CLL Support Association

Ibrutinib and Shingrix issues

Hi Everyone - So i spoke to my oncologist about getting this new Shingrix vaccination for shingles and this is what i was told. “Ibrutinib is an immunosuppressant drug, which may diminish the therapeutic effect of Vaccines (Inactivated). So we would not recommend any vaccinations during this treatment.” I found this dissapointing. I have had shingles once in the past and it was very painful

I have been on Ibrutinib for 4 months and am doing well, now that my out of control hypertension induced by the IB is now almost under control. Anyway... good luck everyone

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That's very disappointing, Roydeane. Lots of us are on Ibrutinib and are likely to stay on it for a long time. It's not as if it's a short term treatment.

I think I'd like to question the assumption that because Ibrutinib "...may diminish the therapeutic effect of vaccines.." no vaccinations are recommended. As long as Shingrix doesn't do us any harm, I would have thought it was worth a try. So much is at stake, with shingles being capable of doing us such harm.

I'd be interested to know if other doctors have different opinions on this.

Paula

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Hi Paula - I agree. My CLL oncologist in New York City is a real who's who in our category. He's a heavyweight. I have another at Ohio State / Wexner who is also considered one of the top in the world and I will reach out to him also. The drugs are also moderately contraindicated when I look at the compatibility of these two drugs on websites but I agree - I want to hear from others about what they are hearing. Best - Roy

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My Oncologist at MSK said that any vaccination with live antibodies is not to be taken for CLL patients

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True... Shingrix the new shingles vaccine is not a live vaccine...

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You might consider adding acyclovir or another anti-viral. Many of us on trials have been taking them prophylacticaly to ward off shingles

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Hi John...I have talked via email with a reknown hematologist at Cornell Weill Hospital in New York City who recommends acyclovir to prevent shingles. His name is Dr Richard Furman. You can Google him and you'll find some videos...One that I watched is: OncLive Peer Review. If I lived up there I'd def be his patient! He referred me to Dr Javier Pinilla at H. Lee Moffitt Cancer in Tampa, FL which is near where I live

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Yes. He is excellent.

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Thanks Jph.

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Roydeane

Can you please attribute that quote?... 🤔

My understanding is that ibrutinib can actually modulate the immune system in a positive manner...as per Dr. Awan's trial at the James...

It might depend on the vaccine, but Shingrix is so new, blanket statements like this I find appalling frankly....

In regards to Imbruvica (ibrutinib) and flu and pneumonia vaccines there are a couple of positive studies..

This randomized phase II trial studies how well ibrutinib works when given together with vaccine therapies in treating patients without clinical signs or indications that raise the possibility of a particular disorder or dysfunction (asymptomatic) who have high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Vaccines, such as pneumococcal 13-valent conjugate vaccine, trivalent influenza vaccine, and diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed, may help the body build an effective immune response to kill cancer cells. Giving ibrutinib together with vaccine therapies may be a better treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma.

also

Our data show that an antibody response to influenza vaccination is permissible in patients receiving single-agent ibrutinib. Up to 74% of patients achieved seroprotective titers against common influenza viruses after vaccination. Consequently, routine immunization against influenza should be considered in accordance with the Centers for Disease Control and Prevention recommendations for immunocompromised patients.

jamanetwork.com/journals/ja...

~chris

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Hi Chris - I do not put any individual names or Drs names on forums and as per your comment that you find this appalling, I am sorry that you feel this way. I am not happy about this either. This is exactly why I put up the post to see what others are hearing or seeing.

FYI: Your link is also not working for me. I will also talk to my people at the James, Sloan and Columbia. Below is an interaction link that I just looked up. I cannot speak to this links accuracy. Best - Roy

online.epocrates.com/drugs/...

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When I read your post, I immediately thought of this paper: ncbi.nlm.nih.gov/pubmed/263... showing that Ibrutinib patients can see a slight recovery in some immunoglobulin levels (indicating a recovery of humoral immunity), so I'm glad Chris posted reference to another paper showing that Ibrutinib may improve, not worsen humoral immunity . (Incidentally his link works fine for me.)

Older CLL drugs do have a reputation for further suppressing the immune system, which can last significantly beyond treatment, (which is one of the reasons why Watch and Wait is good practice). That's not the necessarily the case with lenalidomide and may not be the case for the newer, small molecule drugs.

I note that the reference you provided suggests checking the effectiveness of the Shingrix vaccination, not avoiding it.

I'll be very interested in what you hear from your James, Sloan and Columbia contacts.

Neil

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While it is true that immunosupressive drugs may reduce effectiveness of Shingrix and most vaccines, it does not name ibrutinib specifically on the drug label...

I refer you to section 7.2 of the drug label below.

fda.gov/downloads/Biologics...

However ANY protection is better than none... and CLL patients have a sliding scale of immunity...from pretty good at diagnosis to extremely poor in end stage.

~chris

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And i totally agree. Any protection is better than none. I did hear back from one of my docs today who feels is to early to determine and thinks it is ok to get the shot.

So i am getting what i needed from the forum. Dialog, questions, etc. Its all a moving target right now with all the new treatments and combos as you know. Really good things are happening for us so we need to stick together and see this through to better times.

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Thanks Chris - that was my understanding-

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Hello Roydeane....I had a mild case of shingles in 2008 about a year after I was diagnosed with cll My hematologist in Tampa, FL at Moffitt Cancer Center said no to the shingles vaccine as it is attenuated/a live virus and I could break out in Shingles all over my body. I got the flu shot a few months ago as it wasn't a live virus and I didn't have any problems...best regards Dianne

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It is not the vaccine that is the problem, it is how effective it is while on Ibrutinib because it is an immunosuppressant drug. That is my understanding. But if there is ANY benefit from the vaccine while on Ibrutinib then to me it still makes sense to get the vaccine. Again... we need to find out more which is why I posted.

