? Snickers - Any luck with Lantus 3 ml syringes 5 pack?

Recap - Snickers had a brush with death in May 2017 with a sudden DKA episode when we were unaware she had diabetes. She has done well since then and has gone from 7 pounds of skin and bones to pleasantly plump at 11ish pounds.

I've used the Lantus 10 ml bottles quite a bit since "the episode" but they are $300 each and I only use about one-sixth of them before they *seem* to go bad. I say "seem to go bad" because I went past the recommended 30 day limit initially based some comments I've seen on this board that it seemed to work ok for them. I feel like Snickers' readings degraded when I exceeded that limit with that first bottle so I stopped doing it.

$300 each month is tough though so I also tried Mark's Marine Pharmacy in Canada (mentioned on this board) and tried one of the single 3ml lantus pens. (I used a regular syringe to draw from the pen, rather than using the normal applicator for the pens.) I only stayed with that pen for 3 days as I seemed to be getting a bad response from Snick with a black 550 reading.

For several months I stayed with the $300 10 ml bottles but wanted to try to save some money again. My local pharmacy sells the pens in packs of 5 for about $400 that would (in theory) last me about 5 months. I kept the unused pens in the fridge and the one pen in use at room temp (per the instructions). Snick seemed to do ok with that first pen (though I didn't take a huge number of readings).

I feel like her readings are degrading with pen #2 which I've been using about 6 days. I've bumped up the dose from 3.25 to 3.5 to 4.0. Her readings are barely going down from the mid 300's at shot time to maybe only mid 200's at supposed nadir time. There have been plenty of times that we've gotten down to the low 100's or below with the Lantus bottle.

So my question is, has anyone had luck using the 3 ml pens and had success using them over the space of 4 or 5 months?

It's possible I'm jumping to too quick of a conclusion, but just feels like she's not getting the same results as when she gets a fresh bottle of Lantus from the pharmacy each month.

 

It's great to hear that Snickers is starting to feel better and gain weight back.

You are spending way too much money on insulin. If you haven't already, I would read the Sticky Note on Lantus: syringe and insulin info. There is a lot of great into in there. First of all, always keep your insulin in the fridge, even your current pen. Never use the pen needles, just the syringe to draw insulin. Only take the pen out to draw the insulin, then put it back in the fridge. That way it'll last ot the final drop. How long you'll use the pen depends on the size of dose. At Snicker's current dose, it won't last 4-5 months. If you were using a vial and keeping it in the fridge, it would last for months. Many people here say they've had a vial last for 5-6 months. A vial holds a lot more insulin than a pen, but the pens are more economical cause you can use them to the last drop.

Your pens from Marks could have been perfectly fine. I wouldn't let one black number tell you the pen is wrong. Rather, I would ask the questions - is she bouncing from a low number? You weren't getting many mid cycles tests at the time to tell you how low that dose was taking her. I rather suspect the problem is the dosing, not the insulin. You went up by 0.5 units this last time, and that is too large an increase. And you didn't hold the previous dose long enough either. I recommend looking at the Sticky Notes on Tight Regulation Protocol and Start Low Go Slow Method - those are the two dosing methods used here. Pick one, and follow the guidelines for dosing to keep Snickers safe. Increasing without knowing how a dose is doing can lead to too high a dose.

 

Morning Eric, I second what Wendy says plus I will add our experience. We joined the FDMB back in July shortly after Titan was DX with diabetes. This forum has been invaluable to getting him regulated. My observation tells me you are reading the posts here but not participating with us on a daily/weekly basis based on the number of your messages. There are many folks here that can help get Snickers regulated and back to a "normal" diabetic life. Your post today is great and you are reaching out for help, that's great. We also thought the insulin was bad as Titan was not responding and our vet had a different approach as to how to regulate him, small doses, small increases slowly. Turned out Titan has acromegaly and requires larger doses to stay regulated. It's very rare insulin goes bad. We found regular testing thru the day to see how Titan was responding to the doses and finding his nadir was very important, sometimes it's round the clock testing. Just look at a Titans Sperad Sheet it starts out VERY ugly but thru persistence and lots of handholding with the group here we have him in good numbers. Read, read and reread the stickys, post regularly and ask lots of questions. Good luck Ed .

