New Exjade postmarketing update

[marlene]

For anyone on Exjade, please take the time to read the latest update on the drug. They are now saying you should have your liver monitored monthly and they have changed the criteria for when to start chelation. In the past, they said if your FE was >500, you could start Exjade. They have upped that to >1000.

John has been on Exjade for quite a while and his FE finally dropped below 1000. However, his Creatinine is elevated even at a reduced dose. I can’t help but think that this is related. His Creatinine was 1.59 on Jan 11 so he stopped the Exjade. He had his creatinine checked again on Jan 25 and it was up to 1.7. This was at 750 mg/day. His Fe went from 992 in Dec to 698 in Jan. Right now he’s off the Exjade and is scheduled for a sonogram of his kidneys. Hopefully it’s nothing and things will settle down.

http://www.us.exjade.com/hcp/safety/home.jsp

I copied this from the first PDF listed:
UPDATE TO DOSAGE and ADMINISTRATION SECTION:
The decision to remove accumulated iron should be individualized based on anticipated clinical benefit
and risks of Exjade therapy. In patients who are in need of iron chelation therapy, it is recommended that
therapy with Exjade® (deferasirox) be started when a patient has evidence of chronic iron overload,
such as the transfusion of approximately 100 mL/kg of packed red blood cells (approximately 20 units
for a 40-kg patient) and a serum ferritin consistently > 1000 mcg/L.
We hope that these updates provide you with the latest information you need regarding EXJADE.

[LuAnn]

Hi Marlene, My dad has been on Exjade for a few years now and the dr. has always monitored his kidney and live function levels. They are taken once a month and if too high, he is taken off the Exjade until his Creatinine and BUN #s become norma. His FE is over 5000 and they try to get it down to below 3. Unfortunately, the Dacogen he is also on affects the kidney and liver function so that is also taken into consideration. It’s like a catch 22. Thanks for sharing this with us.

[covergirl]

I too get regular monthly checks on liver and kidney while taking Exjade. This has been SOP since I started it.

[marlene]

LuAnn,

How high does his creatinine get and how long did take for it come down?

Covergirl….We started checking things 2x/month since November. John’s levels would alway normalize after a break from Exjade but this time it went up a bit.

Marlene

[jaxem]

. . . . . and to add to all of this, the manufacturer says to get a baseline check of hearing and sight before doing the drug.

[JSRN]

Mom has had high ferritin levels for years. Sometimes 5000. She gets Desferral with each transfusion. She tried nightly infusions at home for a few months but it didn’t make a difference. Sometimes her ferritin level will drop to 3000 with no treatments. Her oncologist knew she did not want to take Ex-Jade. Now her new oncologist insists she take it. Even went as far as calling ExJade company and placing the order. The cost is way too much, over $5000 per month. Not to mention the side effects. MY thought is she has had the high levels for many years. They fluctuate greatly. Even if she took Ex-JAde, how are we to know if it was really working. She is doing well off of all chemo and just getting blood every 2-3 weeks and Procrit weekly. I don’t like adding a drug that can make her feel bad again. She lives independently, and at 81 years young, wants quality, not quantity.
Can anyone share their ExJade experience?

[Russ P.]

JSRN,
Can’t understand an ONC that would ignore a patient’s wishes and order a drug that she apparently cannot afford. My ferritin is 1910 and being the same age as your mother decided to take my chances on the iron overload. I understand her wanting quality of life more than extra years. Is our treatment prolonging life or prologing death? FYI, I have an excellent, caring Hemo/Onc in South Bend if you happened to be in this area. Prayers,
Russ

[marlene]

JSRN,

When ferritin is that high you cannot really guage how effective Exjade or Desferral is by the Ferritin levels. Pretty much anything can make your FE level rise once it’s already elevated. Any inflammation will effect it. An injury, cold, flue, etc. It is so senstive that even the blood draw itself can effect the reading. So going from 3000 to 5000 does not correlate to the amount of iron in her. I would say she is probably more stable at 3000 which is still high. Serum ferritin gets more accurate at lower levels like around 1000-1500.

When John took desferral, his urine would turn orange…..Usually means the iron is being removed. But not everyone’s urine changes color. When on desferral, your doctor can order a 24 hour urine test where you collect the urine for 24 hours to see how much iron is coming out. When he went on the Exjade, his stool would take on a different color. Again that’s not true for everyone.

I too agree with Russ that it’s your mother’s choice. I would ask this doctor what he thinks will benefit from your mom doing Exjade now. He may be thinking that the iron is further suppressing her bone marrow.

If you start Exjade, ask them to start her off at a low dose, say 500 mg for the first month. Monitor her liver/kidney/CBC weekly, If she tolerates that, then increase it and continue to monitor it weekly. Do this til you get the right dose. My husband John never got to a full dose and he would take a break from it when it got to be too much for him. Nausea was his biggest problem with it. Many side effects are dose related. Lately though, this creatinine levels seem to go up too.

