BEWARE OF ZYDELIG

[Jencarr]

I took Zydelig for 3 months for Follicular Non Hodgkin's Lymphoma. I had a very serious adverse reaction to this drug resulting in Pneumonitis. I was hospitalized for a week and have never been that sick in my life. I almost died. After 2 weeks out of hospital, I had a relapse of pneumonitis. I can't breathe and no matter how many antibiotics and steroids I take, I am not getting better. I believe this is a dangerous drug and needs more research. BEWARE!

[AussieNeil Administrator]

Thanks for the warning on Zydelig/Idelalisib; I hope you can soon breathe easily again after what must have been a very scary experience.

This adds to the previous posts about the risk of dangerous side effects associated with Zydelig/Idelalisib, which appear to be worse in patients not previously treated:

healthunlocked.com/cllsuppo...

healthunlocked.com/cllsuppo...

Several of our members have reported problems too:

MaudMarie healthunlocked.com/cllsuppo...

PaulaS healthunlocked.com/cllsuppo...

Justasheet1 healthunlocked.com/cllsuppo....?

You mention in your profile that you have relapsed twice; what was your first treatment and how did you fare?

Unfortunately, all drugs have side effects and some patients can be more severely impacted than others. It takes brave volunteers like yourself to engage in clinical trials to identify such problems.

We also need to bear in mind that for some of us, our CLL develops resistance to the B Cell Receptor (BCR) inhibitor drugs and the current practice when that happens is to switch to an alternate BCR inhibitor drub. So for that reason and because some of us are running out of alternatives, there will doubtless be a role for Zydelig/Idelalisib at least until a safer new generation drug replaces it.

Neil

[Jencarr in reply to AussieNeil]

My first treatment was Treanda and Rituxan...6 treatments, 21 day rotation. No issues except low WBC. Went into remission for 3 years. Following 3rd year, Pet found enlarged inguinal lymph node and it was removed. One more year remission. Second relapse, had treatment with Fludara. I had a headache reaction to it. Stopped treatment. Started Zydelig Jan 8. I felt fine for a month and then severe fatigue, joint pain, stomach issues, respitory issues creeped in and built up in my system to toxic levels. Was taken off Zydelig April 1, due to adverse reaction. Was hospitalized April 2, for adverse reaction of pneumonitis for a week. FDA sent out an alert on this drug saying it had caused death in several patients. The EMA stopped 6 trial studies in Europe because it was causing deaths from adverse reactions. So... As I said, BEWARE!

Still recovering. I have another Pet in July and will decide my next plan of treatment.

[AussieNeil Administrator in reply to Jencarr]

As BubnJay said, thanks for sharing your concerns when you're still recovering. I hope you at least get a decent remission after all you've been through.

Neil

[Bubnojay]

Hi jencar

so sorry to hear of your bad experience. I hope you are soon on the road to recovery.

Thank you for sharing when you feel so unwell.

Best wishes

Bubnjay1

[amanda1965]

Hi i was on that drug for 3 weeks and then became very ill it affected my liver and together with my spleen they were very swollen Iwas ill for weeks now not on anything

[Jencarr in reply to amanda1965]

It affected my liver as well. My liver enzymes were very high. My abdomen stayed swollen. I didn't have issues with the spleen though. And, I never got diarrhea which was the most reported side effect. However, it sucked the life right out if me after a month.

[Cllcanada Top Poster CURE Hero]

Very sorry to hear the Idelalisib problems you had treating FL. I hope you have filed a report with your drug approval body, like the FDA etc... they need to be advised and doctors might let it slip...

fda.gov/Safety/MedWatch/How...

~chris

[Jencarr in reply to Cllcanada]

Chris,

I mailed in the paperwork yesterday to the FDA to report this adverse reaction to Zydelig. I really think they need more research on this drug to make it safer.

Jenny

[Cllcanada Top Poster CURE Hero in reply to Jencarr]

Good Jenny... they are looking at it now...at least in combination with other drugs...

[june65]

My husband has been on Idelalisib for 9 months and thank goodness no side effects. This was his second line treatment, as he now has heart failure and the options for him were few. Hope you're soon feeling better.