 

Here are specific questions I have if anyone cares to answer them specifically:

1) The manufacturer's instructions that come with the pens state that the pen in use should be left at room temp and the other pens should be kept in the fridge. If you have information as to whether the manufacturer's instructions should be ignored and the pen in use should be kept in the fridge, please share that. If you have insight as to why they provide those instructions and why they should be ignored that would also be helpful (what is their motivation for providing poor guidance on their product?). Further, if you have personal experience with using a box of 5 pens and have found that the 4th and 5th pens are just fine 5 or 7 months down the road (after being refrigerated the whole time), I would find that information valuable.

2) For insulin shipped from Mark's Marine in Canada, although they include a cold pack in the packaging, the insulin likely reaches ambient temperature for a period of time in transit. Have people had success with the insulin from Mark's, is it any issue at all if it reaches ambient temp for a while?

3) On 10 ml vials, have you had personal experience that *strongly* leads you to believe that the 28 day expiration guidance can be safely ignored (presuming constant refrigeration)? Are you confident the insulin can still be used 90 or 120 days after first use with no (or negligible) drop in effectiveness?

Thanks,
Eric

 

Obviously, this isn't the NIH and most here are not doctors or veterinarians. It sounds like you are looking for empirical data to answer your questions. You could peruse medical journals and contact the manufacturers directly if those are the answers you are looking for and I'm sure something will turn up.

Much of the data here is circumstantial and based on numerous experiences of laypersons treating their cats for feline diabetes. Certainly science papers could be written off the data here and places like it, and it has (see the Roomp & Rand TR protocol), but that is not the point of this forum. The forum is peer to peer support provided for navigating feline diabetes. Of course it's up to you to use your best judgement on accepting the advice and information shared.
Lantus (and many other pharmaceuticals prescribed off label and commonly used to treat dogs and cats) is not FDA approved for use in cats, therefore, if you are using it for your cat, you are already making a leap assuming it is safe and effective for feline use. It's meant to be dosed once a day in humans, so you're taking another risk dosing BID in cats, but that is what the data thus far supports for being most effective in felines. Money has a lot to do with this, as I'm sure you well know.

For that same reason, you probably won't find too many studies about the efficacy of insulin past the expiration dates, there isn't much monetary gain in studying that, so who is going to pay for it? Certainly not the pharmaceutical companies. I did a quick search and found one for you if you're interested:

http://care.diabetesjournals.org/content/26/9/2665

The manufacturers went through rigorous testing and the legal guarantee you can hold them to for effectiveness is 28 days (in the case of Lantus). It's a relatively arbitrary number of which you could further research how and why they came up with it for Lantus or any drugs in general. Drugs always have a built in safety measure assuming people will use them past expiry anyhow. Of course this doesn't mean it stops working magically after that time. It degrades over conditions like temperature, light expose, constant use poking needles it in, etc. which contribute to introducing bacteria and breaking it down. Lantus being kept at room temperature isn't for safety reasons, it's for comfort reasons (most people prefer room temperature injections). It will not harm and in fact may further preserve the insulin to be kept refrigerated. Insulin could go bad in less than 28 days and can stay effective for longer.

I don't think anybody here has the exacting data you are looking for, rather, there is a general consensus between hundreds of caretakers, many with years of experience and/or well regulated cats, that Lantus insulin is decently hearty stuff and can be used safely and effectively past the expiration date if kept in the right conditions (handled minimally and kept refrigerated, never frozen). It would be very obvious if the insulin was off for many of the users here because many are following a protocol and if no other conditions are outstanding and numbers have gone wacky high and a new pen or vial fixes the problem, voila! Not as many variables and factors to nail down if you're dosing systematically and consistent with the protocol and you are testing enough to have sufficient data to show patterns unique to your cat on this drug.

I think Wendy was offering some insight as to other factors that could be in play outside of insulin being the culprit, as the experience here says that insulin is rarely the issue, particularly when other factors stand out like red flags. I think most of us also have suspected the insulin and opened a new pen or vial at one time or another (I certainly have, and for me, it wasn't the insulin). You could save a little money and look into those variables suggested and see what turns up, or you can buy a new vial of Lantus and see if that makes a difference. If the money is not so much of an issue and you just have peace of mind buying a new vial every 28 days, by all means, I don't think anyone would think it was a bad idea.

