Our latest case study was on this....
EDIT: for lovenox, I think they use protamine but it's not as effective as it is with heparin.
I believe protamine has about 60% of the efficacy with lovenox that it has with heparin
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Dabigatran Versus Warfarin
Started by Sparda29
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I believe protamine has about 60% of the efficacy with lovenox that it has with heparin
Yes, you are right. That is what I was told.
Which clotting factor would you administer? Its at the end of the pathway. It is a direct thrombin inhibitor which blocks the conversion fibrinogen to fibrin. There really isn't a lot you can do.
There really is nothing you can do.
That's true. Really good point actually. Would giving platelets help? Obviously the problem is not lack of platelets, but would increasing there number help the clotting response regardless of thrombin being inhibited?
Side note: why are we discussing therapy, and why has no one ridiculed me for either being wrong or because I am only a student? I feel like this must all be a dream, surely it can't be real...
Oops, sorry. Guess I'm falling down on the job of administering my daily dose of ridicule! 😀
I think they treat dabigatran induced bleeds with RBCs but I'm not totally sure and I'm too tired to look at the handout we just got on it. Maybe it's fresh frozen plasma. Not sure! LOL
I will let it go this time, but don't let it happen again.
FFP, FTW!
And Owlegrad, we are students. We aren't supposed to know anything yet 😉 or, we are only supposed to know SOME. Which is why I like this forum. Most of the time I can ask honest questions without feeling like a *******. This is in contrast to getting pimped in front of my class which always sucks.
And Owlegrad, we are students. We aren't supposed to know anything yet 😉 or, we are only supposed to know SOME. Which is why I like this forum. Most of the time I can ask honest questions without feeling like a *******. This is in contrast to getting pimped in front of my class which always sucks.
I am doing an inservice on dabigatran at my P3 hospital site on Tuesday. My preceptor wanted the inservice mostly focused on the dosing. I will be sure to have a discussion with the clinical director about associated costs and bleeding reversal. Thanks for the quality discussion!
I found this article with a paragraph concerning the reversal of bleeding: http://www.medscape.com/viewarticle/731795
"Another question is, what do we do if there are bleeding complications while patients are taking dabigatran? The good thing is that the anticoagulation effect tends to reverse within hours after stopping the medication, but if there is an emergency situation and we need to rapidly reverse the effects of the drug, what can we do? Some coagulation experts suggest that the infusion of PCC (protein complex concentrate) can be effective in reducing the anticoagulation effect. Perhaps the one best agent of this type would be FEIBA [factor eight inhibitor bypass activity], which is made by Baxter. This is a very potent PCC combination that has activated clotting factors, so this may be one thing to consider, but clearly there is a paucity of clinical data about how to best do this."
"Another question is, what do we do if there are bleeding complications while patients are taking dabigatran? The good thing is that the anticoagulation effect tends to reverse within hours after stopping the medication, but if there is an emergency situation and we need to rapidly reverse the effects of the drug, what can we do? Some coagulation experts suggest that the infusion of PCC (protein complex concentrate) can be effective in reducing the anticoagulation effect. Perhaps the one best agent of this type would be FEIBA [factor eight inhibitor bypass activity], which is made by Baxter. This is a very potent PCC combination that has activated clotting factors, so this may be one thing to consider, but clearly there is a paucity of clinical data about how to best do this."
I agree. From what I've been able to research on the drug this is one of the major drawbacks. Not to mention the cost factor.
I was talking to a BI rep yesterday and he was mentioning something about Pradaxa. I said "you mean the drug with no reversal mechanism?" 
He said, "well there is FFP". Then he changed the subject.
He said, "well there is FFP". Then he changed the subject.
Clotting factors ain't cheap though. Basically the whole reversal process is expensive and the drug itself is expensive. It really seems to me that the advantage to dabigatran isn't really there yet.
I am partial to it but the one potential advantage is one in oncology. There patients are treated months on end on anticoagulation. Traditionally its been LMWH holding down the fort there. Warfarin has many drug drug interactions with many of the chemotherapeutic regimens which are given in cycles (in other words not given QD) making it a nightmare to use it. And lets be honest who gets excited to tell patients they will be giving themselves shots for the next 6 months or until the cancer is cured?
I am partial to it but the one potential advantage is one in oncology. There patients are treated months on end on anticoagulation. Traditionally its been LMWH holding down the fort there. Warfarin has many drug drug interactions with many of the chemotherapeutic regimens which are given in cycles (in other words not given QD) making it a nightmare to use it. And lets be honest who gets excited to tell patients they will be giving themselves shots for the next 6 months or until the cancer is cured?
