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SEMGLEE is a brand name for Insulin Glargine, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between Semglee and the reference biologic drug Lantus®. Semglee [Insulin Glargine Injection (rDNA Origin)] is a recombinant human insulin analog indicated: • for once-daily subcutaneous administration in the treatment of patients over 17 years of age with Type…
Verbatim from this product's HC label. Tap a section to expand.
). • This insulin product shall not be used if it is not water-clear and colourless or if it has formed a deposit of solid particles on the wall of the cartridge (see 4 DOSAGE AND ADMINISTRATION). 1 Dosing Considerations Semglee [Insulin Glargine Injection (rDNA Origin)] is a novel recombinant human insulin analogue.
Its potency is approximately the same as human insulin. It exhibits a glucose-lowering profile with no pronounced peak with a prolonged duration of action that permits once-daily basal dosing. Semglee is administered subcutaneously once a day.
It may be administered at any time during the day as long as it is administered at the same time every day. The desired blood glucose levels as well as the doses and timing of antidiabetic medications must be determined and adjusted individually.
Dose adjustment may be required, for example, if the patient's timing of administration, weight or lifestyle changes or other circumstances arise that increase susceptibility to hypoglycemia or hyperglycemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypoglycemia and Hyperglycemia).
The dose may also have to be adjusted during intercurrent illness (see 7 WARNINGS AND PRECAUTIONS, Intercurrent Conditions). Any change in insulin dose should be made under medical supervision. The prolonged duration of activity of Semglee is dependent on injection into subcutaneous space.
Semglee is not intended for intravenous or intramuscular administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia (see 7 WARNINGS AND PRECAUTIONS). In cases of insufficient glucose control or a tendency to hyper- or hypoglycemic episodes, patient’s compliance with the prescribed insulin regimen, injections sites and proper injection techniques, the handling of injection devices and all other relevant factors must be reviewed before dose adjustment is considered.
Blood glucose monitoring is recommended for all patients with diabetes. Semglee must not be used for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin should be the preferred treatment. 2 Recommended Dose and Dosage Adjustment Initiation of Semglee therapy In clinical studies with insulin naïve patients with type 2 diabetes, Insulin Glargine Injection (rDNA Origin) was started at a dose of 10 U once daily, and subsequently adjusted according to the patient’s need (see 14 CLINICAL TRIALS).
). Patients should be rigorous with site rotation secondary to prolonged deposition. In clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, thigh, or deltoid subcutaneous administration.
As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.
Preparation and handling:
Semglee is a clear solution, not a suspension. Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. Semglee must only be used if the solution is clear and colourless with no particles visible.
To minimize local irritation at the injection site, it is recommended to allow the insulin to reach room temperature before injection. Patient must be instructed to not re-use needles. INJECTION PENS, CARTRIDGES, NEEDLES, AND SYRINGES MUST NOT BE SHARED.
To prevent the possible transmission of disease, never share an injection pen or cartridge between patients, even if the needle on the injection pen is changed.
Mixing and diluting:
Semglee must not be mixed with any other insulin. Mixing can change the time/action profile of Product Monograph Semglee® Insulin Glargine Injection (rDNA Origin) Page 7 of 48 Semglee and cause precipitation. When Insulin Glargine Injection (rDNA Origin) and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and time to maximum effect for regular human insulin was observed.
The total bioavailability of the mixture was also slightly decreased compared to separate injections of Insulin Glargine Injection (rDNA Origin) and regular human insulin. The relevance of these observations in dogs to humans is not known.
, Endocrine and Metabolism, Hypoglycemia and Hyperglycemia). The dose may also have to be adjusted during intercurrent illness (see 7 WARNINGS AND PRECAUTIONS, Intercurrent Conditions). Any change in insulin dose should be made under medical supervision.
The prolonged duration of activity of Semglee is dependent on injection into subcutaneous space. Semglee is not intended for intravenous or intramuscular administration. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia (see 7 WARNINGS AND PRECAUTIONS).
In cases of insufficient glucose control or a tendency to hyper- or hypoglycemic episodes, patient’s compliance with the prescribed insulin regimen, injections sites and proper injection techniques, the handling of injection devices and all other relevant factors must be reviewed before dose adjustment is considered.
Blood glucose monitoring is recommended for all patients with diabetes. Semglee must not be used for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin should be the preferred treatment. 2 Recommended Dose and Dosage Adjustment Initiation of Semglee therapy In clinical studies with insulin naïve patients with type 2 diabetes, Insulin Glargine Injection (rDNA Origin) was started at a dose of 10 U once daily, and subsequently adjusted according to the patient’s need (see 14 CLINICAL TRIALS).
Product Monograph Semglee® Insulin Glargine Injection (rDNA Origin) Page 6 of 48 Changeover to Semglee When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Semglee, the amount and timing of short-acting insulin or fast-acting insulin analogue or the dose of any oral antidiabetic drug may need to be adjusted secondary to the risk of hypoglycemia.
In clinical studies when patients were transferred from once-daily NPH human insulin or ultralente human insulin to once- daily Insulin Glargine Injection (rDNA Origin), the initial dose was usually not changed. However, in studies when patients were transferred from twice-daily NPH human insulin to Insulin Glargine Injection (rDNA Origin) once daily, the initial dose (U) was usually reduced by approximately 20% (compared to total daily IU of NPH human insulin) and then adjusted based on patient response.
• Semglee [Insulin Glargine Injection (rDNA Origin)] is contraindicated during episodes of hypoglycemia (see 5 OVERDOSAGE) and 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Product Monograph Semglee® Insulin Glargine Injection (rDNA Origin) Page 6 of 48 Changeover to Semglee When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Semglee, the amount and timing of short-acting insulin or fast-acting insulin analogue or the dose of any oral antidiabetic drug may need to be adjusted secondary to the risk of hypoglycemia.
