Thalassemia Patients and Friends
Discussion Forums => Iron Chelation Corner => Topic started by: Pratik on May 20, 2013, 06:49:50 PM
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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.
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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.
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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
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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.
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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.
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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.
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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)...
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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
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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.
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Good catch and appropriate comments from Andy.
Merci Beaucoup!!
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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?
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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.
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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).
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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.
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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?
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Plz do reply someone
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Zara,
20 months of nursing is good score but it will be the baby or you or nature will stop it at some point of time. Make a consent between you and your baby.
yes it could lead to constipation or there could be other reason as well like high temperature environment. This chelator should be consumed with enough fluid.
finding the right chelator and correct dosage and comply tirelessly with it is the life long battle.
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We always ensure that Lil A always has a big meal prior to giving him exjade. He prefers his exjade in liquid. We always place the tablet in lukewarm water, let it dissolve, mix with plastic or wooden spoon and then add a small amount of juice. He gets half his dose after breakfast and half his dose after dinner. We've had some issues wiht stomach upset and reduced appetite over the years - but splitting the dose and allowing him to eat first makes a big difference.
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Zara,
Just stop the chelator for a while. The child is very young and this is the most likely cause for the reaction. Stop for at least two weeks and then start at no more than 200 mg/day for two weeks. It is more important that the child can nurse and take food than it is to chelate at this age. At this age, chelation does not have the urgency that it will later have. Stop the drug and wait until the child is eating normally and having normal bowel movements before starting a low dose. You might even consider just taking it every other day when he starts it again until you are sure his body is ready to handle the drug.
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Thanks alot everyone for ur replies.
His constipation is better now. I am giving him pureed spinach every other day and this is helping him to relieve constipation. I know that spinach is very high in iron but I make it with milk and also give him milk to drink with that. I've read somewhere that milk stops the iron to absorb in the body. He don't like to eat any other fruits or veggies.
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Good to know your son is doing better now Zara...for constipation, you can also give him prune juice. it will also help....and off course more veggies and fruits in diet and lots of fluids...
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Thanks for ur reply but we don't get prune juice here in Pakistan. I've never seen it on any shop.
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Dear Zara,
You are doing great.Its true milk help to stop iron absorption :agree.I also always mix milk with my babies food and after 9 transfusion her ferritin is now 459.So continue it.... :smiley :smiley
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@ zara,
do you still need prune juice for your kid ??
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We always ensure that Lil A always has a big meal prior to giving him exjade. He prefers his exjade in liquid. We always place the tablet in lukewarm water, let it dissolve, mix with plastic or wooden spoon and then add a small amount of juice. He gets half his dose after breakfast and half his dose after dinner. We've had some issues wiht stomach upset and reduced appetite over the years - but splitting the dose and allowing him to eat first makes a big difference.
I will mention to my daughter about taking ex jade on a full stomach and splitting the dose twice a day. What bothers me is that Ava's doctor said to cut down on her ex jade to 5 x week? I guess this is due to her ferritin level being 113.
Ava just turned 7 what a sweetie she is my little half pint!!!!
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Your doctor is right. The ferritin level is to low for a Thal under chelation! Try to keep it over 300 or lower the dose.
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That is a low ferritin and many doctors would order a chelation vacation at this point. 5 days a week may still be more than needed. Also, side effects can present more of a problem when ferritin is very low, so it's not a problem to take a week or two off and let the digestive system have a break from the drug.
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How much ferritin level is standard?
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I would say allways around 300. When I was junger they used to say about 1000 but that's changed...
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I will mention to my daughter about taking ex jade on a full stomach and splitting the dose twice a day. What bothers me is that Ava's doctor said to cut down on her ex jade to 5 x week? I guess this is due to her ferritin level being 113.
Ava just turned 7 what a sweetie she is my little half pint!!!!
Wow how did you manage to maintain her ferritin at such a low point.
This month my son's ferritin was 1450 and Dr suggested us that we should stop asunra and start using desferal pump. We are really confused at this point what to do?
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Standard is 500 in Toronto. Standard practice in Toronto, exjade is stopped at 500 and resumes at 1000. We had asked multiple times the reason for a break. The answer we got that it is safe practice for children, you do not want to overburden their bodies, levels below 500 for longer period of times (in children) will chelate essential minerals from children. Infact time and again it is proven that children are different than adults, who can continue to take exjade at levels below 500.
