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Insulin Glargine U-300 Max is a brand name for Insulin Glargine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Insulin Glargine, U-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. Insulin Glargine, U-300 is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. 2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day.
1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. 1 ) Do not dilute or mix with any other insulin or solution. 4 ) Closely monitor glucose when switching to Insulin Glargine, U-300 and during initial weeks thereafter.
1 Important Administration Instructions Always check insulin labels before administration. This product is TOUJEO (insulin glargine). 4) ] . Visually inspect the Insulin Glargine, U-300 solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles.
Inject Insulin Glargine, U-300 subcutaneously into the abdominal area, thigh, or deltoid. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
2) , Adverse Reactions (6) ] . Use Insulin Glargine, U-300 with caution in patients with visual impairment who may rely on audible clicks to dial their dose. Do not administer Insulin Glargine, U-300 intravenously or in an insulin pump.
Do not dilute or mix Insulin Glargine, U-300 with any other insulin products or solutions. 4) ] . 2 General Dosing Instructions Insulin Glargine, U-300 is available in 2 single-patient-use prefilled pens: The Insulin Glargine, U-300 SoloStar prefilled pen contains 450 units of insulin glargine.
It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection. The Insulin Glargine, U-300 Max SoloStar prefilled pen contains 900 units of insulin glargine. It delivers doses in 2-unit increments and can deliver up to 160 units in a single injection.
It is recommended for patients requiring at least 20 units per day. When changing between Insulin Glargine, U-300 SoloStar and Insulin Glargine, U-300 Max SoloStar, if the patient's previous dose was an odd number, the dose should be increased or decreased by 1 unit to match the dose increments dialable on each prefilled pen.
2) ] . 6) ] Adverse reactions commonly associated with Insulin Glargine, U-300 (≥5%) are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates actually observed in clinical practice.
The data in Table 1 reflect the exposure of 304 patients with type 1 diabetes to Insulin Glargine, U-300 with mean exposure duration of 23 weeks.
The type 1 diabetes population had the following characteristics:
Mean age was 46 years and mean duration of diabetes was 21 years. Fifty-five percent were male, 86% were White, 5% were Black or African American, and 5% were Hispanic or Latino. 73 m 2 . The mean body mass index (BMI) was 28 kg/m 2 .
HbA1c at baseline was greater than or equal to 8% in 58% of patients. The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to Insulin Glargine, U-300 with mean exposure duration of 25 weeks.
The type 2 diabetes population had the following characteristics:
Mean age was 59 years and mean duration of diabetes was 13 years. Fifty-three percent were male, 88% were White, 7% were Black or African American, and 17% were Hispanic or Latino. 73 m 2 . The mean BMI was 35 kg/m 2 . HbA1c at baseline was greater than or equal to 8% in 66% of patients.
1) ] . Common adverse reactions (occurring ≥5%) in Insulin Glargine, U-300-treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively.
5 WARNINGS AND PRECAUTIONS Never share an Insulin Glargine, U-300 SoloStar or Max SoloStar single-patient-use prefilled pen between patients, even if the needle is changed. , insulin strength, manufacturer, type, injection site, or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
2 ) 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 impairment or hepatic impairment or hypoglycemia unawareness.
1 ) Hypoglycemia Due to Medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. 4 ) Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur.
Discontinue Insulin Glargine, U-300, monitor and treat if indicated. 1 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. 6 ) Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
1 Never Share an Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar Pen Between Patients Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed.
Pen sharing poses a risk for transmission of blood-borne pathogens. 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) ] .
3) ] . 5) ] . During episodes of hypoglycemia ( 4 ) Hypersensitivity to insulin glargine or any excipients in Insulin Glargine, U-300 ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The dose counter of the Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar prefilled pen shows the number of units of Insulin Glargine, U-300 to be injected and no conversion is required. Inject Insulin Glargine, U-300 subcutaneously once a day at the same time of day.
2) ] . Individualize and titrate the dosage of Insulin Glargine, U-300 based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. Titrate the dose of Insulin Glargine, U-300 no more frequently than every 3 to 4 days.
7) ] . 3 Starting Dose in Insulin-Naive Pediatric and Adult Patients Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dose of Insulin Glargine, U-300 in insulin-naive patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose.
The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal. 4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin-naive patients with type 1 diabetes.
2) ] . When initiating Insulin Glargine, U-300, monitor glucose daily. 2 units per kilogram of body weight once daily. 3) ]. For patients currently on once-daily long or intermediate-acting insulin, start Insulin Glargine, U-300 at the same unit dose as the once-daily long-acting insulin dose.