June

[canadagoose]

Interesting comment about not being able to breathe and nothing helps. I was hospitalized for high fever, rash, and diarrhea and developed a cough. That was February. I still am breathless. Have seen the pulmonologist and infectious disease folks and no sign of anything. On anti virals, antibiotics and anti fungals and still sound like I smoke 2 packs of cigarettes a day. Thanks Zydelig.

[Jencarr in reply to canadagoose]

It is interesting! That's what I mean about Gilead needing to research this drug more.

I've done the same as you, taking drugs to try to help. I am using a humidifier and find some relief with it. The onc told me this week I might have scaring of the lungs from the Pneumonitis. I cried. I go to pulmonoligist next week. I hope to get a CT Scan to see.

[canadagoose]

So far nothing has shown up on chest X-rays, pet scans and ct scans. I keep on coughing. You should see the dirty looks I get in clinic.

[PaulaS Volunteer]

Re Idelalisib, I did very well on it for a couple of months, then got a nasty rash. I was advised to stop it for a while, in the hope that the rash would clear and not come back again when I re-started the drug. However, in the few days after stopping it, my spleen (which had been very enlarged but shrunk dramatically after I'd started the drug), ballooned up again and ruptured! I had emergency surgery to remove the spleen, and a lot of blood was transfused, but it was only later that I heard that the doctors had told my family I might not make it. (I did wonder why they suddenly came from far and wide to see me)

This wouldn't happen to most people who stop Idela suddenly, but my disease had been very much concentrated in my spleen, which had grown enormous before treatment. And I'd only been on the Idela for a couple of months, so the lymphocytes had been drawn out of the spleen into the blood but hadn't had time to die off. And it seems they all rushed back into the spleen when the Idela was stopped. The sudden expansion was too much for it... (Large spleens become fragile, because of the stretching of the capsule that encloses them). One of the doctors said it might have been better if they'd reduced the Idelalisib dose gradually rather than stopping it all at once.

So, it seems there are many different dangers with Idelalisib... For certain people it can be brilliant... but not for everyone...

I agree with you Jencarr, that this is a dangerous drug. I do hope your appointment with the pulmonologist next week is helpful, and that your lungs recover soon... Let us know how you get on.

wishing you well,

Paula

[Jencarr in reply to PaulaS]

Wow, Paula! I am so sorry the stickin drug caused you so much suffering.

I believe that Giliad rushed Zydelig through to make billions like they did with their HepC drug, Savaldi. Unfortunately, people were dying in trial studies in Europe so they had to stop the trials and the FDA sent out a warning the middle of March 2016! I had my adverse reaction with pneumonitis 2 weeks later. I feel so fortunate to be alive.

I hope you are feeling better now.

Jen

[PaulaS Volunteer in reply to Jencarr]

Hi Jen, I'm sure you're right, that Gilead did rush Zydelig through far too quickly... At first it seemed great - like Ibrutinib, but as time passes, the disadvantages become more apparent for both drugs - especially for Zydelig, which seems to be particularly dangerous, in many different ways.

Hopefully as more time passes, more prolonged research will be done on both drugs, to see who will benefit and why. And who is likely to suffer dire consequences... Maybe different doses need to be used.

They are now saying that Zydelig is safer for those who have already had another treatment first, but I know that you DID have earlier treatments, but that didn't stop the pneumonitis.

I do hope your breathing is easier now... Have you seen the pulmonologist again yet?

wishing you well,

Paula

[Jencarr in reply to PaulaS]

I was such a cheerleader for this Zydelig. I was even asked by Gilead to be an advocate and was so willing the first few weeks. I thought it was a miracle! Then, it all started..

Fatigue, nausea, running nose, cough, joint aches and pains, could barely walk up stairs. I told the nurse that called from Gilead as well as my oncologist but was told it was just the side effects of the drug. As I kept getting weaker, I told a girlfriend that I felt like the drug had killed the cancer but was ranging in through my body. Well, it did exactly that. I have been doing what I'm calling the hillbilly treatment which is a humidifier and Vick's vaborub and I am starting to breathe easier. I go to Inc tomorrow and pulmonary doc next Wed. I'm hoping to spend a few days breathing in the Salt Life at the beach real soon.

