Daptomycin (Cubicin) Stability

[Sparda29]

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Anyone know how long the reconstituted solution is stable for? According to the Cubist pharmaceutical website, it is only stable for 48 hours after reconstitution but the rotation site I'm at right now says it's good for 1 week.

Anyone else who works in a hospital, how long does your institution say Daptomycin is good for?

 

[FruitFly]

Anyone know how long the reconstituted solution is stable for? According to the Cubist pharmaceutical website, it is only stable for 48 hours after reconstitution but the rotation site I'm at right now says it's good for 1 week.

Anyone else who works in a hospital, how long does your institution say Daptomycin is good for?

Your rotation site is WRRRRRRRRRRONG! I don't get why students need to pay for rotational year.

Reconstituted CUBICIN should be further diluted with 0.9% sodium chloride injection to be administered by IV infusion over a period of 30 minutes.

Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of final IV solution. Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature or up to 48 hours if stored under refrigeration at 2 to 8ºC (36 to 46ºF). The diluted solution is stable in the infusion bag for 12 hours at room temperature or 48 hours if stored under refrigeration. The combined time (vial and infusion bag) at room temperature should not exceed 12 hours; the combined time (vial and infusion bag) under refrigeration should not exceed 48 hours.

 

[rxlea]

Your rotation site is WRRRRRRRRRRONG! I don't get why students need to pay for rotational year.

Reconstituted CUBICIN should be further diluted with 0.9% sodium chloride injection to be administered by IV infusion over a period of 30 minutes.

Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of final IV solution. Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature or up to 48 hours if stored under refrigeration at 2 to 8ºC (36 to 46ºF). The diluted solution is stable in the infusion bag for 12 hours at room temperature or 48 hours if stored under refrigeration. The combined time (vial and infusion bag) at room temperature should not exceed 12 hours; the combined time (vial and infusion bag) under refrigeration should not exceed 48 hours.

This.

 

[ttopping]

We used to keep the recon'd vials for 48 hours but we recently started tossing them as a single dose vial (although I don't know why). Did they explain why they think it's good for a week?

 

[Sparda29]

Your rotation site is WRRRRRRRRRRONG! I don't get why students need to pay for rotational year.

Reconstituted CUBICIN should be further diluted with 0.9% sodium chloride injection to be administered by IV infusion over a period of 30 minutes.

Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of final IV solution. Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature or up to 48 hours if stored under refrigeration at 2 to 8ºC (36 to 46ºF). The diluted solution is stable in the infusion bag for 12 hours at room temperature or 48 hours if stored under refrigeration. The combined time (vial and infusion bag) at room temperature should not exceed 12 hours; the combined time (vial and infusion bag) under refrigeration should not exceed 48 hours.

This is exactly from the Cubist website. Reason why I ask is because one of the pharmacists who works here had me reconstitute 5 vials to make 4 doses. The patient that it is for only gets them twice a week (after hemodialysis).

So pretty much they just wasted a bunch of Cubicin didn't they?

 

[rxlea]

This is exactly from the Cubist website. Reason why I ask is because one of the pharmacists who works here had me reconstitute 5 vials to make 4 doses. The patient that it is for only gets them twice a week (after hemodialysis).

So pretty much they just wasted a bunch of Cubicin didn't they?

Yes. Tell him it is coming out of his paycheck. That stuff is NOT cheap! (as you probably already know!)

 

[FruitFly]

Yes. Tell him it is coming out of his paycheck. That stuff is NOT cheap! (as you probably already know!)

👍

 

[njac]

I would be concerned if the hospital uses so much dapto they've gone to making premade doses!

 

[try_infrared]

this came up at my institution this week too... the Cubicin monograph in the CPS has this:

Chemical and physical in-use stability on the reconstituted solution in the vial, or infusion solutions, has been demonstrated for 12 hours at 25°C and up to 10 days if stored under refrigeration (2 to 8°C), under normal lighting conditions. However, because CUBICIN does not contain any preservative or bacteriostatic agent, aseptic technique must be used during preparation for administration and the product should be used promptly. If the reconstituted product is not used immediately, it must be refrigerated at 2 to 8°C. It is recommended that the solution be used within 72 hours due to the possibility of microbial contamination during reconstitution. Avoid excessive heat.

The combined time (vial and infusion bag) at room temperature, up to 25°C, should not exceed 12 hours. The combined time (vial and infusion bag) at 2-8°C should not exceed 10 days.

So we keep extra reconstituted vials/bags in the fridge for up to 10 days. NB: this is a Canadian reference, maybe our arctic conditions lend themselves to better antibiotic stability? Har har...

