Crohn's Disease Forum » Parents of Kids with IBD » Our Tacrolimus journey

12-22-2013, 02:13 PM   #1
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Our Tacrolimus journey

I have been asked a few times to share our experience with Tacrolimus. It is an immunosuppressant used for organ transplant recipients, and crohns is an off label use. She was put on it to prepare her for a subtotal colectomy, which I cancelled against a physicians advice.

10/3/2011: tacrolimus suggested

3/30/12 Her scope is done. She was unable to control herself all night and went in her bed a few times, but thankfully her doc said she was mainly cleaned out. Her stomach shows mild inflammation, which may be a side effect of all of the meds she has been on. Her small intestine is pristine (WOO HOO!!!), but her large intestine is still severe, worse than it was a year ago. I can't help but feel bad that the last 13 months of treatment was all for nothing...I have been torturing this poor girl with all of these meds for nothing. She has a bunch of polyps that he would have removed had her colon looked better.

4/5/12 We need to make an appointment with a surgeon.
He is putting her on Vancocin anyway, just in case she has an infection on top of her disease, but told us we need to go ahead with the surgery.
I am surprised that she has no deep disease: fissures, fistulas, but she is so severe that she needs a colectomy.
While she hasn't been on EVERY drug, she has been on every CLASS of drug and hasn't shown significant, reliable improvement.

4/12/2012 Today reinforced that we need to do something soon. Izz is on spring break...we went to the zoo. We were there 2.5 hours and visited the bathroom 5 times, plus had to stop once on the 30 minute drive home AND had to rush in as soon as we got here to go. She complained of pain for half of the time we were there (I pushed them in a double stroller...we never would have seen half of what we did without it).
Her c-diff is neg...we let her stop the vanco as taking it was making her vomit 4 x a day and (she claims) making her belly hurt.
Can't wait to get things moving here and get her feeling better!

4/15/2012 We are back on PRED in an effort to curb her weight loss (4# in 2 weeks). She was in the bathroom 16 times so far today and has a crazy rash. She had a birthday party today and sat on my lap for most of it while her friends danced and played.

4/16/2012 Still worried...she vomited up the little I got her to eat for breakfast, plus she was in the bathroom hourly last night and is bleeding again....I think I am going to suck it up and let him admit her for fluids, IV steroids, and possibly a new ng tube.

4/17/12 We are inpatient...more news as I get it!

4/19/12 Izz is feeling the same. She was having less pain in the hospital (due to being on clear liquids), but stooling just as frequently. SHe hasn't been nauseated since admission, though, nor has she vomited.
We are otherwise in a holding pattern.

4/20/12 Izz made it to school today but I had to take her brother to the pediatrician (30 minute drive) and we had to stop at seedy restrooms on the way there AND the way back. I can't wait to get her seen!

4/27/12We start Tacro Sunday, get bloodwork Monday, and start Bactrim Wednesday.
I have to drive 45 minutes to get it tomorrow...some days I hate living in a smaller community- but I am thankful we can get it and get her started.
So 6 am meds plus a supplement (still haven't worked her 3 other supplements back in), 2 mid day and 6 pm meds. No *wonder she's cranky! She's pretty stoked about no more Humi shots...although she got nervous when she saw me get mine out today lol! She wouldn't even face me while I was giving it

4/29/12 started tacro

4/30/12 She is the same...up all night (in bed from 7:30p-9a last night) and complaining of twice as much belly pain as usual. SHe does seem to have more energy when she *is* awake though...pred maybe?

5/5/12 Her frequency has decreased and volume has increased per bm...I am super excited that we may be trending upward with the Tacrolimus. I wish it was a drug that we could use long term...I *knew* I was going to have trouble with a drug that makes her better only to have surgery!

5/14/12She was sunny and sweet again today...
and it was the end of the day before I realized that since she got out of bed this am, she hasn't pooped at all!!! YAYAYYYAY! She is still having nocturnal accidents, but I am shocked that Tacrolimus has made such a huge difference.
...and of course, I am ready to message her doc and find out how they manage kiddos that ARE on Tacro long term (it is an anti-rejection drug but causes kidney failure). Even though the GI and surgeon warned me that so many parents hate to do surgery after tacro works its magic.
Just wanted to share some fab news for a change

5/18/12 SO I discussed this with her doc at length. He is SUPER pleased with how she looks right now and tells me if she still looks/feels good in two months he will rescope her. If she has little inflammation, we can discuss long term tacro options. <3

5/19/12 Our Doc attended our CCFA take steps walk with us today...
he pointed out all I have been missing.
She was FLYING around the playground...laughing, playing, FULL of energy.

