Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery. Drugs used in diabetes, insulins and analogues for injection, long-acting. Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH.
It is completely soluble at the acidic pH of the Lantus injection solution pH 4. In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin. The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin but approximately 70 to fold lower than the one of IGF-1 , whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
The total therapeutic insulin concentration insulin glargine and its metabolites found in type 1 diabetic patients was markedly lower than what would be required for a halfmaximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor. Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in Lantus therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
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The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
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In clinical pharmacology studies, intravenous insulin glargine and human insulin have been shown to be equipotent when given at the same doses. As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables. In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Lantus 100 units/ml solution for injection in a vial
The time course of action of insulin and insulin analogues such as insulin glargine may vary considerably in different individuals or within the same individual. In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. Effects of insulin glargine once daily on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study NPH given bid in type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study ETDRS scale was investigated by fundus photography.
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No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin. Participants were randomised 1: The first co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal myocardial infarction MI , or nonfatal stroke, and the second co-primary efficacy outcome was the time to the first occurrence of any of the first co-primary events, or revascularisation procedure coronary, carotid, or peripheral , or hospitalisation for heart failure. Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome. Mean dose of insulin glargine by study end was 0. At baseline, participants had a median HbA1c value of 6. The rates of severe hypoglycaemia affected participants per participant years of exposure were 1.
At the last on-treatment visit, there was a mean increase in body weight from baseline of 1. Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group. There was less severe hypoglycaemia in the insulin glargine group as well. One hundred forty three of the patients treated with insulin glargine in this study continued treatment with insulin glargine in an uncontrolled extension study with mean duration of follow-up of 2 years.
No new safety signals were seen during this extended treatment with insulin glargine. A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin each treatment administered for 16 weeks in random order in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
As in the paediatric study described above, fasting plasma glucose reduction from baseline was greater in the insulin glargine group than in the NPH group. A week parallel group study was conducted in children with type 1 diabetes mellitus aged 2 to 6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin.
Both groups received bolus insulin before meals. The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: Glycohaemoglobin and glucose variabilities were comparable in both treatment groups. No new safety signals were observed in this study. In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. The graph above shows the activity profiles over time of insulin glargine and NPH insulin. Insulin glargine injected once daily will reach steady state levels in days after the first dose. When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
After subcutaneous injection of Lantus in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 21A-Gly-insulin and M2 21A-Gly-desB-Thr-insulin. In plasma, the principal circulating compound is the metabolite M1.
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The exposure to M1 increases with the administered dose of Lantus. The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with Lantus is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of Lantus.
In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population. Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study see section 5. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Keep the vial in the outer carton in order to protect from light. Keep the vial, cartridge or SoloStar pre-filled pen in the outer carton in order to protect from light. Type 1 colourless glass vial with a flanged cap aluminium , a stopper chlorobutyl rubber type 1 and a tear-off cap polypropylene containing 5 ml of solution.
Type 1 colourless glass vial with a flanged cap aluminium , a stopper type 1, laminate of polyisoprene and bromobutyl rubber and a tear-off cap polypropylene containing 10 ml of solution. Type 1 colourless glass cartridge with a black plunger bromobutyl rubber and a flanged cap aluminium with a stopper bromobutyl or laminate of polyisoprene and bromobutyl rubber containing 3 ml of solution.
Inspect Lantus before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Lantus is a solution, it does not require resuspension before use. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins see section 4.
The Lantus cartridges are to be used only in conjunction with the pens: Not all of these pens may be marketed in your country.
The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection. If the insulin pen is damaged or not working properly due to mechanical defects it has to be discarded, and a new insulin pen has to be used.
Before insertion into the pen, the cartridge must be stored at room temperature for 1 to 2 hours. Air bubbles must be removed from the cartridge before injection see instructions for using the pen. Empty cartridges must not be refilled. Before using the pre-filled pen, the instructions for use included in the package leaflet must be read carefully.
We at the McGuff Company, Inc. McGuff work very hard to provide you accurate and timely information on our website. However, it is your obligation to verify such information before using the products purchased from McGuff. McGuff does not make warranty or representation that the information contained on this site is accurate, current, or complete.
McGuff is in no way responsible for any damages whether direct, consequential, incidental, or otherwise suffered by you or others on your behalf as a result of using or relying upon such information for any purpose. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision. Get medical help right away if you have:. It is important to perform a safety test when using a new pen for the first time. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.
The health information contained herein is provided for general education purposes only. Your healthcare professional is the single best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment. These medical problems may make you more likely to get pancreatitis.
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