Insulin Glargine - Insulin Glargine injection, Solution
(Insulin Glargine)Insulin Glargine - Insulin Glargine injection, Solution Prescribing Information
Dosage and administration (
| 6/2023 |
Insulin Glargine is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
- Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ()
2.2 General Dosing Instructions- Administer Insulin Glargine subcutaneously once daily at any time of day but at the same time every day.
- Individualize and adjust the dosage of Insulin Glargine 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, Insulin Glargine 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. This product is LANTUS (insulin glargine)[see Warnings and Precautions (5.4)].
- Visually inspect Insulin Glargine vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
- Administer Insulin Glargine 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 Insulin Glargine with any other insulin or solution.
- The Insulin Glargine SoloStar prefilled pen dials in 1-unit increments.
- Use Insulin Glargine SoloStar 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. This product is LANTUS (insulin glargine)[see Warnings and Precautions (5.4)].
- Visually inspect Insulin Glargine vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
- Administer Insulin Glargine 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 Insulin Glargine with any other insulin or solution.
- The Insulin Glargine SoloStar prefilled pen dials in 1-unit increments.
- Use Insulin Glargine SoloStar 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. This product is LANTUS (insulin glargine)[see Warnings and Precautions (5.4)].
- Visually inspect Insulin Glargine vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
- Administer Insulin Glargine 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 Insulin Glargine with any other insulin or solution.
- The Insulin Glargine SoloStar prefilled pen dials in 1-unit increments.
- Use Insulin Glargine SoloStar 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 diabetes () and how to change to Insulin Glargine from other insulins (
2.3 Initiation of Insulin Glargine TherapyRecommended Starting Dosage in Patients with Type 1 DiabetesThe recommended starting dosage of Insulin Glargine 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 DiabetesThe recommended starting dosage of Insulin Glargine 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.
)2.4 Switching to Insulin Glargine from Other Insulin TherapiesDosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Glargine from other insulin therapies
[see Warnings and Precautions (5.3)].When switching from:
- Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily Insulin Glargine (100 units/mL), the recommended starting Insulin Glargine dosage is 80% of the TOUJEO dosage that is being discontinued.
- Once-daily NPH insulin to once-daily Insulin Glargine, the recommended starting Insulin Glargine dosage is the same as the dosage of NPH that is being discontinued.
- Twice-daily NPH insulin to once-daily Insulin Glargine, the recommended starting Insulin Glargine dosage is 80% of the total NPH dosage that is being discontinued.
- Closely monitor glucose when switching to Insulin Glargine and during initial weeks thereafter. ()
2.4 Switching to Insulin Glargine from Other Insulin TherapiesDosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Glargine from other insulin therapies
[see Warnings and Precautions (5.3)].When switching from:
- Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily Insulin Glargine (100 units/mL), the recommended starting Insulin Glargine dosage is 80% of the TOUJEO dosage that is being discontinued.
- Once-daily NPH insulin to once-daily Insulin Glargine, the recommended starting Insulin Glargine dosage is the same as the dosage of NPH that is being discontinued.
- Twice-daily NPH insulin to once-daily Insulin Glargine, the recommended starting Insulin Glargine dosage is 80% of the total NPH dosage that is being discontinued.
Injection: 100 units/mL (U-100) a clear and colorless solution available as:
- 10 mL multiple-dose vial
- 3 mL single-patient-use Insulin Glargine SoloStar prefilled pen
Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes
Human Data
Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.
Animal Data
Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
Disease-Associated Maternal and/or Embryo-fetal Risk
Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.
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
Human Data
Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.
Animal Data
Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
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.
Insulin Glargine is contraindicated:
- During episodes of hypoglycemia [see]
5.3 HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins, including Insulin Glargine. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient 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 may delay recovery from hypoglycemia.
Risk Factors for HypoglycemiaThe 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 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 HypoglycemiaPatients 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.
- In patients with hypersensitivity to insulin glargine or any of the excipients in Insulin Glargine [see]
5.5 Hypersensitivity ReactionsSevere, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Insulin Glargine
[see Adverse Reactions (6.1)]. If hypersensitivity reactions occur, discontinue Insulin Glargine; treat per standard of care and monitor until symptoms and signs resolve. Insulin Glargine is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.