@ Zara
I am confused as well, your son should continue with exjade for lower levels. Levels at 1450 at no point is low enough to stop exjade. Second, why take desferal if exjade is available. There is no added benefit to use desferal over exjade. You should speak to your doctor and tell him that you do not see any advantage of desferal over exjade, and what is the level he is trageting.
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I agree completely with Canadian Family. Ferritin of 1450 is not high and is not a reason to switch chelators. Be patient and continue the Exjade, making sure that the dose is raised as the child grows, so that the 30 mg/kg dosage is maintained.
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Thanks for ur replies.
My son's serum ferritin reports of last 3 months are:
June: 1650
July: 1100
August: 1450
In June when Dr saw that ferritin is 1650 he said that it is really high and that means asunra is not working on him bcz we are giving it with food (they don't believe it works sane with food) and we should immediately start desferal. We were really worried so we repeated the test next month and the result was 1100. We were really happy but again next month it was 1450.
This month Dr said that we should not depend on the reports bcz they don't show the exact result. He is getting regular transfusions and that means his ferritin is increasing day by day. His organs will start to damage and we should get the level below 1000. He told us to start desferal but we didn't agree. So he said increase asunra dose to 500 for 2 months and give it the proper way like on empty stomach in the morning with water or juice and then repeat the test.
From last 1 and a half month I am giving him 400 asunra with juice just one time. I tried to give him 500 a week before but he stared diarrhea. So I stopped it for 2 days and then again started 400.
Plz suggest me what should I do? Me and my husband are really confused and worried. We don't want to give him desferal.
I will be grateful if you do reply in detail.
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Zara,
At this early age, it is more important to get the child accustomed to the chelation drug than is the actual ferritin level. This must be accomplished first. If the child doesn't get sick when asunra is taken with food and does have problems when taking on an empty, stomach, then it should be taken with food. It does work and many patients take it right after a meal. Just because a doctor is not familiar with something doesn't mean it doesn't work. The trials using Exjade with food were done at some of the best thal centers on earth, with Novartis overseeing the results. They found no difference in effect of the drug when taken with food. When we consider this in practical terms, the only method that should be used is what allows the child to chelate 100%. With small children, it can take some time to get used to it. As long as liver and kidney values stay within range, there is no reason to stop the drug.
Right now, just focus on finding whichever method of taking asunra agrees with the child. Once the child can take it without getting sick, we can talk about what needs to be done about the ferritin. He probably needs a higher dose, but that can't be done until he is taking the drug without issues. Have some patience. As long as he is taking the drug, he will be removing iron.
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Thanks alot ANDY.
I totally agree with you that's why I gave asunra mixed with food for almost 3 months. But our Dr's don't agree and this time he really scared us that he is not chelating well with asunra and his organs will start to damage. We don't know what to do bcz if something happens to my son the Dr's are not responsible for that and they even don't care.
I want to start 500 now but his stomach is not accepting that much dose. I am giving him milk thistle for last 3 months and his ALT has also got down with that. This month his ALT was 68. Thanks for ur advice Andy. May God give you all the happiness in life.
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Scare tactics is the oldest trick in the book, your doctor needs to update himself/herself. I agree with Andy when he said "Just because a doctor is not familiar with something doesn't mean it doesn't work."
As long as your child is taking exjade, he is chelating iron. The changes in ferritn levels are normal, infact I would be satisfied to see the ferritn levels increased from July to August. This is an indicator that exjade is working and iron is chelated from organs and is now in blood stream for removal.
I forgot how old is your child and what is his weight, however, split the dose (half morning, half evening) if you could and take it with food.
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Thanks Canadian family for ur reply.
My son is 2 years old and his weight is 14.5 kg. I have given him asunra in split dose and mixed with food for 3 months but our Dr's don't believe that the medicine is working that way. So I stopped splitting the dose and now I am giving him 400 asunra with juice on empty stomach in the morning.
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Zara, 3 months is not enough to show a decrease in Ferritin as your child just started chelating. Follow Andy's suggestion and you will see a change in 6 months to an year. When my child first started chelating, we didnot see much change in Ferritin for almost a year but then suddenly it started dropping and now we see changes in ferritin with the dose (her ferritin is around 500) and we micromanage the dosage month to month to keep ferritin close to 500.
Also, my child always took exjade with food as she could not tolerate taking it in empty stomach and it did not affect chelation. So, use it with food and try variety of food to see what he likes the most. Taking it is the most important thing so it better taste good so that he will not miss any dosage :).