Semglee100 IU/ml

Semglee is a long-acting (basal) insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

• Type 1 diabetes mellitus (established use): Semglee is used as part of a basal-bolus regimen, combined with short- or rapid-acting insulin for mealtime coverage, in adults and children.
• Type 2 diabetes mellitus (established use): Semglee is used alone or in combination with oral antidiabetic agents or other injectable therapies when diet, exercise, and oral medicines do not achieve adequate glycemic control.

Semglee is not indicated for the treatment of diabetic ketoacidosis; a rapid-acting intravenous insulin is required for that condition.

Each mL of Insulin Glargine injection contains 100 units (U-100) of insulin glargine, a recombinant human insulin analog produced by DNA technology, together with excipients such as zinc chloride, metacresol, glycerol, and water for injection, with pH adjusted using hydrochloric acid and sodium hydroxide. Higher-concentration formulations of Insulin Glargine (U-300) are also available in some markets.

Semglee is a long-acting human insulin analog that differs from human insulin by substitution of glycine for asparagine at position A21 and addition of two arginine residues to the C-terminus of the B-chain. These changes shift the isoelectric point, making the molecule more soluble at acidic pH and less soluble at physiological pH.

After subcutaneous injection, this altered solubility causes Semglee to form microprecipitates at the injection site, from which small amounts are continuously released, producing a relatively constant, peakless glucose-lowering effect over approximately 24 hours.

Semglee belongs to the class of long-acting (basal) human insulin analogs, used in the management of diabetes mellitus.

Mechanism of action: Insulin Glargine binds to the insulin receptor on target tissues (primarily liver, skeletal muscle, and adipose tissue), stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and inhibiting hepatic glucose production. It also inhibits lipolysis and proteolysis while enhancing protein synthesis.

Pharmacokinetics: Following subcutaneous injection, Insulin Glargine is absorbed slowly, with an onset of action of approximately 1–2 hours and a relatively flat, prolonged duration of action of about 24 hours without a pronounced peak, allowing once-daily dosing in most patients.

Semglee is administered by subcutaneous injection only, once daily at the same time each day. Do not administer intravenously or intramuscularly, and do not use in an insulin pump. Rotate injection sites within the same region (abdomen, thigh, or deltoid) to reduce the risk of lipodystrophy. Do not dilute or mix Semglee with any other insulin or solution; if mealtime insulin is also required, give it as a separate injection.

Semglee has clinically significant interactions with several classes of medicines:

• Increased risk of hypoglycemia: other antidiabetic agents, ACE inhibitors, angiotensin receptor blockers, fibrates, fluoxetine, monoamine oxidase inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, salicylates, and alcohol may enhance the glucose-lowering effect of Semglee, requiring dose reduction and closer monitoring.
• Decreased glucose-lowering effect: corticosteroids, thiazide diuretics, atypical antipsychotics, estrogens, thyroid hormones, and sympathomimetics may reduce the effect of Semglee, sometimes requiring a dose increase.
• Masked hypoglycemia symptoms: beta-blockers, clonidine, and reserpine can blunt the warning signs of hypoglycemia when used with Semglee, increasing the need for glucose monitoring.
• Fluid retention/heart failure risk: thiazolidinediones (e.g., pioglitazone) combined with Semglee may cause dose-related fluid retention and worsen or precipitate heart failure.

The most common and most serious adverse effect of Semglee is hypoglycemia, which can be severe and life-threatening (see also Precautions and Warnings).

Other reported side effects of Semglee include:

• Injection site reactions (redness, swelling, itching, or pain)
• Lipodystrophy at injection sites (skin thickening or pitting) with repeated injection in the same spot
• Allergic reactions, ranging from mild local rash to rare severe systemic hypersensitivity/anaphylaxis
• Peripheral edema, particularly when starting therapy or with concomitant thiazolidinedione use
• Weight gain
• Rarely, low potassium levels (hypokalemia)

Pregnancy: Well-controlled blood glucose is important throughout pregnancy to reduce risks of maternal and fetal complications. Available data have not shown a clear association between Semglee and adverse pregnancy outcomes, but data remain limited. Semglee should be used during pregnancy only if clearly needed, and only under close medical supervision, as poorly controlled diabetes itself poses significant risk to both mother and baby. Consult a physician before use during pregnancy.

