Lantus (Insulin) Uses, Dosage, Side Effects, Precautions & Warnings

Lantus SoloStar (Insulin) Generic drug of the Therapeutic class: Metabolism and nutrition
Active ingredients: Insulin glargine

What is Lantus SoloStar used for?

• Insulin is made in the pancreas.
• Insulin ensures that glucose (carbohydrates) from food ends up in the body’s cells and is not left behind in blood.
• In diabetes mellitus (diabetes). In diabetes there is too much glucose in the blood. This is harmful to the heart and blood vessels, nerves, eyes and kidneys.
• Complaints about too much glucose in the blood: thirst, drinking a lot, often urinating, fatigue and lethargy.
• Short-acting insulins work within 10 to 30 minutes, 2 to 8 hours long. Medium-acting insulins within 1-2 hours, 16 to 24 hours. Long-acting insulins work within 1-2 hours, 24 hours.
• You will receive instructions on syringes, using the insulin pen or insulin pump and testing glucose in the blood yourself with a blood glucose meter and test strips.
• The most important side effect of insulin is a hypo. You then have too little glucose in your blood. You notice that hunger, pale skin, trembling, sweating, dizziness, headaches, fatigue and fainting.
• Treat a hypo immediately by eating some grape sugar or drinking a sugary drink. Then eat a sandwich. Make sure someone can spray glucagon and call a doctor when you are no longer approachable due to a hypo.

what is lantus used for and indication?

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

lantus solostar dosage

Dosage

• Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once a day at any time of the day but at the same time each day.
• The dosing schedule (dosage and timing of administration) should be adjusted individually. In patients with type 2 diabetes, Lantus may also be used with oral antidiabetic agents. The activity of this medicine is expressed in units. These units are Lantus-specific and do not correspond to the IUs or units used for other insulin analogues.

Special populations Elderly (≥ 65 years old)

• In elderly patients, progressive impairment of renal function may cause a steady decrease in insulin requirements.

Renal failure

• In patients with renal impairment, insulin requirements may be decreased due to a reduction in insulin metabolism.

Hepatic insufficiency

• In patients with hepatic impairment, insulin requirements may be decreased due to a reduction in the ability of gluconeogenesis and a reduction in insulin metabolism.

Pediatric population

• Teenagers and children from 2 years
• The safety and effectiveness of Lantus have been established in adolescents and children from 2 years of age (Pharmacodynamic properties ). The dosing schedule (dosage and timing of administration) should be adjusted individually.

Children under 2 years old

• The safety and effectiveness of Lantus have not been established. No data is available.

Replacement of other insulins by Lantus

• When replacing an intermediate-acting or long-acting insulin with Lantus, it may be necessary to change the insulin dose and / or adjust the dosage of concomitant antidiabetic therapy (doses and schedules of fast insulin administration or rapid analogues of insulin or dosages of the associated oral antidiabetic agents).
• Replacement of 2 daily injections of NPH insulin with a daily injection of Lantus In order to reduce the risk of onset of hypoglycemia at night or early in the day, patients who replace their basal insulin regimen with 2 daily injections of insulin NPH by a daily injection of Lantus should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.

Replacement of insulin glargine 300 units / ml by Lantus

• Lantus and Toujeo (insulin glargine 300 units / ml) are not bioequivalent and therefore not directly interchangeable. In order to reduce the risk of hypoglycemia, patients who replace their basal insulin regimen with a daily injection of insulin glargine 300 units / ml with a daily injection of Lantus should reduce their dose by approximately 20%.
• During the first weeks, this reduction must, at least in part, be offset by an increase in insulin covering meals, after this period the treatment will have to be adjusted individually.
• It is recommended that close metabolic monitoring be performed during the replacement period and the first few weeks thereafter.
• If there is an improvement in metabolic balance and therefore an increase in insulin sensitivity, it may be necessary to perform additional dosage adjustment. Dosage adjustment may also be required, for example, in the event of changes in body weight or lifestyle of the patient, changes in the time of administration of insulin, or any other circumstance that may increase susceptibility to hypo- or hyperglycemia (see section Warnings and precautions for use ).
• Patients requiring high doses of insulin due to the presence of human insulin antibodies may experience an improvement in their insulin response with Lantus.

