New Exjade Warning

[cthomas555]

I had an appointment with my hem/onc this morning to discuss the new Exjade warning, He says for me to discontinue the drug due to the warning. I developed chronic diarrhea from the Exjade that can lead to dehydration and also cause kidney damage.

Though my ferritin level was over 9,000, the iron study he did in February showed not too much increase of iron in the body tissue so we will go back to the Desferal infusions after my tx each month or as tx are needed.

Chris

[helenr]

Hello Chris.
What was the Exjade warning? We have not heard of it yet here in Australia. David had to stop it because of liver damage and will return to the desferal when he settles down with the Revlimid and lowered neutrophils.

Helen

[AlexD]

cthomas555,

That is incredible. I’ve been on Exjade for 18 months now and started Revlimid about a month ago. Ever since the Revlimid, I’ve been having chronic diarrhea with some serious dehydration.

Also, I noticed you live in Shaker Heights, as do I. Amazing how small a world it really is.

If you don’t mind me asking, who is your hem/onc?

-Alex

[marlene]

FYI…..Here’s a post marketing update on Exjade. It’s pretty much stating what most of us already know about serious side effects….it’s now official.

Revised Warnings and Adverse Reactions Sections for Exjade

5/23/2007
Novartis is notifying health care professionals of changes to the Warnings and Adverse Reactions sections of the product labeling for Exjade (deferasirox), a drug indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Acute renal failure (in some cases fatal) has been reported after the postmarketing use of Exjade. Most fatalities occurred in patients who had multiple comorbidities and were in advanced stages of their hematological disorders. There have also been postmarketing reports of cytopenias (some fatal), including agranulocytosis, neutropenia, and thrombocytopenia in Exjade-treated patients. However, their correlation to Exjade treatment is unknown. Most of these patients had preexisting hematological disorders often associated with bone marrow failure. Cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions (including anaphylaxis and angioedema) were also reported. Health care professionals should monitor serum creatinine in patients who have an increased risk of complications, have preexisting renal problems, have comorbid conditions, are elderly, or are receiving medicinal products that depress renal function. Blood counts should be regularly monitored and treatment interrupted in patients who develop unexplained cytopenia.

[cthomas555]

Marlene, thanks for posting the complete warning. I lost the URL address but I sent the article to my hem/onc and primary immediately with the comment that I thought it was scary. They said they thought it was scary, too.

Chris

[cthomas555]

Alex, It does seem a small world. I see Dr. Alan Lichtin at CCF. I initially saw Dr. Andresen but I didn’t like him. It seem to me that he basically patted me on the head and sent me home to die.

I just read that CCF and UH are both a part of Case Comprehensive Cancer Center. They work hand in hand.

Gosh, I’m so sorry that you have this disease at such a young age. It really saddens me.

There were a couple of young people at:

http://www.marrowforums.org/index.html

before they changed their format. I would also post my profile there too.

Christine

[Frankie]

Help!

I just read some posts here about Exjade. My doctor wants to put me on it. I had been on Desferal for a few years. I’m on Revlimid and no longer receive blood transfusions. My Ferritin level is at 1500.
I got quite frightened reading everyone’s posts about Exjade warnings….especially since I already have chronic diarrhea… probably a side effect of the Revlimid.
Funny thing is I tried to get a prescription for the Exjade filled….my doctor was so sure any pharmacy could order it. They can’t!!! It has to go through some b.s. and my doctor is not very aware of this. So I haven’t heard back from my doctor about it….he’s very bad that way…not answering calls and such.
Do I really need to be on an iron chelator?????

Frankie

[marlene]

Hi Frankie,

Couple of things….If your Hemaglobin is at or near normal, you may want to consider theraputic phlebotomies. I know it sounds counter-intuitive but if you’re able make up the difference, phlebotomies are a an option. You can start with removing just 250 cc of blood each month to see how you do. John did them when his HGB was 10 -11. He was doing them monthly because Exjade wasn’t out yet and the desferral was problematic for him. It got to be too much for him after about a year so he went on Exjade when it came on the market. His HGB is holding around 10.5 – 10.8. Again, this all depends on what’s happening with your HGB. Our doc said one month of Exjade is as effective as removing one unit of blood.

And yes…..drug stores cannot fill this prescription. We have to go through Acredo and it’s mail order. You must be home to sign for it. It’s very expensive if you don’t have a good prescrip coverage insurance.

If you decide to do Exjade, my personal opinion is that you do not need to be on the full dose since you are no longer transfusion dependent, are on Revlimid and your Ferritin is only 1500. A lower dose will bring down your ferritin and at the same time, minimize side effects. John started with 500mg and is now up to 750 mg. This about one half the standard prescribed dose. Many of the side effects are dose related.

Before starting, your doc should have checked your kidney and liver function via a chem panel blood test. He should then do weekly blood test for at least the first month to make sure you do not have any kidney/liver issues from the Exjade and also, make sure it’s not effecting you white blood cells. And then maybe go to two weeks then monthly.

Marlene

[Frankie]

Thank you so much, Marlene.
My hemaglobin is at 9.4 right now. My white count is still low…… 1.9

Once a month my doc does a full CBC. I think he learns more from you all than anything else.
Thanks again.

Frankie

[marlene]

Hi Frankie…..A 9.4 HGB would be too low for phlebotomy. John had to be at 10.

Take care,
Marlene

[Alice S]

Hi Frankie
My mother started exjade 10 days ago, ferritin level was 6800. Doctor waited till exjade became available in South Africa before starting. He ferritin was 5000 in November 2006 (my mother just found out! She’s a bit mad at her doc.)

So far no side effects whatsoever, and for the last five days she feels much better. They will probably test for ferritin later as she received 4 units of blood last weekend.

Take care
Alice

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