New Exjade warning

[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.

[Birgitta-A]

Hi Marlene,
Regarding info from The Aplastic Anemia & MDS International Foundation the ferritin level should not be less than 1000. That is what I have read in many abstracts from studies about iron overload too. Both 992 and 698 as John has had could be too low.

http://www.aplastic.org/aplastic/dis...26e76264fc0ea9

“…Typically, physicians would want to comprehensively evaluate whether there was any contraindication to increasing the Desferal dose a little to see if the ferritin levels could be brought down into the 1500 to 2000 range or even maybe a little bit lower…

… If the patient responds to therapy and no longer requires red cells, the risk of side effects from Desferal or Exjade, especially retinal (vision part of the eye) and nerve damage is increased when the ferritin is less than 800. That might be a reasonable time to stop if there are no ongoing transfusion requirements…”
Kind regards
Birgitta-A
68 yo, MDS Interm-1 dx May 2006, RBC transfusion every 6th week, Desferal 4 days after transfusion, Neupogen 2 injections/week

[Marlene]

In the past, John's FE never dropped that quickly before. It would creep down at an snails pace and it always bounced up and down. So we were pleasantly surprised to see it consistantly trend down. But then it really dropped.

John is no longer transfusion dependent so it may be a good idea to stop.

Per the Exjade drug insert/patient info.....
"Serum ferritin should be measured monthly to assess response to therapy and to evaluate for the possibility of overchelation of iron. If the serum ferritin falls consistently below 500 mcg/L, consideration should be given to temporarily interrupting therapy with Exjade. (See DOSAGE AND ADMINISTRATION.)

In the clinical studies, the correlation coefficient between the serum ferritin and LIC was 0.63. Therefore, changes in serum ferritin levels may not always reliably reflect changes in LIC."
-----
Interesting that they use < 500 as the cutoff once you're on it versus the level stated in the inital dosing info. Seems to be conflicting.

Thanks for the info.

Marlene

[Birgitta-A]

H Marlene,
Wonderful that John isn´t transfusion dependent .

Yes, both Exjade and the other oral iron chelatot, Ferriprox, have similar dosage info: Interruption of therapy should be considered if serum ferritin measurements fall below 500 but with Desferal it is 1000. Perhaps Desferal is more toxic when ferritin is low ?
Kind regards
Birgitta-A