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Crohn's Disease Forum » Parents of Kids with IBD » Remicade dosage change question


 
10-19-2013, 11:12 PM   #1
Tesscorm
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Remicade dosage change question

Still waiting to hear about Stephen's last prometheus test and not expecting any issues but, as we've already had to increase the frequency once, I'd like some info upfront. I feel like I'm always one step behind and end up doing 'catch up' research AFTER decisions are made.

So my questions... if this last prometheus test shows that remicade levels are zero, and assuming also zero on antibodies, the GI would have two options relating to remicade - increase the frequency to 5 or 4 week intervals or increase his dosage (he's currently on 5mg).

Would this be a reason to add an immunosuppressant? ie would that help maintain remicade levels during the full six weeks?

What determines whether the dosage is increased or the frequency increased? Is anyone aware of any info illustrating that one choice is more successful than the other?

Also, is the dosage always upped from 5 to 10mg (which I believe is the max dosage)? Or are smaller increments used when increasing?

Thanks
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Tess, mom to S, 22
Diagnosed May 2011

Treatment:
May-July 2011 - 6 wks Exclusive EN via NG tube - 2000 ml/night, 1 wk IV Flagyl
July 2011-July 2013 - Supplemental EN via NG, 1000 ml/night, 5 nites/wk, Nexium, 40 mg
Feb. 2013-present - Remicade, 5 mg/kg every 6 wks
Supplements: 1-2 Boost shakes, D3 - 2000 IUs, Krill Oil
10-19-2013, 11:56 PM   #2
Clash
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Tesscorm,

I thought that one of the article's David posted mentioned something in relation to your question but so far all I have found is this:

For people on Remicade who start to lose response and are negative on antibodies but have no or no detectable serum levels of the medication, increasing the dose or shortening the interval may work well.
source

This article come from a book he was going through, here is a thread with all the articles from it he has posted so far:
http://www.crohnsforum.com/showthread.php?t=36155

There may be more information in one of the articles he's posted links to in that thread.

C is already at the higher dose and at 6 weeks plus 7.5 mtx, the GI did say when he added MTX back that he was hoping for a synergistic effect to give the remi a boost but I'm not sure how that applies to Stephen's situation.
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C age 19
dx March 2012 CD

CURRENT MEDS: MTX injections, Stelara


Dx May 2014: JSpA
8/2014 ileocecectomy
9/2017 G tube

PAST MEDS: remicade, oral mtx, humira
10-20-2013, 12:11 AM   #3
Maya142
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Regarding the dosage -my daughter was on 5mg and then her dose was increased to 7.5mg and then 10mg. If your son responds at 7.5mg, I don't think they'll need to increase it further.
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diagnosed with Crohn's Disease at 16
Juvenile Idiopathic Arthritis at 12
Juvenile Ankylosing Spondylitis at 16

Mom of S (23)
dx with JIA at 14
Ankylosing Spondylitis at 18
10-20-2013, 04:56 AM   #4
crohnsinct
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I think it depends on the doc and their preference but O's doc shortened interval first and then went up to 10. I have seen people on 7.5 but really he is an adult now and adult dose is 10. O's doc doesn't like 4 week infusions. I don't know why but he did tell me if we got to that point he would rather add Mtx with 5 week schedule.

I don't think burning through the Remicade is a reason to add immunosuppressants as they won't stop that process. Some do help with the building of antibodies (although the jury is debating that of late). Maybe if you have gone through all your options and shortened as much as possible and increased as much as possible an added immunosuppressant will give some added protection for that few days or week where there is no Remi but that is just my guess.

