Should we get more frequent PCR testing during the first year if we start taking the generic?
Generic Gleevec
Started by
SunNsand
, Jan 10 2016 12:46 AM
18 replies to this topic
#2
Trey
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Posted 10 January 2016 - 10:15 PM
I would say only if above MMR. If MMR or better, probably not.
#3
scuba
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Posted 11 January 2016 - 08:53 AM
I would say only if above MMR. If MMR or better, probably not.
Why? The generic is identical to the name brand.
from the FDA's website:
A generic drug isidentical-or bioequivalent-to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
http://www.fda.gov/D...s/ucm100100.htm
Diagnosed 11 May 2011 (100% FiSH, 155% PCR)
with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein
Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate
6-8 grams Curcumin C3 complex.
2015 PCR: < 0.01% (M.D. Anderson scale)
2016 PCR: < 0.01% (M.D. Anderson scale)
March 2017 PCR: 0.01% (M.D. Anderson scale)
June 2017 PCR: "undetected"
September 2017 PCR: "undetected"
#4
r06ue1
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Posted 11 January 2016 - 02:49 PM
I have to admit, I'm a little nervous about switching to a generic also (insurance requires it) even though they state it is all the same.
08/2015 Initial PCR: 66.392%
12/2015 PCR: 1.573%
03/2016 PCR: 0.153%
06/2016 PCR: 0.070%
09/2016 PCR: 0.052%
12/2016 PCR: 0.036%
03/2017 PCR: 0.029%
06/2017 PCR: 0.028%
09/2017 PCR: 0.025%
12/2017 PCR: 0.018%
Taking Imatinib 400 mg
#5
SunNsand
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Posted 11 January 2016 - 03:28 PM
I'm mostly confused. I have read that they are the same, and that they are not. I asked my Oncologist if they were the same and he said that they "should" be. I can't get a solid answer. As far as the FDA, I don't trust them 100%. There have been times in the past when drugs were approved, sent to market, then a few years later they are pulled from the market because of serious health issues they caused.I have to admit, I'm a little nervous about switching to a generic also (insurance requires it) even though they state it is all the same.
My Onccologist said it was up to me as to which I took. lol Evidently he's not too in touch with the insurance world. I did notice that when he wrote my script for Gleevec, he wrote No substitutions. Time will tell how this all plays out.
#6
Terran
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Posted 11 January 2016 - 05:26 PM
It's the -or bioequivalent- that worries me.
#7
Buzzm1
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Posted 11 January 2016 - 06:26 PM
Generic versions of imatinib have been available in Canada, India, and South Korea since 2013.
For the benefit of yourself and others please add your CML history into your Signature
02/2010 Gleevec 400mg
2011 Two weakly positives, PCRU, weakly positive
2012 PCRU, PCRU, PCRU, PCRU
2013 PCRU, PCRU, PCRU, weakly positive
2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)
2015 300, 250, 200, 150
2016 100, 50/100, 100, 10/17 TFR
2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000
2018 01/16 TFR 0.0004 ... next quarterly PCR 04/17
At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.
In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.
longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation. GFR and creatinine vastly improved after stopping Gleevec.
Cumulative Gleevec dosage estimated at 830 grams
Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.
Trey's CML Blog - Stopping - The Odds - Stop Studies - Discussion Forum Cessation Study
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#8
Lucas
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Posted 11 January 2016 - 06:38 PM
we have generic imatinib here in Brazil since 2013 and the vast majority of the patients are doing ok with it. All we have are some anecdotals cases of loss of response and more side effects, but not relevant.
#9
Gail's
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Posted 12 January 2016 - 02:38 AM
Lucas, do you know the cost of your generic imatinib?
