How long between doses?

How long (after loading doses) do you go between doses? I thought I read someones siggy that was < every 6 weeks but I can't find it.

Remicade seems to be helping Izzi, but only for the first 3 weeks. I am unsure if I consider her "under control" when she is only under control for half of the time between infusions.

I have mine very 8 weeks, if its only making her feel fine only for 3 weeks I dont think it is working unfortunately. How many doses has she had. I was only feeling better after 4-5doses

I go every 8 weeks - have been lucky enough that pretty much keeps things under control....

Is she on imuran or 6-MP with the Remicade?

She just got her fifth dose. It wasn't obvious it was helping at all until the fourth infusion, when we increased the dose and shortened from 8 to 7 weeks. I am reluctant to put her on Imuran or 6-MP in conjunction with Remi because of the increased risk of Hepatosplenic t cell lymphoma.

How much of a increase of risk is it?

This info is actually new since she started on Remi...I *think* her doc said there were 9 cases reported as of 2009. The risk may be low, but as another doc once told me...What if YOU are in that 1%...will the numbers matter?


UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy (11/3/2011)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Table

Safety Announcement

[04-14-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.

Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition.1

Facts about TNF Blockers, Azathioprine, and Mercaptopurine

TNF blockers suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases, such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The drugs in this class include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).
Azathioprine (also known as Imuran) and mercaptopurine (known as Purinethol) also suppress the immune system. They are commonly used as part of a combination regimen or used alone to treat Crohn’s disease and ulcerative colitis, although they are not approved for those uses.
Azathioprine is approved for the prevention of rejection following renal transplantation and for the reduction of signs and symptoms of rheumatoid arthritis.
Mercaptopurine is approved to treat acute lymphatic leukemia.

HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.

FDA believes the risks and benefits of using TNF blockers, azathioprine, and/or mercaptopurine should be carefully weighed when prescribing these drugs to children and young adults, especially for the treatment of Crohn’s disease and ulcerative colitis. Patients should continue to talk to their Healthcare Professionals about the potential risk of HSTCL with use of these medications in order to make the best decision about their medical treatment.

FDA previously communicated about the increased risk of lymphomas and other cancers associated with the use of TNF blockers in children and adolescents in June 2008 and in August 2009 when warnings were added to the TNF blocker labels.

The product labels for Remicade (infliximab) and Humira (adalimumab) have been updated and the product labels for azathioprine and mercaptopurine are being updated to include warnings about HSTCL that have been reported in patients treated with these products.

FDA will continue to communicate any new safety information to the public as it becomes available.


Additional Information for Patients

• Be aware that taking TNF blockers, azathioprine, and/or mercaptopurine may increase the risk of HSTCL.
• Review the Medication Guide that accompanies a prescription for TNF blockers.
• Do not stop taking TNF blockers, azathioprine, and/or mercaptopurine without talking to your healthcare professional.
• Discuss any questions or concerns about these medications with your healthcare professional.
• Report any side effects you experience to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of the page.



Additional Information for Healthcare Professionals
• Discuss with patients and caregivers the increased risk of developing HSTCL, especially in adolescents and young adults, taking into account the risks/benefits of TNF blockers, azathioprine, and/or mercaptopurine, and other immunosuppressive therapies.
• Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
• Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
• Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or mercaptopurine.


Data Summary
FDA is updating the public about the number of reported cases of Hepatosplenic T-cell Lymphoma (HSTCL). From initiation of TNF blocker marketing to December 31, 2010, the following HSTCL cases have been identified in the Adverse Event Reporting System (AERS) database (de-duplicated), the literature, and the HSTCL Cancer Survivors' Network in association with the following agents (mutually exclusive): Infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and mercaptopurine (3). Of note, in the 20 cases identified with infliximab use, 18 of the patients also were using concomitant mercaptopurine or azathioprine (for the remaining two patients, concomitant drug use was not reported). Of the 5 cases identified with infliximab/adalimumab use, 4 patients were using concomitant mercaptopurine or azathioprine (for the remaining patient, concomitant drug use was not reported). Complete medical histories have not been obtained on some cases to exclude a history of exposure to a potential confounder/co-factor. See Table 1 for the list of cumulative cases associated with selected immunosuppressant use reported as of December 31, 2010.

Due to the potential increased risk for cancers, including HSTCL, the risks and benefits of using TNF blocker products, azathioprine and/or mercaptopurine should be carefully weighed when prescribing these drugs especially in adolescents and young adults.