If it were up to me as a mom, I would have opted for the higher dose (as our doc explained the higher dose doesn't increase risk) and less frequency. It is just so hard for them to miss school every 5 weeks.
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Daughter O dx 2/1/12 at age 12
Crohns & Remicade induced Psoriasis
Remicade
Methotrexate (12.5mg wkly - oral)
Vit d 2000IU
Multi vitamin plus iron
Calcium
Folic Acid
Previously used - Prednisone, Prevacid, Enteral Nutrition

Daughter T dx 1/2/15 at age 11
Vitaligo, Precoscious puberty & Crohns
Methotrexate (15mg weekly oral)
Enteral Nutrition
Entocort
IBD-AID Diet
Vit d 1000IU
Calcium
Folic Acid
Previously used: Mtx injections
10-20-2013, 06:59 AM   #5
my little penguin
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DS went from 5mg every 6 weeks to 7.5 mg every 6 weeks .
Our go doesn't like every 4 weeks either.
Rheumo wanted 5mg every 4 weeks.
Instead of 10 mg every 8 weeks.
So it does vary .

We were told DS was burning through it since his body was essentially fighting against the remicade ( but no detectable antibodies per the test).
Dermo said basically the test is only good for the known antibodies ( at this time)
And needing a higher dose more often meant his system really was fighting it.

Good luck
Hope the numbers work out this time
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10-20-2013, 11:00 AM   #6
kimmidwife
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Tess,
For us they never increased the dose just the interval. I would think since he is a finished growing and adult size they would give him the adult dose.
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Crohn's Dx'ed Sept 08
Allerg Imuran Sept 08
Fail Remicade Jan 09
Methotrex Oct 09-Aug 11
Pentasa stopped - nosebleeds
EENOct 31 - Nov 28th. Too hard!
Retried Remicade Dec 11
Stopped due 2 Anaphylactic Reaction
LDN Jan 2012-June 2014 Got My daughter back!
New secondary diagnosis: Gastroporesis Dec 2013
Lost remission June 2014
Started Entyvio April 2015. Decreased to every 4 weeks October 2015. Praying for remission.
10-20-2013, 03:17 PM   #7
Tesscorm
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Thanks everyone, it seems that it may simply go back to a GI's opinion based on their experiences?? But, I would've expected that there would be some sort of protocol or, at least, studies on benefits of increasing dose vs. frequency???

I would think keeping a lower dose at greater frequency would keep the levels more consistent (ie as MLP's rheumo suggested) but, certainly less convenient! While S hasn't complained much about the 6 week schedule, I know he would start complaining if it was any more frequent.

I did find one study, on patients with RA (rather than crohns) and, if I understand it correctly, it seems to imply there is greater success with increasing frequency rather than dose. But, to be honest, I'm not completely sure I understood all they said.

http://informahealthcare.com/doi/abs...09740701416758

Conclusion: Infliximab dosages and dosing frequencies are increased frequently in clinical practice: after 3 years, only 42% of patients continued on the original schedule. While frequency increases appear to result in better effect persistence between infusions, the gains from dosage increases are small and may not be better than chance. These data suggest that the total amounts of infliximab needed to obtain satisfactory disease control are greater than the amounts suggested by the original dosing recommendations, and may have bearing on pharmaco‐economic issues pertaining to treatment with infliximab and other therapeutic agents.

Thanks everyone!
11-02-2013, 07:21 PM   #8
DustyKat
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Do you have the results yet Tess?

I can see where increasing the frequency would have benefit over increasing the dosage.

Dusty. xxx
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11-02-2013, 08:02 PM   #9
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I did get results - remicade levels good and no antibodies. But, not sure if I posted this?? maybe??... He also had his annual check-up on the same day and I received the results from those tests as well.

I'm not hugely concerned yet... but, I wasn't happy with the results (but don't want to jump the gun yet...)

His ESR was up to 33, was 2 in August.
His CRP was up to 2.9, was 2.3 in August (under 5 is our norm)
His HGB dropped a bit to 141 from 148 in August (still in normal range though)
His WBC rose to 9.8 from 6.3 in August (under 11 is our norm)

Nothing else was outside of normal nor showed any real change.