Administration mode

Lantus is administered subcutaneously.

• Lantus should not be administered intravenously. The prolonged effect of Lantus depends on the injection into the subcutaneous tissue. Intravenous administration of the usual subcutaneous dose may cause severe hypoglycaemia.
• There are no clinically significant differences in serum insulin and glucose levels, depending on whether Lantus is administered in the abdomen, deltoid, or thigh. It is necessary
• nevertheless rotate the injection sites in the same injection zone, from one injection to another.
• Do not mix Lantus with any other insulin or dilute it. Mixing or dilution may alter the action profile as a function of time and mixing may cause precipitation.

Bottle, cartridge

• For more details on handling, see the section Instructions for use, handling and disposal .

SoloStar Pre-filled pen

• The instructions for use included in the package leaflet must be read carefully before using SoloStar (see section Instructions for use, handling and disposal ).

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the Composition section .

how does lantus work?

Pharmacotherapeutic class: drugs used in diabetes. Injectable insulins and analogues with long duration of action.

ATC Code: A10A E04.

Action mechanism

• Insulin glargine is a poorly soluble human insulin analogue with a neutral pH. It is completely soluble at the acidic pH of the Lantus solution for injection (pH 4). After injection into the subcutaneous tissue, the acid solution is neutralized, which induces the formation of micro-precipitates from which small amounts of insulin glargine are released continuously. As a result, the concentration / time curve is smooth, without peaks, predictable, and the duration of action is prolonged.
• Insulin glargine is metabolized to 2 active metabolites M1 and M2 (see section Pharmacokinetic properties ).
• Insulin receptor binding: In vitro studies indicate that the affinity of insulin glargine and its M1 and M2 metabolites for the human insulin receptor is similar to that of human insulin.
• IGF-1 receptor binding: Insulin glargine affinity for the human IGF-1 receptor is approximately 5 to 8 times greater than that of human insulin (but approximately 70 to 80 times lower than that of IGF-1), whereas M1 and M2 bind to the IGF-1 receptor with a slightly lower affinity than that of human insulin.
• The total therapeutic insulin concentration (insulin glargine and its metabolites) observed in type 1 diabetic patients was significantly lower than would be required to achieve half of the maximal IGF-1 receptor occupancy and activation. of the mitogenic (proliferative) pathway by the IGF-1 receptor. Physiological concentrations of endogenous IGF-1 can activate the mitogenic (proliferative) pathway, but the therapeutic concentrations observed during insulin treatment, especially during treatment with Lantus, are considerably lower than the pharmacological concentrations required to activate the pathway. of IGF-1.
• The main effect of insulin, including insulin glargine, is to regulate glucose metabolism. Insulin and its analogs decrease blood glucose by stimulating peripheral uptake of glucose, particularly in skeletal muscle and adipose tissue, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and stimulates protein synthesis.
• Clinical pharmacology studies have shown that identical doses of insulin glargine and human insulin administered intravenously are equipotent. As with all insulins, physical activity and other parameters may affect the time course of action of insulin glargine.
• Euglycemic clamp studies in healthy subjects and patients with type 1 diabetes showed that the effect of subcutaneous insulin glargine appeared more slowly than that of human NPH insulin, that this effect was consistent , without peaks, and that its duration of action was prolonged.
• This more prolonged effect of insulin glargine subcutaneously is directly related to the fact that resorption of this insulin is slower. As a result, only one administration per day is sufficient. The effect profile of insulin and insulin analogues such as insulin glargine may vary considerably from subject to subject and subject.
• In a clinical study, symptoms of hypoglycaemia and compensatory hormonal responses were similar after intravenous administration of insulin glargine and human insulin in both healthy volunteers and patients with type 1 diabetes.
• In clinical studies, the frequency of occurrence of cross-reactive antibodies to human insulin and insulin glargine was similar in the NPH insulin and insulin glargine groups.
• The effects of insulin glargine (1 injection per day) on diabetic retinopathy were evaluated over 5 years in a controlled open-label versus NPH study (administered twice daily) in 1024 patients with type 2 diabetes and whose progression Retinopathy of 3 points or more on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography. No significant difference was observed in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