Whatever you decide to do, I hope you get to the bottom of it and Snickers is feeling better really soon.

 

Hi Eric,
it is good to see you and Snickers back! How very welcome back the both of you are!
You have risen a lot of very complex questions ; I am going to try to answer to he best of my abilities; please forgive me if it is going to be NOT what you have hoped for:

If by "information" you mean certified lab results or a court room ruling - then No, I have nothing of the kind. Instead, I have my experience of using vial/ pens of Lantus far past manufacture exp. date with success. Is there any from "authority" to certify my finding? - No. There are none. Nothing but my experience.

Those instructions are given to protect the manufacturer from any possible litigation.. " Caveat emptor" , after all, isn't it?..
The manufacturing Co is wiling to bear responsibility to their product greatest capacity at it's peak but not a minute afterwards. The pharma products trial periods take very long time, and is very expensive to say the least.. none of them, Pharma Co, ever reported the lab findings on their product being un-efficient long time after the expiration date, did they? Well, many of us here can say - yes, it works long after the exp date, but we have no "legal proof" to it.When you ask for "information" it's sounds like you want to see only the "certified.' the legally assessed as "valued" findings.. I have none of it.. Sorry.. In the case you are accepting only "certifiable" fact - you are in to spending even more $ you 've done so far - and it was A lot..

They do not provide "poor guidance" per ce.... They just omit some potential pit falls, that's all, and keep you motivated to buy again and again... The motivation? - the investors who, without any med knowledge, dumped milli0ons into the research up front and now do want their lavish returns to be paid... I am surprised it has to spelled out to someone like you..

I am down to my 3rd pen (bought from Mark's in CA) it is just as effective as the 1st one was.


Do you know how good it would be if you post weekly for Snickers? We have soo much experience and are soo willing to share it to help - do come over more often, if you can! You are so so welcome!

 

I have some not too good quality picx - both from ISBN --8385-8067-X :

 

Congrats Eric on the great progress with Snickers. I am responding to your question #3. Yes. I have personal experience with a 10ml bottle lasting significantly longer than the mg stated expiration. My Rose was DX in Jan and is currently using her 3rd vial 10 months later as documented in her SS. I never used pens because I didn't know that was the recommendation if this group before I already had my first vial. I purchase vials locally from Costco. I keep them in the fridge. I have questioned if my insulin might be going bad when I did see high numbers in routine testing, but in each case, a dose change was required.

The sticky recommended above includes details to watch for in insulin going bad (cloudy, floaties). Hope this helps!

 

I have read (here, and on a human diabetes site) that the pen dispensing mechanism may not work as well if it's cold; using syringes to draw from the pen makes that a moot point.

Felix also had DKA in May and was diagnosed with diabetes then. I used his first vial until mid July, then started a second vial although the first had some left, trying to split the difference between the one month Lantus recommends and the three months my vet said it "might" be good. I was taught by the vet to roll these (wrong!) and kept them in the fridge door (wrong!), so I did not handle either vial properly. I ordered my first set of 5 pens from Mark's pharmacy in September--it came a couple days later than indicated (due to the USPS, not Mark's or the Canadian post) and the cold pack was no longer cold, but I put them on a shelf of the fridge right away. I think Mark's encourages customers to stock up in more temperate weather, such as spring and fall--you especially don't want it freezing in transit.

While I was waiting for my pens, I'd gone back to using that first vial for a couple days. I didn't notice a difference when switching back and forth between the May vial and the July vial, nor did I notice a difference when I switched to my first or second pen. So I have experience so far of only two vials and two pens, and the oldest insulin I've used was only four months old, but switching has always been seamless. Felix was on over 6 units for a while, but now he's down to 1.5 units, so we're not going through the insulin so fast anymore.

Glad Snickers is looking and feeling better!

 

The info that comes in the package of pens is for human use. So people could carry the pen with them. Therefore, it would only be good for the 28-30 days. If all pens kept in fridge and depending on how much you give the pen should last for months. Remember do not inject air into pen.

