Lantus Storage and Handling

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stefani&toonces

stefani&toonces

Member Since 2009
I got a question from a rescue group today that prompted me to look up Sanofi-Aventis' online infomation about shelf life and storage of lantus.

I was shocked to see the instructions emphatically said NOT to refrigerate the solostar pens. I always have done that.

Does anyone know why they say this? Do those of you who use the solostar pens refrigerate them or not?

BTW, what prompted me to look this up was my need to prove that lantus is supposed to be discarded after 28 days. Sadly, a woman who contacted the rescue and reported that her cat had recently died from "diabetes and cancer" was offering her left over lantus for use. When I told the rescue lady it would do me no good if it was over 28 days old, the owner of the deceased cat responded that her veterinarian told her the loss of potency after 28 days applies only to humans, not animals, and he advised her to keep using the same vial for up to 6 months. This may explain why diabetic complications played a role in teh cats demise.

This is the second vet I've heard of tell a pet owner they could keep using lantus until it is all used up. A guy came on this list that I went to coach on home testing (Randall and Sheba) and the vet at the shelter clinic (which is well reputed) told him he could keep using the lantus vial until it was gone. No surprise, all of a sudden his cat was showing symptoms of not responding to treatment. I think he had a hard time believing my word over that of a vet.

How can vets be so stuipid that they think loss of drug potency wouldn't apply to cats? Is there any document on this that I can anonymously send to these vets? I am sure they are still telling people they can use a vial up!
 
My pharmacist told me NOT to refrigerate the solostar pen. I'm new to this but I have not refrigerate mine.

According to the instructions, it must be kept between 15-30 C once opened (important these past few days, it’s hot around here above 30 C (if you don’t have AC), I’ve been checking temperature 3-4 times a day where I keep it just to make sure it's OK. Sure would be easier to keep in the fridge.

She also told me it could be used up to 3 months or until I notice it doesn’t seem effective. I kept the first one 30 days…
 
There's been considerable discussion here (both new and old board) and I also think there was a thread in Think Tank about this topic.

There's a statement in the Tilly Protocol about the shelf life of Lantus once opened.
Tight Regulation Protocol said:
• members of the German Diabetes-Katzen Forum buy 3 ml Lantus/Levemir cartridges, refrigerate them after opening and routinely use them for 6 months or more - when refrigerated, opened cartridges of these insulins are extraordinarily stable
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FWIW, when I've bought Lantus from a chain pharmacy, university medical center, or on-line through Canada, the boxes have always been refrigerated. Likewise, I've always kept the unopened and opened pens refrigerated. That said, I believe Monique pointed out that the packaging of Lantus in pens and their not requiring refrigeration was innovative. It gave human diabetics a great deal more flexibility with travel since their medication did not require refrigeration. It should also be noted that humans use more insulin per shot and they would finish a pen much sooner than we do with our cats.

The 28 day issue is one which I was curious enough about that I called the pharmacy at the U of IL vet school and spoke with one of the veterinary pharmacists. She could not find anything in the pharmacology literature about why there is a 28 day duration. She was intrigued enough to post on a vet pharmacy listserv. No one had a clear explanation as to why there was a 28 day shelf life. It is the manufacturers recommendation and ostensibly, the 28-day period had to be approved by the FDA. That said, no one seems to be able to find a justification. The pharmacist did say, though, that she would not recommend using Lantus beyond the 28 days recommended by the manufacturer. From the standpoint of the drug company, if a human used Lantus beyond 28 days and developed DKA, the person could not claim it was the fault of the drug. (Also keep in mind, there is no veterinary indication for Lantus. It is only approved for human use.)

There are many people here who get longer than 28 days from their Lantus providing they don't shake, rattle or roll the vial or pen. On the other hand, I know I find that Gabby's numbers will get wonky if I don't discard my pens at around the 28 day point. The two times I went a week or more beyond that point, Gabby's numbers suffered. I do tend to think some cats are more sensitive to some of the potency issues than other cats.
 