1) ] . For patients currently on twice-daily long or intermediate-acting insulin, start Insulin Glargine, U-300 at 80% of the total daily NPH or insulin detemir twice-daily dosage. 2) ] .
Common adverse reactions for Insulin Glargine, U-300-treated pediatric subjects with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1. Hypoglycemia is discussed in a dedicated subsection below.
Table 1:
Adverse Reactions Occurring ≥5% in Two Pooled Clinical Trials of 26 Weeks and 16 Weeks Duration in Adults with Type 1 Diabetes Insulin Glargine, U-300 + Mealtime Insulin "mealtime insulin" refers to insulin glulisine, insulin lispro, or insulin aspart.
5 Table 2: Adverse Reactions Occurring ≥5% in Three Pooled Clinical Trials of 26 Weeks Duration in Adults with Type 2 Diabetes Insulin Glargine, U-300 one of the trials in type 2 diabetes included mealtime insulin. 7 Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients treated with Insulin Glargine, U-300.
The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for Insulin Glargine, U-300 with the incidence of hypoglycemia for other products may be misleading and also may not be representative of hypoglycemia rates that will occur in clinical practice.
In the Insulin Glargine, U-300 adult program, severe hypoglycemia was defined as an event requiring assistance of another person to administer a resuscitative action. In the pediatric program, severe hypoglycemia was defined as an event with semiconsciousness, unconsciousness, coma and/or convulsions in a patient who had altered mental status and could not assist in his own care, and who may have required glucagon or intravenous glucose.
6% at 26 weeks. 7% at 26 weeks. 3%. 9% respectively at 26 weeks in the two studies where patients received Insulin Glargine, U-300 as part of a basal-insulin only regimen. 6% at 26 weeks and the highest risk was again seen in patients receiving Insulin Glargine, U-300 as part of a multiple daily injection regimen.
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. Peripheral Edema Insulin, including Insulin Glargine, U-300, may cause sodium retention and edema, particularly if previously poor metabolic control was improved by intensified insulin therapy.
1) ] . Weight Gain Weight gain has occurred with insulins including Insulin Glargine, U-300 and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Hypersensitivity Reactions Patients taking Insulin Glargine, U-300 experienced erythema, local edema, and pruritus at the site of injection.
These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported. 2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. , anti-insulin glargine antibody [ADA]) during the study.
Eighty percent of the AIA-positive patients on Insulin Glargine, U-300 with antibody test at baseline remained AIA positive at month 6. In two 6-month studies in type 2 diabetes patients, 25% of patients who received Insulin Glargine, U-300 once daily were positive for AIA at least once during the study, including 42% who were positive at baseline and 20% of patients who developed ADA during the study.
Ninety percent of the AIA-positive patients on Insulin Glargine, U-300 with antibody test at baseline, remained AIA positive at month 6. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease.
For these reasons, comparison of the incidence of antibodies to Insulin Glargine, U-300 with the incidence of antibodies in other studies or to other products may be misleading. 3 Postmarketing Experience The following additional adverse reactions have been identified during postapproval use of Insulin Glargine, U-300.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
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 antidiabetic products may be needed. 2) ] . In clinical trials, patients who changed to Insulin Glargine, U-300 from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS.
1) ] . The onset of action of Insulin Glargine, U-300 develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of Insulin Glargine, U-300 before stopping IV insulin.
2) ] . 3) ] . 3 Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulin, including Insulin Glargine, U-300. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. , driving, or operating other machinery).
Hypoglycemia can happen suddenly, and symptoms may differ in each patient and change over time in the same patient. , beta-blockers) [see Drug Interactions (7) ] , or who experience recurrent hypoglycemia. The long-acting effect of an Insulin Glargine, U-300 may delay recovery from hypoglycemia compared to shorter-acting insulins.
Risk Factors for Hypoglycemia The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. 2) ] . , macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitant drugs [see Drug Interactions (7) ] .
7) ] . 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. To minimize the risk of hypoglycemia, do not administer Insulin Glargine, U-300 intravenously, intramuscularly or in an insulin pump, or dilute or mix with any other insulin products or solutions.
4 Hypoglycemia Due to Medication Errors Accidental mix-ups between insulin products have been reported. To avoid medication errors between Insulin Glargine, U-300 and other insulins, instruct patients to always check the insulin label before each injection.
3) ] . 5 Hypersensitivity Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Insulin Glargine, U-300. If hypersensitivity reactions occur, discontinue Insulin Glargine, U-300; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6) ] .
Insulin Glargine, U-300 is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or any of the excipients in Insulin Glargine, U-300. 6 Hypokalemia All insulins, including Insulin Glargine, U-300, 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. , patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). 7 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, when used in combination with insulin.
Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin Glargine, U-300, 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.