Study of Exjade (defrasirox) taken with food

This maybe interesting, much with parents of infants. I personally don't care whether I take empty stomach or with food. The only dose that goes empty stomach is the morning one. Next evening dose, I combine it with even snacks and tea!


http://www.thalassemia.org/journal-publishes-exjade-food-study-results/

April 30, 2013 – The medical journal Pediatric Blood and Cancer published online on April 23 a study entitled “The Palatability and Tolerability of Deferasirox Taken With Different Beverages or Food.”

This is known to many in the thalassemia community as “the Exjade food study;” as the official title suggests, it looks at the option of taking Exjade with various drinks other than those recommended on the label; with food;  and without food.

The Exjade label currently specifies that the drug should be taken mixed with water, orange juice or apple juice and that it be taken on an empty stomach, 30 minutes before a meal.  Some individuals find the limited choice of beverages and the need to take on an empty stomach inconvenient and would welcome an expanded range of options.  This study provides clear indications that an expanded range of options are possible.

The study enrolled 65 patients with either sickle cell (38%), thalassemia (31%), Myelodysplastic syndromes(14%)  or other anemias (17%).

In the study, patients were given the following options for administering deferasirox:

with breakfast, crushed and added to soft food
with breakfast, dispersed in a beverage of choice
with dinner, crushed and added to soft food
with dinner, dispersed in a beverage of choice
With no meal, dispersed in a beverage of choice
These options began after a four-week “run-in” period during which patients administered deferasirox in the manner recommended on the label.   The above options were implemented during the following 12-week period.

Among the findings:

Favorable palatable ratings increased from 38% during the run-in period to 47% during the 12-week assessment period; unfavorable ratings decreased from 35% to 18%. (Patients like the taste of the food options and dislike the current beverage suggestions on the label!)
Over the course of the study, serum ferritins remained stable among patients aged 18 to 60; ferritins trended downward in other age groups.
37% of patients experience gastrointestinal adverse events in the 4-week run-in phase as compared to 32% during the 12-week assessment phase.
The authors state that the study “demonstrated that deferasirox could be administered by additional modes with potential improvements in palatability and tolerability and without obvious increases in toxicities.”
Ellis Neufeld, MD, Chair of CAF’s Medical Advisory Board, comments that “preliminary results of this  study have been known for more than two years, and it is terrific to see the final published results. Many thalassemia treaters have already been passing on the initial results to patients, and  this paper is encouraging news for patients, families, and the nurses and physicians who work with them.”

The study was authored by Stuart L. Goldberg, MD; Patricia J. Giardina, MS; Deborah Chirnomas, MD; Jason Esposito, MSHS; Carole Paley, MD; and Elliott Vichinsky, MD.  The study was sponsored by Novartis Pharmaceuticals Corporation.

Thanks for sharing Pratik...my daughter is almost 3 and has been taking Exjade with food since October (yogurt and oatmeal) and things seem to be ok.

Hi All,

My daughter is 4.5 year old and weight around 12 KG. Her BT start 6 months back and her ferritin is around 682.9 ng/ml . Doctor start Exjade (Deferasirox) 125 mg daily. I have two question.

1. How we should give this to my daughter for less toxic impact - with Juice/Food  (As i find some controversy) over this medicine. if someone is already taking this they can share this impact.
2.is Deferasirox is advisable for childeren or i should ask my doctor to change this with other medicine.

Thanks & Regards
Sushil Thakur

The drug is appropriate for children.

You can mix Exjade with any soft food or liquid. The only restriction is don't mix it with high fat foods. So find whatever foods she will accept and mix the Exjade with that. All that's important is that the drug is taken. How it is taken makes no difference, so be creative and find foods she will take the med in.

By the way, the dosage is a maintenance dose, which is OK as long as her ferritin is low, but if it begins to rise, the dose should be increased.

Andy is correct. I don't care about the evening dose which I take with (after) I'm done with drinking tea and bread. And I've been fine really. I'd instead recommend it with food as I find it digests better and is easy on stomach with food. But that's just me.

So yes, there should be as such no problems if taken with food. Just take care of what Andy mentioned and she'll be fine.

-P.

I've two questions, appreciate your opinions.

Can Exjade tablets be chewed or swallowed followed by some water? Or it is always recommended to dissolve it in water or mix in food for use. My toddler does not like it when dissolved in water, he likes to chew it and then some water.

And second question, should it be taken empty stomach? Please advise.

i do not know if Exjade can be chewed...i have always seen it dispersed in food/liquid. Have you tried dispersing in juice? my daughter says she don't get the chalkyness when dispersed in juice. May be other members can comment about chewing.

to answer your second question, no , Exjade need not be taken in empty stomach. In fact, I will suggest not to take the medicine on an empty stomach. My daughter used to complain of tummy ache when she used to take it on an empty stomach. Now we give her after dinner....exjade is 1st dispersed in a small amount of water and then we add juice of her choice (orange or apple or mixed berry)...

