EXJADE reaction

Hello All,

We had a detail discussion with our doctor yesterday re. Exjade. It is not prescribed for children under 6 in Canada for the following reason.

1. The clinical trial data for children under 6 is not enough to prescribe a exact dose.
2. The risks and side effects are still unknown (long term), for children under 6 the rate of growth is highest. To avoid any possible interference with their growth rate; exjade is held back as it cannot be compromised.
3. The tolrence level of Exjade is less in children under 6, possibly due to amount of liqiuid one has to take.

Health Canada has designed a program to watch the ongoing trial and prescription/side effects of exjade and will review it in two years.

Regards

I sometimes wonder how medicines ever get approved for children. Is exjade even being trialled on children anywhere? When desferal was introduced, there was nothing else available, so the choice was that or nothing and obviously nothing carried more danger. But now that we have desferal, will other chelators even be studied on young children? The rationale may be why risk it when there is a drug that can get them to the age when they can switch to another drug, so why make young kids guinea pigs. The parents who have to administer the needles may see it differently.

But maybe for a better idea, we should ask the parents. If your child was given the chance to test a new chelator that had already been tested on adults, would you be willing to allow your child to take part in the trial? What do the parents have to say?

Hi Andy,

That is a very interesting question. I honestly do not know what I will decide when the time comes for Lauryn to chelate.
In all honesty, I trust the Dr.s at Phoenix childrens, and they seem to think it is safe enough for her. Same thing with Hydroxyurea. they dont know if there are long term effects, but at the present time,(for thal kids) it seems to be working.?
In a nut shell, yes I would try Exjade for Lauryn,and take it from there.

To answer your question Andy, Yes I will have my daughter participate under a watchful eyes for scientific and trial purpose. But please note if it is just for the sake of getting rid of needles than absolutely not.

Regards

Hi, here in Australia where Exjade is now approved and on pbs its now being used successfully by almost all the patients in our unit including children under the age of 6. Just thought I would let you know. By the way, I have been on it now for almost a month and there are no words to describe how wonderful it is to use this simple method of eliminating ferritin. Its a Godsend. I will keep my fingers crossed that all the thal patients around the world will also be using it as soon as possible. Its the best Christmas present I have ever received. Christmas blessings to all......

Hi Siena,

Do you know what is the youngest age that exjade is being used on in Australia?

Hi Andy, I will find out more and get back to you on that one. My next visit will be in 2 weeks time. Merry Christmas.....Siena

Hi everyone, I live in Australia. My son Jia, now 3 years and 4 months, is on exjade. He took it for a week and had bad rash. So, we've been instructed to stop it for a week. We will start with exjade again in 2 days. He has never had any other form of chelation before. This is the first one. I shall tell you what the outcome is after the next round of exjade and whether the ferritin level drops.

Hi all

As some of you may know I was using L1 recently in combination with Desferal. My ferritin levels had dropped whilst on this method of chelation.

It has been about 6 weeks now that I have been on Exjade and things are going ok. I also developed the rash but not as bad as some reported cases. I didn't stop taking Exjade as my case was very mild and only lasted 3 days. However I must say that I do suffer alot with diarhia especially when I eat fatty foods. My ferritin levels have dropped since being on Exjade.

I will keep you posted.
Miaki

Jia is now back on exjade again. It has been 3 days, and the rash hasn't come back. He'll go for transfusion tomorrow, and we can check his ferritin level then too. Hope for the best.

HI freinds
         my son Abdulwahab ferritin level  is 1900 i talk with Dr javed a bout it he told me when you come for next check up we will see what the best drug for him or to take blood from him and throw it and this procedure must do it evey month as i think.. my quistion is is the EXJADE good for the post bone marrow transplant ? if no what the best drug for him? ...
                                           thank you
             
                                           khalifa
                                    state of kuwait

my quistion is is the EXJADE good for the post bone marrow transplant ? if no what the best drug for him?