5/24/12 ...and more bizarre good news. CRP is down to 2.4. From 60's in April.

5/25/12 Talked to our Boston doc today (should have held off on calling her...ignorance is bliss) who is thrilled she is doing so well BUT feels that we have 5 months to plan her surgery. Organ transplant pts are on it long term because there is no other option; we have another option (surgical), which she wants to pursue. If it stops working (biggest if EVER) we are looking at emergent surgery, which we are trying to avoid.

5/31/12 UGH...she had an accident at school today
Not sure if this is a sign of things to come.
There has been a lot of stress at home-her dad is creating quite a bit of drama lately and I can only hope that it is affecting her and that she isn't going to flare. Plus he is stressing me out, which I am sure she is picking up on.
THe good news is she went to the nurse, got cleaned up/changed/finished going and went on her merry way.

6/18/12 She is still fairly healthy on Tacrolimus and Bactrim, with 2-3 episodes of diarrhea a day and fecal incontinence every one to two days.

7/16/12 Oh, and our CRP??? 1.4 After being in the 60's a few months ago, and not being "normal" for 18 months.

7/27/12 Her bowel is showing improvement with vasculature showing and scattered ulcerations. It is FAR better than ever before, although It still has some distance to go.

Her doc discussed her Tacro use with some peds GI's in Boston this past week. They AGAIN reiterated it is a BRIDGE therapy. When pressed, they claim that there is no documentation using Tacro long term for Crohns. (ummm...there aren't large, well documented studies for a LOT of drugs used for pediatric Crohns.)


Still on Tacrolimus therapy. We have had to increase her dose as she gained quite a bit of weight this year. (We test her Tacro levels, CRP, Potassium, CBC, etc with monthly bloodwork). She also takes Bactrim daily to avoid a certain type of pneumonia. She still has fecal urgency, and occasional leakage, but only stools once a day most days and rarely complains of pain.

There are still no other children under her physicians care on Tacro therapy.
It is an off label use, and it has been stressed to me that it may cause complications down the road. In my mind worst case is cancer or organ failure, both are risks with many other drugs we have tried. When I reread these excerpts and remember how ill my little girl was, I can only hope that we can cross that bridge when we come to it, if ever.

I have one friend whose little boy has been on Tacro for a while...they attempted to wean him and his symptoms returned...they upped his dose again.

Another acquaintance has a little one that has been on tacro (for another disorder) for 8 years- no problems other than those regarding dose.

Edited to add:
We traveled to Albany to seek out a second opinion. The doc we visited with would love to try 6mp, although he thinks it is unlikely to help. The risks are significantly lower, and he would like to see it fail before continuing long term tacro therapy. Barring that, he agrees with our path-continue tacro for as long as it will work, and no need to rescope at the present time. He isn't convinced her 24# weight gain last year is gi related, which is reassuring.
I haven't decided whether or not to try 6mp.

After a week of worsening belly pain and resulting loss of interest in food, we had labs drawn Monday. Her Tacro level is higher than normal at 11, but her CRP is elevated for the first time in years at 22. She will need to be seen this week and likely rescoped.

Izzi started on Carafate and omeprazole. Her belly pain has decreased and she has far more interest in food. We are supposed to get a stool sample and xray, but haven't gotten it done yet. (I swear she only poops on days we can't make the drive lol).

09/14 stool sample normal. Crp still elevated.

10/14 izz is having belly pain and 8-12 bathroom trips a day, including nocturnal. Scopes scheduled for 10/10

10/10/14 upper endoscopy shows mild gastritis. Colonoscopy shows moderate to severe inflammation with a perfect ti. Histology to follow, but it looks as if our time with Tacrolimus is coming to an end.

12/2/2014 We were scheduled to start Simponi tomorrow, so I took Izzi off Tacrolimus 11/24. By 11/26, her pain had increased to a point I was uncomfortable with, so I gave her Tacrolimus again. While it isn't having the desired effect, it is certainly still making a difference.

Simponi is on hold as she is fighting a cold (x 2 months-ugh!) and I am unwilling to introduce another drug into her system until she is "well".

1/7/15 after facing admission, we finally got an answer (her 3 month cough is likely allergies) and got our loading dose of simponi.

