Insulin Expiration Date
Brunilda Nazario, MD, is the Lead Medical Director at WebMD and is responsible for reviewing WebMD content and ensuring its accuracy, timeliness, and credibility. Nazario works with WebMD's network of expert doctors and health care professionals where she shares her goals, vision, and the challenges faced in helping to develop an educational and successful learning experience for WebMD's readers. Nazario is dedicated to helping readers understand health information. She is a board certified Internist and Endocrinologist, she is also certified in Advanced Diabetes Management. Upon completion of a certification in bariatric medicine, Dr Nazario is now a Diplomate for the American Board of Obesity Medicine. She is Chair-elect for The Obesity Society's Latin American Association Section. Continue reading >>
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Generic Insulins Out Of Reach For Now
A Diabetes Health reader writes in to ask: Is there a generic alternative to Humalog insulin? If so, what is its cost compared to Humalog? Generic drugs are amazing. They offer lifesaving promise for a cheap price tag, and given that the underlying drugs have been tested and proven, there’s no doubt about safety or effectiveness. But don’t expect to see generic “human” insulin any time soon. If you do spot it eventually, don’t expect it to be too cheap or widespread. It seems that the complex manufacturing involved in insulin drugs isn’t easily duplicated. The processes are so complicated–and government guidance in the area so lacking–that there are still no generic alternatives to insulin brands with expired patents in the United States. Humulin insulin, for example, saw its patent expire in 2000, but Eli Lilly still sold $1.3 billion worth of the brand last year. Lilly’s patent on Humalog will expire next year, but its most worrisome competitor, a company in India associated with Pfizer, called off its generic insulin work in March. That’s expected to keep Humalog sales strong into the near future. Some semi-generic forms of human insulin are available in other countries, but they’re called “biosimilars” because they’re only similar, not identical, to the name brand stuff. Patients don’t necessarily react to them in the same way. The US Department of Health and Human Services is working on rules for these generic insulins, and a plant to manufacture them is being built. But companies will still have to run tests on the new insulins–something they don’t have to do for most other generic drugs–which will slow their introduction even further. Ultimately, insulin is a highly specialized drug that’s used by a relatively small number of Continue reading >>
How Long Does Insulin Last Once It's Been Opened?
A fellow caregiver asked... My mother has type 2 diabetes and needs help with her insulin injections. After I open a new bottle, how long does insulin last for, how should I store it, and how do I know whether it's gone bad? Expert Answers As a general rule, most bottles of insulin are good for 28 days once they're opened. Of course, how quickly a person goes through a vial is highly individual. Some may go through a bottle in a week or two. Others, on a lower dosage, may not use all the insulin within four weeks. But the drug's stability and potency is only guaranteed for 28 days. Opened insulin pens typically last 14 days, though some last only 10 days. If you're uncertain, check with your mother's pharmacist to find out how long her insulin should last. When either of you opens a new vial or pen, make a note on the calendar -- and note the date when you'll need to throw out any remaining insulin. It's best to store an opened bottle of insulin at room temperature, even though manufacturers often recommend refrigeration for opened containers. It's usually less painful to inject insulin when it's at room temperature than when it's cold. Store unopened insulin vials and pen cartridges in the fridge, though, where they should last until their expiration date. Insulin shouldn't be exposed to extreme temperatures, so don't leave it in the car, next to the stove, in the freezer, or in the bathroom. If the bottle freezes, it must be discarded. Two typical signs that insulin has gone bad: poor performance and unusual appearance. If your mother is following her treatment plan and her glucose levels stay stubbornly, inexplicably high, her insulin may have lost its potency. Insulin that's cloudy when it's supposed to be clear or that contains particles, crystals, or small clumps Continue reading >>
Can Insulin Go Back In The Fridge?