 

[xiphoid2010]

I would be concerned if the hospital uses so much dapto they've gone to making premade doses!

+1. No joke.

I interned in a ~1000 bed hospital, and we didn't need to pre-make dapto.

 

[Quiksilver]

Psssh we don't have anyone on dapto or zyvox currently

 

[rxlea]

this came up at my institution this week too... the Cubicin monograph in the CPS has this:

Chemical and physical in-use stability on the reconstituted solution in the vial, or infusion solutions, has been demonstrated for 12 hours at 25°C and up to 10 days if stored under refrigeration (2 to 8°C), under normal lighting conditions. However, because CUBICIN does not contain any preservative or bacteriostatic agent, aseptic technique must be used during preparation for administration and the product should be used promptly. If the reconstituted product is not used immediately, it must be refrigerated at 2 to 8°C. It is recommended that the solution be used within 72 hours due to the possibility of microbial contamination during reconstitution. Avoid excessive heat.

The combined time (vial and infusion bag) at room temperature, up to 25°C, should not exceed 12 hours. The combined time (vial and infusion bag) at 2-8°C should not exceed 10 days.

So we keep extra reconstituted vials/bags in the fridge for up to 10 days. NB: this is a Canadian reference, maybe our arctic conditions lend themselves to better antibiotic stability? Har har...

Interesting...I actually pulled up our "hospital guidelines" rather than just the manufacturer information. Although we don't keep dapto more than 48 hours, our hospital guideline says the piggyback is good for 7 days in the fridge....hmmmmmmmmmmmmmmmmm 😕

 

[rxlea]

Psssh we don't have anyone on dapto or zyvox currently

Eh, we see dapto and zyvox often. We are sort of a "last resort" type hospital.

 

[Farmercyst]

no current access, but does Trissel's address it?

 

[browneyes021]

Yes. Tell him it is coming out of his paycheck. That stuff is NOT cheap! (as you probably already know!)

Amen rxlea! We always wait till the nurses call for it and never send it before then.

 

[confettiflyer]

yeah what the hell, one week? what genius came up with that one?... we date ours 24hrs after reconstitution and make them daily, we haven't had a pt on that in a few weeks. we're ~400 beds and have ONE person on linezolid, none on dapto.

i'm paranoid about cost, i'll casually double check to make sure the pt wasn't d/c'd or something before cracking a bottle open. that and argatroban comes to mind wrt cost.

 

[rxlea]

yeah what the hell, one week? what genius came up with that one?... we date ours 24hrs after reconstitution and make them daily, we haven't had a pt on that in a few weeks. we're ~400 beds and have ONE person on linezolid, none on dapto.

i'm paranoid about cost, i'll casually double check to make sure the pt wasn't d/c'd or something before cracking a bottle open. that and argatroban comes to mind wrt cost.

The other day, we had to dump out 150mg of Antithymocyte Globulin (Rabbit) because the doc changed his mind 40 minutes after the bag was supposed to be hung (ie we made it for the scheduled time). I might as well have watched a stack of hundred dollar bills go down the drain.

EDIT: Then there was that one time that a tech made Zometa in the wrong solution...

 

[Sparda29]

There are only two patients I know of currently on it. We use it rather fast here, it is a geriatric rehabilitation post-hospital facility. Apparently, we have a lot of VRE and VRSA running around here.

 

[FruitFly]

The other day, we had to dump out 150mg of Antithymocyte Globulin (Rabbit) because the doc changed his mind 40 minutes after the bag was supposed to be hung (ie we made it for the scheduled time). I might has well have watched a stack of hundred dollar bills go down the drain.

Shoulda come out of his (or her) paycheck

 

[rxlea]

shoulda come out of his (or her) paycheck

qft

 

[Praziquantel86]

There are only two patients I know of currently on it. We use it rather fast here, it is a geriatric rehabilitation post-hospital facility. Apparently, we have a lot of VRE and VRSA running around here.

A lot of VRSA? I'd hope not. Maybe hVISA, but high-level vancomycin resistance is still extremely rare (thankfully). I think the CLSI breakpoints are set unrealistically high, but that's another issue.

I honestly think daptomycin is underused. The way it's currently used, especially in enterococcal infections is almost backwards. Almost half the isolates in some institutions are vanco-resistant, yet vanco is still the standard empiric treatment. Vanco is still standard treatment for MRSA endocarditis, but isn't a bactericidal drug and may take some time and adjustment to finalize an adequate dose (or not, depending on the MIC of the isolate).