Hello Khalifa,

I know of a patient (whose Iron level was around 25000) who is on Desferal after his Bone Marrow Transplant but his Iron level is NOT decreasing much (currently is around 2300) after taking it for 5 years after BMT. His doctor has also suggested to remove blood from his body now to get rid of the Iron level. This patient is in India and as most of us know no one in India has got on Exjade yet, so don't know if Exjade is recommended for post BMT.

Do give us an update on your son's visit to the doctor and what he mentions for getting rid of the Iron. Abdul Wahab is quite young and his Iron level might NOT be a major issue as this boy's who is around 18 years now, so don't compare both cases directly. I just wanted to let you know what I have heard.

-Narendra

 Dear Narendra
                 thank you for exeplination but also me i heard there is some who have BMT is unders desferal also some of them they have blood remove every month ..
                                 
                                       khalifa
                                state of kuwait

In the US, Exjade is approved for use with children 2 years and older. The suggested dosage is also based on body weight, the same as for adults.

From http://www.drkoop.com/ency/93/guides/000058_7_6.html

In 2005, the drug deferasirox (Exjade) was approved for the treatment of transfusion-related iron overload in patients ages 2 and older.

From http://www.us.exjade.com/index.jsp?usertrack.filter_applied=true&NovaId=3350119478090341153

Pediatric Use
Of the 700 patients who received Exjade during clinical studies, 292 were pediatric patients 2 to <16
years of age with various congenital and acquired anemias, including 52 patients age 2 to <6 years, 121
patients age 6 to <12 years and 119 patients age 12 to <16 years. Seventy percent of these patients had
β-thalassemia. Children between the ages of 2 to <6 years have a systemic exposure to Exjade
approximately 50% of that of adults (see CLINICAL PHARMACOLOGY). However, the safety and
efficacy of Exjade in pediatric patients was similar to that of adult patients, and younger pediatric
patients responded similarly to older pediatric patients. The recommended starting dose and dosing
modification are the same for children and adults. (See CLINICAL STUDIES, INDICATIONS AND
USAGE, and DOSAGE AND ADMINISTRATION.)

Hopefully, this will soon be followed in other countries so that all thal children can have a chance to have a life without the needle.

Exjade is recommended as a replacement for desferal in patients 2 years and older. Use for patients following a bone marrow transplant was anticipated when the drug was approved in 2005.

From http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=185693

Although Exjade was primarily tested on patients with thalassemia, it is also indicated for others who need frequent transfusions. Patients with sickle cell disease and hemochromatosis, a hereditary disease in which the body absorbs too much iron from food, also need iron chelation therapy, Mackenzie said. It could also be used after transfusions following bone-marrow transplants, Bridges added.

As Narendra mentioned, bloodletting or phlebotomy, is often used in post BMT patients who have high ferritin levels. It has been shown to be an effective method of lowering ferritin levels.

From http://www.bloodjournal.org/cgi/content/full/90/3/994

In the 41 treated patients, adherence to protocol was only 72% ± 23% despite treatment being designed to maintain an almost completely normal life. Psychological rather than medical difficulties were encountered. No cases of graft failure, prolonged anemia, or protein depletion were seen, while it was possible to achieve normal liver iron concentrations (Fig 1). The speed with which this can be accomplished will also be affected by growth rate, natural low intensity iron chelation, variability in iron distribution due to BMT, and variability in iron absorption over the years. This study clearly shows that a moderately intensive phlebotomy program is safe for thalassemic patients after BMT. Other reports confirm the feasibility of regular phlebotomy after BMT...and this form of therapy is likely to be much safer, cheaper, and more widely applicable than alternative iron chelation therapy.

One factor that will affect how much blood can be taken is how high the Hb level is maintained. If it is towards the anemic side, it reduces the amount of blood that can be taken at one time.

Khalifa, Dr Javed will be able to tell you if they have experience using exjade with post BMT patients. If the chelation route is taken, it may be much more desirable than desferal.