Diagnosed 1/15/15
FISH 92%
BMB 9:22 translocation
1/19/15 began 400 mg gleevec
1/22/15 bcr 37.2 IS
2/6/15 bcr 12.5 IS
3/26/15 bcr 10.3 IS
6/29/15 bcr 7.5 IS
9/24/15 bcr 0.8 IS
1/4/16 bcr 0.3 IS
Started 100 mg dasatinib, mutation analysis negative
4/20/16 bcr 0.03 IS
8/8/16 bcr 0.007 IS
12/6/16 bcr 0.002 IS
Lowered dasatinib to 70 mg
4/10/17 bcr 0.001 IS
Lowered dasatinib to 50 mg
7/5/17 bcr 0.004 IS
8/10/17 bcr 0.001. Stopped TKI in prep for September surgery.
9/10/17 bcr 0.006
10/10/17 bcr 0.088
FISH 92%
BMB 9:22 translocation
1/19/15 began 400 mg gleevec
1/22/15 bcr 37.2 IS
2/6/15 bcr 12.5 IS
3/26/15 bcr 10.3 IS
6/29/15 bcr 7.5 IS
9/24/15 bcr 0.8 IS
1/4/16 bcr 0.3 IS
Started 100 mg dasatinib, mutation analysis negative
4/20/16 bcr 0.03 IS
8/8/16 bcr 0.007 IS
12/6/16 bcr 0.002 IS
Lowered dasatinib to 70 mg
4/10/17 bcr 0.001 IS
Lowered dasatinib to 50 mg
7/5/17 bcr 0.004 IS
8/10/17 bcr 0.001. Stopped TKI in prep for September surgery.
9/10/17 bcr 0.006
10/10/17 bcr 0.088
#10
chriskuo
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Posted 12 January 2016 - 02:47 AM
I'm sure the generic in the US will be more expensive than in Brazil, just like the branded drug is most expensive in the US.
Based on what I have heard from a friend who works for an international generic drug manufacturer, it is not a slam dunk to get the the output of their Indian drug factories to meet US or Japan standards even for relatively simple drugs. I hope the FDA is monitoring generic imatinib very closely.
#11
Lucas
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Posted 12 January 2016 - 11:39 AM
Gail, imatinib is free via our national health system, but you can also find others brand at the drugstores. nowadays the price is around 1200-1500 dollars the box with 30 pills (400mg).
#12
SunNsand
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Posted 12 January 2016 - 02:19 PM
we have generic imatinib here in Brazil since 2013 and the vast majority of the patients are doing ok with it. All we have are some anecdotals cases of loss of response and more side effects, but not relevant.
"vast majority, doing ok, loss of response and more side effects" ...
I was diagnosed in 2009 and it took me until the summer of 2015 to finally get on top of my health issues, it's pretty relevent to me :/
#13
SunNsand
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Posted 12 January 2016 - 02:23 PM
Generic versions of imatinib have been available in Canada, India, and South Korea since 2013.
Is there any data anywhere from those countries?
#14
Buzzm1
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Posted 12 January 2016 - 02:37 PM
Much like here, data is only likely available via the STOP studies; other than that you are left with anecdotal evidence.
Here are quick summaries of some of the STOP studies: http://bit.ly/1XyGyL5
The only question now is: were persons taking a generic allowed into the studies?
For the benefit of yourself and others please add your CML history into your Signature
02/2010 Gleevec 400mg
2011 Two weakly positives, PCRU, weakly positive
2012 PCRU, PCRU, PCRU, PCRU
2013 PCRU, PCRU, PCRU, weakly positive
2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)
2015 300, 250, 200, 150
2016 100, 50/100, 100, 10/17 TFR
2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000
2018 01/16 TFR 0.0004 ... next quarterly PCR 04/17
At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.
In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.
longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation. GFR and creatinine vastly improved after stopping Gleevec.
Cumulative Gleevec dosage estimated at 830 grams
Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.
Trey's CML Blog - Stopping - The Odds - Stop Studies - Discussion Forum Cessation Study
Big PhRMA - Medicare Status - Social Security Status - Deficit/Debt
#15
chriskuo
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Posted 12 January 2016 - 05:51 PM
Sun received approval from the FDA for shipping generic Gleevec in the US beginning in February.