I realize daptomycin is expensive, but keeping a patient a few extra days to stabilize the vancomycin dosage is certainly not cheap.

Flame away!

 

[HaloKing]

this came up at my institution this week too... the Cubicin monograph in the CPS has this:

Chemical and physical in-use stability on the reconstituted solution in the vial, or infusion solutions, has been demonstrated for 12 hours at 25°C and up to 10 days if stored under refrigeration (2 to 8°C), under normal lighting conditions. However, because CUBICIN does not contain any preservative or bacteriostatic agent, aseptic technique must be used during preparation for administration and the product should be used promptly. If the reconstituted product is not used immediately, it must be refrigerated at 2 to 8°C. It is recommended that the solution be used within 72 hours due to the possibility of microbial contamination during reconstitution. Avoid excessive heat.

The combined time (vial and infusion bag) at room temperature, up to 25°C, should not exceed 12 hours. The combined time (vial and infusion bag) at 2-8°C should not exceed 10 days.

So we keep extra reconstituted vials/bags in the fridge for up to 10 days. NB: this is a Canadian reference, maybe our arctic conditions lend themselves to better antibiotic stability? Har har...

we use 48 hours at our hospital... but just a few weeks ago we had a pt come in who brought her own daptomycin from home.. they were labeled with a 7 day expiration.. her home infusion pharmacy must be using a reference similar to you

the RN wanted an ok from me to hang the pt's home dapto that was dated to expire the next day.. umm.. no!

 

[iFarm]

We use 48h stability (refrigerated) for reconstituted dapto

And once diluted in 50ml NS, its 10 days refrigerated.

 

[charfdorn]

no current access, but does Trissel's address it?

Should be OK refrigerated for 10 days or more, so if the hospital is refrigerating it, 7 days is reasonable.

 

[Thumper17]

We try to make it as needed and date it 12 hours once we send it to the unit.

Otherwise, if it is needed during overnight and/or weekend and we have to make it ahead of time due to lesser staffing we put it in the fridge for no more than 24 hours and then have it dated 12 hours once sent to the floor.

Where is everyone getting these 7-10 day dates? I have never heard of such.

 

[Sparda29]

Talked to the DOP about it. Apparently they contacted Cubist who told them that a 7 days is fine if refrigerated after being reconstituted and mixed into solution.

 

[confettiflyer]

Talked to the DOP about it. Apparently they contacted Cubist who told them that a 7 days is fine if refrigerated after being reconstituted and mixed into solution.

Man, I wouldn't batch for a week...what if the pt expires, that's a lot of wasted dapto....

 

[Sparda29]

Man, I wouldn't batch for a week...what if the pt expires, that's a lot of wasted dapto....

I agree, I'd rather make it as needed. I wonder if they'll ever figure out a way to develop Cubicin into the IV-addvantage system. I ****ing love those things, twist the vial onto the IV bag and that's it.

 

[p-rog]

I honestly think daptomycin is underused. The way it's currently used, especially in enterococcal infections is almost backwards. Almost half the isolates in some institutions are vanco-resistant, yet vanco is still the standard empiric treatment. Vanco is still standard treatment for MRSA endocarditis, but isn't a bactericidal drug and may take some time and adjustment to finalize an adequate dose (or not, depending on the MIC of the isolate).

I realize daptomycin is expensive, but keeping a patient a few extra days to stabilize the vancomycin dosage is certainly not cheap.

Flame away!

Cost probably isn't the real concern here; Reserving cubicin for the truly vanc-resistant infections has to be a consideration.

 

[Praziquantel86]

Cost probably isn't the real concern here; Reserving cubicin for the truly vanc-resistant infections has to be a consideration.

Agreed, but at what point do you decide that switch? Anytime Staph aureus is isolated from a patient in the ICU, vancomycin is started with no questions asked, and then switched to nafcillin if sensitivities allow. If you switched that treatment order around, you'd be run out of town faster than you can say boo.

So my question is where does the line lie that you decide resistance to a drug is so high that you can no longer use it empirically? Comparing Staph and Enterococcus, it looks like that line is somewhere between 50 and 30% susceptible. But, looking at Pseud, double-coverage is almost mandated even in places with 80% susceptibility rates to a single agent.

Virulence definitely plays a role in this, and I don't think that anyone would argue that Entero is nearly as bad a bug as Staph or Pseud. Still, the line has to be drawn at some point, and I don't know where that is.

I don't think there's an answer to this, so just some food for thought. Where's that StewardshipDude when you need him?

 

[iFarm]

Add-ease would be really nice, but it seems like dapto doses vary a bit too much.