Just a quick note. I've used pens and vials both for longer than the 28 day mark. In fact, my vial was still producing good numbers after the 6 month mark. And my understanding on not putting Lantus in the fridge, according to a Lantus using human, is that it doesn't feel good when it's injected cold. Cats, with exception of Acro kitties, get much smaller doses so it doesn't seem to affect them.
 
hi stef. a few years ago i called sanofi-adventis to ask why open pens were not supposed to be refrigerated. their response made sense. plastic contracts when it gets cold. if open pens were refrigerated, they couldn't guarantee the accuracy of the dose when using the pen as intended. since we use syringes to draw insulin, this is not of concern to us.

4 years ago, my first vial of lantus lasted 2.5 months before i saw floaties. it probably would have lasted longer, but that was back in the days when we would shoot the excess back into the vial if we had drawn out too much insulin. alex went OTJ after only a few weeks on the second vial, so i don't know how long that vial would have lasted.

up until a couple years ago, many lantus peeps used their insulin for months... some to the last drop. as cheryl mentioned, a survey was taken on the german katzen forum. caregivers were able to use refrigerated lantus for at least 6 months.

fwiw, i'd use insulin until i saw floaties or the insulin became cloudy, discolored, or froze...
 
This is all very interesting. Thank you.

I have used lantus with 5 cats, and I have always seen a loss of potency no later than 6 weeks. The only person I personally knew who was shooting lantus they'd had for months had a cat who was no longer responding and voila -- a new vial fixed the problem. I would at least always recommend monitoring for loss of potency if someone wanted to try to keep it longer, and I remain baffled that vets don't recommend that, and that when a cat shows up suddenly not responding anymore to their shots coming out of a vial several months old, they don't think to try a new vial.
 
I do wonder whether vets don't think about switching out a pen or vial because they don't see numbers fluctuate the way we do as a result of home testing and close monitoring. A vet who may see a cat once a month for a curve or a fructosamine level doesn't have a SS to study and note that numbers aren't following their usual trend. The first time Gabby's numbers were weird, Jojo pointed out that it was probably that my Lantus was toast. The next time, I caught it because I knew what to look for, I'm a testaholic, and I will study a SS (and I have everyone here to help puzzle through an odd set of numbers).
 
The company guarantees that the Lantus is good up to 28 days after first use. But, it doesn't just stop working over night. Its a legal CYA, thing. People are stupid and like to sue, so the company is going to play it on the safe side.

I still like the analogy someone (human diabetic) gave me comparing insulin to milk. If you keep both out of the fridge too long, then it will begin to spoil faster. If you take too much out of the container, don't put it back into the container. Avoid extremes of temp. After getting close to freezing or too warm, it will never quite be the same again. Should be used up within a certain time of opening (use by dates are basically useless). But, always inspect for visual signs of spoilage. Sometimes it will go bad on the day it expires, some times you will get a bit more time out of it. The maker attempts to make each container the same as every other, but minor differences can occur.
 
I don't use the pen as I like the vial and am used to it. I used my last vial of Lantus for four months, being very careful not to roll it. With a new vial her numbers were consistent with the former four months old vial. The very first vial I got when my kitty was first diagnosed I rolled the vial, not knowing better, and the vial lasted less than a month. I could not get rid of the bubbles. The Pharmacist says only one month for the vial, and the Vet says a few months?
 
Well if a human saw a 1/3 reduction in how long it lasted, then it would go from lasting 24 hours to only 16 hours. For a cat, they would only go from 12 to 8. And cats are much more tollerant of BG fluctuations (on the high side), than people are.
 
Say whatever you like, when I purchase my insulins from the pharmacy, the boxes are taken OUT OF THE FRIG.
If the pharmacy stores the insulin in the frig, why would I store it any differently?

You can keep yours wherever you like, but I am keeping mine in the frig with a thermometer beside to know the temp in the spot it's stored.
 
In a private communication with a staff pharmacist at Novo Nordisk, I received the following message: “If human insulin vials that are stored under refrigeration are used beyond 30 days, the stability of human insulin vials is dependent upon a number of factors in addition to temperature. These factors include the number of injections per day, volume of insulin remaining in the vial, exposure to light, agitation, and technique used for dose preparation. The impact of these factors is difficult to measure and the health professional should advise patients on an individual basis concerning long-term storage of opened insulin vials when refrigerated.”

