Loading…
LYUMJEV TEMPO PEN is a brand name for Insulin Lispro, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Lyumjev (insulin lispro injection) is indicated for treatment of adult patients with diabetes mellitus who require insulin for the control of glucose homeostasis (see 15 CLINICAL TRIALS). Lyumjev should generally be used in a regimen with intermediate- or long-acting insulin to maintain adequate glucose control (see 8…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of Lyumjev corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues. Always check insulin label before administration (see 8 WARNINGS AND PRECAUTIONS).
Inspect Lyumjev visually before use and discard for particulate matter or discolouration. Only use Lyumjev if the solution appears clear and colourless. The dose counter of Lyumjev prefilled pens (100 units/mL and 200 units/mL) shows the number of units of Lyumjev to be injected.
No dose conversion is required if transferring a patient between the 100 units/mL and 200 units/mL strengths. Lyumjev should not be used by patients with visual impairment without help of a trained person. Lyumjev in a vial is to be used with insulin syringes with the corresponding unit scale (U-100 or 100 Units/mL) or in Continuous Subcutaneous Insulin Infusion (CSII) therapy.
V. infusion fluids under medical supervision. Train patients on proper use and injection technique before initiating Lyumjev. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. 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 to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis (see 8 WARNINGS AND PRECAUTIONS). Serious Warnings and Precautions Hypoglycemia is the most common adverse effect of insulin products. As with all insulin products, the timing of hypoglycemia may differ.
Glucose monitoring shall be performed for all patients with diabetes mellitus treated with insulins. (See 8 & 5 HYPOGLYCEMIA, HYPERGLYCEMIA AND OVERDOSAGE). Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma or even death.
(See 8 ENDOCRINE AND METABOLISM – HYPOGLYCEMIA). Any conversion of insulin products should be made cautiously and only under medical supervision. (See 4 DOSING AND ADMINSTRATION). Due to its rapid onset of action and shorter duration of action, Lyumjev should be administered 0 to 2 minutes before the start of the meal.
When necessary, Lyumjev may be administered up to 20 minutes after starting a meal (see 15 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION). Lyumjev should not be used if it is not water clear and colourless. Lyumjev 200 units/mL should not be administered via a subcutaneous infusion pump or mixed with any other insulin (including Lyumjev 100 units/mL).
). 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.
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 long -standing diabetes. Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement (see 9 ADVERSE REACTIONS, Hypoglycemia and 5 OVERDOSAGE).
Omission of a meal or unplanned strenuous physical exercise may lead to hypoglycemia. Hypoglycemia can occur regardless of what type of insulin you take and can cause fatigue, sweating, heart palpitations, disturbed behavior, hunger, convulsions, loss of consciousness , temporary or permanent impairment of brain function, or, in extreme circumstances, even death which can occur without recognizable symptoms.
Some people may not recognize when their blood sugar drops low. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin preparations, the glucose lowering effect time course of Lyumjev may vary in different individuals or at different times in the same individual and depends on ma ny conditions.
Factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to co-administered medication. Patients with renal or hepatic impairment may be at high risk of hypoglycemia.
and DOSAGE AND ADMINISTRATION). Lyumjev vials may also be used for continuous subcutaneous insulin infusion (CSII) in pump systems that are licensed in Canada for insulin infusion. Refer to the insulin infusion pump manufacturer’s user manual to see if Lyumjev can be used.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥65 years of age): Evidence from clinical studies and experience with insulin lispro suggests that use in the geriatric population is not associated with differences in safety or effectiveness (see 8 WARNINGS AND PRECAUTIONS, Special Population).
2 CONTRAINDICATIONS Lyumjev is contraindicated in patients: during episodes of hypoglycemia (see 8 WARNINGS AND PRECAUTIONS). 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. 1 Dosing Considerations The potency of insulin analogues, including Lyumjev, is expressed in units. One (1) unit of Lyumjev corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.
Always check insulin label before administration (see 8 WARNINGS AND PRECAUTIONS). Inspect Lyumjev visually before use and discard for particulate matter or discolouration. Only use Lyumjev if the solution appears clear and colourless.
