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TRESIBA is a brand name for Insulin Degludec, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRESIBA® is indicated for once-daily treatment of adults with diabetes mellitus to improve glycemic control. 1.1 Pediatrics Pediatrics (≥2 years old): TRESIBA® is also indicated for the treatment of pediatric patients (≥2 years old) with Type 1 diabetes mellitus. TRESIBA® has not been investigated in pediatric…
Verbatim from this product's HC label. Tap a section to expand.
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Product Monograph Master Template Template Date:
September 2020 TRESIBA® (insulin degludec injection Page 5 of 68 Inspect Tresiba® visually prior to administration and use only if the solution appears clear and colourless. Never mix Tresiba® with any other insulin. 1 Dosing Considerations Tresiba® is for subcutaneous use only.
DO NOT administer Tresiba® intravenously as it may result in severe hypoglycemia. DO NOT administer Tresiba® intramuscularly as it may change the absorption. DO NOT administer Tresiba® in an insulin infusion pump. Inspect visually for particulate matter and discolouration.
Only use Tresiba® if the solution appears clear and colourless. , overdose and hypoglycemia). Instruct patients who are blind or have poor vision to always get assistance from another person who has good vision and is trained in using the delivery device.
The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) insulin degludec corresponds to one international unit (IU) of human insulin, 1 unit of insulin glargine 100 U/mL or 1 unit of insulin detemir.
Tresiba® is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Always rotate injection sites 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.
Tresiba®should not be injected into areas of lipodystrophy or localized cutaneous amyloidosis (see 8 ADVERSE REACTIONS and 7 WARNINGS AND PRECAUTIONS). Use Tresiba® with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
DO NOT perform dose conversion when using the Tresiba® U-100 or U-200 FlexTouch® pens. The dose window shows the number of insulin units to be delivered and no conversion is needed. Tresiba® is a long-acting basal insulin for once-daily subcutaneous administration at any time of Product Monograph Master Template Template Date: September 2020 TRESIBA® (insulin degludec injection Page 6 of 68 day.
In patients with type 2 diabetes mellitus, Tresiba®can be used in combination with: oral antidiabetic agents (OADs), when treatment with OADs does not achieve adequate glycemic control. rapid-acting or short-acting insulin with or without metformin, when basal, basal-bolus or premix insulin therapy with or without metformin do not achieve adequate glycemic control.
and 7 WARNINGS AND PRECAUTIONS). Use Tresiba® with caution in patients with visual impairment that may rely on audible clicks to dial their dose. DO NOT perform dose conversion when using the Tresiba® U-100 or U-200 FlexTouch® pens.
The dose window shows the number of insulin units to be delivered and no conversion is needed. Tresiba® is a long-acting basal insulin for once-daily subcutaneous administration at any time of Product Monograph Master Template Template Date: September 2020 TRESIBA® (insulin degludec injection Page 6 of 68 day.
In patients with type 2 diabetes mellitus, Tresiba®can be used in combination with: oral antidiabetic agents (OADs), when treatment with OADs does not achieve adequate glycemic control. rapid-acting or short-acting insulin with or without metformin, when basal, basal-bolus or premix insulin therapy with or without metformin do not achieve adequate glycemic control.
Tresiba® has not been studied in combination with all OAD combinations (see 14 CLINICAL TRIALS). In patients with type 1 diabetes mellitus, Tresiba®must be used in regimens containing rapid- acting or short-acting insulin to cover mealtime insulin requirements.
2 Recommended Dose and Dosage Adjustment Inject Tresiba® subcutaneously once-daily at any time of day. The dosage of Tresiba®should be individualized and titrated under the supervision of a health care provider in accordance with the metabolic needs of the patient and the glycemic control target and with appropriate glucose monitoring.
Blood glucose monitoring is essential in all patients receiving insulin therapy (see 7 WARNINGS AND PRECAUTIONS). Dose adjustments may be needed with changes in physical activity, changes in meal pat terns, changes in renal or hepatic function or during acute illness, to minimize the risk of hypoglycemia or hyperglycemia.
, Endocrine and Metabolism, Hypoglycemia). Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma, and death. Changes in insulin regimen from other insulins to Tresiba®can cause serious hypoglycemia or hyperglycemia; changes should be made cautiously and only under medical supervision (see 6 DOSAGE AND ADMINISTRATION).
Product Monograph Master Template Template Date:
September 2020 TRESIBA® (insulin degludec injection Page 5 of 68 Inspect Tresiba® visually prior to administration and use only if the solution appears clear and colourless. Never mix Tresiba® with any other insulin. 1 Dosing Considerations Tresiba® is for subcutaneous use only.
DO NOT administer Tresiba® intravenously as it may result in severe hypoglycemia. DO NOT administer Tresiba® intramuscularly as it may change the absorption. DO NOT administer Tresiba® in an insulin infusion pump. Inspect visually for particulate matter and discolouration.
Only use Tresiba® if the solution appears clear and colourless. , overdose and hypoglycemia). Instruct patients who are blind or have poor vision to always get assistance from another person who has good vision and is trained in using the delivery device.
The potency of insulin analogues, including insulin degludec, is expressed in units (U). One (1) unit (U) insulin degludec corresponds to one international unit (IU) of human insulin, 1 unit of insulin glargine 100 U/mL or 1 unit of insulin detemir.
Tresiba® is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Always rotate injection sites 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.
Insulin degludec 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING.
During episodes of hypoglycemia (see 5 OVERDOSAGE)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Tresiba® has not been studied in combination with all OAD combinations (see 14 CLINICAL TRIALS). In patients with type 1 diabetes mellitus, Tresiba®must be used in regimens containing rapid- acting or short-acting insulin to cover mealtime insulin requirements.