• ORIGIN (Outcome Reduction with Initial Glargine Intervention) was a multicentre, randomized, 2×2 factorial design in 12,537 patients with high cardiovascular (CV) risk who had either fasting glucose abnormality or glucose intolerance (12). % of patients), either type 2 diabetes treated with zero or oral diabetes medication (88% of patients). Patients were randomized (1: 1) to receive either insulin glargine (n = 6264), titrated to achieve fasting blood glucose ≤ 95 mg / dL (5.3 mmol / L), or standard (n = 6273).
• The first primary efficacy endpoint was the time until a first event with CV-related death, nonfatal myocardial infarction or nonfatal stroke occurred. The second main co-criterion was the time until one of the events of the first primary co-criterion, or a revascularization procedure (coronary, carotid or peripheral), or a hospitalization for insufficiency occurred. heart. 
• Secondary efficacy endpoints included all-cause mortality and a composite endpoint of microvascular involvement. 
• Insulin glargine did not alter the relative risk of CV morbidity and mortality compared with standard therapy.No difference was observed between insulin glargine and standard treatment for the two co-primary efficacy endpoints, nor for each of the events evaluated separately in these two criteria, nor for all the causes of mortality, nor for the microvascular disorders. 
• The average dose of insulin glargine at the end of the study was 0.42 U / kg. The median value of HbAlc was 6.4% at baseline, then this value under treatment was between 5.9% and 6.4% in the insulin glargine group and between 6.2% and 6.6%. % in the standard treatment group for the duration of the follow-up.
• The rates of severe hypoglycaemia (number of patients per 100 patients per year of exposure) were 1.05 in the insulin glargine group and 0.30 in the standard treatment group; the rates of confirmed non-severe hypoglycaemia were 7.71 in the insulin glargine group and 2.44 in the standard treatment group. In this 6-year study, 42% of patients in the insulin glargine group never experienced hypoglycaemia. 
• At the last follow-up visit, there was a mean increase in body weight of 1.4 kg in the insulin glargine group and an average decrease of 0.8 kg in the standard treatment group. 

Pediatric population 

• In a randomized controlled clinical trial, children and adolescents (6-15 years) with type 1 diabetes (n = 349) were treated for 28 weeks with a basal / bolus regimen, with rapid human insulin before each meal . Insulin glargine was administered once a day at bedtime and human NPH insulin was administered once or twice daily. The effects on glycated hemoglobin and the incidence of symptomatic hypoglycaemia were similar between the two treatment groups, however the fasting blood glucose level decreased more than its initial value with insulin glargine compared with NPH insulin. . There was also less severe hypoglycaemia with insulin glargine. One hundred and forty-three of the patients treated with Insulin glargine in this study continued their treatment with insulin glargine during an uncontrolled extension of the study, with an average follow-up duration of 2 years. No new safety signals were identified during the extension of insulin glargine therapy. 
• A cross-over study in 26 type-1 diabetic adolescents aged 12 to 18 years comparing insulin glargine with insulin lispro to NPH insulin with human rapid insulin (each treatment being given for 16 weeks in a random order) was also conducted. As in the pediatric study described above, the reduction in fasting blood glucose from baseline was greater with insulin glargine than with NPH insulin. Variations of HbA1c compared to baseline were similar between the two treatment groups, however nighttime blood glucose values ​​were significantly higher in the insulin glargine / insulin lispro group than in the insulin NPH / insulin group fast human, with an average nadir of 5.4 mmol / L against 4.1 mmol / L. As a result, the incidence of nocturnal hypoglycaemia was 32% in the insulin glargine / insulin lispro group versus 52% in the NPH insulin / human fast insulin group.
• A 24-week, parallel-group study was conducted in 125 type-1 diabetic children aged 2 to 6, comparing insulin glargine, once a day in the morning, with NPH insulin once or twice daily administered as basal insulin. Both groups received boluses of insulin before meals.
• The primary objective of demonstrating the non-inferiority of insulin glargine compared to NPH on total hypoglycaemia was not achieved and the number of hypoglycemic events tended to be higher with insulin glargine [ratio of hypoglycaemia insulin glargine / NPH = 1.18 (95% CI: 0.97-1.44)].
• Changes in glycated hemoglobin and blood glucose were comparable between the two treatment groups.No new tolerance signal was identified in this study.

