Indication*

For the treatment of type-1 and type -2 diabetes mellitus patients who require basal (long-acting) insulin for the control of hyperglycemia. Limitations of Use: Insulin Glargine (GLARITUS) is not recommended for the treatment of diabetic ketoacidosis.

Directions for Use*

Important Administration Instructions: Administer Insulin Glargine (GLARITUS) subcutaneously once daily at any time of day but at the same time every day. Prior to initiation of Insulin Glargine (GLARITUS), train patients on proper use and injection technique. Patient should follow the Instruction for Use of pen device to correctly administer Insulin Glargine (Glaritus) from cartridge. Administer Insulin Glargine (GLARITUS) 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. Visually inspect Insulin Glargine (GLARITUS) cartridges for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Refrigerate unused (unopened) Insulin Glargine (GLARITUS) cartridges. Do not administer intravenously or via an insulin pump. Do not dilute or mix Insulin Glargine (GLARITUS) with any other insulin or solution. The cartridges to be used in pen device are for single patient use only. General Dosing Instructions: Individualize and adjust the dosage of Insulin Glargine (GLARITUS) based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustment 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 adjustment should only be made under medical supervision with appropriate glucose monitoring. Initiation of GLARITUS Therapy: Type 1 Diabetes: In patients with type 1 diabetes, Insulin Glargine (GLARITUS) must be used concomitantly with short-acting insulin. The recommended starting dose of GLARITUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements. Type 2 Diabetes: The recommended starting dose of Insulin Glargine (GLARITUS) 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. One may need to adjust the amount and timing of short-or rapid-acting insulins and dosages of any oral anti-diabetic drugs. Changing to Insulin Glargine (GLARITUS) From Other Insulin Therapies: If changing patients from once daily insulin glargine 300 Units/mL to once daily Insulin Glargine (GLARITUS) the recommended initial GLARITUS dose is 80% of the insulin glargine 300 Units/mL dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia. If changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Insulin Glargine (GLARITUS) a change in the dose of the basal insulin may be required and the amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may be needed to be adjusted. If changing patients from once-daily NPH insulin to once-daily GLARITUS, the recommended initial Insulin Glargine (GLARITUS) dose is the same as the dose of NPH that is being discontinued. If changing patients from twice-daily NPH insulin to once-daily Insulin Glargine (GLARITUS) the recommended initial Insulin Glargine (GLARITUS) dosage is 80% of the total NPH dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.

Administration*

*written indications, directions, and administration are updated as of March 05, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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