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Unrefrigerated Lantus Question

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#1
owlyn

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Went to the drug store, picked up new boxes of Lantus Solostar and Humalog Pens. Went home, got distracted, forgot to put pens in fridge for almost two hours. They were at room temperature, no sunlight or other warmth exposure. Did some research on the net and also called the manufacturers.

Bottom line is this: Humalog should be okay with only very minimal efficacy difference (<1% difference), so I'm okay there. Sanofi Aventis tells me that the Lantus pens will only be good for 28 days, even though they were not opened. This translates to my having to throw out 2 of the 5 Solostar pens.

Question- anyone have any experience with using unrefrigerated Lantus longer than 28 days?
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#2
valc3

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I always kept my Lantus at room temperature. I used it beyond the 28 days without a problem.
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#3
Scratch

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I've had Lantus vials, being used, out at room temp for up to 60 days with no measurable signs of lost potency for me. Room temp in the summer time can be in the upper 70s for short periods.

I don't see having left the pens out at room temp for 2 hours as a problem here.
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#4
hodgsonsurvivor

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I keep my Lantus at room temperature. I only refrigerate vials if I know I'm not going to be using it any time soon. 1 vial usually lasts me about 45 days, so I'm guessing it fits in the "average use" range. I think your insulin should be fine after just 2 hours.
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#5
gettingby

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Owlyn, I kept my Lantus that was currently in use at room temps and used it for more than 28 days with no problem. Leaving it out for 2hrs should not cause you any problems.
BTW, welcome back. :)

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#6
owlyn

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Thank you everyone. BTW, my research found that the 28 day timing on opened bottles of any insulin was due to the growth of bacteria. The contents of a bottle or pen are sterile until opened. After that, bacteria starts to grow, and the manufacturers aren't real happy with the amount of bacteria by the 28 day point. The potency of Humalog is still fine at that point, as long as it hasn't been exposed to many temperature changes. In fact, the reason for refirgeration (of Humalog, and maybe others) is that a refrigerator is apt to provide the most stable temperature- it's really not so much because it's cold. There are a few factors that affect the potency of insulin: changes in temperature, movement, and light. A refrigerator solves all of those problems.

Here is a link to the pertinent study: How Long Should Insulin Be Used Once a Vial Is Started? -- Grajower et al. 26 (9): 2665 -- Diabetes Care

Here are some quotes of interest:

Regarding Lantus: "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. "

Their "Summary" isn't supported by the facts, at least as far as efficacy is concerned. My 2 hours should be nothing.

Regarding Humalog: "At the time of manufacture, insulins available in the U.S. have a label potency of 100 units/ml. However, regulatory limits allow for ±5% variation around that standard. Internal standards for insulins manufactured by Eli Lilly are within ±3.0% at the time of release. At room temperature, the degradation of insulin is an approximately linear function. At elevated temperatures, insulin loses chemical potency, which is accelerated as the temperature increases. For example, at room temperature (77°F), insulin will lose <1.0% of its potency over 30 days, or <0.03% potency lost per day. In contrast, insulin stored in a refrigerator will lose <0.1% of its potency over 30 days (Lilly Research Laboratories, data on file). For this reason, and to maintain consistent temperature exposure, we recommend that any unused insulin be refrigerated. Importantly, the relatively small amount of degradation products that develop during storage, such as B-3 and A21-desamido insulin, remain partially biologically active. Although refrigeration should be used when possible, the loss of the biological potency of insulin is so slow that if one carefully protects insulin supplies from extreme temperature, any losses of potency should have minimal, if any, effect on the control of diabetes. Ultimately, although "main peak" chemical potency as measured by high-performance liquid chromatography may decrease over time, the effect on insulin biological potency may be minimal."

Basically, there's really no problem as long as there's not a wide temperature variation.

Check out the link for more details.
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#7
owlyn

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BTW, welcome back. :)


Thank you! 11 12 13 14 15
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Unless otherwise stated, the opinions expressed here are my own and are in no way intended to be considered as anything other than my opinion. That's my story and I'm stickin' to it.




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