However, the following article indicates that Sun had to shift its manufacturing to a new location, because the Halol, Gujrat facility it was using has run into issues with the FDA.
#16
Lucas
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Posted 12 January 2016 - 06:45 PM
Sim, not many patients here had those problems. As i said, it was anecdotal and not confirmed as a result from the change of meds.
#17
Gail's
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Posted 12 January 2016 - 09:42 PM
My onc today told me she read the generic will be $3000/mo. Not sure where she read it.
Diagnosed 1/15/15
FISH 92%
BMB 9:22 translocation
1/19/15 began 400 mg gleevec
1/22/15 bcr 37.2 IS
2/6/15 bcr 12.5 IS
3/26/15 bcr 10.3 IS
6/29/15 bcr 7.5 IS
9/24/15 bcr 0.8 IS
1/4/16 bcr 0.3 IS
Started 100 mg dasatinib, mutation analysis negative
4/20/16 bcr 0.03 IS
8/8/16 bcr 0.007 IS
12/6/16 bcr 0.002 IS
Lowered dasatinib to 70 mg
4/10/17 bcr 0.001 IS
Lowered dasatinib to 50 mg
7/5/17 bcr 0.004 IS
8/10/17 bcr 0.001. Stopped TKI in prep for September surgery.
9/10/17 bcr 0.006
10/10/17 bcr 0.088
FISH 92%
BMB 9:22 translocation
1/19/15 began 400 mg gleevec
1/22/15 bcr 37.2 IS
2/6/15 bcr 12.5 IS
3/26/15 bcr 10.3 IS
6/29/15 bcr 7.5 IS
9/24/15 bcr 0.8 IS
1/4/16 bcr 0.3 IS
Started 100 mg dasatinib, mutation analysis negative
4/20/16 bcr 0.03 IS
8/8/16 bcr 0.007 IS
12/6/16 bcr 0.002 IS
Lowered dasatinib to 70 mg
4/10/17 bcr 0.001 IS
Lowered dasatinib to 50 mg
7/5/17 bcr 0.004 IS
8/10/17 bcr 0.001. Stopped TKI in prep for September surgery.
9/10/17 bcr 0.006
10/10/17 bcr 0.088
#18
chriskuo
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Posted 12 January 2016 - 10:05 PM
Sun will have 6 months of exclusivity for the generic starting in February. It will be interesting to see their pricing strategy during that period.
Will they price it low enough to keep out competition or will they try to maximize short-term profit?
Will they price it low enough to keep out competition or will they try to maximize short-term profit?
#19
Buzzm1
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Posted 12 January 2016 - 10:25 PM
My onc today told me she read the generic will be $3000/mo. Not sure where she read it.
that sounds about right; early insinuations suggested the generic would likely be priced at about 30% of current retail.
I've watched the news for early info on the generic pricing but hadn't seen anything.
$3,000/mo. ($100/400mg tablet), if true, is far higher than generic Imatinib elsewhere
http://www.pharmacyc...matinib/400 mg/
For the benefit of yourself and others please add your CML history into your Signature
02/2010 Gleevec 400mg
2011 Two weakly positives, PCRU, weakly positive
2012 PCRU, PCRU, PCRU, PCRU
2013 PCRU, PCRU, PCRU, weakly positive
2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)
2015 300, 250, 200, 150
2016 100, 50/100, 100, 10/17 TFR
2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000
2018 01/16 TFR 0.0004 ... next quarterly PCR 04/17
At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.
In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.
longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation. GFR and creatinine vastly improved after stopping Gleevec.
Cumulative Gleevec dosage estimated at 830 grams
Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.
Trey's CML Blog - Stopping - The Odds - Stop Studies - Discussion Forum Cessation Study
Big PhRMA - Medicare Status - Social Security Status - Deficit/Debt
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