After removing insulin glargine (Lantus) from the refrigerator for use, can it be refrigerated over and over again after having warmed to room temperature, or does this degrade it? Continue reading >>
The Insulin Market Is Heading For A Shakeup. But Patients May Not Benefit
The insulin market, dominated by old drugs that have skyrocketed in price, is on the verge of a shakeup. The first “follow-on” insulin for diabetics, similar to a generic medication for synthetic drugs, will hit the market in December. It’s expected to be followed in the coming months and years by a wave of new follow-on and “biosimilar” insulins that have the same protein structures as brand-name products. Experts predict that these new insulins will carry lower prices — but it’s far from certain that the competition will drive down costs overall. The stakes are high: About 6 million Americans with diabetes use insulin, either alone or in combination with an oral drug. The annual cost of insulin reached $736 per patient in 2013, up threefold since 2002. Diabetes medicines, including insulin, are the second most expensive category of prescription drugs, according to Express Scripts, the big pharmacy benefits manager. Here’s what you need to know about how insulin prices got so high — and what you should expect from the coming shifts in the market. What’s on the market now? The vast majority of diabetics who need insulin choose from a menu of a half-dozen “analog” brands, which are chemically altered from natural human insulin. They’re manufactured by just three different drug makers: Novo Nordisk, Sanofi-Aventis, and Eli Lilly. Some are long-acting insulins, injected once or twice a day; others act rapidly and patients inject or deliver them with a pump as needed. Many patients use both. A few of these products — like Novo Nordisk’s Tresiba and Sanofi’s Toujeo, which are both long-acting — have only been on the market a matter of months, and aren’t yet widely used. But the others have generally been around for at least a decade, and s Continue reading >>
Expired Insulin - To Use Or Not
Registration is fast, simple and absolutely free so please,join our community todayto contribute and support the site. This topic is now archived and is closed to further replies. I have a vial of Humalog, new and unopened, that has an expiration date of 12/07. Am I risking by using this insulin? As far as I know the worst thing that will happen will be that it won't work. I wouldnt personally use it, but that is just because I dont want to risk a huge bg spike from lack of insulin after a meal, its not worth the risk. I would use it and test. I might not use it in a pump (infusion set, etc) without first trying one shot to confirm viability. The stuff doesn't go from 100% perfect to useless in 3 months. It loses potency over time. The only caveat is cloudiness. It has to be clear. I have a vial of Humalog, new and unopened, that has an expiration date of 12/07. Am I risking by using this insulin? Do you have an vials of humalog that are NOT expired? If so, it is unnecessary to use the expired one. The viability of expired insulin is QUESTIONABLE at best. I **ALWAYS** feel like I did something wrong when I have BG spikes that I am directly responsible for and feel like I should be sitting in the naughty chair for having done so.. Hey, if you have NO other choice, you do what you've got to do, but if you have insulin within it's shelf life range, stick with the "good stuff". While sticking a proverbial fly in the ointment is entertaining, guinea pigs are just that because they can't say NO. And just an FYI, I am GREAT at giving advice *cough* at times lousy at taking it. If the insulin has been kept in the fridge the entire time and it is within 2 or 3 months of the expiration date, I'd have no reservations about using it. Of course, I'd try to use it within 30 days of Continue reading >>
Why Humalog® U-100?
You may have been taking a long-acting insulin for a while now. So why did your doctor prescribe another insulin? Well, it’s to help control the blood sugar spikes that happen naturally when you eat. Everyone gets them, but when you have diabetes you may need extra help controlling them. That’s where Humalog comes in. Humalog is different than your long-acting insulin. Long-acting insulin helps control your blood sugar throughout the whole day. Humalog is fast-acting insulin—it helps control the blood sugar spikes that happen naturally when you eat. Humalog is available in the Humalog U-100 KwikPen, which is portable and easy to use. And, since it shouldn’t be refrigerated after the first use, you can take it just about anywhere. Continue reading >>
Insulin Pens Are Welcome Back To The Fridge!
We all know that unopened insulin must be kept in the refrigerator. But once in use can we put it back in the fridge to protect it from excessive heat? The answer to this simple question is not as easy as one might think. All manufacturers explicitly recommend to ‘Not refrigerate’ insulin pens in use. This guideline that causes confusion among users is now being revoked by one manufacturer. Let’s try to understand the reasoning behind it and what it means for users now. What? I shouldn’t put my insulin pen back in the refrigerator? When it comes to storing medications, it is recommended you follow the leaflet or packaging instructions. For insulin in particular, there are two different situations: storing and in-use. · Before Opening: When insulin is to be stored long-term and has not been opened, keeping it in the fridge ensures it lasts until expiration date. · During Use: Once a vial, a cartridge or a new disposable pen are used for the first time, the insulin can be kept at room temperature. But it needs to be used within weeks. It makes sense: higher temperatures and an open product mean a shorter shelf life. But there is one extra sentence on insulin pens packages, which has caused quite some confusion: Pens in use — ‘Do not refrigerate.’ What does ‘do not refrigerate’ mean for users? Let’s take a trip back to 2003, when the recommendation to not refrigerate opened insulin first appeared. Take Lilly’s Humalog for example, for which the label was first altered 14-years ago: What was the reason behind this? People started to speculate this warning was a result of preventing any kind of temperature extremes from affecting the insulin once it is in use. Many insulin users know from experience that high temperature can lower the effectiveness of Continue reading >>
How Long Should Insulin Be Used Once A Vial Is Started?