 

I have been injecting air into the pen, so perhaps that is the issue. The pharmacist advised I inject air into the *bottle* in an equal dose I was pulling out (in order to prevent the creation of a vacuum in the bottle making it difficult to pull the dose out). When I switched to a pen, since I was not using the pen's normal injection mechanism which reduces the volume of the reservoir as shots are discharged, I also did the air injection procedure.

I'm not disagreeing with you about injecting air, but please explain why. The pharmacist instructed to inject air into the bottle. Is this an advisable procedure in your opinion for a *bottle*? If not, why? If the answer is yes, do it for a bottle, but no, don't do it for a pen, please explain your thought process.

To the gentleman pointing me to NIH, etc., I understand that it is lay-people on this forum. I am asking for opinions based on user's experience -- nothing more. There is a strange contradiction in this forum of "hey we're only lay people here, don't take this as medical advice" and then "how dare you deviate from the dosing outlined in SLGS"?

Here is additional information for those that want it so you can (perhaps) understand a bit more of my thought process. This is anecdotal of course. (We are all attempting to record data to help make this more scientific and less anecdotal.)

On 5/10 I brought Snickers home from the ER and got very poor readings for 6 days with the insulin that was sent home with me. Black, black, black, black, black. I decided to buy a fresh bottle of insulin on 5/16 and almost immediately we were out of the black. We had some pretty good luck over the next month and saw lots of yellows, blues, and greens.

Starting around 6/30, we got 9 straight days of pink and red numbers. I started to wonder if the *lay person's* advice that the insulin could be used well past the 28 day recommendation was accurate. Since Snicker's had just been through a near death trauma and a one week stay in ER at a cost of $10,000, I felt discretion was the better part of valor and that I had better grab another bottle of insulin on 7/9 (especially since $300 was comparatively small in relation to $10,000). I *seemed* to start getting better results with numbers dropping back down into the yellows fairly quickly, though I also realized there were other factors in play. In short, it was a new data point, but it was clearly anecdotal.

We did pretty well with our readings over the next month (not great, but decent all things considered). Given the extreme trauma Snick had been through, I decided to go with fresh insulin again near the recommended expiration date. Did I mention that Snick had been through extreme trauma? Since new insulin could only hurt my wallet, and (in theory) should not hurt Snick, I decided to just play it on the safe side and give her fresh insulin. However, I thought I would try the insulin from Mark's Marine as it had been recommended as a more cost effective option. As usual, I got going on my efforts a bit late and didn't get the insulin shipped and in my hands until 8/14 -- or 5 or 6 days past the recommended expiration.

Over the next 2 days, the readings didn't seem quite as good (don't jump to a conclusion to quickly Eric!!) and on the third day she got a black reading of 552. She hadn't had a black reading in a good two and a half months. Did I mention that Snick had been through a near death trauma and was in the ER for 7 days, the first 2 of which she was more or less catatonic? I decided to play it safe, write off the $100 I had spent on the pen from Mark's, and go back to shots from my old vial until I could get a new vial. I purchased a fresh 10 ml vial from my drugstore two days later on 8/19.

We immediately got much better numbers with a good amount of blues and greens mixed in. A month went by with quite good numbers and on 9/20 I said to myself, ya know, Snicks been through a lot. Let's not take a chance -- let's get her a fresh bottle of insulin (for $300) and keep the good results going. I slacked off a bit on the number of readings I took over the next month (ya know, cuz I have a job and a life) and took fewer mid-cycle readings but stayed with a reading at shot time. I took enough mid-cycle to still feel like things were going pretty good.

A month later, on 10/20, I decided to experiment one more time to see if I could break from the need to spend $300 on insulin every month for the next 8 years. I bought a box of 5 pens from my local pharmacy for $400. If these pens would stay fresh, one per month, I would be more than ecstatic. I read the instructions in the box from the manufacturer and it stated clearly to *not refrigerate* the pen that was in use but to refrigerate the unused pens until first use. I decided to follow the instructions. On the first pen from Mark's I had not followed the instructions and had kept the pen refrigerated (and believed I had gotten a bad result).