2 Recommended Dose and Dosage Adjustment Inject Tresiba® subcutaneously once-daily at any time of day. The dosage of Tresiba®should be individualized and titrated under the supervision of a health care provider in accordance with the metabolic needs of the patient and the glycemic control target and with appropriate glucose monitoring.
Blood glucose monitoring is essential in all patients receiving insulin therapy (see 7 WARNINGS AND PRECAUTIONS). Dose adjustments may be needed with changes in physical activity, changes in meal pat terns, changes in renal or hepatic function or during acute illness, to minimize the risk of hypoglycemia or hyperglycemia.
Geriatric patients (>65 years of age):
No dosage adjustment is recommended in the geriatric population. Caution is warranted when Tresiba®is administered to geriatric patients since greater sensitivity of some older individuals to the effects of Tresiba®cannot be ruled out.
The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia, which may be particularly difficult to recognize in the elderly.
Pediatric patients (2-18 years of age) with type 1 diabetes:
Tresiba® can be used in adolescents and children with type 1 diabetes from the age of 2 year s. Inject Tresiba® subcutaneously once-daily at approximately the same time of the day. When changing basal insulin to Tresiba®, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimize the risk of hypoglycemia.
A 20% dose reduction is recommended when initiating Tresiba® in pediatric patients in order to minimize the risk of hypoglycemia.
Product Monograph Master Template Template Date:
September 2020 TRESIBA® (insulin degludec injection Page 7 of 68 Patients with renal impairment: No dosage adjustment is recommended in subjects with mild, moderate, or severe renal impairment. In patients with renal impairment, glucose monitoring should be intensified and Tresiba® dosage adjusted on an individual basis as necessary.
Patients with hepatic impairment:
No dosage adjustment is recommended in subjects with mild, moderate, or severe hepatic impairment. In patients with hepatic impairment, glucose monitoring should be intensified and Tresiba®dosage adjusted on an individual basis as necessary.
Initiation of Tresiba® Therapy in Insulin Naïve Patients Adult and pediatric patients with type 1 diabetes mellitus Tresiba® is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments. The recommended starting dose of Tresiba® in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose.
The remainder of the total daily insulin dose should be administered as a short -acting insulin and divided between each daily meal. 4 units of insulin per kilogram of body weight can be used to calculate […]
Geriatric patients (>65 years of age):
No dosage adjustment is recommended in the geriatric population. Caution is warranted when Tresiba®is administered to geriatric patients since greater sensitivity of some older individuals to the effects of Tresiba®cannot be ruled out.
The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia, which may be particularly difficult to recognize in the elderly.
Pediatric patients (2-18 years of age) with type 1 diabetes:
Tresiba® can be used in adolescents and children with type 1 diabetes from the age of 2 year s. Inject Tresiba® subcutaneously once-daily at approximately the same time of the day. When changing basal insulin to Tresiba®, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to minimize the risk of hypoglycemia.
A 20% dose reduction is recommended when initiating Tresiba® in pediatric patients in order to minimize the risk of hypoglycemia.
Product Monograph Master Template Template Date:
September 2020 TRESIBA® (insulin degludec injection Page 7 of 68 Patients with renal impairment: No dosage adjustment is recommended in subjects with mild, moderate, or severe renal impairment. In patients with renal impairment, glucose monitoring should be intensified and Tresiba® dosage adjusted on an individual basis as necessary.
Patients with hepatic impairment:
No dosage adjustment is recommended in subjects with mild, moderate, or severe hepatic impairment. In patients with hepatic impairment, glucose monitoring should be intensified and Tresiba®dosage adjusted on an individual basis as necessary.
Initiation of Tresiba® Therapy in Insulin Naïve Patients Adult and pediatric patients with type 1 diabetes mellitus Tresiba® is to be used once-daily with meal-time insulin and requires subsequent individual dosage adjustments. The recommended starting dose of Tresiba® in insulin naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose.
The remainder of the total daily insulin dose should be administered as a short -acting insulin and divided between each daily meal. 4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naïve patients with type 1 diabetes.
Adult patients with type 2 diabetes mellitus The recommended starting dose of Tresiba® in insulin naïve patients with type 2 diabetes mellitus is 10 units once daily. Initiation of Tresiba® Therapy in Patients Changing from Other Insulin Therapies Close glucose monitoring is recommended during the transfer and in the following weeks.
Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted. Adult and pediatric patients with type 1 diabetes mellitus For patients with type 1 diabetes, it is recommended that the dose of Tresiba® is reduced by 20% from the total daily long- or intermediate-acting insulin dose, or basal component of a continuous subcutaneous insulin infusion regimen, to lower the risk of hypoglycemia.
The amount and timing of the prandial insulin may need to be adjusted as well. Adult patients with type 2 diabetes mellitus For patients with type 2 diabetes taking once-daily long or intermediate-acting insulin, start Tresiba® at the same unit dose.
For patients transferring from twice daily long or intermediate - acting insulin, or insulin glargine (300 units/mL), it is recommended that the dose of Tresiba® is reduced by 20% to lower the risk of hypoglycemia. 4 Administration Refer to the instructions provided at the end of this Product Monograph in the section “Instructions on How to Use Tresiba® 100/200 units/mL Solution for Injection in Pre-filled Pen” for information on Tresiba® FlexTouch®.
For Tresiba® Penfill®, refer to the instructions provided with your Novo Nordisk Insulin Delivery Device manual. 5 Missed Dose Instruct patients who miss […]
Tresiba®should not be injected into areas of lipodystrophy or localized cutaneous amyloidosis (see