Xarelto (rivaroxaban) - recommendation for holding prior to injection?

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Just saw my first patient on Xarelto. Not aware of any guidelines on how long to hold prior to ESI and when it can be restarted. Any thoughts on this? Thanks!

An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO®. The next XARELTO® dose is not to be administered earlier than 6 hours after the removal of the catheter. Delay the administration of XARELTO® for 24 hours if traumatic puncture occurs

Just my first patient on Xarelto-

Are people treating this like Pradaxa?

3 days off for most patients, 5 days off for renal dysfunction?

Originally Posted by pacucare

An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO®. The next XARELTO® dose is not to be administered earlier than 6 hours after the removal of the catheter. Delay the administration of XARELTO® for 24 hours if traumatic puncture occurs

The information above is from the package insert. Also, it is contraindicated in renal impairment (creatinine clearance < 15 mL/min), moderate and severe hepatic impairment with elevated INR.

I recommend to my patients to hold for 24 hours.

Originally Posted by NOSfan

The information above is from the package insert. Also, it is contraindicated in renal impairment (creatinine clearance < 15 mL/min), moderate and severe hepatic impairment with elevated INR.

I recommend to my patients to hold for 24 hours.

Why only 24 hours? It seems like it would take more than 24 hours for the body to completely replace the Factor Xa, (and that's once the drug has left the body).

It seems that a few years after every new blood thinner is introduced, the required time to hold it for neuroaxial procedures is increased, (after unexpected bleeds are reported).

I'd rather skip that possibility in my patient needing a cervical ESI.

From the PI:

WARNINGS: (A) DISCONTINUING XARELTO® IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE,
(B) SPINAL/EPIDURAL HEMATOMA
A. DISCONTINUING XARELTO® IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION

Discontinuing XARELTO® places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following XARELTO® discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation with XARELTO® must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant.

B. SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas have occurred in patients treated with XARELTO® who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Use of indwelling epidural catheters

Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, see Drug Interactions

A history of traumatic or repeated epidural or spinal punctures

A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.



Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation: Discontinuing XARELTO®, in the absence of adequate alternative anticoagulation, increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from XARELTO® to warfarin in clinical trials in atrial fibrillation patients. If XARELTO® must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant.



A specific antidote for rivaroxaban is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable. Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving rivaroxaban. There is neither scientific rationale for benefit nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving rivaroxaban. Use of procoagulant reversal agents such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC), or recombinant factor VIIa (rFVIIa) may be considered, but has not been evaluated in clinical trials.


Spinal/Epidural Anesthesia or Puncture: When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.

An epidural catheter should not be removed earlier than 18 hours after the last administration of XARELTO®. The next XARELTO® dose is not to be administered earlier than 6 hours after the removal of the catheter. Delay the administration of XARELTO® for 24 hours if traumatic puncture occurs.



I'm guessing that there was 1+ epidural hematoma's during the study of the drug in Phase 3 trials. Also guessing that there were a number of CVA's when the drug was stopped for whatever reason. Because of the labeling, I'd defer the anticoagulation regimen to the Cardiologist. I'd also use a different informed consent for this drug that includes all the info above.

Originally Posted by bedrock

Why only 24 hours? It seems like it would take more than 24 hours for the body to completely replace the Factor Xa, (and that's once the drug has left the body).

It seems that a few years after every new blood thinner is introduced, the required time to hold it for neuroaxial procedures is increased, (after unexpected bleeds are reported).

I'd rather skip that possibility in my patient needing a cervical ESI.

Due to it's pharmacokinetics, and PI, I treat it as other Xa inhibitors such as LMWH and follow the ARSA Guidelines for therapeutic doses -> hold for 24 hours.

Originally Posted by NOSfan

Due to it's pharmacokinetics, and PI, I treat it as other Xa inhibitors such as LMWH and follow the ARSA Guidelines for therapeutic doses -> hold for 24 hours.

So is everyone just having patients hold Xarelto for 24 hrs before procedures?