For the first several weeks I felt I was getting decent readings from that room temperature pen. For 8 or 9 days I got lazy and didn't take any mid-cycle readings. When I did take a few about 3 weeks in, the numbers seemed a bit high. I decided to go with a new pen after only 3 weeks on 11/13.

Even then it didn't seem like I was getting much movement. Readings at mid-300s at shot time and only down to 270 at normal nadir time (or still in 300's). Over the past 2 days or so, I have elected to use *my judgment* and bump the dose up from 3.5 to 4.0 all in one swoop! The *guidance* laid out in the SLGS protocol did not come down from a mountain inscribed on stone tablets, I reasoned. The people have said "every cat is different" I reasoned. My reason for bumping the dose up in a larger increment than the commandments provide for, and in a shorter wait period from the previous dose, was because I wanted to try to figure out if the insulin in the pen was causing any action after shot or if I had to abandon the effort to use more economical pens and go out, right now, and buy another fresh vial of insulin for $300.

I recognize that what I am looking at (the data) is anecdotal, and that what I am seeing might be due to other variables.

Before going straight to the new vial for $300, I decided to ask for guidance on this forum as to whether other users have felt they have hit "staleness" issues on their insulin, whether they have had luck with the pens, etc. It doesn't mean I need empirical evidence and I'm well aware this is not professionally backed veterinary advice.

If you want to share your experience with your cat on these matters, as best you can tell, please do. If you want to try to provide your opinion on the question I am asking, like "why refrigerate the pen in use when the manufacturer says don't", please do. If you can explain your reasoning or who suggested it and why, that is helpful.

Tonight I will try a fresh pen (#3 of 5) and will change up from the protocol of the last month by A) leaving the pen in the fridge and B) not injecting air into it. I will stay at 4.0 units and will hope to see some definitive movement in readings after the shot.

 

I have heard the pen needle mechanism doesn't work well if refrigerated, hence the manufacturer saying to not refrigerate as humans use the pen needles. The pen also has a negative pressure mechanism that moves an internal stopper down th container, when you remove insulin. It's harder to see in a pen, but obvious in a cartridge, which is a pen refill, that I used in Canada, and not available now in the US. The only time I had a cartridge fail on me, was when I took a 6 day car trip when the temperatures were mostly above 90. Otherwise they were good to the last drop. I started with a vial that I used for three months.

The SLGS guidelines are there for safety of the cat. It is our guiding principle. They were developed over years of experience, good and bad, on this forum.

 

The vials need the air to help keep the pressure equal....the pens don't....they have a stopper that slowly goes down as you pull insulin out of the pen which does that for you (basically)

 

You can thank Europe for the arbitrary 28-day expiration date. According to The Angry Pharmacist, the European Medicines Agency promulgated a rule in the late '90s that applicants for a drug approval license need to provide studies showing, among other things, the maximum shelf life of sterile products for human use after opening. The guideline, which can be found here requires that a product label or insert contain the following claims:

and that:

There you have it. The EMA told applicants that they only need to show potency/efficacy up to 28 days after opening, so drug manufacturers didn't study it for any longer than minimally-necessary to gain approval. The FDA later adopted this same rule allegedly without any studies to back it up, which is why the United States has the same 28-day use-by date.

In short, 28 days is the way it is because some regulatory agency somewhere in the world said so and everybody else just followed along.

It would be great if there was some independent research to confirm or refute that number, but I can't seem to find any. Unless someone can convince an insurance company or philanthropist to fund the research, there likely won't be a financial incentive to do the studies because the manufacturers certainly aren't going to finance anything that may cut off their cash cow. Even if research pointed to a significantly extended shelf life, researchers and physicians may still be unwilling to recommend using insulin beyond its approved use-by date because doing so might subject them to legal liability should someone rely on that advice and have an adverse reaction.

From a purely scientific standpoint, such research might prove challenging to conduct even if it did have funding. As Novo Nordisk revealed in an earlier link:

Many of those factors may be difficult, if not impossible, to control for in an experimental setting.

Thus, we're left with the anecdotal evidence of countless caretakers gained through trial and error, including statements by veterinarians in articles like this:

At the end of the day, you have to do what you believe is in the best interest of your cat. If that includes purchasing new insulin every 28 days, and it is within your means to do so, then that's absolutely what you should do.