2 shots-one in each leg after icing ten minutes. We chose to use injectors as izzi has shown some interest in injecting herself. She claims she hardly felt the injection. That evening she claimed she had less pain. (I wondered if this was partially for to the fact that the injection was far less painful than she anticipated). However, 4 days later she hasn't complained once of pain and is in the bathroom once daily and not at all at night (after weeks of pain, 8 trips a day, and regular accidents).
She will get a second dose two weeks from the first and labs at three weeks.
Right now she is still on tacrolimus but if she continues to do well I may discounting it...I am guardedly excited!

1/18 tried to d/c Tacrolimus again. restarted 1/21 due to worsening symptoms

1/21/15 dose 2 of simponi
the positive response from the first dose has worn off. She is back to regular pain, 8 bathroom trips plus nocturnal, and about 5 accidents a week.
2/20/15 dose 3 of simponi
possibly a reduction in pain. no other changes.
we are going to do simponi every three weeks.
3/13/15 dose 4 of simponi

We upped her tacro dose in early March, as her trough levels were low.
It appears simponi isn't helping, and our gi consult from ct tells us if she had no improvement with remi or humi simponi is unlikely to have an effect.

We will move onto entyvio, with uceris to bridge. She will need to be off tacro before starting either.

Isabelle had her last 4mg tacrolimus dose this morning, 4/24/15.
Angie, mom to Izzi,10 Crohn's Colitis 1/11 prednisone, entyvio since 2015 Tried: Tacrolimus, Bactrim, simponi, Levsin, Prevacid, Prednisilone, Humira, Remicade, EN via ng, vancomycin, Pentasa, carafate, Sulfasalazine, Cortifoam enemas, dietary changes, fish oil, VSL#3.

Last edited by izzi'smom; 04-24-2015 at 08:03 PM.
12-22-2013, 04:48 PM   #2
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I remember reading through your struggles to get Izzy well. I am so happy that Tacrolimus has worked for your precious girl. It is so hard to put your child on these meds, but when you see her growing and gaining weight, going to school and having a normal life, you can be comforted that she is truly healthier with these meds.
Mom of Johnny
Dx Oct 11 2011 Crohns disease
Prednisone done 12/30/11
6mp 50mg every day
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12-22-2013, 06:50 PM   #3
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Can I ask how you managed to convince your GI to rx tacro long term? My daughter (dx UC but I fear CD) has not responded to all meds and many alt therapies and is due for colectomy in the next months. I've asked her GI (top ped IBD specialist) about tacro and she says no wat - she does not even use it short term though some of her colleagues do - 1 in 100 kids on it die from toxicity. Needless to say I'm terrified but I'd have liked to try it at least to exclude it. So glad it's working for you guys and long may it continue without any side effects EVER. I don't know what to do with this info.
12-22-2013, 07:17 PM   #4
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Who is your GI? I haven't ever read that statistic. I researched it fairly heavily before begining therapy, and the main risks seem to be kidney and liver toxicity, which haven't been studied well enough to decide whether the damage is reversible. There is also a risk of lymphoma, as there is with many IBD meds. There was little to no research regarding IBD and tacro when we began therapy, which is why one of our GI's discouraged long term use. (The risk of SE increased with prolonged use). We began therapy under a GI from Boston childrens, and have consulted GI's from CHOP and in Seattle regarding the use of it. It was originally prescribed in order to prep her colon for surgery; surgery done on a healthy colon tends to have a better outcome. On top of all of this, the therapeutic trough level for IBD is far lower than that for organ transplant; it is believed that this reduces risk as well.
12-22-2013, 09:10 PM   #5
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Wow Ang! Reading those old entries I totally remember ALL of those days and am so glad that something is working for your girl. You are such a terrific mom and advocate for her. You are so right. When nothing else is working you have to grab what you can and hold on. There isn't a drug out there for IBD that I would jump up and down begging to put down my daughter's throat. They all have risks but seeing your daughter healthy and happy us so worth it isn't it. Glad you don't have much reason to visit us but we do miss you.
Daughter O dx 2/1/12 at age 12
Crohns & Remicade induced Psoriasis
Vit d 2000IU
Multi vitamin plus iron

Previously used - Prednisone, Prevacid, Enteral Nutrition, Methotrexate oral and injections, Folic Acid, Probiotics, Cortofoam

Daughter T dx 1/2/15 at age 11
Vitaligo, Precoscious puberty & Crohn's
Vit D 2000IU

Previously used, Exclusive Enteral Nutrition, Methotrexate (injections and oral), Folic Acid, Entocort,IBD-AID Diet
12-22-2013, 09:48 PM   #6
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Well bless her little heart, Angie.
I hope you enjoy every moment and I pray theirs a life time of moments like this.

