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LEVEMIR PENFILL is a brand name for Insulin Detemir, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEVEMIR® (insulin detemir) is indicated for: the treatment of type 1 diabetes mellitus in adults, adolescent and children 2 years and above; the treatment of type 2 diabetes mellitus in adults when insulin is required for the control of hyperglycemia; the treatment of type 2 diabetes mellitus in combination with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Levemir® should be used once daily in combination with: Oral antidiabetic drugs (OADs); or Short- or rapid-acting meal time insulin. When Levemir® is used as part of a basal-bolus insulin regimen; Levemir® has the option of being administered twice daily, depending on patients’ needs.
For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered either with the evening meal or at bedtime. Dosage of Levemir® is individual and determined, based on the physician’s advice, in accordance with the needs of the patient.
2 Recommended Dose and Dosage Adjustment New Patients: Patients being initiated on insulin for the first time can be started on Levemir® in the same manner as they would be on human insulin. 2Units/kg. The dose of Levemir® should be titrated based on individual patients’ needs.
1 mmol/L -4 Type 2 patients adding Levemir® to glucagon-like peptide (GLP)-1 receptor agonist: When using Levemir® with a glucagon-like peptide (GLP)-1 receptor agonist, administer as separate injections. Never mix. It is acceptable to inject Levemir ® and a GLP-1 receptor agonist in the same body region but the injections should not be adjacent to each other.
The recommended starting dose of Levemir® in patients with type 2 diabetes inadequately controlled on a GLP-1 receptor agonist is 10 units given once daily in the evening.
Transfer Patients:
When patients are transferred from other insulin to Levemir®, the change should be made as directed by the physician. Patients transferring to Levemir® from intermediate or long-acting insulin may require adjustment of dose and timing of administration to achieve glycemic target.
Close glucose monitoring is recommended during the transition and in the initial weeks thereafter. Concomitant antidiabetic treatment may need to be adjusted (dose and timing of concurrent short-acting insulins or the dose of oral antidiabetic agents, see WARNINGS AND PRECAUTIONS, General).
4 Administration Levemir® should not be mixed or diluted with any other insulin for injection (see WARNINGS AND PRECAUTIONS). Levemir® is for subcutaneous administration only.
Levemir® must not be administered Product Monograph Master Template Template Date:
) Thiazolidinediones (TZDs), alone or in combination with other antidiabetic agents (including Insulin), can cause heart failure and oedema. The combination of Insulin with a TZD is not indicated for the treatment of Type 2 Diabetes Mellitus.
Please refer to the respective TZD product monograph WARNINGS AND PRECAUTIONS information when the use of these drugs in combination with any insulin, including Levemir®, is contemplated. Never share a Levemir® FlexTouch®, Penfill® or a Novo Nordisk Insulin Delivery Device Between Patients.
Levemir® FlexTouch®, Penfill® or a Novo Nordisk Insulin Delivery Device should never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens Carcinogenesis and Mutagenesis See PART II: SCIENTIFIC INFORMATION – NON-CLINICAL TOXICOLOGY.
Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed. Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. Endocrine and Metabolism Hypoglycemia Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia.
As with other insulins, hypoglycemia is the most common adverse effect of insulin therapy, including Levemir® - and may occur if the insulin dose is too high in relation to the insulin requirement (see ADVERSE REACTIONS and HYPOGLYCEMIA AND TREATMENT OF OVERDOSAGE).
When a GLP-1 receptor agonist is used in combination with Levemir®, the Levemir® dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control.
General When using Levemir® in combination with oral anti-diabetic agents (OADs) , please refer to the respective product monograph for OADs for their Warnings and Precautions Information. Stress or concomitant illness, especially infectious and febrile conditions may change insulin requirement.
In these instances, patients should contact their physician and carefully control their blood glucose. Hypokalemia is among the potential clinical adverse effect associated with the use of all insulins therapies. g. diarrhoea). (see Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients subcutaneous solution for injection / 100 U/mL disodium phosphate dihydrate, glycerol, metacresol, phenol, sodium chloride, zinc acetate and water for injection.
Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
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Levemir® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Levemir® (insulin detemir) is contraindicated during episodes of hypoglycemia (see HYPOGLYCEMIA AND TREATMENT OF OVERDOSAGE).
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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September 2020 LEVEM IR® insulin detemir Page 7 of 70 intravenously as it may result in severe hypoglycemia. Intramuscular administration should also be avoided. Levemir® must not be used in insulin infusion pumps. Levemir® (insulin detemir) is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region.
Injection sites should always be rotated within the same region from one injection to the next so that the same site is not used more than approximately once a month in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS) .
As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Levemir® should never be used if it has become viscous (thickened) or cloudy; it should only be used if it is clear and colourless. Levemir® should not be used after its expiration date. In patients with diabetes mellitus, optimized metabolic control effectively delays the onset and slows the progression of late diabetic complications.
Optimized metabolic control, including glucose monitoring is therefore recommended. Before travelling between different time zones the patient should seek the doctors’ advice since this means that the patient has to take the insulin and meals at different times.
As a precautionary measure, patients should always carry a spare insulin delivery device in case the insulin delivery device is lost or damaged.
g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycemia, and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Concomitant illness, especially infections and feverish conditions, usually increase the patient’s insulin requirement.
Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. Hypoglycemia can occur regardless of what type of insulin you take and can cause fatigue, sweating, heart palpitations, disturbed behaviour, hunger, convulsions, and loss of Product Monograph Master Template Template Date: September 2020 LEVEM IR® insulin detemir Page 10 of 70 consciousness or, in extreme circumstances, even death which can occur without recognizable symptoms.
The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. g. driving or using machines). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia.
The advisability of driving should be considered in these circumstances. Some people may not recognize when their blood sugar drops low. Glucose monitoring is recommended for all patients with diabetes. Hyperglycemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia and diabetic ketoacidosis.
Usually the first symptoms of hyperglycemia develop gradually over a period of hours or days. They include thirst, increa sed frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, and loss of appetite as well as acetone odour of breath.
In type 1 diabetes, untreated hyperglycemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Hepatic/Biliary/Pancreatic Hepatic Impairment:
As with other insulins, the requirements for Levemir® may need to be adjusted in patients with hepatic impairment (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). Hypoalbuminaemia There are limited data in patients with severe hypoalbuminaemia.
Careful monitoring is recommended in these patients. Immune Lipodystrophy and Cutaneous Amyloidosis Subcutaneous administration of insulin products, including Levemir® can result in lipoatrophy (thinning of adipose tissue) or lipohypertrophy (thickening of adipose tissue) or localized cutaneous amyloidosis (skin lumps) which may affect insulin absorption.
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. Patients should be advised to consult their health professional if they notice any of these conditions and before changing the injection site.
There is a potential risk of delayed insulin absorption and worsened glycemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycemia.
Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered. Local Allergic Reaction As with any insulin therapy, injection site reactions may occur and include pain, redness, itching, hives, swelling, bruising and inflammation.
Continuous rotation of the injection site Product Monograph Master Template Template Date: September 2020 LEVEM IR® insulin detemir Page 11 of 70 within the particular injection area may help to reduce the risk of de veloping these reactions.
Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of Levemir®.
Systemic Allergic Reaction:
Systemic allergic reactions have rarely occurred […]