Lactation: There is limited information on the presence of Semglee in human milk; insulin is a normal component of human milk. Use of Semglee during breastfeeding should be guided by a physician, weighing the established benefits of breastfeeding against the mother's insulin requirements.

Hypoglycemia: The most common risk with Semglee; can be serious and life-threatening. Its long duration of action may delay recovery from hypoglycemia. Risk is increased by dose errors, skipped or delayed meals, unusual physical exertion, alcohol intake, and certain concomitant drugs. Patients with long-standing diabetes, diabetic nerve damage, or those using beta-blockers may not sense the early warning signs of low blood sugar (hypoglycemia unawareness).

Do not share pens/needles: Insulin pens and syringes used for Semglee must never be shared between patients, even if the needle is changed, due to the risk of transmitting blood-borne infections.

Changes in insulin regimen: Any change in insulin strength, brand, type, or manufacturer of Semglee must be made only under medical supervision, with more frequent blood glucose monitoring during the transition.

Do not dilute or mix: Semglee must not be diluted or mixed with any other insulin or solution in the same syringe, as this can alter its prolonged, peakless action profile; if mealtime insulin is also needed, give it as a separate injection.

Hypersensitivity reactions: Severe, generalized allergic reactions, including anaphylaxis, have been reported with insulin products including Semglee; discontinue and seek medical care if this occurs.

Hypokalemia: Semglee, like all insulins, causes potassium to shift into cells; monitor potassium levels in patients at risk (e.g., those on potassium-lowering medicines or with poor nutrition).

Renal and hepatic impairment: Patients with kidney or liver problems may need closer monitoring and dose adjustment, as insulin requirements can change.

An overdose of Semglee causes hypoglycemia, which may present as sweating, tremor, palpitations, confusion, drowsiness, seizures, or loss of consciousness, and can also cause low blood potassium. Mild hypoglycemia can often be managed by consuming a fast-acting source of sugar (such as glucose tablets or juice). Any suspected overdose of Semglee or severe/persistent hypoglycemia is a medical emergency — seek immediate medical attention or contact emergency services; a physician may need to administer glucagon or intravenous glucose along with careful monitoring.

Store unopened Semglee in a refrigerator (2°C to 8°C); do not freeze, and discard if it has been frozen. Once in use (opened vial, cartridge, or pen), Semglee may be kept at room temperature (below 30°C), away from direct heat and light, and should generally be used within 28 days and then discarded, even if some medicine remains. Keep out of reach of children. Always check the product-specific storage instructions provided with the pack.

Pediatric use: Semglee may be used in children with type 1 diabetes; safety and effectiveness have been established in pediatric patients from 6 years of age. Use in younger children should be individualized and supervised by a pediatric specialist.

Elderly: No overall differences in safety or effectiveness have been observed, but conservative initial dosing and cautious titration of Semglee are recommended, since hypoglycemia may be harder to recognize and more harmful in older adults.

Renal impairment: Insulin requirements may be reduced due to decreased insulin clearance; monitor closely when using Semglee in patients with kidney impairment.

Hepatic impairment: Insulin requirements may be reduced due to decreased capacity for gluconeogenesis; monitor closely when using Semglee in patients with liver impairment.

Semglee is generally used long-term (often lifelong) as part of ongoing diabetes management, since it replaces or supplements the body's basal insulin. The duration of treatment with Semglee should be determined and periodically reviewed by the treating physician based on glycemic control, changing health status, and treatment goals.

Insulin Glargine is classified as a long-acting (basal) insulin analog, a subclass of antidiabetic agents / insulins.

Insulin Glargine exerts its glucose-lowering action by binding to insulin receptors, promoting cellular glucose uptake (mainly in muscle and fat), suppressing hepatic glucose output, and inhibiting fat breakdown, mimicking the basal (background) insulin secretion of a healthy pancreas over approximately 24 hours.

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Semglee is approved for use in children with type 1 diabetes mellitus aged 6 years and older, with dosing individualized based on metabolic needs and blood glucose monitoring, under close supervision of a pediatrician or diabetes specialist. Safety and efficacy of Semglee in children younger than 6 years and in children with type 2 diabetes have not been established.