From Aventis:

RESPONSE FROM AVENTIS

We appreciate the opportunity to respond to Dr. Grajower’s request for information regarding Lantus (insulin glargine [rDNA origin] injection) and the following associated topics: stability information and prefilled syringe stability. Lantus is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes or adult patients with type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia.
Warnings

Hypoglycemia is the most common adverse effect of insulin, including Lantus. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal and human), or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need to change dosage. Concomitant oral antidiabetes treatment may need to be adjusted. Lantus must not be diluted or mixed with any other insulin or solution.
Stability information

The following information is stated in the Lantus package insert (2):
Storage.

Unopened vial: Unopened Lantus vials should be stored in a refrigerator at 36–46°F (2–8°C). Lantus should not be stored in the freezer and should not be allowed to freeze. The vial should be discarded if the contents are frozen.
Open (in-use) vial.

Opened vials, whether or not refrigerated, must be used within 28 days. They must be discarded if not used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days in a place away from direct heat and light, as long as the temperature is not >86°F (30°C).

This letter briefly describes the analytical processes and testing procedures used to support the labeled stability. The stability of Lantus has not been evaluated in containers other than those described for commercial distribution, nor has it been evaluated under physical conditions other than those described herein. Stability under other circumstances cannot be inferred from these data.
Analytical procedures

Lantus stability testing assesses the following parameters (Aventis, data on file): 1) appearance, 2) particulate matter, 3) sterility and bacterial endotoxin content, 4) pH, 5) insulin glargine and noninsulin glargine protein content, 6) preservative (m-cresol) content and stability, and 7) active insulin glargine content (bioactivity). Unless otherwise stated, Lantus met or exceeded stability requirements in these studies (Aventis, data on file).
Stability testing
Photostability.

Lantus was found to degrade after extended exposure to either room light or artificial sunlight (Aventis, data on file). Due to this finding, all other stability testing was conducted in an environment protected from light. When not in active use, Lantus should be protected from light. An in-use vial of Lantus is stable in room light for a period of 28 days. Lantus should be protected from direct sunlight.
In-use stability (open vial).

The in-use stability of Lantus was assessed over a 4-week period with or without refrigerated storage (Aventis, data on file). During the study, 2 units of Lantus were removed each day and discarded. The samples were stored at either 41 or 77°F (5 or 25°C) for a period of 28 days. The remaining product after 4 weeks met all stability criteria. It is recommended that Lantus be discarded after 28 days following the first use, regardless of refrigeration.
Long-term storage stability (unopened vial).

Lantus was found to meet stability criteria for at least 24 months when stored between 36 and 46°F (2 and 8°C) (Aventis, data on file). Accelerated stability testing at 77°F (25°C) revealed a slight loss in activity by 9 months. Testing at 95–102°F (35–39°C) for 1 month revealed an increase in impurities without loss of activity. Lantus should be stored in a refrigerator to maintain the labeled expiration date. In the absence of refrigeration, unopened vials of Lantus should be discarded after 28 days.
Adverse shipping condition stability.

The stability of Lantus was determined under conditions mimicking extreme temperature changes that may occur during shipment (Aventis, data on file). Two separate 28-day investigations of temperature fluctuations from 5 to 77°F (−15 to 25°C) and from 41 to 77°F (5 to 25°C) were conducted, with repeating cycles of 4 days at the lower temperature and then 3 days at 77°F (25°C). The content of Lantus did not change appreciably under either set of conditions and met stability criteria.
Summary

Unopened Lantus stored under refrigeration and without freezing will maintain stability to the expiration date stated on the packaging (Aventis, data on file). Should Lantus freeze, it should be discarded. If refrigeration is not available, unopened Lantus may be stored at controlled room temperature (≤86°F, ≤30°C) for a maximum of 28 days. Lantus should be discarded 28 days after first use, regardless of refrigeration.
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As you can see Lantus was not tested beyond the 28 point, therefore they cannot gaurentee that it will be useable beyond that time (due to lack of data). In addition typically you would test several containers, lets say theoretically 10 vials, 1 vial is cloudy after 15 days, 3 vials cloudy after 28 days, 5 vials after 42 days, and 1 vial still good after 90 days. The majority of the vials lasted AT LEAST 28 days, beyond that time the viablitity is variable so manufacturer can recommend only 28 days useage.