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Shingrix is a Herpes Zoster vaccine (non-live recombinant, AS01B adjuvanted) it can not trigger shingles reactivation.

The old vaccine Zostavax was a live vsccine and it could trigger reactivations...

Two different vaccines... apples and oranges...

~chris

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The new Shingrex vaccine, which is just coming to market this year (2018) is not a live vaccine and will be safe to take with a CLL diagnosis. It has been approved in Canada and the States for people over 50 yrs.

Sandy Beaches

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Correct but that is not the issue. From what I understand is its efficacy. Again, this is al early so I am thankful for everyones input.

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From what I have read, in the US it is not yet approved for immunocompromised which we are, of course.

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Hi Sandy Beaches....I had shingles once in 2008. Does this mean shingrex could prevent a future breakout?

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According to Dr Furman, there is no downside to taking the Shingrex vaccine for immunosuppressed patients, but as you say to early to tell if it will be effective. However, I will be getting the vaccine as soon as it is available as I would rather try to ward off a shingles outbreak if at all possible, and will be worth the expense I will have to pay out of pocket,

You may wish to look into having a script waiting at your pharmacy for an antiviral so in case you do have a break out, or suspect one is on the way, treatment can be started without delay.

Sandy Beaches

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I specifically asked Dr. Furman about Shingrix and also sent him the article below that cites clinical trial results on Immune Compromised patients. He has agreed to give me Shingrix as soon as it is available at NY Presbyterian.

drugstorenews.com/article/g...

GlaxoSmithKline on Wednesday announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix ((Zoster Vaccine Recombinant, Adjuvanted) in preventing shingles (herpes zoster) when given to adults 18 years and above shortly after undergoing autologous hematopoietic stem cell transplant (auHSCT).

“The immune systems of these stem cell transplant recipients is substantially weakened compared to the general older adult populations studied in other Shingrix efficacy trials,” Emmanuel Hanon, senior vice president and head of vaccines R&D for GSK said. “This puts them at much higher risk for viral diseases like shingles and, at the same time, makes developing an effective vaccine to help protect them more challenging. Today’s results, demonstrating the vaccine’s ability to help prevent shingles and its complications with just two doses, may provide a much-needed benefit to these patients considering the high incidence and burden of disease they face.”

"The immune systems of these stem cell transplant recipients is substantially weakened compared to the general older adult populations studied in other Shingrix efficacy trials.”

GSK is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. All these data will be shared and discussed with regulatory as well as public health agencies with the objective of best informing health care providers on the use of Shingrix in those patients with greatest medical need.

Shingrix is a non-live, recombinant adjuvanted subunit vaccine given intramuscularly in two doses and is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

Shingrix is now approved in Canada and U.S. for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan.

Len

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Does this pertain to those of us on watch & wait or those getting treatment or just stem cell transplant recipients? Best Regards, Dianne

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When we are diagnosed with CLL, it is medically recognised that we are immune compromised - even on Watch and Wait: healthunlocked.com/cllsuppo... Thus the standard recommendation that anyone with a CLL diagnosis should not have live/attenuated vaccinations.

Neil

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Ibrutinib is not part of my cocktail, but I did recently ask my local Oncologist about Shingrix. While he is excited about the breakthrough, he was non-committal about using it because there's so little experience in immune-compromised populations. From reading the posts in this thread, it sounds like we're close, but doctor's practicing outside of research hospitals are cautious.

I may send my oncologist some of the links in this thread, because, of course, he loves it when I consult Dr. Google...

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Hi Roydeane

My husband was diagnosed 8/31/2011 with stage IV, had 4 months FCR from Sept. to Dec, went in remission. Developed a severe case of shingles in Jan 2012). Doc gave him the Shingles Vaccination Fall 2012(he was out of remission, but held off on FCR until July 2013 when Numbers got high). He went until Spring 2014 and counts started climbing again (it mutated to deletion p17) Doc then put him on Imbruvica. He stayed on Imbruvica until Fall of 2015(started the Car-T Gene Therapy clinical trial in PA). Came home Feb 2016, it didn’t work and lnumbers started climbing Doc put him back on Imbruvica in March 2016 and he’s still on it and Doc said he would take it till it quit working. I’m pretty sure he only had the shot that one time(not sure if you are suppose to get it more then once), but has not had shingles since he had the shot.

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Was he given a LIVE vaccine? I hope not. Shingrix wasn’t available then unless through a clinical trial.

Jeff

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I’d have to Ask his doc which one it was. His doc said the new studies showed it was ok to get it.

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Per Dr Furman via “Ask the Doctor “ on the CLL Society web site,

“Shingrix is a recombinant (not live) vaccine and should not present any problems to immunosuppressed patients. The questions that remain relate more to whether it has any efficacy in immunocompromised individuals. I believe there is no downside to taking the Shingrix, so it is worth doing.”

cllsociety.org/2017/12/ask-...

Jeff

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WOW !!! You guys are AWESOME! Thanks.

Many doctors may not even be aware that a non-live vaccine exists, and this CLL group explored, dissected, and got right to the heart of it in only 1-2 days.

And, that "heart" appears to me to be "efficacy" and "should I take it anyway?"

I suspect your efforts will help spur further studies and expert opinions on this, and as a previous shingles survivor (admittedly not the right word, but if you've had shingles, you know it's not too far off), I'll certainly be interested to read what they say/find.

Thanks again to you all for sharing your knowledge.

Gary

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