Lyumjev

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of LYUMJEV to improve glycemic control in pediatric patients with diabetes mellitus have been established.
• Use of LYUMJEV for this indication is supported by evidence from an adequate and well-controlled study in 716 pediatric patients with type 1 diabetes mellitus aged 1 year and older, and from studies in adult and pediatric patients with diabetes mellitus [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.5 )] .
• LYUMJEV-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to LYUMJEV-treated
• adults [see Adverse Reactions ( 6.1 )] .
• It is expected that LYUMJEV-treated pediatric patients who receive continuous subcutaneous insulin infusion (CSII) are more likely to have infusion site-related adverse reactions than those who receive subcutaneous injections [see Adverse Reactions ( 6.1 )] .
• Monitor injection and infusion sites closely when initiating therapy with LYUMJEV in pediatric patients.
• If persistent injection or infusion site reactions occur, discontinue LYUMJEV and initiate therapy with an alternative insulin.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the total number of LYUMJEV-treated patients in clinical studies for type 1 or type 2 diabetes (PRONTO-T1D and PRONTO-T2D, respectively), 17% (187/1,116) were 65 years of age and older, while 2% (18/1,116) were 75 years of age and older [see Clinical Studies ( 14.2 , 14.3 )] .
• No overall differences in safety or effectiveness of LYUMJEV have been observed between patients 65 years of age and older and younger adult patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are also discussed elsewhere:
• Hypoglycemia [see Warnings and Precautions ( 5.3 )] .
• Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] .
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] .
• Adverse reactions observed with LYUMJEV include hypoglycemia, injection/infusion site reactions, allergic reactions, rash, pruritus, lipodystrophy, 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.
• 6.1 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.
• Adverse Reaction Database – Adult Patients with Type 1 and Type 2 Diabetes The data in Table 1 reflect the exposure of 780 adult patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.2 )] .
• The mean age was 44 years, the mean duration of diabetes was 19 years, 55% were male, 77% were White, 2% were Black or African American, and 9% were Hispanic.
• The mean BMI was 26.6 kg/m 2 and the mean HbA 1c at baseline was 7.3%.
• The data in Table 2 reflect the exposure of 336 adult patients with type 2 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.3 )] .
• The mean age was 60 years, the mean duration of diabetes was 16 years, 55% were male, 69% were White, 4% were Black or African American, and 24% were Hispanic.
• The mean BMI was 32.1 kg/m 2 and the mean HbA 1c at baseline was 7.3%.
• The data in Table 3 reflect the exposure of 215 adult patients with type 1 diabetes to LYUMJEV via CSII administration with a mean exposure duration of 16 weeks [see Clinical Studies ( 14.4 )] .
• The mean age was 48 years, the mean duration of diabetes was 26 years, 44% were male, 94% were White, 3% were Black or African American, and 8% were Hispanic.
• The mean BMI was 27.0 kg/m 2 and the mean HbA 1c at baseline was 7.6%.
• Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% and at the same rate or greater for LYUMJEV-treated patients than HUMALOG-treated patients.
• Table 1.
• Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 1 Diabetes Mealtime LYUMJEV + basal insulin (N=451) % Postmeal LYUMJEV + basal insulin (N=329) % Nasopharyngitis 14.2
• 14.6 Table 2.
• Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 2 Diabetes Mealtime LYUMJEV + basal insulin (N=336) % Nasopharyngitis
• Upper Respiratory Tract Infection
• 7.4 Table 3.
• Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion CSII LYUMJEV administration (N=215) % Infusion site reaction
• Infusion site pain
• Nasopharyngitis
• 6.0 Adverse Reaction Database – Pediatric Patients with Type 1 Diabetes The data in Table 4 reflect the exposure of 418 pediatric patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.5 )] .
• The mean age was 12 years; 50% were male, 91% were White, 1% were Black or African American; and 24% of the US subpopulation in this trial were Hispanic.
• The mean BMI was 20.5 kg/m 2 , the mean duration of diabetes was 5 years, and the mean HbA 1c at baseline was 7.8%.
• Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% and at the same rate or greater for LYUMJEV-treated patients than HUMALOG-treated patients.
• Table 4.
• Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Pediatric Patients with Type 1 Diabetes Mealtime LYUMJEV + basal insulin (N=280) % Postmeal LYUMJEV + basal insulin (N=138) % Nasopharyngitis 8.2
• 5.1 Upper Respiratory Tract Infection 5.4
• 1.4 Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LYUMJEV.
• 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 LYUMJEV with the incidence of hypoglycemia for other products may be misleading and also may not be representative of hypoglycemia rates that occur in clinical practice.
• Incidence rates for severe hypoglycemia in
• adults with type 1 and type 2 diabetes mellitus and pediatric patients with type 1 diabetes mellitus treated with LYUMJEV in clinical trials are shown in Table 5 [see Clinical Studies ( 14 )] .
• Table 5.
• Proportion of Patients with Type 1 Diabetes and Type 2 Diabetes Who Experienced at Least One Episode of Severe Hypoglycemia in Adult and Pediatric Clinical Trials a Severe hypoglycemia:
• an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions PRONTO-T1D (Adult Type 1) PRONTO-T2D (Adult Type 2) PRONTO-Pump-2 (Adult Type 1 CSII) PRONTO-Peds (Pediatric Type 1) Mealtime LYUMJEV + basal insulin (N=451) % Postmeal LYUMJEV + basal insulin (N=329) % Mealtime LYUMJEV + basal insulin (N=336) % LYUMJEV (N=215) % Mealtime LYUMJEV + basal insulin (N=280) % Postmeal LYUMJEV + basal insulin (N=298) % Severe hypoglycemia a 5.5 4.6 0.9 1.4 1.1 0 Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LYUMJEV, and may be life threatening.
• Generalized hypersensitivity reactions such as skin rashes and hypersensitivity were reported in adult patients treated with LYUMJEV:
• eczema (0.4%), rash (0.4%), dermatitis (0.3%), hypersensitivity (0.2%), and pruritus (0.2%).
• Generalized hypersensitivity reactions reported in more than 1 pediatric patient treated with LYUMJEV included:
• rhinitis (0.7%), dermatitis (0.7%), rash (0.5%), and hypersensitivity (0.5%).
• Lipodystrophy Administration of insulin, including LYUMJEV, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin).
• Lipodystrophy was reported in 0.2% of adult and pediatric patients treated with LYUMJEV [see Dosage and Administration ( 2.2 )] .
• Injection/Infusion Site Reactions Injection or infusion site reactions can occur with insulin therapy.
• With LYUMJEV, adult and pediatric patients have experienced rash, redness, inflammation, pain, bruising, or itching at the site of LYUMJEV injection or infusion.
• LYUMJEV contains treprostinil sodium and sodium citrate dihydrate as inactive ingredients [see Description ( 11 )] which have been associated with infusion and injection site reactions with other non-insulin products.
• Subcutaneous Injection Site-Related Reactions :
• In studies PRONTO-T1D and PRONTO-T2D, injection site-related reactions occurred in 2.7% of adult patients treated with LYUMJEV (mild in 2.2% and moderate in 0.5%). with <0.1% of patients discontinuing from treatment due to injection site-related reactions.
• In Study PRONTO-Peds, injection site-related reactions occurred in 6.2% of pediatric patients treated with LYUMJEV (mild in 5.7% and moderate in 0.5%), with <0.5% of patients discontinuing from treatment due to injection site-related reactions.
• Continuous Subcutaneous Insulin Infusion (CSII) Site-Related Reactions:
• In Study PRONTO-Pump-2, infusion site-related reactions were reported in 37.7% of adult patients treated with LYUMJEV (mild in 27.9%, moderate in 7.9%, and severe in 1.9%), with 3.3% of patients discontinuing from treatment due to infusion site-related reactions.
• See Table 4 .
• Weight Gain Weight gain can occur with insulin therapy, including LYUMJEV, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
• Adult patients with type 1 diabetes treated with LYUMJEV gained an average of 0.6 kg and patients with type 2 diabetes treated with LYUMJEV gained an average of 1.5 kg.
• Peripheral Edema Insulin, including LYUMJEV, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy.
• Peripheral edema occurred in 0.2% of adult patients treated with LYUMJEV.
• 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of insulin lispro.
• 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 with insulin use.
• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
• Never Share a LYUMJEV Prefilled Pen, Cartridge, or Syringe Between Patients Advise patients that they must never share a LYUMJEV prefilled pen or cartridge with another person, even if the needle is changed.
• Advise patients using LYUMJEV vials not to share needles or syringes with another person.
• Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] .
• Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin.
• Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LYUMJEV therapy.
• Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.
• Instruct patients on the management of hypoglycemia.
• Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia.
• Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions ( 5.3 )] .
• Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.2 )] .
• Hypoglycemia due to Medication Errors Instruct patients to always check the insulin label before each injection to
• avoid mix-ups between insulin products.
• Inform patients that LYUMJEV U-200 contains 2 times as much insulin per mL as LYUMJEV U-100.
• The LYUMJEV U-200 KwikPen dose window shows the number of units of LYUMJEV U-200 to be injected so no dose conversion is required [see Dosage and Administration ( 2.1 )] .
• Instruct patients to not transfer LYUMJEV U-200 from the LYUMJEV U-200 KwikPen to a syringe [see Warnings and Precautions ( 5.4 )] .
• Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with LYUMJEV.
• Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] .
• Instructions for Patients Using Continuous Subcutaneous Infusion (Insulin Pump)
• Do not use LYUMJEV U-200 in an insulin pump.
• Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
• Instruct patients to follow healthcare provider recommendations when setting pump basal rates and bolus settings.
• Refer to the continuous subcutaneous infusion pump user manual to see if LYUMJEV can be used with the pump.
• See recommended reservoir and infusion sets in the insulin pump user manual.
• Instruct patients to replace insulin in the reservoir at least every 9 days, or according to the pump user manual whichever is shorter.
• By following this schedule, patients
• avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
• Instruct patients to discard insulin exposed to temperatures higher than 98.6°F (37°C).
• Instruct patients to inform healthcare provider and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
• Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin.
• Instruct patients on the risk of hypoglycemia from pump malfunction.
• If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their healthcare provider [see Warnings and Precautions ( 5 ) and How Supplied/Storage and Handling ( 16.2 )] .
• Eli Lilly and Company, Indianapolis, IN 46285, USA US License No. 1891 Copyright © 2020, 2022, Eli Lilly and Company.
• All rights reserved.
• LUM-0003-USPI-20221014