what are the side effects of lantus?

Side effects usually have to do with underdosing or overdose.

The main side effects are the following.

• Too high blood glucose. If you do not inject enough insulin, your blood glucose level becomes too high ( hyper ); The characteristics of high blood glucose (more than ten mmol per liter) are: frequent urination, drinking a lot, thirst, dry tongue, fatigue and drowsiness.
• Too low amount of blood glucose. If you spray too much, your blood glucose will become too low ( hypo ). A too low amount of blood glucose can also be the result of great physical exertion, eating too little, eating too late or spraying insulin in a different body part than normal, for example belly instead of buttock. The insulin is then taken up too quickly and the amount of blood sugar decreases faster than normal. The characteristics of low blood glucose (less than three mmol per liter) are: hunger, paleness, shaking and sweating, varying mood, fatigue, dizziness and headache.
• The doctor or diabetes nurse will discuss with you how often you need to measure your blood glucose every day. The normal value is 4 to 10 mmol per liter. If you always tolerate your insulin well and still suddenly suffer from too high or too low blood glucose, then it is advisable to consult your doctor or pharmacist. Especially the hypo must be treated well, because otherwise you can lose your consciousness.
• Hypersensitivity is possible by the insulin or by additives such as the preservative. In the past, animal insulin was used, which often caused allergic reactions. Nowadays one is able to make ‘human’ insulin in the laboratory. This insulin is very similar to the human insulin, so allergic reactions (usually) are omitted. If you appear to be hypersensitive to this medicine, always report this to your pharmacist. The pharmacy team can then ensure that you do not get this (or a related) remedy.
• Spray spots . These are hard spots or bumps on the skin. If you notice this, please contact your doctor. DO NOT inject insulin into these areas. In these places the absorption of insulin is different. This can make your blood glucose fluctuate a lot. Spray marks usually disappear gradually if you stop spraying there.
• Blurred vision at the start of treatment. Your vision may also change in the first months. This is because your eyes have to get used to the changes in blood glucose. So wait preferably a few weeks with the fitting of a (new) reading glasses.

Lantus Interactions

• Various substances affect glucose metabolism, which may require adjustment of the insulin glargine dose.
• Drugs that may cause an increase in hypoglycemic effect and sensitivity to hypoglycemia include oral antidiabetic drugs, ACE inhibitors, disopyramide, fibrates, fluoxetine, inhibitors of monoamine oxidase (MAOI), pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
• Drugs that may reduce the hypoglycemic effect include, but are not limited to, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestins, phenothiazines, somatropin, sympathomimetic drugs [eg epinephrine (adrenaline), salbutamol, terbutaline], thyroid hormones, atypical antipsychotics (eg, clozapine and olanzapine) and protease inhibitors. 
• Beta-blockers, clonidine, lithium salts and alcohol can either potentiate or attenuate the hypoglycemic effect of insulin. Pentamidine may cause hypoglycemia, sometimes followed by hyperglycemia.
• On the other hand, under the influence of sympatholytic agents such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic compensatory reaction can be attenuated or absent.