Not many people chimed on this thread.

So nobody has an opinion on this besides NOSFAN?

No one ever sees patients on Xarelto besides me?

Originally Posted by bedrock

So nobody has an opinion on this besides NOSFAN?

No one ever sees patients on Xarelto besides me?

It depends on when surgery is scheduled. It's supposed to be taken with the heaviest meal of the day (typically dinner), so it could be closer to 30+ hours if you take it with dinner Wednesday night and surgery is Friday morning.

Originally Posted by NOSfan

Due to it's pharmacokinetics, and PI, I treat it as other Xa inhibitors such as LMWH and follow the ARSA Guidelines for therapeutic doses -> hold for 24 hours.

Has anyone heard of using for surgeries other than knee/hip replacement? Just curious of outcomes/types of surgery where experience is being gained (no locations, just patient type/outcomes).

No experience yet, but I would hold for at least 3-5 days, and 12-24h after.

Thought I'd bump this thread since I just saw my first referral on Xarelto. Some of the stories I've seen from surgeons are horrifying.

Anything new?

Originally Posted by Mister Mxyzptlk

Thought I'd bump this thread since I just saw my first referral on Xarelto. Some of the stories I've seen from surgeons are horrifying.

Anything new?

I've bumped it several times and nobody wants to say a damn thing......




What are the horror stories from the surgeons?

Excessive bleeding in patient that were off for several days, excessive bleeding in emergency surgeries where the patients wasn't off for several day?

Spontaneous bleeding?

All of the above.

One surgeon said it helped him make an early dx of rectal CA because the pt started bleeding.

Originally Posted by Mister Mxyzptlk

All of the above.

One surgeon said it helped him make an early dx of rectal CA because the pt started bleeding.

Ah,

I only had the one patient on it so far, cervical radic of course. I had him hold it for 4 days. Did fine, great response to ESI, and no problems, but I"m really hoping he never comes back....

Originally Posted by bedrock

Why only 24 hours? It seems like it would take more than 24 hours for the body to completely replace the Factor Xa, (and that's once the drug has left the body).

It seems that a few years after every new blood thinner is introduced, the required time to hold it for neuroaxial procedures is increased, (after unexpected bleeds are reported).

I'd rather skip that possibility in my patient needing a cervical ESI.

Xarelto reversibly binds Xa and does not deplete it. It has a plasma half-life of 5 to 9 hours in healthy subjects (ages 20 to 45 years) and 11 to 13 hours in the elderly. Therefore, the anticoagulant effect is only present when the drug is taken.

Our protocol for Xarelto is a hold time of 48 hrs prior to neuraxial blockade and do not resume Xarelto until 6 hours post-procedure.

Any guidelines about when each antiplatelet/anticoagulant can be restarted post epidural ?

Great Question.

Here's what we use as guidelines to restart agents post-injection:

Most Anti-platlet agents: 2 hours post injection
Pradaxa : 6 hours
Thrombolytics: 10 days (except for catheter clearance doses there are no restrictions)
Xarelto: 6 hours
Heparin, Coumadin, Arixtra: 2 hours
Lovenox: 24 hours (which I do not agree with btw, IMHO)

And to clarify, those times were for minumum time between single neuraxial injection OR catheter removal until first dose of anticoagulant.

Yet another new drug... Apixaban, trade name Eliquis

Eliquis

48 hours is what the cardiologist say for eliquis

Originally Posted by olafa

48 hours is what the cardiologist say for eliquis

Cardiologist always underestimate these things, because their priority is different from ours. 10 years ago they would say you only need to hold plavix for 3 days, lovenox for 10 hrs, etc.

I always at least double whatever time period the cardiologist thinks

Originally Posted by bedrock

Cardiologist always underestimate these things, because their priority is different from ours. 10 years ago they would say you only need to hold plavix for 3 days, lovenox for 10 hrs, etc.

I always at least double whatever time period the cardiologist thinks

Any new thoughts on xarelto?