I'm mom to............... Little Farm Girl 9 yr old
Ibd (microscopic)
dx Juvenile Arthritis
dx Erthema Nodosum
Bladder and Bowel Dysfunction
Ehlers-Danlos Syndrome dx (1/26/17)
Remicade started on (9/8/14)Every 2 wks
MTX started AGAIN on 11/21/17
EN/EEN- since (1/12/13)
Past Meds- LDN, Humira, Pred, MTX, Sulfasalazine,
12-23-2013, 07:06 AM   #7
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Angie it was so good to read your update and it's great to hear izzi is doing so well. Hope you all have a great Christmas
12-23-2013, 08:27 AM   #8
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Thanks Angie, Your story helps others that TNF drugs aren't working for. I know when you put your story out there then its up for debate and that can be hard. I think when your child is doing great on a medicine and loving life and she's healing then you've made a good decision and its a right fit for your daughter's body. I'm so happy she's doing so well. You'll have a great holiday. Thanks for sharing with us
Kathy, Mom of 14 yr old Brian
symptoms 2005, official dx 6/2010

Praying for Remission
Vedolizumab 8-8-14
Ileostomy 3/22/14
Multivitamin,Iron,Vit D

Total EEN 12-10-13 to:TPN 1-29-14 - 4-2-14
Tried:Azathioprine,Pred,Pentasa,Cimzia Bi weekly & MTX 9/2013 to 8/2014, Humira 1/2011-9/2013, w/oral mtx 5 mos in 2013. Remicade: Had allergic reaction Jan 2011 Built up antibodies by 3rd infusion.
Has done round of Flagyl due to abcess 12/10 and 10-21-13 which helped both heal quickly.
12-23-2013, 11:03 AM   #9
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Thanks for the update Angie, I'm so glad she continues to do well. Her journey certainly gives hope when you think there is none.

Mom to Jack (18) dx Crohn's 2/2010
Remicade - started 1/9/14; 7.5ml/kg every 6 weeks
Past meds: Imuran/Azathioprine; allopurinol; methotrexate; LDN; Prednisone; Apriso; Pentasa; EEN

Husband dx Crohn's 3/1993
currently none due to liver issues
12-23-2013, 11:16 AM   #10
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She is Anne Griffiths in Toronto. Hmmm, to be honest I've given up hope trying to get it here as I've asked several times so I've not researched it but it's good to know that you've not come across that info. Maybe she was just trying to scare me so that I would stop asking for it? I suppose in our case we will have to go to surgery and tacro will always be a "what if" unfortunately. It does irk me that different Drs have such different protocols with this disease. Good luck and may her (and your!) remission last for many years (until there's a cure).
12-23-2013, 12:47 PM   #11
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Here is a large study of kiddos on tacro -
There were only a small % of deaths in general
And the tacro kiddos survived at a higher rate
DS - -Crohn's -Stelara -mtx
12-23-2013, 01:29 PM   #12
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Great to hear the update! Glad she is doing so well! Keeping my fingers crossed that it only continues!

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.
12-23-2013, 01:44 PM   #13
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MLP you always come through with research...TY! Briansmom hit it on the head-coming here and posting opens up the old wounds about whether or not I am making the right decision for my daughter. They were healed over nicely. It does put my decision out there for interpretation-which can be painful.

ETA_I read the article-tough to compare as kids that undergo liver transplants have a host of unrelated problems...and even infections that cause mortality may be influenced by the transplant/other meds/the condition causing the need for a transplant.
12-23-2013, 02:59 PM   #14
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Background Several published studies have evaluated the efficacy of tacrolimus in the management of Crohn's disease with variable conclusions.
Aim To review systematically the evidence examining the efficacy and safety of tacrolimus in treating Crohn's disease.
Methods The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PUBMED) and EMBASE (1984 to January 2011) were searched. Also, references from selected articles were examined. Case series (five or more patients), cohort and randomised controlled trials were eligible for inclusion, incorporating oral, intravenous or topical tacrolimus therapy. The primary outcome was induction of remission of active Crohn's disease.
Results Eleven studies met the inclusion criteria which included 163 patients, of which 127 received tacrolimus therapy. In patients with luminal Crohn's disease, the crude pooled remission rate for tacrolimus was 44.3% (range, 7–69%) and the crude pooled response rate was 37.1% (range, 14–57%). For patients with perianal disease using systemic tacrolimus, crude pooled remission rate was 28.6% (range, 0–64%) and crude pooled response rate was 38.8% (range, 0–57%). Combining data from two studies using topical tacrolimus, 35.7% of patients achieved remission and 28.6% partial response. Nonserious adverse effects are common, particularly tremor, paraesthesia and headache. Reversible nephrotoxity occurred in 16% of patients.
Conclusions The current evidence; although of a poor quality, appears to support the use of tacrolimus in Crohn's disease. High quality randomised controlled trials are needed.