The insulin doesn't become "dangerous" even if it is ineffective (of course poor BG control can be unhealthy including DKA) but the insulin will not become a poison. I suggest using common sense, always store and handle it properly to maximize the shelf life, inspect it every use for signs of spoilage (like you sniff the milk), replace when you suspect it may be losing potency (based on your BG readings) or if you see evidence of spoilage (also if you know or suspect it has been frozen or exposed to prlonged light or high temps).

I also recommend if you "think" your insulin may be pooping out (loss of regulation can be due to other factors....stealing forbidden foods, infection, other medications, unusual stress) I would open a new pen/vial but don't toss the questionable one just yet, it could still be used in an emergency (like if you drop the new one and break it on a friday evening, no vet, no script) also if your new pen doesn't prove to give you better numbers then the insulin was not the problem, you can still use that pen.

up until a couple years ago, many lantus peeps used their insulin for months... some to the last drop. as cheryl mentioned, a survey was taken on the german katzen forum. caregivers were able to use refrigerated lantus for at least 6 months.
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In the German forum the questionarre showed that Lantus could often be used for up to 6 months or until empty, there were some that either used all the insulin before 6 months or cats when OTJ after a few months and several had insulin go bad before 6 months. But in general we found that it could in most cases be used well beyond the 28 day recommendation.
 
Well this is interesting...I have not changed my vile of Lantus and have been using it since 5/10/10...I keep refrigerated, couldn't tell you the temp.
I have it securely nested in the top shelf of the fridge door....hmmm maybe I should move? But I haven't experienced anything weird yet. I check
the vile each time to see if it's cloudy or anything weird in it.
Doodles numbers seem to continue to go down. But this will certainly give me an idea if her numbers start going weird.
I was told at least 6 months by my vet also. Granted I am her only Lantus user, but this is the first time I've heard it's only good for 28 days! At a $100 bucks
a vile and only 1U, are you kidding? Really? I'm hoping this is not going to be the case.
 
Heidi, that's the reason why many people get the package of 5 cartridges. The vial is 10ml and each cartridge is 3ml.
Yours may well be fine, but some have issues.
 
Basically, the mfg. only guarantees for 28 days , but it may last longer. As has been stated, it's a legal safety net for them. This is why most of us use cartridges or pens rather than the larger vials. We only open 3ml. at a time , so if it looses effectiveness we are throwing a lot less out.

I've done both, gone over 28 days and changed on schedule. It depends on where Tess's numbers are. Right now we are on day 45 and Tess's numbers have been great. I keep the cartridge refrigerated, check visually at every shot and keep it in a padded case in the fridge.
 
Basically, the mfg. only guarantees for 28 days , but it may last longer.
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As you can see from the statement I posted from Aventis, the main reason is because they didn't test it beyond 28 days so they just can't speculate that it does last longer. I can't tell you that I can run 10 kilometers if I have never done it because the maximum I have ever run was 5km that I can verify.

WE have "tested" Lantus and have many reports that it lasts longer than 28 days, although we don't have an absolute "in most cases" time frame because our data is not a controlled study ( I assume many cases of it going bad before 6 weeks or so is likely due to the person just assuming it was bad when it in fact was still good, or imporoper handeling and storage) a good percentage did get 6 months useage (even if the potency decline a small bit this was likely compensated for because either the cats own pancreas was healing and helping out or the dose was adjusted according to the numbers) I think you have to consider that the insulin doesn't just overnight become completely inaffective but rather it may slowly become slightly less potent but not so significant or quickly that it would be blatantly obvious.

As it states in the "Sticky" about handeling and storage, often regaurless of how long the insulin has been in use it is often the case that the last 10-20 units have less potency. This is because the universal gas laws apply to liquids to some degree as well. as volume decreases (the amount of liquid is less) it experiences more rapid cooling and warming. So when your vial has just a small amount of liquid in it each time you take it out of the fridge it warms up to room temp in a short period of time and cools again quickly when you put it away again this fluctuating likely has a deterirating effect on the insulin.
 
