Semglee

SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.

• Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. (

  2.2 General Dosing Instructions

  • Administer SEMGLEE subcutaneously once daily at any time of day but at the same time every day.
  • Individualize and adjust the dosage of SEMGLEE based on the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function. Dosage adjustments should only be made under medical supervision with appropriate glucose monitoring [
    see Warnings and Precautions (5.2)
    ].
  • In patients with type 1 diabetes, SEMGLEE must be used concomitantly with short-acting insulin.
  )

• Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. (
  2.1 Important Administration Instructions

  • Always check insulin labels before administration [see
    Warnings and Precautions (5.4)
    ]
  • Visually inspect SEMGLEE vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
  • Administer SEMGLEE subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [
    see Warnings and Precautions (5.2) , and Adverse Reactions (6)
    ].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [
    see Warnings and Precautions (5.2)
    ].
  • Do not administer intravenously or via an insulin pump.
  • Do not dilute or mix SEMGLEE with any other insulin or solution.
  • The SEMGLEE prefilled pen dials in 1-unit increments.
  • Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  )
• Do not dilute or mix with any other insulin or solution. (
  2.1 Important Administration Instructions

  • Always check insulin labels before administration [see
    Warnings and Precautions (5.4)
    ]
  • Visually inspect SEMGLEE vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
  • Administer SEMGLEE subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [
    see Warnings and Precautions (5.2) , and Adverse Reactions (6)
    ].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [
    see Warnings and Precautions (5.2)
    ].
  • Do not administer intravenously or via an insulin pump.
  • Do not dilute or mix SEMGLEE with any other insulin or solution.
  • The SEMGLEE prefilled pen dials in 1-unit increments.
  • Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  )
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (
  2.1 Important Administration Instructions

  • Always check insulin labels before administration [see
    Warnings and Precautions (5.4)
    ]
  • Visually inspect SEMGLEE vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
  • Administer SEMGLEE subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [
    see Warnings and Precautions (5.2) , and Adverse Reactions (6)
    ].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [
    see Warnings and Precautions (5.2)
    ].
  • Do not administer intravenously or via an insulin pump.
  • Do not dilute or mix SEMGLEE with any other insulin or solution.
  • The SEMGLEE prefilled pen dials in 1-unit increments.
  • Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  )

• See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetis (

  2.3 Initiation of SEMGLEE Therapy

  • Recommended Starting Dosage in Patients with Type 1 Diabetes
    
    
    The recommended starting dosage of SEMGLEE in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of the daily insulin requirements.

  • Recommended Starting Dosage in Patients with Type 2 Diabetes
    
    
    The recommended starting dosage of SEMGLEE in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily.
  ) and how to change to SEMGLEE from other insulins. (
  2.4 Switching to SEMGLEE from Other Insulin Therapies

  Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to SEMGLEE from other insulin therapies [

  see Warnings and Precautions (5.3)

  ].When switching from:

  • Once-daily insulin glargine 300 units/mL to once-daily SEMGLEE (100 units/mL), the recommended starting SEMGLEE dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued.
  • Once-daily NPH insulin to once-daily SEMGLEE, the recommended starting SEMGLEE dosage is the same as the dosage of NPH that is being discontinued.
  • Twice-daily NPH insulin to once-daily SEMGLEE, the recommended starting SEMGLEE dosage is 80% of the total NPH dosage that is being discontinued.
  )

• Closely monitor glucose when switching to SEMGLEE and during initial weeks thereafter. (
  2.4 Switching to SEMGLEE from Other Insulin Therapies

  Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to SEMGLEE from other insulin therapies [

  see Warnings and Precautions (5.3)

  ].When switching from:

  • Once-daily insulin glargine 300 units/mL to once-daily SEMGLEE (100 units/mL), the recommended starting SEMGLEE dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued.
  • Once-daily NPH insulin to once-daily SEMGLEE, the recommended starting SEMGLEE dosage is the same as the dosage of NPH that is being discontinued.
  • Twice-daily NPH insulin to once-daily SEMGLEE, the recommended starting SEMGLEE dosage is 80% of the total NPH dosage that is being discontinued.
  )

Injection: 100 units/mL (U-100) clear and colorless solution available as:

• •10 mL multiple-dose vial
• •3 mL single-patient-use prefilled pen

Published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes

Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown.

• •
  Never share
  a SEMGLEE prefilled pen, insulin syringe, or needle between patients, even if the needle is changed. (
  5.1 Never Share a SEMGLEE Prefilled Pen, Insulin Syringe, or Needle Between Patients

  SEMGLEE prefilled pens must never be shared between patients, even if the needle is changed. Patients using SEMGLEE vials must never re-use or share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  )
• •
  Hyperglycemia or hypoglycemia with changes in insulin regimen: 
  Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. (
  5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

  Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia

  [see Warnings and Precautions (5.3)]

  or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia

  [see Adverse Reactions (6)]

  .

  Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant oral and antidiabetic products may be needed.
  )
• •
  Hypoglycemia:
  May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. (
  5.3 Hypoglycemia

  Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patients and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

  Hypoglycemia can happen suddenly, and symptoms may differ in each patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers)

  [see Drug Interactions (7)]

  , or who experience recurrent hypoglycemia.

  The long-acting effect of insulin glargine products may delay recovery from hypoglycemia.

  Risk Factors for Hypoglycemia

  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. As with all insulins, the glucose lowering effect time course of insulin glargine products may vary in different patients or at different times in the same patient and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [

  see Clinical Pharmacology (12.2

  )]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitant drugs [

  see Drug Interactions (7)

  ]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [

  see Use in Specific Populations (8.6, 8.7)

  ].

  Risk Mitigation Strategies for Hypoglycemia

  Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
  )
• •
  Hypoglycemia due to Medication Errors:
  Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (
  5.4 Hypoglycemia Due to Medication Errors

  Accidental mix-ups among insulin products have been reported. To avoid medication errors between SEMGLEE and other insulins, instruct patients to always check the insulin label before each injection

  [see Adverse Reactions (6.3)]

  .
  )
• •
  Hypersensitivity reactions
  : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue SEMGLEE. Monitor and treat if indicated. (
  5.5 Hypersensitivity Reactions

  Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including insulin glargine products

  [see Adverse Reactions (6.1)]

  . If hypersensitivity reactions occur, discontinue SEMGLEE; treat per standard of care and monitor until symptoms and signs resolve. SEMGLEE is contraindicated in patients who have had hypersensitivity reactions to insulin glargine products or one of the excipients.
  )
• •
  Hypokalemia:
  May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (
  5.6 Hypokalemia

  All insulins, including insulin glargine products, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
  )
• •
  Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs)
  : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs. (
  5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

  Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin including SEMGLEE, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
  )