The dose counter of Lyumjev prefilled pens (100 units/mL and 200 units/mL) shows the number of units of Lyumjev to be injected. No dose conversion is required if transferring a patient between the 100 units/mL and 200 units/mL strengths.
Lyumjev should not be used by patients with visual impairment without help of a trained person. Lyumjev in a vial is to be used with insulin syringes with the corresponding unit scale (U-100 or 100 Units/mL) or in Continuous Subcutaneous Insulin Infusion (CSII) therapy.
Lyumjev is contraindicated in patients: during episodes of hypoglycemia (see 8 WARNINGS AND PRECAUTIONS). 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. Lyumjev™, Lyumjev™ KwikPen®, Lyumjev™ Junior KwikPen®, Lyumjev™ Tempo Pen™ Product Monograph Page 5 of 75
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Insulin Lispro in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
DO NOT transfer insulin lispro solution in the Lyumjev 200 units/mL KwikPen to other devices, such as a syringe. The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycemia.
V. infusion fluids under medical supervision. Lyumjev™, Lyumjev™ KwikPen®, Lyumjev™ Junior KwikPen®, Lyumjev™ Tempo Pen™ Product Monograph Page 6 of 75 Before travelling between different time zones, the patient should seek the health professional’s advice since this means the patient has to take insulin and meals at different times.
Lyumjev 200 units/mL should not be administered via a subcutaneous infusion pump or mixed with any other insulin (including Lyumjev 100 units/mL). DO NOT transfer insulin lispro solution in the Lyumjev 200 units/mL KwikPen to other devices, such as a syringe.
The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycemia. When used via a subcutaneous insulin infusion pump, Lyumjev (insulin lispro injection) 100 units/mL should not be diluted or mixed with any other insulin.
Patients should carefully read and follow the insulin infusion pump manufacturer's instructions and Part III - Patient Medication Information before use. 2 Recommended Dose and Dosage Adjustment The dosage of Lyumjev must be individualized.
Individualize and adjust the dosage of Lyumjev based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. , amount and type of food or timing of food intake), changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia.
Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS).
Starting Dose in Insulin-Naïve Patients:
Type 1 Diabetes Mellitus: Lyumjev is to be used as mealtime insulin and requires subsequent individual dosage adjustments. The recommended starting dose of Lyumjev in insulin naïve adult patients with type 1 diabetes is approximately 50% of the total daily insulin dose and should be divided between each daily meal.
The remainder of the total daily insulin dose should be administered as intermediate- or long-acting insulin. 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.
Type 2 Diabetes Mellitus:
The suggested initial dose for adult patients is 4 units at one or more meals. The number of injections and subsequent titration will depend on individua l glycemic targets. Converting to Lyumjev from Other Insulins Close glucose monitoring is recommended when converting from other mealtime insulins and in the initial weeks thereafter.
If converting from another mealtime insulin to Lyumjev, the change can be done on a unit-to-unit basis. Due to the faster onset of insulin action, Lyumjev should be injected at the start of a meal. When necessary, Lyumjev may […]
The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. g. driving a car or operating machinery). 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. Hyperglycemia The use of inadequate doses or discontinuation of treatment, especially in patients requiring insulin, may lead to hyperglycemia and diabetic ketoacidosis; conditions which are potentially lethal.
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction Pump or infusion set malfunctions can lead to rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary.
Interim therapy with subcutaneous injection of Lyumjev may be required. Patients using Lyumjev™, Lyumjev™ KwikPen®, Lyumjev™ Junior KwikPen®, Lyumjev™ Tempo Pen™ Product Monograph Page 11 of 75 continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure (see 4 DOSAGE AND ADMINISTRATION, and 12 STORAGE, STABILITY, AND DISPOSAL).
Hepatic and Renal Impairment Patients with hepatic or renal impairment may be at increased risk of hypoglycemia and may require more frequent Lyumjev dose adjustment and more frequent glucose monitoring. Immune Injection site and local allergic reaction With insulin therapies including Lyumjev, patients may experience rash, redness, bruising, swelling, pain, inflammation, or itching at the site of injection (see 9 ADVERSE REACTIONS).
Most of these minor reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of LYUMJEV. They may occur if the injection is not properly made (irritants in the skin cleansing agent or poor injection technique), or if the patient is allergic to the insulin or any excipients (see 2 CONTRAINDICATIONS).