The Role of Tacrolimus in the Management of Crohn's Disease
K. McSharry, A. M. Dalzell, K. Leiper, W. El-MataryDisclosures
Aliment Pharmacol Ther. 2011;34(11):1282-1294.

12-23-2013, 03:18 PM   #15
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To report the results of a prospective, open-label, uncontrolled study in 13 patients affected by Crohn’s disease with resistance to steroids.

The patients were treated long-term with oral tacrolimus, aiming to both resolve acute attacks and maintain remission. Tacrolimus was administered at the dose of 0.1–0.2 and adjusted in order to achieve levels of 5–10 ng/mL; only mesalazine was continued concomitantly. Steroids and total parenteral nutrition were tapered when appropriate.

Median treatment was 27.3 months. Only one patient dropped out due to adverse events. Crohn’s disease activity index score significantly decreased after 6 months in 11 patients; for 1 year in nine of them, and 7 years in two of them. The inflammatory bowel disease life-quality questionnaire score significantly increased over the same periods. A marked drop in hospitalizations was recorded. In three out of six patients complete closure of fistulas occurred. Tacrolimus allowed total parenteral nutrition to be withdrawn in three out of five patients. Supplementation with low-dose steroids was required in five patients. Two patients underwent surgery.

Tacrolimus therapy appears to be associated with both short- and long-term benefits, and may represent a therapeutic option in Crohn’s disease when conventional therapies fail. This study encourages its use in controlled trials.

You have full text access to this OnlineOpen article
Oral tacrolimus long-term therapy in patients with Crohn’s disease and steroid resistance

E. Ierardi1, M. Principi1, R. Francavilla2, A. Pisani1, M. Rendina1, M. Ingrosso1, F. W. Guglielmi1, C. Panella3, A. Francavilla1
Article first published online: 7 JUL 2008

DOI: 10.1046/j.1365-2036.2001.00938.x

Alimentary Pharmacology & Therapeutics
Volume 15, Issue 3, pages 371–377, March 2001

12-23-2013, 04:36 PM   #16
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Is this the same article? Maybe I was missing part of it...TY again! <3
12-24-2013, 10:05 AM   #17
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I'm so happy to hear that Izzi is doing well!!! After so many struggles for so long, you certainly do deserve a long, long stretch of remission!!!! Praying 2014 brings nothing but continued improvement!
Tess, mom to S
Diagnosed May 2011

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
12-01-2014, 02:51 PM   #18
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just a bump with updates.
12-01-2014, 03:14 PM   #19
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Hope the Simponi goes well! My daughter really thought it was the least painful of all the biologics (Enbrel, Humira, Remicade). She took about 2 months to respond but then did well for a while.
Mom of M (20)
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
12-01-2014, 03:56 PM   #20
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I haven't read up on how long to expect it to take-I expect we'll be piggybacking with Tacro for a while. Wishing for a cure-but we are lucky Tacro is doing something-after seeing how sick she was without it I am thankful <3
12-06-2014, 02:27 AM   #21
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Sending you both all the luck in the world that Simponi works wonderfully well for Izzi, bless her.

Fingers, toes and everything else crossed!

Dusty. xxx
Mum of 2 kids with Crohn's.
12-06-2014, 08:05 AM   #22
my little penguin
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Good luck
Let us know how things are going
03-01-2015, 08:36 PM   #23
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· Stoma
Thanks for sharing this link Angie for me to catch up. I know our girls are a wide age apart, but this is very useful.
Mom of 16 yr. girl w/Indeter.Colitis Sep. 2012(age 11) Nov.2012 Crohn's Sep. 2014 Crohn's Colitis, UC Nov 2015, Crohn's Feb. 2016

Ileostomy surgery July 2015

Current Meds: None!
Previous Meds: Humira, Remicade, Methotrexate, Cipro, Flagyl, Zofran, Cortifoam, 5-ASA suppository, Questran, Mezavant, EEN (Peptamen Jr. 1.5) by NG tube, Antibiotic Cocktail (Vancomycin, Metronidazole & Doxycycline), Simponi, Prevacid, Imuran, prednisone ☆
04-24-2015, 08:05 PM   #24
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Updated tacrolimus thread, likely for the last time.

Crohn's Disease Forum » Parents of Kids with IBD » Our Tacrolimus journey
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