I used one vial (bottle) of Lantus from October through March. Basil went OTJ or it would have lasted longer than that.

It kills me to see people wasting money, medication and packaging because of drug company greed, and that's what it is. Why don't they test beyond 28 days? The answer is easy. All they could do is make people buy less of their product. Why are antibiotic tests not redone for decades? Because the drug companies are happy with the results. Why prove people need less or that they can store t he drugs for longer?

Many meds last FAR longer than their freshness dates.

Feline Lantus users have no reason to store the pen refills outside the refrig since they are not using automatic dosage. And they have no reason to discard it after 28 days. Anyone's Lantus can go bad at any point due to mishandling of it in its past. But kept cool throughout its lifetime, it will last quite a long time.

I think if you find your Lantus is not having the same effect as it was and if the liquid looks clear, try adding a hair to the dose. It's just a matter of the amount in the shot in that case.

My two cents!

(Basil says hi!)
 
This is a very helpful, interesting discussion! Thanks for starting it, Stefani. :-D

To answer your question, I have used one 5-pack of SoloStar pens, and I am currently using a 10 ml vial which I just started a few weeks ago. I refrigerated the SoloStar pens per the instructions of folks here. I never got more than 30 days' use out of a pen.

The instructions in the insert for the vial say that you should inject air into the vial equal to the amount of insulin you draw out, but I am not doing that either, also per the recommendations of people here. The pharmacist told me to do that, and it's what you do with PZI, so I'm not sure why you don't with Lantus, but I'll go with the experience of FDMB peeps over some dude at Walgreens who couldn't get past the fact that I a) shoot my cat, b) check her BG, and c) am able to measure such a small dose (as compared to humans, I assume). :lol:
 
My cat was just diagnosed with diabetes a little over a week ago and to say the least I've been freaking out since then. When I got the news about his diagnosis, I immediately typed in "feline diabetes" and found this website. It's been a life saver and I'm glad to see there are so many others out there that I can get help and guidance from!

Ok, so on to my question....My vet prescribed Lantus (she actually told me it was Glargine and no one at the pharmacy knew what I was talking about), but she told me that I need to roll it in my hands very slowly in order to "activate" it before I insert the syringe. Everything I've been reading on here tells me that I shouldn't roll it and now I'm confused. Am I doing something wrong? The last thing I want to do is end up hurting my kitty so if anyone can please tell me what I should do I would appreciate it.

Thank you - Pamela and Lightning
 
The instructions in the insert for the vial say that you should inject air into the vial equal to the amount of insulin you draw out, but I am not doing that either, also per the recommendations of people here. The pharmacist told me to do that, and it's what you do with PZI, so I'm not sure why you don't with Lantus,
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Actually Sahrah, you SHOULD inject air into a vial, but not into a pen or cartridge, they are different systems. The pen is like a syringe, you probably noticed as you removed insulin from the pen a black (or orange) rubber stopper moved down the barrel always keeping the liquid pressed towards the membrane where the insulin comes out. When using the pen as an autoinjector as it is designed it works just like a syringe, that plunger squeezes the insulin out when you push the button. Because the liquid is always under pressure injecting air into the pen before removing insulin can cause an overpressure in the pen (this isn't so damaging to the insulin itself) but it can damage the pen, the membrane may start to leak, or worse the membrane (which is like a little ball) could completely be popped out, or the clear plastic barrel which holds the insulin could crack or possibly explode (maybe in you hand!)

A vial on the hand is meant to have air injected to maintain equallibrium. If you continue to remove liquid and don't replace it with air you create an under pressure inside the vial (the rubber stopper is air tight) it will create a vacuum inside the vial. Think of a plastic soda bottle, if you put your lips on it and seal the opening and start drinking eventually you can't get anymore cola to come out and you have to romove your lips and allow air into the bottle to equalize the pressure, if you have a cheap think recycling plastic bottle it will even begin to collapse. A glass vial probably won't implode but you may find at some point you can no longer "suck" the insulin out and you need to inject a good amount of air to get it flowing again. So the same applies as with PZI in a vial, yes inject air, sorry you got bad advice.
 