The tablets should not be chewed or swallowed. They have to be mixed into a drink.

THE DO'S AND DON'TS OF TAKING EXJADE

The Do's
Each day the parent and child should carefully count the number of tablets together. Then, drop the tablets into the amount of water, orange juice, or apple juice that your doctor recommended. (Doses less than 1 g should be mixed into 3.5 ounces of liquid and doses of 1 g or more should be mixed into 7 ounces of liquid)

You or your child will then stir the tablets until they dissolve and are mixed into the drink. The mixture may become thick. Finally, your child will drink the mixture. You or your child may notice that the texture of the liquid is different and may take some getting used to. But it's important to drink the whole glass. If there's  any left in the glass, add more liquid, stir it again, and make sure your child drinks it again until all of the medicine is gone.

You or your child may find it helpful to mix the EXJADE and liquid in the EXJADE Mixing Cup.

The Don'ts

The tablets should not be chewed or swallowed. They have to be mixed into a drink.
Antacids like Maalox® or others that have aluminum should not be taken at the same time as EXJADE.

For more details follow the link
http://www.us.exjade.com/patient/giving-children-exjade.jsp

 

Novartis needs to update their information to include foods. After all, it was Novartis that ran the trials using foods that showed no difference in efficacy of the drug. I still don't understand why they stick to the liquid instructions of not crushing the tablets, when that's exactly how it's used when taken with foods. I guess they would have to spend money getting the new instructions approved by the FDA and they certainly wouldn't want to have to spend any of the billions they've made off the drug. They should also update the once per day instructions, but I doubt their marketing department will ever allow it. They still don't get that the selling point of Exjade isn't once a day. It's whether or not it works that keeps patients on the drug.

Good catch and appropriate comments from Andy.

Merci Beaucoup!!

Thank you very much to all of you for all of this useful information.

I'm still confused about taking the Exjade with empty stomach. As it is mentioned on Exjade packing that tablets should be taken with empty stomach.

@ Canadian_Family: Is there any specific reason not to chew or swallow Exjade?

I usually like Andy to comment on issues however I have been with Novartis Representatives and Doctors personally and they all stated that Exjade works BETTER WITH FOOD and the only reason they haven't changed the labels is because of the cost to do so. Foods such as high fat yogurt and butter believe it or not work best to deliver medication.

Exjade works better when taken with food. Now, here in the forum, members reported with experience (long before Norvatis reported) that they feel less/or no symptoms of nausea, vomiting or abdominal pain when exjade is taken with food. As JV mentioned, Norvatis came with the same conclusion. The label change is an expense issue for them. Do not get confused.

Members reported different ways of taking exjade, some dissolve in water, orange juice etc. Some crush it and take with food. Now, this is an interesting scenario, isn't chewing and crushing the same thing (in a sense). If Norvatis is okay with crushing and mixing it with food, should they change the label and remove chewing part as well or it is a question of expense for them.

However, as I cannot speak to the molecular chemistry of Exjade (I would follow the instructions or any other proved conclusion).

My thoughts exactly. How can chewing it being any different from crushing it and mixing it with food. The molecular structure cannot be affected by physical crushing, so there can't really be any difference. My only advice would be don't chew the tablets on an empty stomach.

I've always thought that the administration advice for Exjade made no sense, but I understand why it is so. One specific method was used for trials and that method was approved. To change this would require trials and applications to the FDA for approval. I have seen no resistance from Novartis to the informal changing of these instructions. In fact, the Novartis reps had nothing to say at the Philly conference when various new methods of taking Exjade were discussed. Their silence was telling. If there was a problem, they would speak up, but they also cannot say take it anyway you like, as Dr Coates did, because it isn't technically approved to be taken anyweay you want. Dr Coates used some strong words but the gist was it really doesn't matter how you take the drug as long as it's taken.

Hello everyone
I've been giving my son asunra 400 mg in food since last 3 days bcz giving with juice was a big problem(also increased the dose from 300 to 400 since last 6 days).
One time in yogurt and one time in cereal. But he is constipated since then and being very irritable crying all the day. He is not eating anything properly and is not even nursing now. He is just 20 months old so can't tell me what's the problem with him. I want to tell you one more thing when I was giving him 300 asunra he was constipated on and off but when I increased the dose to 400 and gave with juice for 3 days his constipation was better. May be hw can't digest it with food and don't drink enough water but I try to give him little sips all the time.
I am really tensed bcz whatever the problem is with him he never stopped nursing. Plz tell me if anyone's child had the same problem and what to do now?