I spoke with the GI's assistant, told her I was concerned about the ESR and that I was forwarding the results to her/GI. She offered to have the tests rerun right away but, as Stephen's not showing any outward symptoms, I suggested waiting until his next infusion to run the tests (Nov. 23). He did have a cold/sore throat a week before these tests were run so I'm hoping it's just the cold affecting the ESR and WBC and by waiting until Nov. 23, it'll be enough time for the ESR to drop (if it's only related to the cold). (Do you agree??)

I did see Stephen today and he looks good and says he feels fine... then again, even with the ongoing inflammation he had until starting remicade, he rarely showed outwards signs... so, how he feels isn't really a great indicator.

So for now, just in 'wait and see' mode...
11-02-2013, 08:19 PM   #10
DustyKat
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Good to hear the Remicade results are good!

I agree Tess, nothing jumps out as bad, IYKWIM, so I too would give bloods that extra distance before repeating. Even if the ESR isn't back in NRR you will at least have a clearer idea of which way it is trending.
And I so hear you on the not happy results...yeah they aren't bad but still...you are so not alone Tess!

Do you know where he is at right now with his Vit D, Magnesium and Zinc levels?

Dusty. xxx
11-02-2013, 08:31 PM   #11
Tesscorm
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It certainly does get easier but the waiting for the 'other shoe to drop' is never too far away!

I don't have his zinc but others are:

B12 - 672 (was 587 in Aug)
D - 93 (this was from Aug, GP didn't include it in his Oct. test)
Magnesium - .78 (again, from August)
11-02-2013, 09:02 PM   #12
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I go barefoot a lot these days.

After much reading and consultation with David I am aiming for Matt to head up to 125 with his vit D. I assume you use the same value we do? nmol/L?
I have reached a point where I am not happy with him below 100 and he did start trending down over Winter so I have doubled his Vit D supplement to 4,000iu daily.
Since you are now coming into Winter I imagine Stephen will start trending down.

Matt's Magnesium has always been higher than Stephen's, about smack bang mid range. David feels that the the minimum NRR should be set at 90 and after reading links he provided I don't disagree. Now those links will be buried in my Matthew thread......but I imagine you will find them in the wiki.

Matt's Zinc was low when first tested 12 months ago so I am supplementing there as well.

The point to all this for the last 6 months or more Matt's CRP was trending up. Not high by any means but hey, you know the feeling. Nothing untoward happening that I could see just that the asterisk was creeping back in and boy do I hate that! Of course I did the one thing that you should never do and that was to make more than one change to his meds so I can't reliably say if one or indeed any of the changes made difference but last draw his CRP was right down to the lower limits of normal.

He had just had his GI appointment and Pentasa was added but only a very small dose 1grm daily. I also increased his Vit D to 4,000iu and doubled his Magnesium to one tablet twice daily. I am leaning toward this return to normal not being a fluke but rather the upping of supps. Maybe I just don't want to acknowledge that Pentasa may have played a part.

Dusty. xxx
11-02-2013, 09:42 PM   #13
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I do remember Matts thread... It was actually his thread that prompted me to request that the vitamin levels be tested. The zinc?.. I did want that as well but not sure if I forgot to include it in my requests or if GI forgot to add it.

I'll have to watch his vitamin levels a bit more closely now. While he was on EN, he was getting 1500 calories per night so I was fairly assured that he was being well supplemented but it does make sense that some of his levels may be dropping now as he's only drinking 250-500 per day (and wouldn't surprise me if there have been days when he's completely forgotten to have even one shake... I much preferred that overnight NG tube!! )

It also did cross my mind that his crp was at 0.2 and 0.3 may to July and then rose to 2.3 in August... I started to gradually reduce the EN in the spring (didn't want to just suddenly reduce his caloric intake by 1500 cal/day), so by July he was already only taking 500 cal two-three nights per week and by August his crp rose to 2.3??? And then he left for school... So, now all I can do is regularly remind/ask him abt his shakes ??? But, maybe it's time for a few more reminders.
11-02-2013, 10:01 PM   #14
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Tesscorm,

How much magnesium is there per shake he's drinking? And one shake is how many calories?
11-02-2013, 10:03 PM   #15
DustyKat
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Hard not to try draw a line between his results and his changing EN Tess.

