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Blood monitoring on biologics

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Posted 12/10/2014 3:58 PM (GMT 0)
I was wondering what standard procedure is for having blood tests when you're on biologics? Because quite frankly I'm concerned about the lack of follow-up I'm having on Simponi. When I started azathioprine there was a clear system, I had them weekly for two months, and then monthly, something that turned out to be very necessary as it was threatening to harm my liver. But there's been none of that on Simponi. I had a screening blood test to make sure I didn't have TB before I started (not a full blood count or anything), and one the week after, but since that, nothing. I've been on this drug for ages now and I'm concerned they don't want to make sure everything's going okay. I threw up yesterday morning, something really uncharacteristic, and whilst it's probably nothing it scares me that something bad might be happening.

Surely biologics are even stronger than immunosuppressants? Why did I receive so much more attention on aza? Is this normal procedure?
Posted 12/10/2014 4:27 PM (GMT 0)
My last gi bloodwork was in june and then i see him again in december. Ive had other blood work between then from four other doctors but my gi doesnt know. I think since my june bloodwork was fine that he thought id still be good by december.
Posted 12/10/2014 4:46 PM (GMT 0)
The blood work is dictated by the "monitoring" information in the "full prescribing information" document. Purines require monitoring of liver function. Annual check of kidney function is recommended for 5-asa. The only suggested monitoring for Simponi is for infection.

"Monitoring
Closely monitor patients for the development of signs and symptoms of infection
during and after treatment with SIMPONI. Discontinue SIMPONI if a patient
develops a serious infection, an opportunistic infection, or sepsis. For a patient
who develops a new infection during treatment with SIMPONI, perform a prompt
and complete diagnostic workup appropriate for an immunocompromised
patient, initiate appropriate antimicrobial therapy and closely monitor them."

However, the exact metabolic pathway for the drug working is not known. So, it might become clearer in the future whether any organs of metabolism need monitoring.
Posted 12/10/2014 5:11 PM (GMT 0)
The reason you needed blood monitoring on aza, is that drug lowers your body's white blood cell count, and it can damage your liver if your body cannot metabolize it correctly. Aza blood monitoring is frequent at first, and then backed off to tri-monthly once your numbers are fine (liver is fine, white blood cell count isn't too low).

Biologics do not work in the same way; entirely different mechanism of action. Due to that fact, blood monitoring isn't required or recommended. Biologics put a biologically-engineered protein in your blood stream. The protein itself does no harm to the liver, and it doesn't change your white blood counts at all (as aza does). What biologics do is attach to a tnf-alpha protein in your bloodstream and make it inert (tnf-alpha would otherwise signal an immune attack is needed that would cause inflammation in your large intestine). Blood tests can be done to measure the biologic-level within your blood, and test for antibody buildup against your biologic. Those are given on an as-needed basis, and not scheduled.

So no worries, no need for regular blood monitoring while on a biologic medication. Unless you are concurrently on aza at the same time.
Posted 12/10/2014 5:19 PM (GMT 0)
Ah okay I see, thanks for explaining! (I am on aza too, but have been on it ages so three-monthly will do for that).

I just got concerned with my uncharacteristic nausea, and hope nothing is going wrong.
Posted 12/10/2014 6:24 PM (GMT 0)
I'm on Humira and there is definitely a lot of blood monitoring going on and very scheduled...
when I first started taking Humira I had to get my blood tested once a week for the first month, then once a month after that for 6 months I believe and now I'm at once every 3 months.

I don't know about other biologics and how they are monitored but with Humira they keep a very close eye on my blood work.
Posted 12/10/2014 8:18 PM (GMT 0)
@pb4: what are they testing. the monitoring for infection instructions are almost the same.
Posted 12/10/2014 9:39 PM (GMT 0)
He's monitoring the following;
CBC includes Diff
Creatinine
Electrolytes
ALT
Ferritin
as well as;
Albumin
Alkaline Phosphatase
Bilirubin- total and direct
C reactive Protein
Posted 12/10/2014 9:44 PM (GMT 0)
I don't know whether to be concerned or not then :(
Posted 12/10/2014 9:57 PM (GMT 0)
Pb4 that seems a bit excessive, how often is it done?
Posted 12/10/2014 11:42 PM (GMT 0)
You should inquire about the blood tests.  I was on 6mp and remicade until last Monday.  At first it was every week, then every month then every three months as long as everything came back ok.  Last blood test the doc did in February showed slightly high liver enzymes and he did not do any follow up.  I got a new doc in August and she noted the elevated liver enzymes as well as possible markers for auto immune hepatitis.  Now after two trips to a liver specialist, and the continued increase of liver enzymes, despite decrease in dose of 6mp, I am now off it all.  (Remicade due to pain, but Remicade can also cause liver damage.)
Posted 12/11/2014 12:44 AM (GMT 0)

iPoop said...
Pb4 that seems a bit excessive, how often is it done?


when I first started taking Humira I had to get my blood tested once a week for the first month, then once a month after that for 6 months I believe and now I'm at once every 3 months.


Maybe it's monitored differently in Canada or from GI to GI IDK, I just go for my routine blood work as I was asked to. Or maybe it has to do with the fact that I've had nothing but issues with all the other oral meds I've tried in the past...I feel like I'm getting adequate care so I never questioned it.
Posted 12/11/2014 2:55 AM (GMT 0)
well thats a lot of tests, but all are fairly routine things.

can't see how it is related to biologic protocols.
Posted 12/11/2014 4:03 AM (GMT 0)
Couldn't tell ya, but he's been ordering these tests since he started me on Humira...guess he likes to be thorough as well as paying close attention to what's going on with my blood results while on Humira.
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