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AntidiabeticsSUBCUTANEOUS / INTRAVENOUSHigh Alert

LYUMJEV

INSULIN LISPRO-AABC

Standard Dose
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 ) Subcutaneous Injection ( 2.2 ): Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. Rotate injection sites within the same region to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Should generally be used in regimens with an intermediate or long-acting insulin. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if LYUMJEV can be used. Use in accordance with the insulin pump instructions for use. Administer LYUMJEV U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not administer LYUMJEV U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2.2 ): Administer LYUMJEV U-100 intravenously only under medical supervision. DO NOT administer LYUMJEV U-200 by intravenous infusion. Dilute LYUMJEV U-100 to a concentration of 1 unit/mL. Individualize and adjust the dosage of LYUMJEV based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal. ( 2.3 ) Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function, or during acute illness. ( 2.3 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Inspect LYUMJEV visually before use. It should appear clear and colorless. Do not use LYUMJEV if particulate matter and discoloration is seen. Use LYUMJEV prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do not perform dose conversion when using any LYUMJEV U-100 or U-200 prefilled pens. The dose window of LYUMJEV prefilled pens shows the number of units of LYUMJEV to be delivered and no conversion is needed . Do not transfer LYUMJEV U-200 from the prefilled pen to a syringe for administration [see Warnings and Precautions ( 5.4 )] . Do not mix LYUMJEV with any other insulin products. Do not administer LYUMJEV U-200 using continuous subcutaneous infusion insulin pump. Do not administer LYUMJEV U-200 intravenously. 2.2 Route of Administration Instructions Subcutaneous Injection for LYUMJEV U-100 or U-200 Administer LYUMJEV at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. 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 Adverse Reactions ( 6.1 , 6.2 )]. LYUMJEV given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. The LYUMJEV U-100 KwikPen, LYUMJEV U-100 Tempo Pen, and LYUMJEV U-200 KwikPen each dial in 1 unit increments and deliver a maximum dose of 60 units per injection. The LYUMJEV U-100 Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection. Continuous Subcutaneous Insulin Infusion (Insulin Pump) for LYUMJEV U-100 Only Do not administer LYUMJEV U-200 using an insulin pump. Refer to the continuous subcutaneous insulin infusion pump user manual to see if LYUMJEV can be used with the insulin pump. Use LYUMJEV in accordance with the insulin pump system's instructions for use. Administer LYUMJEV U-100 by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not infuse into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . Train patients using continuous subcutaneous insulin infusion (CSII) therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure [see Warnings and Precautions ( 5.8 )] . Change LYUMJEV U-100 in the pump reservoir at least every 9 days or according to the pump user manual, whichever is shorter. Change the infusion sets and the infusion set insertion site according to the manufacturer's user manual. Do not dilute or mix LYUMJEV U-100 when administering by CSII. Do not expose LYUMJEV in the pump reservoir to temperatures greater than 98.6°F (37°C). Intravenous Administration for LYUMJEV U-100 Only Do not administer LYUMJEV U-200 intravenously. Administer LYUMJEV U-100 intravenously only under medical supervision with close monitoring of glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.5 )] . Dilute LYUMJEV U-100 to a concentration of 1 unit/mL using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP infusion solutions. Dilutions to concentrations below 1 unit/mL are not recommended. Diluted LYUMJEV may be stored for up to 4 days when refrigerated or up to 12 hours at room temperature [see HOW SUPPLIED/STORAGE AND HANDLING ( 16.2 )]. 2.3 General Dosage Instructions Individualize and adjust the dosage of LYUMJEV based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal. If converting from another mealtime insulin to LYUMJEV, the change can be done on a unit-to-unit basis. Dosage adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions ( 5.2 , 5.3 ), Drug Interactions ( 7 ) and Use in Specific Populations ( 8.6 , 8.7 )] . During changes to a patient's insulin regimen, increase the frequency of glucose monitoring [see Warnings and Precautions ( 5.2 )] . Instruct patients who forget a mealtime dose to monitor their glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Summary

Indications and usage 1 INDICATIONS AND USAGE LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

LYUMJEV ® is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 ) Subcutaneous Injection ( 2.2 ): Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LYUMJEV ® is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 ) Subcutaneous Injection ( 2.2 ): Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. Rotate injection sites within the same region to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Should generally be used in regimens with an intermediate or long-acting insulin. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if LYUMJEV can be used. Use in accordance with the insulin pump instructions for use. Administer LYUMJEV U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not administer LYUMJEV U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2.2 ): Administer LYUMJEV U-100 intravenously only under medical supervision. DO NOT administer LYUMJEV U-200 by intravenous infusion. Dilute LYUMJEV U-100 to a concentration of 1 unit/mL. Individualize and adjust the dosage of LYUMJEV based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal. ( 2.3 ) Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function, or during acute illness. ( 2.3 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Inspect LYUMJEV visually before use. It should appear clear and colorless. Do not use LYUMJEV if particulate matter and discoloration is seen. Use LYUMJEV prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do not perform dose conversion when using any LYUMJEV U-100 or U-200 prefilled pens. The dose window of LYUMJEV prefilled pens shows the number of units of LYUMJEV to be delivered and no conversion is needed . Do not transfer LYUMJEV U-200 from the prefilled pen to a syringe for administration [see Warnings and Precautions ( 5.4 )] . Do not mix LYUMJEV with any other insulin products. Do not administer LYUMJEV U-200 using continuous subcutaneous infusion insulin pump. Do not administer LYUMJEV U-200 intravenously. 2.2 Route of Administration Instructions Subcutaneous Injection for LYUMJEV U-100 or U-200 Administer LYUMJEV at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. 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 Adverse Reactions ( 6.1 , 6.2 )]. LYUMJEV given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. The LYUMJEV U-100 KwikPen, LYUMJEV U-100 Tempo Pen, and LYUMJEV U-200 KwikPen each dial in 1 unit increments and deliver a maximum dose of 60 units per injection. The LYUMJEV U-100 Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection. Continuous Subcutaneous Insulin Infusion (Insulin Pump) for LYUMJEV U-100 Only Do not administer LYUMJEV U-200 using an insulin pump. Refer to the continuous subcutaneous insulin infusion pump user manual to see if LYUMJEV can be used with the insulin pump. Use LYUMJEV in accordance with the insulin pump system's instructions for use. Administer LYUMJEV U-100 by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not infuse into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . Train patients using continuous subcutaneous insulin infusion (CSII) therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure [see Warnings and Precautions ( 5.8 )] . Change LYUMJEV U-100 in the pump reservoir at least every 9 days or according to the pump user manual, whichever is shorter. Change the infusion sets and the infusion set ins

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Never share a LYUMJEV prefilled pen or cartridge 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 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 impairment or hepatic impairment or hypoglycemia unawareness.

Interaction Notes

  • • 7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with LYUMJEV.
  • • Table 6.
  • • Clinically Significant Drug Interactions with LYUMJEV 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 LYUMJEV is co-administered with these drugs.