Dusty. xxx
11-02-2013, 10:47 PM   #16
kiny
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What determines whether the dosage is increased or the frequency increased? Is anyone aware of any info illustrating that one choice is more successful than the other?
The first tests of Remicade for crohn's disease patients did use 10mg but it became apparent that lower doses are more effective than higher doses for whatever reason. (the immune system is complex, it's possible that TNF-alpha orchestrates the destructive inflammation but also keeps the disease in check, remicade binds to TNF-alpha on the cell surface whic is probably causing apotosis of the activated leukocyte, the effects of remicade would be over after a few hours if true, which makes a higher dosage pointless)

That first big study is the reason it is always 5mg as a standard dosage.

Many hospitals prefer to increase the frequency slightly because this way they can remain at a 5mg dosage (remicade has a 2 week half-life or something).

Just info, it's really not my place to say anything more, I'm not that aware of any changes lately.
11-02-2013, 10:57 PM   #17
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David, I don't have one of his shakes with me now but, online, it shows that one Boost shake provides 36% of daily recommended and it's 240 cal. I do believe most days he has one or two shakes. However, when he was on the elemental formula, he was getting 335 mg magnesium/day, five times per week. 1500 cal/night.

Dusty, I agree with you that there's a good chance they are related. Also ties in with the study that kiny initially posted and I reposted in the kid's diet section, highlighting significantly improved remicade success when combined with 1200 cal/day of EN.

I feel a bit neglectful that I haven't been more on top of this, especially having questioned the correlation earlier but... With S away, my influence is limited and his GI has straight out said that he didn't believe the supplemental EN was doing anything to help Stephen! So, just makes it a bit tougher for me to convince Stephen of its necessity.

Last edited by Tesscorm; 11-02-2013 at 11:25 PM. Reason: Spelling
11-02-2013, 11:23 PM   #18
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Far too hard maintain influence when they are out of your sights Tess and as you say, when the GI isn't on the same wave length it makes the hard nigh on impossible.

Dusty. xxx
11-03-2013, 08:09 AM   #19
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Tess, as this study highlights, there is a correlation between magnesium intake and CRP. Just as with Dusty's Matt, I bet if you get him on a quality magnesium supplement, you'll see that CRP drop. It is REALLY HARD to get sufficient RDA with a western diet and I believe magnesium deficiency plays a part in the pathogenesis of some forms of Crohn's disease. If I'm correct about any part of the above, then the supplemental EN was absolutely helping Stephen.
11-03-2013, 08:54 AM   #20
my little penguin
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Groups at Risk of Magnesium Inadequacy
Magnesium inadequacy can occur when intakes fall below the RDA but are above the amount required to prevent overt deficiency. The following groups are more likely than others to be at risk of magnesium inadequacy because they typically consume insufficient amounts or they have medical conditions (or take medications) that reduce magnesium absorption from the gut or increase losses from the body.
People with gastrointestinal diseases

The chronic diarrhea and fat malabsorption resulting from Crohn's disease, gluten-sensitive enteropathy (celiac disease), and regional enteritis can lead to magnesium depletion over time [2]. Resection or bypass of the small intestine, especially the ileum, typically leads to malabsorption and magnesium loss [2].


From
http://ods.od.nih.gov/factsheets/Mag...hProfessional/


I know DS feels better when he gets at least 3 peptamen a day ( 150 extra mg of mg).