 

@Eric Minor Since Snicks had dka, you are testing for ketones daily with these readings correct? If not you need to start. Catching it early you could possibly avoid another hospitalization, by intervening at home. Not always but sometimes you can. Using urine dip sticks is the most affordable way, using a meter (just like glucose meter) is the most accurate way, strips for it are really pricey. Of course you can do both, if dip stick shows abnormal use meter to double check.

Most of us have done the same thing, using new vial of pen because we think it went bad because we are seeing the numbers go up not down or staying the same. I did and I had one pen that did go bad because my husband injected the air and we got the "floaties". I think we all went through this in the beginning.

Not to throw anymore confusion into the mix and you and Snicks haven't been into this to long and need more time and stay consistent. There are a few conditions that could also cause the readings to keep going high even though you see occasional good numbers. Acromegaly and insulin resistance. Your vet can draw the blood and it's sent out. Takes 7-10 days to get results. Most vets claim it's rare and never think a cat has it, however, I believe the stats are 1 in 4 does have one or the other and usually both to some degree. Both these conditions require large doses of insulin and some are extremely high amounts until it breaks through. There is info here on both of these conditions and a few people here have cats with it. You might want to consider having Snicks tested if for no other reason but to rule it out. If it's ruled out then it's just tweaking how you are going about it.

It could be Lantus just isn't the right insulin for Snicks, I don't think you been on it long enough to know yet. However, if the dose keeps going up you might consider levemir since its more comfortable when given in high dose situations.

 

My experience with Lantus.

Jones was prescribed the Lantus pen right from the get go from his vet. She (also a diabetic kitty Mom), indicated that the pen could be used to the last drop. The vets instructions was to always keep the pen refrigerated. It is marked on the pen with a red sticky - all of them I have gotten has that sticky. So I did as instructed, I didn't even bother to look for manufacturing guidelines. It was actually on the FMDB that I learned that humans keep it on their person, purse etc and it was to last only 28 days outside the fridge as per the manufacturer.


I have had 4 pens since Jones' diagnoses a year ago. Once I started using the SLGS protocol I ended up using a syringe vs. the vet pen needle provided to get those 1/2 and 1/4 units.

• One of them I dropped and it had broken so there were pieces inside of glass/plastic inside the pen. There were air bubbles inside it too. I ordered a new pen from the vet. It was about 3/4 the way full then this happened. I still used that insulin until I could pick up the new pen the next day. I didn't see a big change in his numbers.
• I once thought the old pen was going bad as his numbers started to slide up....got new pen and no change. Went back to the old pen used it to the last drop and then started the new pen again about a month later.
• One pen I don't know what happened....it started to turn cloudy. Jones' number seemed to be holding but I ordered a new pen any way and threw out the cloudy one. It was about half gone. I never left it out, never dropped it...so not sure what happened there. I had it for about 2 months. Bad batch maybe?
• I just got 5 pens and all have an expiry date of January 2020 if kept refrigerated. I am just about to crack a new on of these but I have about 2-3 doses in my last pen.
• The ones I used to the last drop lasted for months. At .25 units or less, it takes a while to get through a pen.
• In my experience they can last up to 2-5 months if you don't drop them and they break.

The pens have a negative pressure mechanism as Wendy mentioned. As you draw you will see the stopper move down on its own over time. So you don't need to inject air into the pen to cause pressure like you would with a vile. (I have to do the inject air for Jones B-12 injections out of a vial.) I like the pen as I can grip it nicely. I have never tried the vial or the cartridge alone for the insulin.

With Jones, the first questions when his numbers increase are...did he get any contraband (more treats than usual, get into his sisters food)?, did he eat well during the cycle or not?, is he feeling ok? (he has IBD which can lead to discomfort), did he vomit today (the acidy tummy type of stuff which makes him feel a little achy), was there something else that went on today that could lead to higher numbers. The big one - is he bouncing? Did he go low and I didn't catch it or did he drop quickly and didn't catch it? I really try not to play with dose unless he meets the criteria for his modified SLGS approach.


With Lantus being consistent is key. Keep as close as you can to the every 12 hour shot timing, keep your dose consistent until the pattern tells you to change and if in doubt ask the board.