Eu Gives Green Light To Toujeo, A Better Insulin Glargine?
EU Gives Green Light to Toujeo, a Better Insulin Glargine? The European Union has given the nod to a new formulation of insulin glargine (Toujeo, Sanofi), which is a higher-strength insulin (300 units/mL) than the existing insulin glargine product on the market (100 units/mL); the latter was first authorized in the European Union as Lantus and Optisulin (both Sanofi) in June 2000. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued its positive opinion on Toujeo for the treatment of adults with type 1 and type 2 diabetes just a day after the US FDA approved the product for the same indication. As well as containing three times the concentration of insulin glargine, Toujeo is designed to release the insulin more gradually; thus, the product has been labeled an ultralong-acting insulin (U300), or "a next-generation insulin," as Sanofi is calling it. When Lantus was first launched, it was marketed as a "24-hour-insulin," but, with a half-life of 12 hours, insulin glargine always struggled to live up to that promise and has found itself eclipsed by the long-acting insulin degludec (Tresiba, Novo Nordisk), which has been available in the European Union since January 2013. Insulin degludec is not approved in the United States, however. Another extremely long-acting basal insulin, peglispro, has just suffered a setback ; its manufacturer, Lilly, has said it will have to postpone the marketing application by at least 2 years to evaluate why some patients developed excess liver fat in late-stage studies. Toujeo Likely Available Within EU Within 2 Months EU approval is normally a formality 2 months after a positive CHMP opinion, and Sanofi says once approved , its new product will be available in the Toujeo SoloSTAR, a disposab Continue reading >>
Insulin Glargine Overdose
Go to: CASE REPORT A 76-year-old male presented to our Emergency Department (ED) after an intentional overdose of insulin glargine (LANTUS®). He was found by his friend diaphoretic and anxious, but responsive. He reported that he attempted to suicide by injecting himself 500 units insulin glargine subcutaneously. There was no information about blood glucose level at the time of ambulance arrival. On initial ED evaluation, he was conscious, Glasgow Coma Score was 15/15; and vital signs were as follows: Blood pressure 120/70 mmHg, pulse rate 98 bpm, body temperature 36 °C; and respiratory rate 18 pm. Diaphoresis was still continuing and physical examination revealed nothing pathological but tachycardia. Finger-stick glucose was 30 mg/dl (Reference range: 70-106 mg/dl). Simultaneous chemistry revealed 41 mg/dl. He was started 50 cc 50 % dextrose IV and continued on 10 % dextrose at 50 cc/h. Over the next 96 h he received a 10 % dextrose infusion at 50 cc/h and he was needed to administer extra glucose boluses for several times because of hypoglycemia periods [Figure 1]. Serum potassium level was 3.11 meq/l (Reference range: 3.5 – 5.2 meq/l). Other parameters such as sodium, phosphate, calcium and liver function tests were in the normal range. Oral potassium chloride was started since serum level was found as low as 3.17 meq/l. Oral potassium chloride was arranged as needed during follow up period. In his past medical history, he emphasized insulin-dependent diabetes for 25 years, hypertension, parkinson disease, panic disorder; and dementia. Current medications included insulin glargine 14 units twice daily, Losartan plus, levodopa+carbidopa+entacapone and piracetam. After 96 h, he was transferred to Internal Medicine ward for close monitoring; then consulted to psychi Continue reading >>
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Long-acting Insulin: How It Works
When you eat, your pancreas releases a hormone called insulin. Insulin moves sugar (glucose) from your blood to your cells for energy or storage. If you take insulin, you may need some at mealtime to help lower your blood sugar after you eat. But even between meals, you need insulin in small amounts to help keep blood sugar stable. This is where long-acting insulin comes in. If you have diabetes, either your pancreas can’t produce enough (or any) insulin, or your cells can’t use it efficiently. To control your blood sugar, you need to replace or supplement the normal function of your pancreas with regular insulin injections. Insulin comes in many types. Each type differs in three ways: onset: how quickly it starts working to lower your blood sugar peak: when its effects on your blood sugar are strongest duration: how long it lowers your blood sugar According to the U.S. Food and Drug Administration (FDA), the five types of insulin are: Rapid-acting insulin: This type starts to work just 15 minutes after you take it. It peaks within 30 to 90 minutes, and its effects last for three to five hours. Short-acting insulin: This type takes about 30 to 60 minutes to become active in your bloodstream. It peaks in two to four hours, and its effects can last for five to eight hours. It is sometimes called regular-acting insulin. Intermediate-acting insulin: The intermediate type takes one to three hours to start working. It peaks in eight hours and works for 12 to 16 hours. Long-acting insulin: This type takes the longest amount of time to start working. The insulin can take up to 4 hours to get into your bloodstream. Pre-mixed: This is a combination of two different types of insulin: one that controls blood sugar at meals and another that controls blood sugar between meals. Lo Continue reading >>
Insulin Actions Times And Peak Times
A good way to improve your glucose levels is to track the peaks and drops in your glucose , so you can figure out why they happened and how to correct them. Once you identify glucose patterns (they ARE there!), you also want to understand when each of your insulins is active and when they typically stop lowering your glucose. This helps you adjust your doses or food intake to stop unwanted ups and downs in your readings. The table below shows the start, peak, and end times for various insulins with some explanations and typical uses for each. When Does My Insulin Peak and How Long Does It Last? designed to peak, covers meals and lowers high BGs Humalog , Novolog and Apidra insulins currently give the best coverage for meals and help keep the glucose lower afterward. Their glucose lowering activity starts to work about 20 minutes after they are taken, with a gradual rise in activity over the next 1.75 to 2.25 hours. Their activity gradually falls over the next 3 hours with about 5 to 6 hours of activity being common with these insulins.Although insulin action times are often quoted as 3-5 hours, the actual duration of insulin action is typically 5 hours or more. See our article Duration of Insulin Action for more information on this important topic. In general, "rapid" insulins are still too slow for many common meals where the glucose peaks within an hour and digestion is complete within 2-3 hours. The best kept secret on stopping post meal spiking is to eake the injection or bolus earlier before the meal and to eat slower low glycemic carbs. Regular insulin still carries its original name of "fast insulin" but its slower action often works better for people who take Symlin or for those who have gastroparesis (delayed digestion). It is also a great choice for those who Continue reading >>
Insulin glargine, marketed under the names Lantus, among others, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours, with a "peakless" profile (according to the insulin glargine package insert). Pharmacokinetically, it resembles basal insulin secretion of non-diabetic pancreatic beta cells. Sometimes, in type 2 diabetes and in combination with a short acting sulfonylurea (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin—type 1 diabetes, depleted type 2 (in some cases) or latent autoimmune diabetes of adults in late stage—insulin glargine needs the support of fast acting insulin taken with food to reduce the effect of prandially derived glucose. Medical uses The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral protamine Hagedorn (NPH) insulin but have a significantly greater cost making them, as of 2010, not cost effective. It is unclear if there is a difference in hypoglycemia and not enough data to determine any differences with respect to long term outcomes. Mixing with other insulins Unlike some other longer-acting insulins, glargine must not be diluted or mixed with other insulin or solution in the same syringe. However, this restriction has been questioned. Adverse effects Cancer As of 2012 tentative evidence shows no association between insulin glargine and cancer. Previous studies had raised concerns. Pharmacology Mechanism of action Insulin glargine has a substitution of glycine for Continue reading >>