Kid boost has 48mg per shake not sure on adult
11-03-2013, 12:16 PM   #21
momoftwinboys
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My son's gi increased his dose from 5 to 7.5 this last time while maintaining his 8 week schedule. He has been on remicade for a year and believe he is in remission. The gi increased the dose as he was 76lbs when started a year ago and is now 106lbs. The dose was increased due to his weight gain as the gi said this would help maintain his dose to keep him in remission based on his increase in weight.
When I asked about it, the infusion nurse indicated some gi's hold the dose as long as things are going okay and some will increase it as ours did based on growth. I got the impression that at his weight, 10 would be the recommended dose, so he was still under.


The first tests of Remicade for crohn's disease patients did use 10mg but it became apparent that lower doses are more effective than higher doses for whatever reason. (the immune system is complex, it's possible that TNF-alpha orchestrates the destructive inflammation but also keeps the disease in check, remicade binds to TNF-alpha on the cell surface whic is probably causing apotosis of the activated leukocyte, the effects of remicade would be over after a few hours if true, which makes a higher dosage pointless)

That first big study is the reason it is always 5mg as a standard dosage.

Many hospitals prefer to increase the frequency slightly because this way they can remain at a 5mg dosage (remicade has a 2 week half-life or something).
Kiny, do you know if the 5mg standard dose is true in the US as well? Can you provide the link for the lower dose? Hoping we do not regret this increase in dose.
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11-03-2013, 12:36 PM   #22
momoftwinboys
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Thanks DustyKat, David, Tesscorm, and My Little Penguin on your discussion re Mg and shakes.

From
Kid boost has 48mg per shake not sure on adult
H is still averaging one kids boost a day so it is good to know he is getting Mg thru that.

H also has WellesseŽ Calcium & Vitamin D3, liquid supplement every day which includes
Amount Per Serving - % Daily Value*:
Calories 15, Total Carbohydrates 0 g - 0%, Sugars 0 g, Vitamin D3 1,000 IU - 250%, Calcium 1,000 mg - 100%, Magnesium 40 mg - 10%, Phosphorus 190 mg - 19%, Boron 250 mcg.
Unfortunately it also contains Corn Dextrose, Xanthan Gum, Potassium Sorbate (to preserve freshness), Sodium Benzoate (to preserve freshness), Sucralose, Carageenan, Not thrilled with these ingredients, however it does taste really good(like an orange creamcicle) and he and his brother happily take it. A compromise in our world.
11-03-2013, 01:06 PM   #23
Tesscorm
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Thanks David, I will absolutely be following up on Stephen's vitamin intake (both with his compliance and the dosages in his supplements - shakes and others), particularly his magnesium and vitamin D. I will also ask his GI about zinc supplementation.

momoftwinboys - as with everything else in crohns, much seems to come down to a particular GIs preference, experience, etc. Stephen is 170-175 lbs and is at 5 mg. When on an 8 week schedule, there was no remicade left at 8 weeks so his schedule was shortened to 6 weeks. Last test did show 'adequate' remicade level at the six week mark so no change has been recommended. I wonder if weight is useful as a 'starting point' in determining dosage but following that, it becomes more dependent on the efficacy of the current dosage and a person's individual metabolism???
11-03-2013, 01:41 PM   #24
my little penguin
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The dose is weight based in that
You get 5 mg per ever kg you weigh so if your weight increases you still get the corresponding amount period. The volume of remicade infused increases .
Or the mid dose is 7.5 mg/kg
High dose 10mg /kg

Some like 5 mg every 4 weeks instead of 10 mg every 8 weeks .
Depends on the doc
11-03-2013, 02:38 PM   #25
kiny
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Yes.

5mg/kg should be standard in the US too for crohn's disease.

Here they measure the weight of the person, and then you decide the amount of remicade needed.

Infliximab comes in vials but they're usually 100mg vials, meaning there is 100mg diluted infliximab in the vial, they just take the vial and pull out 100mg with a syringe with a sharp needle so nothing gets contaminated, then they inject that into the bag to dilute it with water.

