Lantus Solution for Injection in a Cartridge

BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for treating diabetic ketoacidosis. ( 1 ) Limitations of Use BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

• Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, prior insulin use
• Administer subcutaneously once daily at any time of day, but at the same time every day
• Rotate injection sites into the abdominal area, thigh, or deltoid to reduce the risk of lipodystrophy and localized cutaneous amyloidosis
• Closely monitor glucose when converting to BASAGLAR and during initial weeks thereafter
• Do not dilute or mix with any other insulin or solution
• Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ]
• Visually inspect BASAGLAR prefilled pens for particulate matter and discoloration prior to administration
• Only use if the solution is clear and colorless with no visible particles
• Administer BASAGLAR 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 and Adverse Reactions ]
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ]
• Use BASAGLAR with caution in patients with visual impairment that may rely on audible clicks to dial their dose
• Do not dilute or mix BASAGLAR with any other insulin or solution. …

Injection: 100 units/mL (U-100) clear and colorless solution available as: 3 mL single-patient-use BASAGLAR KwikPen 3 mL single-patient-use BASAGLAR Tempo Pen Injection: 100 units/mL (U-100) is available as: ( 3 ) 3 mL single-patient-use BASAGLAR KwikPen ® 3 mL single-patient-use BASAGLAR Tempo Pen TM

• The safety and effectiveness of BASAGLAR have been established
• Pediatric patients (age 6 to 15 years) with type 1 diabetes based on an adequate and well-controlled trial of another insulin glargine product, 100 units/mL, in
• Pediatric patients (age 6 to 15 years) with type 1 diabetes and additional data
• Adults with type 1 diabetes [see Clinical Studies ]
• The safety and effectiveness of BASAGLAR
• Pediatric patients younger than 6 years of age with type 1 diabetes and
• Pediatric patients with type 2 diabetes has not been established. …

Of the total number of subjects in clinical studies of patients with type 2 diabetes who were treated with BASAGLAR or another insulin glargine product, 100 units/mL, each in combination with oral agents in a controlled clinical trial environment, 28.3% were 65 and over, while 4.5% were 75 and over. …

• See FDA-approved patient labeling (Patient Information and Instructions for Use)
• Never Share a BASAGLAR Prefilled Pen Between Patients Advise patients that they must never share a BASAGLAR prefilled pen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions ]
• Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin
• Inform patients of the symptoms of hypoglycemia
• Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. …

• BASAGLAR is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ]
• In patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR [see Warnings and Precautions ]
• During episodes of hypoglycemia
• Hypersensitivity to BASAGLAR or any of its excipients

Table 6 includes clinically significant drug interactions with BASAGLAR Table 6: Clinically Significant Drug Interactions with BASAGLAR Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when BASAGLAR is co-administered with these drugs. …

Never share a BASAGLAR prefilled pen between patients, even if the needle is changed. ( 5.1 ) 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 ) Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. …

The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] . Hypokalemia [see Warnings and Precautions ( 5.6 )] . Adverse reactions commonly (≥5%) associated with insulin glargine products are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

8.1 Pregnancy Risk Summary Published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). …

Excess insulin administration relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. …

Dispense in the original sealed carton with the enclosed Instructions for Use. Protect BASAGLAR from heat and light. Do not freeze BASAGLAR. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.