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 100 units/mL (U-100) clear and colorless solution available as:
• 10 mL multiple-dose vial 3 mL single-patient-use LYUMJEV KwikPen 3 mL single-patient-use LYUMJEV Junior KwikPen 3 mL single-patient-use LYUMJEV Tempo Pen 3 mL single-patient-use cartridges Injection:
• 200 units/mL (U-200) clear and colorless solution available as:
• 3 mL single-patient-use LYUMJEV KwikPen Injection:
• 100 units/mL (U-100) available as:
• 10 mL multiple-dose vial ( 3 ) 3 mL single-patient-use KwikPen ® ( 3 ) 3 mL single-patient-use Junior KwikPen ® ( 3 ) 3 mL single-patient-use Tempo Pen ® ( 3 ) 3 mL single-patient-use cartridges ( 3 ) Injection:
• 200 units/mL (U-200) available as:
• 3 mL single-patient-use KwikPen ® ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 12 .
• Table 12.
• How Supplied a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen ® Luxura ® HD insulin delivery device.
• Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.
• LYUMJEV NDC Number Concentration Total Units in Presentation Dose Increment Package Size U-100 multiple-dose 10 mL vial 0002-7728-01 100 units/mL 1,000 units n/a 1 vial U-100 single-patient-use 3 mL cartridge a 0002-7726-05 100 units/mL 300 units n/a 5 cartridges U-100 single-patient-use 3 mL KwikPen 0002-8207-05 100 units/mL 300 units 1 unit 5 pens U-100 single-patient-use 3 mL Junior KwikPen 0002-8351-05 100 units/mL 300 units 0.5 unit 5 pens U-100 single-patient-use 3 mL Tempo Pen b 0002-8235-05 100 units/mL 300 units 1 unit 5 pens U-200 single-patient-use 3 mL KwikPen 0002-8228-27 200 units/mL 600 units 1 unit 2 pens
• 16.2 Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use.
• Refrigerate unopened LYUMJEV vials, pens, and cartridges between 36°F to 46°F (2°C to 8°C) until time of use and keep in the original carton to protect from light.
• Do not freeze or use LYUMJEV if it has been frozen.
• Do not expose to direct heat.
• Discard opened or unopened LYUMJEV vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days.
• The storage conditions for vials, pens, and cartridges are summarized in Table 13 .
• Table 13.
• Storage Conditions for Vials, Pens, and Cartridges a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time.
• LYUMJEV Presentation Not In-use (Unopened) In-use (Opened) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 10 mL vial a,b 28 days Until expiration date 28 days 28 days 3 mL cartridge b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV KwikPen (U-100 and U-200) b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Junior KwikPen b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Tempo Pen b 28 days Until expiration date 28 days Do not refrigerate Storage of LYUMJEV in Insulin Pump Change the LYUMJEV U-100 in the pump reservoir at least every 9 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).
• Storage of LYUMJEV in Intravenous Infusion Fluids Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use.
• The same solution may be stored up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see Dosage and Administration ( 2.2 )].
• LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 12 .
• Table 12.
• How Supplied a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen ® Luxura ® HD insulin delivery device.
• Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter.
• LYUMJEV NDC Number Concentration Total Units in Presentation Dose Increment Package Size U-100 multiple-dose 10 mL vial 0002-7728-01 100 units/mL 1,000 units n/a 1 vial U-100 single-patient-use 3 mL cartridge a 0002-7726-05 100 units/mL 300 units n/a 5 cartridges U-100 single-patient-use 3 mL KwikPen 0002-8207-05 100 units/mL 300 units 1 unit 5 pens U-100 single-patient-use 3 mL Junior KwikPen 0002-8351-05 100 units/mL 300 units 0.5 unit 5 pens U-100 single-patient-use 3 mL Tempo Pen b 0002-8235-05 100 units/mL 300 units 1 unit 5 pens U-200 single-patient-use 3 mL KwikPen 0002-8228-27 200 units/mL 600 units 1 unit 2 pens