Paper...makes for an interesting read for those interested...

A systematic review of factors that contribute to hepatosplenic T-cell lymphoma in patients with inflammatory bowel disease.

http://www.mendeley.com/research/systematic-review-factors-contribute-hepatosplenic-tcell-lymphoma-patients-inflammatory-bowel-disease-2/

Dusty. xxx

I find it helpful to read that adding one of these drugs to Remi only increases the remission rate by about 12%:

Results

Of the 169 patients receiving combination therapy, 96 (56.8%) were in corticosteroid-free clinical remission at week 26 (the primary end point), as compared with 75 of 169 patients (44.4%) receiving infliximab alone (P=0.02) and 51 of 170 patients (30.0%) receiving azathioprine alone (P<0.001 for the comparison with combination therapy and P=0.006 for the comparison with infliximab). Similar numerical trends were found at week 50. At week 26, mucosal healing had occurred in 47 of 107 patients (43.9%) receiving combination therapy, as compared with 28 of 93 patients (30.1%) receiving infliximab (P=0.06) and 18 of 109 patients (16.5%) receiving azathioprine (P<0.001 for the comparison with combination therapy and P=0.02 for the comparison with infliximab). Serious infections developed in 3.9% of patients in the combination-therapy group, 4.9% of those in the infliximab group, and 5.6% of those in the azathioprine group.

I think that if it were a decision I was making for myself the extra 12% chance of remission might be one I would be willing to take (plus I am completely out of the risk pool...34 and female). Because Izz is so young and already more prone to Lymphoma, I am more hesitant to proceed with the increased risk.

Thanks for asking that question, pasobuff...I love learning more about this wretched disease. Even if it doesn't make my treatment decisions easier I am thankful for the additional knowledge

...and thanks to Dusty, as usual, for the cited study...I should probably be paying you for doing research for me... You rock!:hug:

I am in the same camp as Izzi - the Remicade takes about 4 days to kick in after an infusion, but only lasts about 3-4 weeks. For a solid two weeks, I feel completely amazing (what I suppose healthy people would refer to as "normal" - yes, I am still in the bitter phase of post-diagnosis). After that, my Crohn's symptoms come back full force and it is horrible. I don't think I have a choice but to ask my GI to increase the frequency to 6 or 4 weeks. Do you mind my asking how high a dosage Izzi is on (e.g. 5 mg/kg)?

We did the first 3 doses at 4mg/kg and the following 2 at 6mg/kg. My doc insinuated that he isn't comfortable going less than 6 weeks. Scoutfinch...is it worth it for you? Obviously she is 5 and the IV troubles her a bit, plus the day exhausts her. I am assuming if her symptoms come back at the halfway point, her colon is inflamed and we are dealing with long term damage being done while she has symptoms (which brings her closer to surgery). Do you mind telling me your is your dose, and are you in the US?

I must say it has been super helpful to have the opportunity to chat with people from other areas...it is nice to explore options we may not be considering in this area for one reason or another. One more reason I love this forum! :hug:

I changed my infusions from 8 weeks to 6 weeks. This is just perfect it works great.

When I was on 8 weeks, the last 10 days I was in pain with the D in full force. I would get my infusions and it would take 10 days to take effect. It was pretty nasty stuff. Now on six weeks, I never fall ill.

As for the the risk of getting cancer. I fro one prefer to risk it and have a good life now than to suffer for years and maybe never getting it. The % of risk is so low that I probably have the same risk from eating Vinigar chips ever week.

But that's just me.

Good luck.

izzi'smom - My daughter goes every 6 weeks for her infusions now. The doc will not go less than that and the nurses at the Peds Surgery ward where she goes for the infusion say the same thing. They don't see any kids coming sooner than 6 weeks. I am not sure what her dosage is, if this stops working for her they tell me they will increase her dose.