Marlene

[JSRN]

Thanks for the info. I sent mom lots of info on Ex-Jade. She does not think she wants to try it. Especially after reading it can affect vision. She just had cataract surgery and doesn’t want to mess with that.
I don’t like the idea of it as she had hepatitis B 20 some years ago after a car accident and she needed 32 pints of blood back then. Too many side effects with Ex-Jade.
The only thing the oncologist says is she has iron in her liver. Well, she is doing ok for now, so why mess with it.
This week she received blood and the nurse mentioned her port site still looked bad. I said still? Apparently she has had a rash there for a few months. The doctor had looked at it a while back and said use cortisone on it. Obviously that didn’t help so I had the doctor come look at it again. She ordered blood and fungal cultures and Vfend. Well, Vfend is almost $400. So we called her back and said order something cheaper. She said no, she wanted mom to take it. We are holding off until the cultures come back. IF they are growing any fungus, then we will spend the money.
I don’t get these doctors that demand one spend money they can’t afford!
Russ, I may be checking into your oncologist!

[1Chris]

I had recently had cataract surgery and was delighted that my vision was sharp and clear for the first time in many year, and then I took Exjade and now I can not read anything without a magnifying glass. I did have a base line test.

I am also awaiting approval from Medicaid for a hearing aid. I had slight hearing problems prior to Exjade but I have had to drop some group activities such as a Tai Chi class because I could not hear nor participate in the conversations during class nor hear the instructor, thus I got bored.

I had a lot of problems with Exjade such as diarrhea. I hated the stuff. I have since been diagnosed with a encapsulated tumor in my stomach.

It is possible that all of the above issues may be unrelated to the Exjade.

Exjade phoned me for an interview last month and paid me $125 for my time. I had nothing good to say about it.

I also told them about how many people who needed it could not pay the co-payment and how cruel that was.
~~~

Christine Thomas – Age 76, Diag. 1997, Trisomy 8, RARS, Treatment with Desferal once a month with tx for Iron overload. Procrit & Aranesp failed after several months. Diabetes 2, Auto-immune Diseases and COPD. Also on oxygen 24/7.

[marlene]

JSRN…..John had a hickman port. He developed redness around the opening and at times it would bleed. Between all the docs and nurses, none thought it was infected. We decided to see a wound specialist who immediately said it needed to come out and that it was infected around the cuff area that holds the port in place. So it was pulled and a week later they did some minor surgery on it to clean it out and fix the area. These low grade infections can take a toll on your immune system. At the time, John’s count were very low….all three lines.

If your mom tolerates desferral, can she do it at home say 4x/week and rest 3 days? Since she has a port, that could be a good option for her.

And….sorry her doc is so clueless.

Marlene

[Russ P.]

JSRN, My clinic has a web page: http://www.mhopc.com/index.html

The ph. # is: 574 234-5123 (There’s also a toll free.) A nurse can be contacted 24/7. The nurses are the most well trained and nicest people. There are several hemp/oncs but my experience has been only with Dr. Taber. Note that they have offices that may be closer to you -my doc makes regular visits to the office in Plymouth. Best wishes and prayers,
Russ

[JSRN]

Quote:

Originally posted by marlene:

If your mom tolerates desferral, can she do it at home say 4x/week and rest 3 days? Since she has a port, that could be a good option for her.
Marlene

Mom already went the Desferral route at home. It didn’t seem to make much difference in her levels. So now she just gets it during her transfusions.
Mom thinks the port site is looking better using the antifungal cream. Even the place she had tape after drawing blood cultures last week had gotten a little red. She is allergic to Betadine. So I wonder if the new prep now being used to clean the sites is causing some of this.
Fortunately her white count is good at 4.5.

[marlene]

John acquired problems with adhesives and cleaners also. We finally had to use just sterile saline water to clean the site. We tried chloraprep, betadine and diluted peroxide. They all seemed to irritate him after a while and make things worse.

On the Desferral, or any chelator, it’s a challenge to get the iron down when you are still getting red cell transfusions. Most of the time, you are just able to maintain where you are at and not go any higher…..which is very discouraging. So you may not see the effect, but know that it is chelating out iron. Unfortunately, the rate of accumulation can be faster than you are able to chelate. We knew of another transfusion dependent person who ran his desferral seven days a week, 24 hours a day in order to get his FE level down past 1000. That’s pretty extreme, but then he was only 40 yrs old and tolerated it really well.

Wishing your mom the best….M

[Jimbob]

Thanks to chemo and all of the drugs after SCT, my liver was in poor shape and I did not want to risk Exajade to reduce my iron overload. After more than 80 packed RBC transfusions, my serum ferritin level was over 5400. I haven’t needed any transfusions in over three years. Instead I have been able to take the opposite route; I have been doing therapeutic phlebotomy (bloodletting). They take two pints every month and after four months I am down to 3500. Of course, I would not be able to do bloodletting if I still needed transfusions.
Jim

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