Lantus Warnings and Precautions

Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. In this situation, it is recommended to administer fast insulin intravenously.

If the glycemic equilibrium is not optimal or if the patient tends to have hyperglycemic or hypoglycemic episodes, it must first be checked that the patient complies with the prescribed treatment, the sites and the appropriate technique of injection and the patient. all other relevant factors before considering adjusting the insulin dose.

Any change in the type of insulin or brand of insulin must be done under strict medical supervision. The change in concentration, brand (manufacturer), type of insulin (fast, NPH, slow, long-acting, etc.), of origin (animal, human, human insulin analogue) and / or manufacturing method may require dose adjustment.

hypoglycemia

• The time of onset of hypoglycemia depends on the action profile of the insulins used and can therefore change after modification of the treatment regimen. Due to increased basal insulin intake with Lantus, decreased nighttime hypoglycaemia and increased early morning hypoglycaemia may be expected.
• Particular caution and intensification of blood glucose monitoring should be exercised in patients for whom hypoglycaemic episodes may have particularly serious clinical consequences, for example in cases of severe stenosis of the coronary or carotid arteries (risk of cardiac or cerebral complications). hypoglycemia), as well as proliferative retinopathy, especially if it is not treated with photocoagulation (risk of transient amaurosis after hypoglycaemia).

Patients should be aware of the circumstances in which the warning symptoms of hypoglycemia are alleviated. The warning symptoms of hypoglycaemia may be modified, attenuated or absent in certain risk groups, namely:

• in patients whose glycemic balance has been markedly improved,
• in the event of progressive hypoglycaemia,
• in elderly patients,
• after switching from animal insulin to human insulin
• in case of vegetative neuropathy,
• in long-term diabetic patients,
• in patients with psychiatric disorders,
• in patients receiving concomitant medications (see section Interactions with other medicinal products and other forms of interaction ).
• In such situations, severe hypoglycaemia (possibly with loss of consciousness) may occur before the patient becomes aware of hypoglycemia.
• The prolonged effect of insulin glargine subcutaneously may delay the recovery of hypoglycaemia.
• If the level of glycosylated hemoglobin is normal or lowered, the possibility of recurrent hypoglycaemic episodes that have gone unnoticed (especially at night) should be mentioned.
• To reduce the risk of hypoglycaemia, it is essential that the patient follow the dosing and dietary instructions, administer insulin correctly, and be aware of the symptoms of hypoglycaemia. Factors that increase susceptibility to hypoglycemia require particularly strict monitoring and may require

dose adjustment. These factors are:

• change of injection zone,
• improved insulin sensitivity (for example, after removal of stressors),
• unusual physical exercise, increased or prolonged,
• intercurrent illness (eg vomiting, diarrhea),
• variations in regime,
• omission of meals,
• alcohol intake,
• certain non-compensated disorders of the endocrine system (for example, hypothyroidism, hypopituitarism or adrenal insufficiency),
• co-administration of certain other medicines (see section Interactions with other medicinal products and other forms of interaction ).

Intercurrent illnesses

• Any intercurrent illness requires enhanced metabolic monitoring. It is often advisable to look for the presence of ketone bodies in the urine and often need to adjust insulin doses. Insulin requirements are often increased. Patients with type 1 diabetes should continue to consume at least a small amount of carbohydrate regularly, even if they can not eat, or hardly eat, vomiting, etc. They must never stop insulin completely.

Anti-insulin antibodies

• Insulin administration may cause the formation of insulin antibodies. In rare cases, the presence of these insulin antibodies may make it necessary to adjust the insulin dose to correct a tendency to hypo- or hypoglycaemia.
• Pens that can be used with Lantus cartridges

Lantus cartridges should only be used with the following pens:

• JuniorSTAR that delivers Lantus in increments of 0.5 unit
• OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO, which deliver Lantus in increments of 1 unit.
• These cartridges should not be used with any other reusable pen since the accuracy of the dose has been established only with the aforementioned pens.
• All these pens may not be marketed in your country.

