression (and i switched straight from azathioprine to xeljanz so it wasn't an option to get it beforehand either). He did say he would check with his colleagues about that.
Posted 3/11/2019 4:53 PM (GMT 0)
Interesting, thanks for following up.

Any one else know more about PE's and the effectiveness of shingles vaccine while on Xeljanz?

Guess would be either doc is totally wrong on the shingles, or that a weakened immune system doesn't respond as well to the vaccine. I had some plantar warts, that I fought for the better part of a year with a dermatoligist, repeatedly freezing, me using compound W, etc etc. I guess an immune response is required (from all of that irritation freezing/acid/etc) and it is much harder to get as I was on remicade and 6mp.
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