No rolling needed with Lantus. Many other insulins do require rolling to "redistribute" the insulin in the suspension, but not Lantus. It can actually reduce the lifespan of your vial.
 
Ok, so on to my question....My vet prescribed Lantus (she actually told me it was Glargine and no one at the pharmacy knew what I was talking about), but she told me that I need to roll it in my hands very slowly in order to "activate" it before I insert the syringe. Everything I've been reading on here tells me that I shouldn't roll it and now I'm confused. Am I doing something wrong? The last thing I want to do is end up hurting my kitty so if anyone can please tell me what I should do I would appreciate it.
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Hi there and welcome!

You should not roll Lantus, there are different types of insulin, some are crystalline particles suspended in water (it will usually say SUSPENTION on the bottle) you can even see a white sediment on the bottom of the vial when it has been sitting and those you need to roll to mix the particles evenly throught the liquid. Lantus (generic name is Glargine) and Levemir (simular to Lantus it's generic name is Detemir) are both homogenous solutions all of the active insulin is dissolved in the liquid and it does not need mixing. I guess you could think of it like fresh milk and homoginized milk. The milk you buy directly at the farm is not homoginized and when it stands in the fridge it separates. On the bottom you have mostly water and on the top is a layer of thick cream which contains most of the protein and fat in the milk. Homoginized milk from the store has had the fat and protein molecules mechanically broken down into very small peices so they fully dissolve in the water part and don't separate anymore so you don't need to shake the milk.

If your curious I can tell you that milk is homoginized by spraying the milk with high pressure (like a pressure washer) through a thin hose which has a very fine screen on the end of it. As the larger fat and protien molecules are pressed through the tiny holes in the screen they are broken into much smaller peices which are able to completely mix and dissolve into the liquid (water) part of the milk. :-D

Rolling or shaking a solution like Lantus may not be good for it, first holding the insulin in your hands or between you warm hands will warm it up more each time you do it then it will need to cool again in the fridge, this more significant temperature swings twice a day will shorten the life of the insulin. In addition constant rolling or shaking could damage those tiny dissolved insulin molecules causing them to clump together and become to big to stay dissolved, when they are bigger they don't remain dissolved and thus you get cloudy or "floaties" in you insulin and it needs to discarded.

Another possible hazard to rolling a vial.....the risk of it rolling out of your hands and landing on the floor, they break pretty easy and you insulin is then definately toast! ohmygod_smile
 
Monique-
I love your explanations; clear, concise, and to the point. :-D Thank you! I will definitely start to inject air into the vial. I haven't noticed it getting harder to draw out insulin, so hopefully you alerted me before any issues cropped up.
 
Sarah and Buzz said:
Monique-
I love your explanations; clear, concise, and to the point. :-D Thank you! I will definitely start to inject air into the vial. I haven't noticed it getting harder to draw out insulin, so hopefully you alerted me before any issues cropped up.
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Thanks Monique, from me, too. I have not been injecting air into the vial of Lantus either, but will now be doing it.
 
Sarah and Buzz said:
This is a very helpful, interesting discussion! Thanks for starting it, Stefani. :-D

To answer your question, I have used one 5-pack of SoloStar pens, and I am currently using a 10 ml vial which I just started a few weeks ago. I refrigerated the SoloStar pens per the instructions of folks here. I never got more than 30 days' use out of a pen.

The instructions in the insert for the vial say that you should inject air into the vial equal to the amount of insulin you draw out, but I am not doing that either, also per the recommendations of people here.
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You are welcome Sarah. Yes, I have noticed that if I don't re-inject insulin back into the vial after withdrawing into the syringes, and if I don't inject air into the syringe, it lasts longer. Longer in my case being up to 6 weeks instead of just 4 weeks. But then, if it's >4 weeks, and I noticed higher numbers, I assume it might be the insulin and start a new vial. Half the time it seems to be right, the other half not. Still, I usually do notice a potenty issue 4-6 weeks. The more careful you are with it, the longer till that happens. I just don't think people should keep using it all that time without testing, this is the first time I've heard of a vial going 6 months or more. I've never seen it myself.
 
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