Moogie...I completely understand, and if I were making the decision for myself, I might do the same. It's so hard to bear the potential responsibility of making my daughter more ill than she already is, though. (No one would blame me but myself, but it is a heavy burden nonetheless). I think bringing it down from 7 to 6 weeks will help, though: I would like to see how she does this time around first.
Kat, I am so happy for your daughter!! She was diagnosed just a month before us...I hope Remi continues to be a miracle drug for you all! (((HUGS)))

This is off topic a bit and Izzi's mom I hope you don't mind me asking on your thread, but when I talked to my G.I. about the risks of Lymphoma he tells me that they very closely monitor my son's blood cell counts. He said most of these cases occured when the blood wasn't monitored as closely as is standard now and if they started seeing white blood cell counts off they would take him off of 6mp. Is this correct? He certainly didn't say it couldn't happen but he did make it sound like it was even less likely now as a result of the studies done.

I worry about the risk everyday.
Tiffany

Tiffany, I completely don't mind you asking...I have no experience with it as it scares me too much. So is he saying you can avoid lymphoma with regular checkups??
(I am thinking it is like abnormal cervical cells///if left untreated they can turn in to cancer but if you keep an eye on them/remove them you can avoid it (?))
I am sorry...it was insensitive of me to mention she ISN'T in the risk pool without considering those of you with kiddos that ARE. (((HUGS)))

How is he feeling?

Just a funny thing to note...Izz and Johnny are on an almost identical regimen right now...just sub Remi for the 6mp & allopurinol (plus she is still on Pred right now)...she wants to know if he has Crohns also?

Hi Izzi's mom,

Your description of the abnormal cervical cells is how I understood him but I was wondering if anyone else heard/read the same info? He did say sometime it spontaneously happens but keeping an eye on blood counts lowers the risk even more.

Johnny does have crohn's. He is feeling pretty good but has lost some weight this week. He is not eating as much since off the prednisone and is on an intense basketball team with lots of work outs so I am hoping that is all it is. But it has to stop soon or we are going to be right back where we started.

Not insensitive at all of you to mention the risk pool for boys. It is a good information for parents of both boys and girls to know before making a decision about meds. I have been questioning our decision lately. The risk does not sit well with me. But what option do we have? No meds has it's risks too and he is much more likely to deal with those. I am going to look at LDN and do some more research. I don't feel like I have to change anything today but I do want to talk to his Dr. at his next appointment in March. I always feel better when I talk to him.

Hope the Remi every 6 weeks works well for Izzi, let us know how she is doing.

((((hugs)))))
Tiffany

izzi'smom said:

We did the first 3 doses at 4mg/kg and the following 2 at 6mg/kg. My doc insinuated that he isn't comfortable going less than 6 weeks. Scoutfinch...is it worth it for you? Obviously she is 5 and the IV troubles her a bit, plus the day exhausts her. I am assuming if her symptoms come back at the halfway point, her colon is inflamed and we are dealing with long term damage being done while she has symptoms (which brings her closer to surgery). Do you mind telling me your is your dose, and are you in the US?

Click to expand...

Is it worth it? Yes, even though Remicade doesn't work 100% of the time, it still is the only drug so far that has worked at all (Pentasa, Apriso and Entocort didn't do much for me). Also, when it does work - those 2 or 3 fantastic weeks out of 8 - I feel like I am LIVING again, whereas in a flare I feel like I'm surviving and sometimes even suffering.

I started off at 5 mg/kg and then after the 5th infusion (when it really started to fade quickly), I got bumped to 8 mg/kg. Unfortunately, the increased dosage has not extended the efficacy of the drug. Also, I'm from NYC.

Your concern for Izzi and the long term damage caused by inflammation (potential scarring, stricturing, etc) is very real. I am afraid of the damage caused during the weeks that the drug doesn't work because every wave of pain reminds me that I'm probably marching toward surgery. I truly hope you find something that really works for your daughter - whether it's adjusting dosing, frequency, or even switching drugs completely - and soon. My Crohn's symptoms were sporadic during my teens and only surfaced majorly when I entered my early/mid-twenties. I wish I had treated it more aggressively early on.

We've only done Pentasa (It is the only one available in non-pill form...we tried for a while to get her to swallow pills but it was torture for both of us and not worth it at that time...it may be something we revisit at some point in the near future). She is steroid dependent, which used to keep her in remission but no longer does, although I am hesitant to stop it in case it is helping marginally...I certainly don't want her worse. I was also hesitant to treat her aggressively but time has shown that her refractory disease won't be fooled by diet changes alone. The specialist we visited for a second opinion said she won't make it three years without surgery. I am hoping to hold out as long as possible if only because I hear that surgery will help for a while but often Crohns will creep back in and you are back to square one.
Ah, thanks for all of your insight and best of luck to you!