Lantus Solostar
(Insulin Glargine)Lantus Solostar Prescribing Information
LANTUS 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 LANTUS subcutaneously once daily at any time of day but at the same time every day.
- Individualize and adjust the dosage of LANTUS 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, LANTUS 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 LANTUS 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 LANTUS 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 LANTUS with any other insulin or solution.
- The LANTUS SoloStar prefilled pen dials in 1-unit increments.
- Use LANTUS SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
- Always check insulin labels before administration
- 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 LANTUS 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 LANTUS 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 LANTUS with any other insulin or solution.
- The LANTUS SoloStar prefilled pen dials in 1-unit increments.
- Use LANTUS SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
- Always check insulin labels before administration
- 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 LANTUS 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 LANTUS 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 LANTUS with any other insulin or solution.
- The LANTUS SoloStar prefilled pen dials in 1-unit increments.
- Use LANTUS SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
- Always check insulin labels before administration
- See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes () and how to change to LANTUS from other insulins (
2.3 Initiation of LANTUS TherapyRecommended Starting Dosage in Patients with Type 1 DiabetesThe recommended starting dosage of LANTUS 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 LANTUS 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 LANTUS from Other Insulin TherapiesDosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to LANTUS from other insulin therapies
[see Warnings and Precautions (5.3)].When switching from:
- Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued.
- Once-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is the same as the dosage of NPH that is being discontinued.
- Twice-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is 80% of the total NPH dosage that is being discontinued.
- Closely monitor glucose when switching to LANTUS and during initial weeks thereafter. ()
2.4 Switching to LANTUS from Other Insulin TherapiesDosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to LANTUS from other insulin therapies
[see Warnings and Precautions (5.3)].When switching from:
- Once-daily TOUJEO (insulin glargine 300 units/mL) to once-daily LANTUS (100 units/mL), the recommended starting LANTUS dosage is 80% of the TOUJEO dosage that is being discontinued.
- Once-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS dosage is the same as the dosage of NPH that is being discontinued.
- Twice-daily NPH insulin to once-daily LANTUS, the recommended starting LANTUS 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 LANTUS 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.
LANTUS is contraindicated:
- During episodes of hypoglycemia [see]
5.3 HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins, including LANTUS. 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 LANTUS 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 LANTUS 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 LANTUS [see]
5.5 Hypersensitivity ReactionsSevere, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including LANTUS
[see Adverse Reactions (6.1)]. If hypersensitivity reactions occur, discontinue LANTUS; treat per standard of care and monitor until symptoms and signs resolve. LANTUS is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.
- Never sharea LANTUS SoloStar prefilled pen, insulin syringe, or needle between patients, even if the needle is changed. ()
5.1 Never Share a LANTUS SoloStar Prefilled Pen, Insulin Syringe, or Needle Between PatientsLANTUS SoloStar prefilled pens must never be shared between patients, even if the needle is changed. Patients using LANTUS 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 RegimenChanges 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 HypoglycemiaHypoglycemia is the most common adverse reaction associated with insulins, including LANTUS. 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 LANTUS 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 LANTUS 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.
- 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 ErrorsAccidental mix-ups among insulin products have been reported. To avoid medication errors between LANTUS 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 LANTUS. Monitor and treat if indicated. ()
5.5 Hypersensitivity ReactionsSevere, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including LANTUS
[see Adverse Reactions (6.1)]. If hypersensitivity reactions occur, discontinue LANTUS; treat per standard of care and monitor until symptoms and signs resolve. LANTUS is contraindicated in patients who have had hypersensitivity reactions to insulin glargine 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 HypokalemiaAll insulins, including LANTUS, 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 AgonistsThiazolidinediones (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 LANTUS, 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.