GLARITUS Insulin Glargine 100IU / mL Solution for SC Injection 3mL 1's

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.

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 Instructions 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 [see ADVERSE REACTIONS].
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 [see PRECAUTIONS].
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 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 PRECAUTIONS].
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.

Insulin Glargine (GLARITUS) is contraindicated: During episodes of hypoglycemia.
In patients with hypersensitivity to or one of its excipients.

Never Share an Insulin Glargine (GLARITUS) Cartridge or Needle Between Patients: Insulin Glargine (GLARITUS) cartridges must never be shared between patients, even if the needle is changed. Patients using Insulin Glargine (GLARITUS) must never reuse or share needles with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant oral and anti-diabetic products may be needed.
Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulin, including Insulin Glargine (GLARITUS). Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual 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 individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers), or in patients who experience recurrent 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 insulin preparations, the glucose lowering effect time course of Insulin Glargine (GLARITUS) may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. 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 co-administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
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.
The long-acting effect of Insulin Glargine (GLARITUS) may delay recovery from hypoglycemia.
Medication Errors: Accidental mix-ups among insulin products, particularly between long-acting insulins and rapid-acting insulins, have been reported. To avoid medication errors between Insulin Glargine (GLARITUS) and other insulins, instruct patients to always check the insulin label before each injection.
Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Insulin Glargine (GLARITUS). If hypersensitivity reactions occur, discontinue Insulin Glargine (GLARITUS); treat per standard of care and monitor until symptoms and signs resolve. Insulin Glargine (GLARITUS) is contraindicated in patients who have had hypersensitivity reactions to Insulin Glargine (GLARITUS) or one of the excipients.
Hypokalemia: All insulin products, including Insulin Glargine (GLARITUS), 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 PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin Glargine (GLARITUS), 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.
Hepatic Impairment: The effect of hepatic impairment on the pharmacokinetics of Insulin Glargine (GLARITUS) has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for Insulin Glargine (GLARITUS) in patients with hepatic impairment.
Renal Impairment: The effect of renal impairment on the pharmacokinetics of Insulin Glargine (GLARITUS) has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Frequent glucose monitoring and dose adjustment may be necessary for Insulin Glargine (GLARITUS) in patients with renal impairment.
Obesity: Subgroup analyses based on BMI in reported controlled clinical studies, did not show differences in safety and efficacy between insulin glargine and NPH.
Use in Children: The safety and effectiveness of Insulin Glargine (GLARITUS) have been established in pediatric patients (age 2 to 15 years) with type 1 diabetes in reported clinical studies. The safety and effectiveness of insulin glargine in pediatric patients younger than 2 years of age with type 1 diabetes and pediatric patients with type 2 diabetes have not been established.
The dosage recommendation when changing to Insulin Glargine (GLARITUS) in pediatric patients (age 2 to 15 years) with type 1 diabetes is the same as that described for adults [see DOSAGE & ADMINISTRATION]. As in adults, the dosage of Insulin Glargine (GLARITUS) must be individualized in pediatric patients (age 2 to 15 years) with type 1 diabetes based on metabolic needs and frequent monitoring of blood glucose.
In the reported pediatric clinical study, pediatric patients (age 2 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes.
Use in the Elderly: Use Caution should be exercised when Insulin Glargine (GLARITUS) is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.

The following adverse reactions are discussed elsewhere: Hypoglycemia [see PRECAUTIONS]; Hypersensitivity and allergic reactions [see PRECAUTIONS]; Hypokalemia [see PRECAUTIONS].
Peripheral Edema: Some patients taking insulin glargine have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy: Administration of insulin subcutaneously, including Insulin Glargine (GLARITUS), has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.
Insulin Initiation and Intensification of Glucose Control: Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Weight Gain: Weight gain has occurred with some insulin therapies including Insulin Glargine (GLARITUS) and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Allergic Reactions: Local Allergy: As with any insulin therapy, patients taking Insulin Glargine (GLARITUS) may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation.
Systemic Allergy: Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including insulin glargine and may be life threatening.
Immunogenicity: As with all therapeutic proteins, there is potential for immunogenicity. All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose.
Medication errors have been reported in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of insulin glargine. To avoid medication errors between Insulin Glargine (GLARITUS) and other insulins, patients should be instructed to always verify the insulin label before each injection.
Other adverse event reported in patients administered with Insulin Glargine (GLARITUS) include upper respiratory tract infection, peripheral edema, hypertension, influenza, sinusitis, cataract, bronchitis, arthralgia, pain in extremity, back pain, cough, urinary tract infection, diarrhea, depression, headache, accidental injury, infection and retinal vascular disorder.

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, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.
Intervention: Dose reductions and increased frequency of glucose monitoring may be required when Insulin Glargine (GLARITUS) is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Glargine (GLARITUS): Drugs: Atypical antipsychotics (e.g. olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g. in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g. albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention: Dose increases and increased frequency of glucose monitoring may be required when Insulin Glargine (GLARITUS) is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Glargine (GLARITUS) Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Glargine (GLARITUS) is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia: Drugs: beta-blockers, clonidine, guanethidine, and reserpine.
Intervention: Increased frequency of glucose monitoring may be required when Insulin Glargine (GLARITUS) is co-administered with these drugs.

Insulin Preparations