Editor’s comment: The commentary by Dr. Grajower has such important clinical relevance that responses were invited from the three pharmaceutical companies that supply insulin in the U.S. and the American Diabetes Association, and all of these combined in this commentary. The commenting letter and individual responses were authored separately and are completely independent of each other. Diabetic patients treated with insulin, whether for type 1 or type 2 diabetes, are prone to often unexplained swings in their blood glucose. These swings can vary from dangerously low to persistently high levels. Most diabetic patients, and most physicians, will adjust insulin regimens so as to avoid hypoglycemia at the expense of hyperglycemia. Among the “textbook” reasons for variable glucose responses to any given insulin regimen are 1) site of administration, 2) exercise, 3) bottles not adequately mixed before drawing the insulin (for NPH, Lente, or Ultralente), and 4) duration of treatment with insulin (1). A new insulin was marketed by Aventis Pharmaceuticals about 1 year ago, insulin glargine (Lantus). The manufacturer seemed to stress that patients not use a started bottle of this insulin for >28 days (2). Two patients of mine highlighted this point. L.K. is a 76-year-old woman with type 2 diabetes, diagnosed at 55 years of age, and treated with insulin since age 56. Her insulin regimen was changed to Lantus at night together with Novolog before meals. She monitors her blood glucose four times a day. She used a bottle of Lantus until it ran out; therefore, a bottle lasted for 2 months. Her recent HbA1c was 7.6%. I retrospectively analyzed her home glucose readings by averaging her fasting blood glucose levels for the first 15 days of a new bottle and the last 15 days of tha Continue reading >>
The drug: Humalog Generic: Insulin lispro The company: Eli Lilly ($LLY) Estimated Global Sales 2012: $2.52 billion The scoop: Sales of Humalog slipped in the third quarter, alarming analysts who had expected its numbers to stay strong through the year. The problem: Third party payers are demanding discounts, and new diabetes drugs like Tradjenta are eating into market share as physicians try new strategies to control blood sugar ahead of insulins. With Humalog's patent expiration on the horizon, though, it's clear that Lilly has to make some impressive gains in the clinic with new drugs to replace its fading blockbusters. And the pharma giant has been reporting progress on the diabetes front. The GLP-1 analog dulaglutide has scored positive data in a slate of Phase III studies. Lilly has four diabetes drugs in the late-stage pipeline, an important effort to regain the lead in a huge drug market now dominated by Sanofi ($SNY) and Novo Nordisk ($NVO). It's not an easy field. Regulators demand clear safety data on these drugs. But winners can gain megablockbuster status as this market grows by leaps and bounds around the world. For more: Lilly scores a slate of PhIII wins in push for once-weekly diabetes drug Fitch flags big obstacles ahead for Eli Lilly Pfizer, Lilly earnings drop on new generic rivals Eli Lilly's profits fall 5% in Q3 Which diabetes meds lead fast-growing U.S. market? Continue reading >>
The Revenue Challenge Ahead For Eli Lilly And Co
One of the toughest pills investors have to swallow when investing in big pharma is the constant challenge of patent expiration. Blockbuster drugs that were generating billions of dollars in revenue can suddenly disappear from the income statement as their patents expire and generic competition enters the picture. Losing a single drug can be painful enough, but investors can get really hurt when several key drugs lose patent protection around the same time. Just ask an Eli Lilly and Co (NYSE:LLY) investor, and they'll tell you all about it. Patent expirations of blockbuster drug Zyprexa, Cymbalta, and Evista have taken a toll on the company's financials over the last few years. After revenue and earnings per share (EPS) peaked in 2011, the company has struggled to make up for the shortfall, and earnings have fallen by more than 50% since. As difficult as these revenue losses have been for the company over the fast few years, it looks like there could be more pain on the way. Lilly has several key drugs that will be coming off patent in the next few years: When you add up how much each drug brings in, the total represents a massive 48% of Lilly's 2014 revenue that could be at risk in the next few years. Altima alone was responsible for 14% of Lilly's 2014 revenue, and it will see its first leg of international patent protection disappear in December of this year. 2017 in particular appears to be an especially rough year for the company, as Alitma, Cialis, Strattera, and Effient all lose at least a portion of their stateside patent protection. The biosimilar threat? It should also be noted that Lilly has two key drugs currently driving billions of dollars in sales that are not on that list. Why aren't they on the list? Their patents have already expired! Humalog and Humul Continue reading >>
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How Long Should You Keep Insulin Pens?