Lantus® Can Still Be Your Choice For A Product With Demonstrated Efficacy And Safety
Lantus® is a long-acting insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Lantus® should be administered once a day at the same time every day. Limitations of Use: Lantus® is not recommended for the treatment of diabetic ketoacidosis. Contraindications Lantus® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin glargine or one of its excipients. Warnings and Precautions Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles. Monitor blood glucose in all patients treated with insulin. Modify insulin regimen cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Do not dilute or mix Lantus® with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Lantus® via an insulin pump or intravenously because severe hypoglycemia can occur. Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®, and may be life-threatening. Medication errors, such as accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. Patients should be instructed to always verify the insulin label before each injection. Severe life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Lantus®, treat and monitor until symptoms resolve. A reduction in the Lantus® dose may be re Continue reading >>
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Levemir Vs. Lantus: Similarities And Differences
Levemir and Lantus are both long-acting injectable insulins that can be used for long-term management of diabetes. Insulin is a hormone that is naturally produced in the body by the pancreas. It helps convert the glucose (sugar) in your bloodstream into energy. This energy is then distributed to cells throughout your body. With diabetes, your pancreas produces little or no insulin or your body is unable to use the insulin correctly. Without insulin, your body can’t use the sugars in your blood and can become starved for energy. The excess sugar in your blood can also damage different parts of your body, including your blood vessels and kidneys. Everyone with type 1 diabetes and many people with type 2 diabetes must use insulin to maintain healthy blood sugar levels. Levemir is a solution of insulin detemir, and Lantus is a solution of insulin glargine. Both are basal insulin formulas. That means that they work slowly to lower your blood sugar levels. They’re both absorbed into your body over a 24-hour period. They keep blood sugar levels lowered for longer than short-acting insulins do. Although the formulations are slightly different, Levemir and Lantus are very similar drugs. There are only a few differences between them. Children and adults can use both Levemir and Lantus. Specifically, Levemir can be used by people who are 2 years or older. Lantus can be used by people who are 6 years or older. Levemir or Lantus can help with daily management of diabetes. However, you may still need to use short-acting insulin to treat spikes in your blood sugar levels and diabetic ketoacidosis (a dangerous buildup of acids in your blood). Learn more: All about diabetic ketoacidosis » Administration Both Levemir and Lantus are given through injection in the same way. You can gi Continue reading >>
How To Use The Lantus® Solostar® Pen
Please check the leaflet for the insulin for complete instructions on how to store SoloSTAR®. If your SoloSTAR® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject. Keep SoloSTAR® out of the reach and sight of children. Keep your SoloSTAR® in cool storage (36°F–46°F [2°C–8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack. Once you take your SoloSTAR® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloSTAR® in use must not be stored in a refrigerator. Do not use SoloSTAR® after the expiration date printed on the label of the pen or on the carton. Protect SoloSTAR® from light. Discard your used SoloSTAR® as required by your local authorities. Protect your SoloSTAR® from dust and dirt. You can clean the outside of your SoloSTAR® by wiping it with a damp cloth. Do not soak, wash, or lubricate the pen as this may damage it. Your SoloSTAR® is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloSTAR® might be damaged. If you are concerned that your SoloSTAR® may be damaged, use a new one. Continue reading >>
Lantus 100 Units/ml Solution For Injection In A Cartridge