Continuous rotation of the injection site within a given area may help to reduce or prevent these r eactions. Systemic Allergic Reaction Systemic allergic reactions have rarely occurred with insulin treatments, including Lyumjev (see 9 ADVERSE REACTIONS).
These reactions may be characterized by a generalized rash (with pruritus), shortness of breath, wheezing, angioneurotic edema and drop in blood pressure (see 9 ADVERSE REACTIONS). Severe cases of generalized allergy including anaphylactic reaction may be life threatening (see 2 CONTRAINDICATION).
If hypersensitivity reactions occur, discontinue Lyumjev; treat per standard of care and monitor until symptoms and signs resolve. Antibody production As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The presence of such antibodies may necessitate adjustment of the insulin dose to correct for tendencies toward hyper- or hypoglycemia. In a 26-week study in type 1 diabetes patients (N=777), 49% were anti-drug (insulin lispro) antibody (ADA)-positive at baseline, 91% of which were cross-reactive with native insulin.
, either new ADA or a 57% increase in assay signal over baseline), 75% of which were cross-reactive with native insulin. In a 26-week study in type 2 diabetes patients (N=335), 35% were ADA-positive at baseline, 81% of which were cross-reactive with native insulin.
, either new ADA or a 57% increase in assay signal over baseline), 68% of which were cross-reactive with native insulin. Avoidance of accidental mix-ups/medication errors Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Lyumjev and other insulin products.
Lyumjev™, Lyumjev™ KwikPen®, Lyumjev™ […]
V. infusion fluids under medical supervision. Train patients on proper use and injection technique before initiating Lyumjev. Training reduces the risk of administration errors such as needle sticks and incomplete dosing. 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 to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis (see 8 WARNINGS AND PRECAUTIONS). Serious Warnings and Precautions Hypoglycemia is the most common adverse effect of insulin products. As with all insulin products, the timing of hypoglycemia may differ.
Glucose monitoring shall be performed for all patients with diabetes mellitus treated with insulins. (See 8 & 5 HYPOGLYCEMIA, HYPERGLYCEMIA AND OVERDOSAGE). Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma or even death.
(See 8 ENDOCRINE AND METABOLISM – HYPOGLYCEMIA). Any conversion of insulin products should be made cautiously and only under medical supervision. (See 4 DOSING AND ADMINSTRATION). Due to its rapid onset of action and shorter duration of action, Lyumjev should be administered 0 to 2 minutes before the start of the meal.
When necessary, Lyumjev may be administered up to 20 minutes after starting a meal (see 15 CLINICAL TRIALS and 4 DOSAGE AND ADMINISTRATION). Lyumjev should not be used if it is not water clear and colourless. Lyumjev 200 units/mL should not be administered via a subcutaneous infusion pump or mixed with any other insulin (including Lyumjev 100 units/mL).
DO NOT transfer insulin lispro solution in the Lyumjev 200 units/mL KwikPen to other devices, such as a syringe. The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycemia.
V. infusion fluids under medical supervision. Lyumjev™, Lyumjev™ KwikPen®, Lyumjev™ Junior KwikPen®, Lyumjev™ Tempo Pen™ Product Monograph Page 6 of 75 Before travelling between different time zones, the patient should seek the health professional’s advice since this means the patient has to take insulin and meals at different times.
Lyumjev 200 units/mL should not be administered via a subcutaneous infusion pump or mixed with any other insulin (including Lyumjev 100 units/mL). DO NOT transfer insulin lispro solution in the Lyumjev 200 units/mL KwikPen to other devices, such as a syringe.
The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycemia. When used via a subcutaneous insulin infusion pump, Lyumjev (insulin lispro injection) 100 units/mL should not be diluted or mixed with any other insulin.
Patients should carefully read and follow the insulin infusion pump manufacturer's instructions and Part III - Patient Medication Information before use. 2 Recommended Dose and Dosage Adjustment The dosage of Lyumjev must be individualized.
Individualize and adjust the dosage of Lyumjev based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. , amount and type of food or timing of food intake), changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia.
Health Canada has not authorized an indication for pediatric use (see 1 […]