Quoted from the official label, section “How Supplied”.

How to store it

• Dispense in the original sealed carton with the enclosed Instructions for Use.
• Refrigerate unopened LYUMJEV vials, pens, and cartridges between 36°F to 46°F (2°C to 8°C) until time of use and keep in the original carton to protect from light.
• Do not freeze or use LYUMJEV if it has been frozen.
• Do not expose to direct heat.
• Discard opened or unopened LYUMJEV vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days.
• The storage conditions for vials, pens, and cartridges are summarized in Table 13 .
• Table 13.
• Storage Conditions for Vials, Pens, and Cartridges a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time.
• LYUMJEV Presentation Not In-use (Unopened) In-use (Opened) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 10 mL vial a,b 28 days Until expiration date 28 days 28 days 3 mL cartridge b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV KwikPen (U-100 and U-200) b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Junior KwikPen b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Tempo Pen b 28 days Until expiration date 28 days Do not refrigerate Storage of LYUMJEV in Insulin Pump Change the LYUMJEV U-100 in the pump reservoir at least every 9 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).
• Storage of LYUMJEV in Intravenous Infusion Fluids Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use.
• The same solution may be stored up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see Dosage and Administration ( 2.2 )].

Quoted from the official label, section “Storage and Handling”.

What is in it

• Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose.
• Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli .
• Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline.
• Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5808 daltons, both identical to that of human insulin.
• Insulin lispro-aabc has the following primary structure:
• LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration.
• Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients:
• glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP.
• Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients:
• glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP.
• Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
• LYUMJEV has a pH of 7.0 to 7.8.
• Primary Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Insulin Lispro-Aabc