Handling the SoloStar Pre-filled Pen

• The instructions for use included in the package leaflet must be read carefully before using SoloStar. SoloStar should be used as recommended in this manual (see section Instructions for use, handling and disposal ).

Medication errors

• Medication errors have been reported in which other insulins, particularly fast-acting insulins, have been accidentally administered in place of insulin glargine.
• The insulin label should always be checked before each injection to avoid medication errors between insulin glargine and other insulins.

Association of Lantus with pioglitazone

• Cases of heart failure have been reported when pioglitazone is associated with insulin, particularly in patients with risk factors for developing heart failure. This should be taken into account if a combination of Lantus with pioglitazone is being considered.
• If the combination is used, it is recommended to monitor the signs and symptoms of heart failure, weight gain and edema. Pioglitazone should be stopped in the presence of any deterioration of cardiac symptoms.

excipients

• This medicine contains less than 1 mmol (23 mg) of sodium per dose, ie it is essentially “sodium-free”.

Drive and use machines

Patients’ ability to concentrate and react may be impaired by hypoglycaemia or hyperglycemia or, for example, by visual disturbances. This can be a risk in situations where these faculties are of primary importance (for example, driving or using machines).

Patients should be advised to take precautions before driving to avoid hypoglycemia, particularly if hypoglycemic warning symptoms are absent or reduced or if episodes of hypoglycaemia are common.

The question is whether it is recommended to drive a vehicle or use a machine in these circumstances.

Lantus and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy

• There are no data from controlled clinical studies on the use of insulin glargine in pregnant women. A large number of data in pregnant women (more than 1000 pregnancies) did not reveal any specific adverse effects of insulin glargine on
• pregnancy, nor any specific malformative or toxic effect for the fetus or the newborn of insulin glargine.
• Studies in animals have not shown reproductive toxicity. Prescription of Lantus may be considered during pregnancy if necessary.
• In case of pre-existing diabetes or gestational diabetes, it is imperative to maintain a good metabolic balance throughout pregnancy to prevent adverse effects associated with hyperglycemia. Insulin requirements may decrease during the first trimester of pregnancy and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decrease rapidly (increased risk of hypoglycaemia). Careful monitoring of the glycemic balance is essential.

feeding

• It is not known whether insulin glargine is excreted in breast milk.
• No metabolic effects of insulin glargine ingested in neonates / breastfed infants are expected since insulin glargine, like any peptide, is digested into amino acids at the gastrointestinal level.
•  Adjustment of insulin dose and diet may be necessary during breastfeeding.

Fertility

• Studies in animals have not shown any direct deleterious effects on fertility.

What should I do if I miss a dose?

If you forget a dose, check your blood glucose level and still inject some insulin.

What happens if I overdose from Lantus ?

SYMPTOMS

• Overdose with insulin may cause severe hypoglycaemia, which may be prolonged and life-threatening.

Supported

• Episodes of mild hypoglycemia can usually be treated with oral carbohydrate. It may be necessary to adjust the dose of the drug, diet or physical activity.
• More severe episodes, with coma, seizures or neurological disorders, may be treated with intramuscular or subcutaneous glucagon or intravenous concentrated glucose. Since hypoglycemia may recur after apparent clinical improvement, it may be necessary to continue carbohydrate intake and monitoring.

What is  Forms and Composition?

• Lantus 100 units / ml in vial:Solution for injection SC (clear, colorless):   10 ml vial, unitary box.
• Lantus 100 units / ml in cartridge: Solution for injection SC (clear, colorless):   3 ml cartridges, box of 5. 
• Lantus 100 units / ml in pre-filled pen SoloStar ^®  :Solution for injection SC (clear, colorless):   3 ml cartridges , sealed in disposable pre – filled pen (needles not supplied), box of 5.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.