So let's say a person is 50kg and needs to get 5mg/kg. That would be 250mg, so if you check what the nurse is doing, he or she would take out 3 vials of 100mg, inject 2 in the bag, and measure half of another vial by looking at the markings on the syringe and inject that too, so they now have 250mg at 5mg/kg.

I was one of the first batch of people who got infliximab after the first studies (was never part of the studies, but got infliximab after them). Before infliximab all they had was imuran or antibiotics, if imuran or antibiotics didn't work it was surgery, so even though the doctor told me that they didn't know how infliximab really worked, I agreed to try it, since the alternative was surgery, which I didn't want.


To this day, they still do not understand what infliximab does for crohn's disease. It's a TNF-alpha blocker. The first explanation was simple, TNF-alpha is a cytokine, it increases inflammation, you remove TNF-alpha, it lowers inflammation and people get better.

That was a good explanation until they tried etanercept for crohn's disease, also a TNF-alpha blocker, just as effective in removing TNF-alpha as infliximab. It should work just as well as infliximab. Surpise..it's completely ineffective in treating crohn's disease, it works for other inflammatory diseases, it does not work for crohn's disease and was never used again for it.

Infliximab, when it binds to TNF-alpha, is able to cause apoptosis of active leukocytes (white blood cells), humira, while it hasn't been tested I think, is assume is doing the same thing. Etanercept doesn't do this.

Why this matters for crohn's disease they don't really understand fully yet, maybe infliximab is some kind of antibacterial, in the sense that it is destroying active leukocytes that are activated through bacteria and should have died through programmed autophagy or some other process. (autophagy abnormalities are present in crohn's disease, ATG16L1 = autophagy 16L1, NOD2 = able to activate ATG16L1, IL23 is related to autophagy too).

So, I think that's the reason why no one is fully clear on what to do when it comes to 5mg or 10mg or increasing the time between dosage. The standard dose should be 5mg, but the rest is up to the individual hospital and their interpretation of studies / knowledge about the disease and their own bias.

Last edited by kiny; 11-03-2013 at 03:12 PM.
11-03-2013, 03:01 PM   #26
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Some like 5 mg every 4 weeks instead of 10 mg every 8 weeks .
Depends on the doc
Oh, just to clarify, here in Europe the standard dose is 5mg, regardless of the amount of weeks used. I know some clincis have used 10mg, but that is when 5mg doesn't work, and many prefer just to decrease the time between infusions, by one week, by 2 weeks if that doesn't work and then reevaluate. I know some use 10 weeks too after infliximab has been used for several months and people are in remission. I really don't know about how it works in the US, nor have I ever been there, I would be surprised if it differed from Europe though.
11-03-2013, 03:22 PM   #27
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To this day, they still do not understand what infliximab does for crohn's disease.
I believe the clue can be found here.
11-03-2013, 03:23 PM   #28
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Be careful with zinc supplementation. In my opinion, it's one that should only be supplemented if you are shown to be deficient.
11-03-2013, 03:26 PM   #29
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Thanks, so I think I need to ask more questions from the gi clinic. I will try to talk to the head nurse since she is really helpful with questions. The increase may be due to the vials and they needed to go up a vial to maintain being above a certain level since he has gained weight? I got the impression from the infusion clinic that the vial became yours, once it was opened and you might as well use it rather than toss it. Due to the increase in the vial, he was at 7.5? Does that make sense at all?

H has never been tested for antibodies or remicade levels in his system. Is that common as long as all is well? Are those test more common when there are problems?

Thanks again Kiny for putting things in easy to understand language. You would be an incredible instructor. Especially impressive, since I think I remember that english may not be your first language.
11-03-2013, 03:29 PM   #30
crohnsinct
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hmmmm still wondering then why my daughter's psoriasis is out of control even on 10mg/kg of Remicade every 6 weeks and 10 mg of Mtx per week! Sorry about this...just feeling really pissy about the darned psoriasis right now. Small potatoes compared to what most are dealing with but just goes to show that medicine really is just a practice not so much a science.
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