Lantus 100 units/ml solution for injection in a cartridge This information is intended for use by health professionals Lantus 100 units/ml solution for injection in a vial Lantus 100 units/ml solution for injection in a cartridge Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen 2. Qualitative and quantitative composition Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg). Each vial contains 5 ml of solution for injection, equivalent to 500 units, or 10 ml of solution for injection, equivalent to 1000 units. Each cartridge or pen contains 3 ml of solution for injection, equivalent to 300 units. *Insulin glargine is produced by recombinant DNA technology in Escherichia coli. For the full list of excipients, see section 6.1. Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. 4.2 Posology and method of administration Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1). In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements. In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism. In patients with hepatic impairment, insulin requirements may be diminished due to re Continue reading >>
Novo Nordisk’s New Insulin Tresiba To Take On Lantus
Novo Nordisk’s insulin degludec injection, known by the brand name Tresiba, met with FDA approval in late September. It is expected to be available to patients with a doctor’s prescription in the first few months of 2016, according to Novo Nordisk’s chief medical officer for North America, Dr. Todd Hobbs. “This insulin is very predictable and stable,” Hobbs says about Tresiba, which is a long-acting basal insulin. “It has a half life of 25 hours, and can last at least 42 hours.” Hobbs points out while it’s advisable, and desirable, for diabetics to take their daily dose, or doses, of insulin at the same time each day, sometimes that simply isn’t possible. Sometimes, he says, life intrudes and a person is delayed in taking their medication. But, with Tresiba, such an occurrence wouldn’t necessarily impact blood sugar in a significant way. “A patient might miss their dose by a few hours, but we designed Tresiba to accommodate those sorts of events,” he says. Approval for Tresiba comes almost a decade after the molecule that forms the basis for the treatment was first isolated. Hobbs says that even before Novo filed its first attempt for approval through the FDA in 2012, Tresiba had already been in pre-clinical development for five or six years. Tresiba is poised to be a direct competitor to the long-acting insulin, Lantus, which is sold by the pharmaceutical company Sanofi SA. Lantus is the market leader in long acting insulin with more than 80 percent of market share and annual sales of almost $8 billion. These figures, however, were before the patent on Lantus expired in Europe and the U.S. earlier this year. Tresiba already boasts a commanding presence in the world insulin market. According to Science Times, Tresiba is sold in 30 countries aroun Continue reading >>
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Rapid-Acting Analogues Short-Acting Insulins Intermediate-Acting Insulins Long-Acting Insulins Combination Insulins Drug UPDATES: TRESIBA ®- insulin degludec injection [Drug information / PDF] Click link for the latest monograph Dosing: Click (+) next to Dosage and Administration section (drug info link) Initial U.S. Approval: 2015 Mechanism of Action: The primary activity of insulin, including TRESIBA, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. TRESIBA forms multi-hexamers when injected into the subcutaneous tissue resulting in a subcutaneous insulin degludec depot. The protracted time action profile of TRESIBA is predominantly due to delayed absorption of insulin degludec from the subcutaneous tissue to the systemic circulation and to a lesser extent due to binding of insulin-degludec to circulating albumin. INDICATIONS AND USAGE: TRESIBA is indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use TRESIBA is not recommended for the treatment of diabetic ketoacidosis. Dosing: Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. Rotate injection sites to reduce the risk of lipodystrophy. Do not dilute or mix with any other insulin or solution. Administer subcutaneously once daily at any time of day. Do NOT perform dose conversion when using the TRESIBA U-100 or U-200 FlexTouch pens. The TRESIBA U-100 and U-200 FlexTouch pens dose window shows the number of insulin units to be delivered and NO conversion is needed. HOW SUPPLIE Continue reading >>
What Are The Possible Side Effects Of Insulin Glargine (lantus, Lantus Opticlik Cartridge, Lantus Solostar Pen)?