I'm bringing this up in class in T minus 15 minutes. Let's see if I get shot down.
Excitting!
I was talking to a BI rep yesterday and he was mentioning something about Pradaxa. I said "you mean the drug with no reversal mechanism?"
Nice work, I like keeping them on their toes too. The BI reps I spoke were not pushy by any means and did offer some nice Marcov modeling regarding big picture cost between warfarin and dabigatran.
I was just ribbing him and they are fully aware of the limitations of Pradaxa. I like the BI guys I talk to, we're working on cool COPD stuff.
Oh the suspense!
Is there data in these patients? I personally haven't seen any, but I haven't done a full lit search on that.
So my prof didn't shoot me down- he said it will be interesting to see how many bleeding events we see since the studies were "well controlled". He said it is certainly a concern just as the cost and short expiration date is a concern. But eliminating the need for INR monitoring is a positive.
Is there a reason you couldn't just give plasma to reverse the dabigatran? Load the pt up with activated factors, the works...and let it do its work. Not sure of the MOA of dabigatran...if it's hit and run obviously it wouldn't work, but otherwise I'd think it would improve bleeding.
EDIT: I decided to combat my laziness and actually look up the drug. It appears a lot of the concerns above are already addressed..it comes in blisterpacks which means no expiration of 30 days. It's also worth pointing out that if it has a highly predictable PK profile, it would rarely be an issue that excess bleeding occurs - the main reason we see this in warfarin pts is due to the unpredictable profile. As for GI upset - effectiveness is decreased with PPIs, probably because of the low pH requirement for absorption. That's an issue.
EDIT: I decided to combat my laziness and actually look up the drug. It appears a lot of the concerns above are already addressed..it comes in blisterpacks which means no expiration of 30 days. It's also worth pointing out that if it has a highly predictable PK profile, it would rarely be an issue that excess bleeding occurs - the main reason we see this in warfarin pts is due to the unpredictable profile. As for GI upset - effectiveness is decreased with PPIs, probably because of the low pH requirement for absorption. That's an issue.
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If we've been able to isolate and administer clotting factors, I feel that we should be able to do that with thrombin as well. Would it be possible to overcome the thrombin inhibition by simply adding more thrombin? Or even go further downstream and give fibrin, bypassing the thrombin altogether. I'm going to guess that there's a good reason we don't/can't do this. Would you just clot outrageously and get a PE if you tried it?
For the concerns about shelf life: bottle of 60 (bid dosing), once open it's only good for 30 days, must keep in original fancy BI container (I swear they make the most bizarre bottles.)
For the concerns about shelf life: bottle of 60 (bid dosing), once open it's only good for 30 days, must keep in original fancy BI container (I swear they make the most bizarre bottles.)
As far as dabigatran in oncology, no. But its a nice idea for a project.
I am a medical consultant for BI in COPD. Thanks for giving us some crap. It makes the job more fun for most people and I think you will find that out of all companies, BI has more laid back people.
But no stock options!
That was actually my impression of the BI folks I met, very laid back, they presented some good info and any question they could not answer there, they had their MSL get back to us.
Yep. PhARMA code won't allow them to answer off-label questions. Plus, you'd rather speak to a MSL. Most of them are Pharm.D. and either residency or fellowship trained.
True, but I get somewhere around 50 to 60 vacation and holidays per year. Stocks in pharma are not great anymore. Unless you get into an IPO, don't hold your breath. Most of the small companies are being acquired via mergers anyway. But again, good catch.
Dingerx,
How do you like working in industry? I am most likely going to pursue a fellowship in medical information or MSL upon graduation in 2012.
How do you like working in industry? I am most likely going to pursue a fellowship in medical information or MSL upon graduation in 2012.
The industry is pretty good as long as you have a little information and come to terms with it before you start. First, you have no stability (in reality you do have some). Pharma companies let people go at the drop of a hat if they need to and nobody is safe. I have seen R&D, MSLs, sales, marketing, etc., get let go over the last couple of years. If you are with a strong company, you can expect to have 5 years or so before a product line starts to wind down its MSL team. MSLs are a dime-a-dozen right now. There are a lot of people with experience. IF you decide that's what you want to do, you need to do a fellowship (Rutgers is probably the best). If you want more information, PM me. This is just a generalization, but the industry presents many opportunities, but there is a lot of instability.
http://www.annals.org/content/early/2010/11/01/0003-4819-154-1-201101040-00289
is the article that you guys are talking about, I believe.
is the article that you guys are talking about, I believe.