Jenny

[Jencarr in reply to Jencarr]

Sport about typos. I'm typing from my iPhone and my figures sometimes get in the way. Haha.

I felt like Zydelig was "raging" through my body and it was. I'm going to "onc"tomorrow.

[PaulaS Volunteer in reply to Jencarr]

Hi Jenny, Sounds horrific - like you had almost every possible side effect with the Zydelig! I had nothing like that, and felt very well for my first couple of months on it. It quickly shrank my very enlarged spleen, which took away a lot of the nasty symptoms I'd been having. I never felt the drug was raging through my body - more the opposite - I felt MUCH better while taking it. But then I got a rash and the problems started when I stopped the Zydelig.

Strange how different people react so very differently to the same drug.

I was relieved to hear you're starting to breathe easier now. Sounds like your "hillbilly" treatment has been working. Phew...

I hope things go well with your "onc" appointment tomorrow. Let us know how you get on...

Best wishes,

Paula

P.S. You say you have a Follicular Non Hodgkin's Lymphoma. I presume that isn't the same as CLL, but has some similarities? Treatments seem very similar anyway.

[MaudMarie]

After several problems with Idelalisib I developed pneumonia and then pneumonitis. Came off the drug straight away and was treated with high dose prednisolone and oxygen. Pleased to say that I recovered well from the pneumonitis and Sat O2 is 98/99% now.

However my CLL progressed quickly when off the drug and I was put on Ibrutinib but within a month I was diagnosed with Richters Transformation. Very poorly but now on clinical trial with Acalabrutinib and doing much better.

Please make sure that you are being monitored regularly for progression and why not try oxygen.

Very best wishes

Tricia

[Justasheet1 in reply to MaudMarie]

Tricia,

I'm so sorry to see your post but glad Acalabrutinib is working.

There was s post yesterday by Chris about the addition of Pembrolizumab for the Richters. Did you see it.

God bless and be strong.

Jeff

[MaudMarie in reply to Justasheet1]

Yes thank you Jeff, I have seen it. Recruiting in Germany, may need to follow it up later.

Bless you too.

Tricia

[PaulaS Volunteer in reply to MaudMarie]

Dear Tricia,

I was so sorry to hear that you'd been diagnosed with Richters Transformation! I was just thinking of you the other day, wondering how you were... Then I read your post this morning... What a shock!

I long to hear more... How was the RT recognised? What symptoms did you have? Do they know what sort it is? Are you now having Acalabrutinib by itself, or combined with something?

I'll understand if you'd rather not answer all these questions, and maybe this isn't the place to do it, but you are very much in my thoughts and prayers...

Paula

[MaudMarie in reply to PaulaS]

Thank you Paula, I'll write more about this tomorrow. But this is my 'big' birthday weekend and the family are spoiling me something rotten!

Best wishes for your continued good health too.

Tricia

[Peggy4 in reply to MaudMarie]

Happy 'big birthday' Tricia. 21 again? 😀😀

Have a lovely time with your family.

Peggy x

[PaulaS Volunteer in reply to MaudMarie]

Happy Birthday Weekend, Tricia! Enjoy!

Paula x

[Jencarr in reply to MaudMarie]

Thanks for your info, Tricia. I'm sorry there has been a Transfirmation. Hopefully, the new trial drug will help

I am having a PetScan July 8. That will tell the tale. The Zydelig did shrink the lymph nodes in my abdomen but who knows what 2 months off the drug will do. I'm hoping for a continued remission. But, I'm ready for anything that comes my way! Fight on!

[mnmnewtons in reply to MaudMarie]

I too have been on Ibrutinib an Idelalisib. Could you tell me where your clinical trial with Acalabrutinib is?

Rick

[Bubnojay]

Hope you had a lovely birthday surrounded by family. Wishing you many more.

Good luck

Bubnjay1