Did you read our blog on insulin vials and think to yourself, does this apply to my insulin pens too? If so, this post is for you! With so many different insulin and insulin-like products out there these days it can be hard keep track of how long each of these pens stays good. Depending on your dose, you may still have insulin left in your pen at the manufacturer-recommended time to throw it away. If this sounds like a familiar situation, know that it is important to throw away your pen regardless of whether you have any leftover. You might think it’s wasteful, but using the medication past the recommended time can actually do you more harm than good. You may notice if you continue to use insulin from a pen that’s past the manufacturers discard date, your blood glucose may be higher or a greater dose may be needed to achieve a normal blood glucose reading. There are several different types of insulin and a variety of other injectable diabetes medications, and they don’t all have the same recommendations. As a quick reminder, the different categories of insulin are: Rapid-acting. Short-acting (regular). There are no short-acting insulin pens available Intermediate-acting. Long-acting. So how long can you hold on to your insulin pen after you start to use it? Rapid-acting insulin Novolog FlexPen: use within 28 days after first use Novolog cartridge (for use in a re-useable pen): use within 28 days after first use Humalog KwikPen: use within 28 days after first use Humalog cartridge (for use in a re-useable pen): use within 28 days after in-use Apidra SoloStar: use within 28 days after first use Intermediate-acting insulin Long-acting insulin Lantus SoloStar: use within 28 days after first use Toujeo SoloStar: use within 28 days after first use Levemir FlexTouch: use Continue reading >>
Biosimilars Of Insulin Lispro Posted 18/08/2017
Last update: 18 August 2017 Insulin glargine is a fast acting insulin analogue used to treat people living with Type 1 or Type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control. The originator product, Eli Lilly’s Humalog (insulin lispro), was approved by the US Food and Drug Administration (FDA) in June 1996 and by the European Medicines Agency (EMA) in April 1996 . Humalog generated an estimated US$2.8 billion in net sales income globally for Eli Lilly in 2016. Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US. Some of the insulin lispro biosimilars and non-originator biologicals approved or in development are presented in Table 1. Table 1: Biosimilars and non-originator biologicals* of insulin lispro approved or in development Company name, Country Product name Stage of development Biocon/Mylan, India*/USA - ‘Similar biologic’ currently under preclinical/ scale-up development Sanofi, USA Insulin lispro Sanofi Approved by EMA in May 2017  EMA: European Medicines Agency. *See editor’s comment Sanofi’s insulin lispro biosimilar was approved by EMA’s Committee for Medicinal Products for Human Use on 19 May 2017 . Generics giant Mylan and India-based Biocon have made an agreement to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Lantus, as well as Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog Continue reading >>
Why Humalog® U-200 Kwikpen®?
You may have been taking a long-acting insulin for a while now. So why did your doctor prescribe another insulin? Well, it’s to help control the blood sugar spikes that happen naturally when you eat. Everyone gets them, but when you have diabetes you may need extra help controlling them. That’s where Humalog comes in. Humalog is different than your long-acting insulin. Long-acting insulin helps control your blood sugar throughout the whole day. Humalog is fast-acting insulin—it helps control the blood sugar spikes that happen naturally when you eat. Humalog is available in the Humalog U-200 KwikPen, which is portable. And, since it shouldn’t be refrigerated after the first use, you can take it just about anywhere. Continue reading >>
What Are The Possible Side Effects Of Insulin Lispro (humalog, Humalog Cartridge, Humalog Kwikpen, Humalog Pen)?
HUMALOG (insulin lispro) Injection DESCRIPTION HUMALOG® (insulin lispro injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. HUMALOG has the following primary structure: HUMALOG is a sterile, aqueous, clear, and colorless solution. Each milliliter of HUMALOG U-100 contains insulin lispro 100 units, 16 mg glycerin, 1.88 mg dibasic sodium phosphate, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.0197 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%. Each milliliter of HUMALOG U-200 contains insulin lispro 200 units, 16 mg glycerin, 5 mg tromethamine, 3.15 mg Metacresol, zinc oxide content adjusted to provide 0.046 mg zinc ion, trace amounts of phenol, and Water for Injection. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid 10% and/or sodium hydroxide 10%. font size A A A 1 2 3 4 5 Next What is Type 2 Diabetes? The most common form of diabetes is type 2 diabetes, formerly called non-insulin dependent diabetes mellitus or "adult onset" diabetes, so-called because it typically develops in adults over age 35, though it can develop at any age. Type 2 diabetes i Continue reading >>