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Repeat Loading Dose of Stelara

Hi Everyone,

Just want to say I appreciate this site as an amazing resource! I have been on stelara for 2.5 years, and it has worked amazing. Over the last 2 months I have had a flare. Few months prior to the flare I was on augmentin for a sinus infection. Previously I responded very well to entocort, but now not much response. More response to Uceris, which shows that the Crohn's has probably spread to the large intenstine (previously ileocecal area). Previously on every 4 week dosing but recently was extending to every 6-7 weeks dosing and that is when the flare started. I am thinking that I have probably lost response to stelara. Interestingly my fecal calprotectin and ESR/CRP were normal. I am scheduled for an MRI this coming week. Any thoughts on repeat IV infusion of stelara? The only other thing that I can think of is maybe the stelara was stored improperly since sometimes the refrigerator door doesn't fully lock, so now I will make sure to use the stelara as soon as I receive it and make sure the fridge is not fluctuating in temperature. However, this has always been the case before and no previous problems.
 
The only other thing that I can think of is maybe the stelara was stored improperly since sometimes the refrigerator door doesn't fully lock, so now I will make sure to use the stelara as soon as I receive it and make sure the fridge is not fluctuating in temperature. However, this has always been the case before and no previous problems.
I didn't know this can be such a problem, but apparently it is:

 
Location
San Diego
While it is important to store biologic IBD drugs such as Stelara properly, I think they are generally pretty stable provided they have not been frozen nor stored at room temperature or higher for long periods of time. These drugs are antibodies, and antibodies are generally pretty stable proteins unless they are subjected to fairly harsh conditions.

I think the biggest risk from most home refigerators is making sure the drug doesn't get accidently frozen more than whether the temperature fluctuated above 8 deg. C. Freeze/thaw cycles will damage many proteins much more more quickly and certainly than a brief exposure to a few degrees above the recommended storage temperature. For that reason I store my Stelara prior to use down in the salad crisper drawers in the bottom of the fridge rather than up high near the freezer, where sometimes my milk gets a little icy.

Another point is that FDA generally requires that drugs have a storage safety zone and they must be shown to be stable at temperatures and for time periods far outside the conservative range that is stated on the label. For that reason, drugs that modestly exceeded storage temperaure or that have recently exceeded their expiration dates are almost always still safe and effective to use.
 

my little penguin

Moderator
Staff member
We have spoken to Jansen about temps /time etc..
Stelara is only good for 4 hours at room temp
So unless your fridge door remains open
Getting too warm probably isn’t the issue
Too cold ...another story

we have had freeze thaw issues with humira
Milk/sour cream had ice crystals
Thought Humira wasn’t effective for ds
Bought a new fridge (cheaper than humira )
And no more issues
There is a wireless thermostat that can be placed next to the meds and WiFi to your phone to track temp if needed
 
So apparently the MRI showed no signs of inflammation. Doc thinks it may be SIBO. Although I am thinking maybe these symptoms are caused by the Florastor probiotic i've been taking.
 
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