LANTUS® (insulin glargine) Injection DESCRIPTION LANTUS (insulin glargine injection) is a sterile solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analog that is a long-acting, parenteral blood-glucose-lowering agent [see CLINICAL PHARMACOLOGY]. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows oncedaily dosing as a basal insulin. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Insulin glargine has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 Units (3.6378 mg) insulin glargine. The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. The 3 mL prefilled pen presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for inje Continue reading >>
What is Lantus? Lantus is a brand name medication marketed by Sanofi-Aventis consisting of insulin glargine. This is a prescription diabetes medication, and it is a long-acting form of insulin. This type of insulin is not recommended for the treatment of diabetic ketoacidosis, as short-acting and intravenous insulin is preferred for the treatment of that condition. There are presently no generic forms of this drug approved within the US. Lantus is thought to be a ‘biologic’ medicine, and regulations and rules keep manufacturers from making generic biologics. Plus, patents presently prohibit generic Lantus from becoming manufactured. It’ll work by decreasing glucose levels in your blood. Lantus consists of micro crystals that are thought to slowly release insulin, and it can have a long duration of action between 18 and 26 hours. This profile is also considered to be peak less. Lantus Uses Lantus is used to treat type 1 and type 2 diabetes. It works by lowering the amount of sugar within the blood, and since it is long-acting insulin, it is usually only taken once per day. It is used in injection form, and it is important that directions should be followed properly. It can be taken at any time during the day, but it needs to be taken consistently at the same time. Patients should also not take any more or less of the medication than prescribed, and the appearance should always be checked before using it. Lantus is usually prescribed as part of a full treatment program which also may involve exercise, diet, weight control, as well as testing the blood sugar. Follow your medication, diet and exercise regimen extremely closely. Altering any of these could affect your level of blood sugar. How Lantus is used Lantus will be injected underneath your skin. You might be sh Continue reading >>
Lantus Half Life - Medhelp
Common Questions and Answers about Lantus half life Even still, I would wake with 30's-40's, even with cutting back on Lantus . Cutting back hurt my overall numbers. Lantus info in package shows graph of effects...there is a climb to an even level at around 5 hours. This is the peak I've been struggling with. Does anyone else have this effect in early a.m. after taking Lantus at night? Last doctor was neutral on the subject.Now in a different city and new endocrinologist. Thankfully (for us), this hasn't happened in so long that I cannot remember what the formula is to calculate the lantus . I do remember that prior to going on the pump, her endocrinologist switched her lantus shot from AM to PM as her morning bg's were higher than they wanted them. You should discuss this possibility with your endo along with your thoughts of splitting the dose, however I have never heard of this as an option. After the third incident, I began to split my Lantus dose, taking half in the morning and half in the evening. I've had no problems since - but if I do, I know that I'll be dealing with the effects of only half as much insulin. I do like using Lantus - especially the (usually) flat action, without a peak in the middle of the day. It make life (especially meal scheduling) much easier. Who knows, maybe one of the new insulins in the approval pipeline (e.g. The high levels at night are probably happening because the evening Lantus is not truly lasting 24 hours. See if this makes sense to you... Lantus is marketed as a 24-hour insulin, but it doesn't work full force for exactly 24 hours and then -- poof -- suddenly quit. If you read the paperwork in your Lantus box, you will read that it lasts anywhere between 20-24 hours. It's affecting her social lfe as well as academically. She's Continue reading >>
Lantus And Levemir: What’s The Difference?
Lantus and Levemir have a lot in common. Both are basal insulin formulas, which means that they last for a long time in the body and act as background insulin, with a slow feed that mimics the constant low output of insulin produced by a healthy pancreas. Both are insulin analogues, which means that their insulin molecules are analogous to human insulin, but engineered, or recombined, with slight differences that slow their absorption. Lantus is a clear formula made with glargine, a genetically modified form of human insulin, dissolved in a special solution. Levemir is also a clear formula, but it contains dissolved detemir, a different form of genetically modified insulin. Human insulin is made of two amino acid chains, called A and B, that have two disulfide bonds between them. In glargine, one amino acid has been switched out, and two extra amino acids have been added to one end of the B chain. The modifications make glargine soluble at an acidic pH, but much less soluble at the neutral pH that’s found in the body To make Lantus, first the glargine is produced by a vat of E. coli bacteria. Then it’s purified and added to a watery solution containing a little zinc and some glycerol; a dash of hydrochloric acid is also added to make it acidic, bringing its pH down to about 4. At that degree of acidity, glargine completely dissolves into the watery solution, which is why the vial is clear. After you inject it into your subcutaneous tissue, the acidic solution is neutralized by your body to a neutral pH. Because glargine is not soluble at a neutral pH, it precipitates out into a form that’s not soluble in subcutaneous fat, and there forms a relatively insoluble depot. From that pool, or depot, of precipitated glargine in the tissues, small amounts slowly move back Continue reading >>