In clinical studies when patients were transferred from once-daily NPH human insulin or ultralente human insulin to once- daily Insulin Glargine Injection (rDNA Origin), the initial dose was usually not changed. However, in studies when patients were transferred from twice-daily NPH human insulin to Insulin Glargine Injection (rDNA Origin) once daily, the initial dose (U) was usually reduced by approximately 20% (compared to total daily IU of NPH human insulin) and then adjusted based on patient response.
To reduce the risk of hypoglycaemia, when patients are transferred from once daily insulin glargine 300 Units/mL to once daily Semglee, the recommended initial Semglee dose is 80% of the insulin glargine 300 Units/mL dose that is being discontinued.
A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. The amount and timing of short-acting insulin or fast-acting insulin analogue may need to be adjusted.
This is particularly true for patients with acquired antibodies to human insulin needing high-insulin doses and occurs with all insulin analogues. Such patients may experience a greater insulin response to Semglee. With improved metabolic control and resulting increase in insulin sensitivity, adjustment of the dose(s) of antidiabetic treatments may become necessary.
4 Administration Semglee is administered by subcutaneous injection. The injection area must not be rubbed. As with all insulins, injection sites within an injection area (abdomen, thigh, buttock or deltoid) must be rotated 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 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). Patients should be rigorous with site rotation secondary to prolonged deposition. In clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, thigh, or deltoid subcutaneous administration.
As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.
Preparation and handling:
Semglee is a clear solution, not a suspension. Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. Semglee must only be used if the solution is clear and colourless with no particles visible.
To minimize local irritation at the injection site, it is recommended to allow the insulin to reach room temperature before injection. Patient must be instructed to not re-use needles. INJECTION PENS, CARTRIDGES, NEEDLES, AND SYRINGES MUST NOT BE SHARED.
To prevent the possible transmission of disease, never share an injection pen or cartridge between patients, even if the needle on the injection pen is changed.
Mixing and diluting:
Semglee must not be mixed with any other insulin. Mixing can change the time/action profile of Product Monograph Semglee® Insulin Glargine Injection (rDNA […]
Semglee must not be diluted. Diluting can change the time/action profile of Semglee. 5 Missed Dose If you have missed a dose of Semglee or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycemia).
Check your blood sugar frequently. ” in the PATIENT MEDICATION INFORMATION. Do not take a double dose to make up for a forgotten dose. 5 OVERDOSAGE Symptoms: An excess of insulin relative to food intake, energy expenditure or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia (see 7 WARNINGS AND PRECAUTIONS).
Symptoms of hypoglycemia may occur suddenly. They may include cold sweat, cool pale skin, fatigue, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation. Nocturnal hypoglycemia is common in people taking insulin and symptoms can include restlessness, making unusual noises, attempting to get out of bed or accidentally rolling out of bed, sleepwalking, nightmares and sweating.
Patients may wake with a headache in the morning if their blood sugar was low during the night. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may be fatal. In some cases, the first sign of hypoglycemia may be confusion or loss of consciousness (hypoglycemia unawareness).
Severe hypoglycemia, resulting in seizures, is more likely to occur at nighttime (nocturnal hypoglycemia) than during the day.
Management:
Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed. It is therefore recommended that patients with diabetes carry sugar-containing products.
5 mg) given intramuscularly or subcutaneously by a trained person, or by glucose given intravenously by a medical professional. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. For management of a suspected drug overdose, contact your regional poison control centre.
Product Monograph Semglee® Insulin Glargine Injection (rDNA Origin) Page 8 of 48 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Solution for injection 100 units/mL Glycerol 85%, m-cresol, water for injection and zinc.
Hydrochloric acid and sodium hydroxide for pH adjustment. The pre-filled disposable pen contains a sterile solution of insulin glargine for use as an injection. Semglee [Insulin Glargine Injection (rDNA Origin)] consists of insulin glargine dissolved in a clear aqueous fluid.
Each milliliter of Semglee [Insulin Glargine Injection (rDNA Origin)] contains insulin glargine 100 units. Each milliliter also contains excipients: glycerol 85%, m-cresol, water for injection and zinc. Semglee has a pH of approximately 4.
The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Semglee [Insulin Glargine Injection (rDNA Origin)] 100 units per mL (U 100) is available in 3-mL pre-filled disposable pens, in packages of 1, 3 or 5.
Pen, Plunger stoppers, cartridge, lined seals are not made with natural rubber latex. Description Semglee [Insulin Glargine Injection (rDNA Origin)] is a recombinant human insulin analogue that is a long-acting, parenteral blood-glucose-lowering agent.
Semglee is produced by recombinant DNA […]
To reduce the risk of hypoglycaemia, when patients are transferred from once daily insulin glargine 300 Units/mL to once daily Semglee, the recommended initial Semglee dose is 80% of the insulin glargine 300 Units/mL dose that is being discontinued.
A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. The amount and timing of short-acting insulin or fast-acting insulin analogue may need to be adjusted.
This is particularly true for patients with acquired antibodies to human insulin needing high-insulin doses and occurs with all insulin analogues. Such patients may experience a greater insulin response to Semglee. With improved metabolic control and resulting increase in insulin sensitivity, adjustment of the dose(s) of antidiabetic treatments may become necessary.
4 Administration Semglee is administered by subcutaneous injection. The injection area must not be rubbed. As with all insulins, injection sites within an injection area (abdomen, thigh, buttock or deltoid) must be rotated 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 7 WARNINGS AND PRECAUTIONS and