Insulin Lispro

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 , 2.3 , 2.4 ) Subcutaneous Injection ( 2.2 ):
• Administer Insulin Lispro by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal.
• Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ):
• Refer to the insulin infusion pump user manual to see if Humalog can be used.
• Use in accordance with the insulin pump instructions for use.
• Administer Insulin Lispro by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
• Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• Intravenous Infusion ( 2.2 ):
• Administer Insulin Lispro by intravenous infusion ONLY after dilution and under medical supervision.
• The dosage of Insulin Lispro must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
• ( 2.3 ) Do not perform dose conversion when using the Insulin Lispro prefilled pens.
• The dose window shows the number of insulin units to be delivered and no conversion is needed.
• ( 2.1 , 2.3 )
• 2.1 Important Administration Instructions Always check insulin labels before administration.
• This product is HUMALOG (insulin lispro) [see Warnings and Precautions ( 5.4 )] .
• Inspect Insulin Lispro visually before use.
• It should appear clear and colorless.
• Do not use Insulin Lispro if particulate matter or coloration is seen.
• Use Insulin Lispro prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
• Do NOT mix Insulin Lispro with other insulins
• when using a continuous subcutaneous infusion pump.
• Do NOT perform dose conversion when using any Insulin Lispro prefilled pens.
• The dose window shows the number of insulin units to be delivered and no conversion is needed.
• 2.2 Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Administer the dose of Insulin Lispro within fifteen minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks.
• Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
• Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6 )] .
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] .
• Insulin Lispro administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
• The Insulin Lispro KwikPen dials in 1 unit increments and delivers a maximum dose of 60 units per injection.
• The Insulin Lispro Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection.
• Subcutaneous Injection:
• Diluted Insulin Lispro Insulin Lispro may be diluted with Sterile Diluent for Insulin Lispro for subcutaneous injection ONLY under medical supervision.
• Dilute one part Insulin Lispro to:
• Nine parts diluent to yield a concentration one-tenth that of Insulin Lispro (equivalent to U-10).
• One part diluent to yield a concentration one-half that of Insulin Lispro (equivalent to U-50).
• Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C).
• Continuous Subcutaneous Infusion (Insulin Pump) This Insulin Lispro product can be used with continuous subcutaneous insulin infusion pumps labeled for use with Humalog (insulin lispro).
• Refer to the insulin pump user manual to see if Humalog can be used.
• Use Insulin Lispro in accordance with the insulin pump system's instructions for use.
• Administer Insulin Lispro 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 inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6 )] .
• Train patients using continuous subcutaneous insulin infusion therapy to administer insulin by injection and have alternate insulin therapy available in case of insulin pump failure [see Warnings and Precautions ( 5.8 )].
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] .
• Change Insulin Lispro in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter.
• Follow the Humalog-specific information for in-use time because Humalog-specific information may differ from general pump manual instructions.
• Change the infusion set and the infusion set insertion site according to the manufacturer's user manual.
• Do NOT dilute or mix Insulin Lispro when administering by continuous subcutaneous infusion.
• Do NOT expose Insulin Lispro in the pump reservoir to temperatures greater than 98.6°F (37°C).
• Intravenous Administration Administer Insulin Lispro intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to
• avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 ) and How Supplied/Storage and Handling (16.4)] .
• Dilute Insulin Lispro to concentrations from 0.1 unit/mL to 1.0 unit/mL using 0.9% Sodium Chloride Injection, USP.
• Infusion bags prepared with Insulin Lispro are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.
• 2.3 Dosage Recommendations Individualize and adjust the dosage of Insulin Lispro based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
• When switching from another insulin to Insulin Lispro. a different dosage of Insulin Lispro may be needed [see Warnings and Precautions ( 5.2 )].
• Dosage modifications may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )] .
• Do NOT perform dose conversion when using the Insulin Lispro prefilled pens.
• The dose window shows the number of insulin units to be delivered and no conversion is needed.
• 2.4 Dosage Modifications for Drug Interactions Dosage modification may be needed when Insulin Lispro is used concomitantly with certain drugs [see Drug Interactions ( 7 )] .
• 2.5 Instructions for Mixing with Other Insulins The table below includes administration instructions regarding mixing Insulin Lispro with other insulins.
• Insulin Lispro subcutaneous injection route Insulin Lispro may be mixed with NPH insulin preparations ONLY .
• If Insulin Lispro is mixed with NPH insulin, Insulin Lispro should be drawn into the syringe first.
• Injection should occur immediately after mixing.
• Insulin Lispro continuous subcutaneous infusion route (Insulin Pump) Do NOT mix Insulin Lispro with any other insulin.

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 Insulin Lispro to improve glycemic control have been established in pediatric patients with diabetes mellitus.
• Use of Insulin Lispro for this indication is supported by evidence from adequate and well-controlled studies in 831 pediatric patients with type 1 diabetes mellitus aged 3 years and older and from studies in
• adults with diabetes mellitus [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )] .

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

Use in older people

• Of the total number of patients (n=2,834) in eight clinical studies of Insulin Lispro, twelve percent (n=338) were 65 years of age or over.
• The majority of these patients had type 2 diabetes.
• HbA 1c values and hypoglycemia rates did not differ by age.
• Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Insulin Lispro action have not been performed.

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

Side effects

• The following adverse reactions are discussed elsewhere:
• Hypoglycemia [see Warnings and Precautions ( 5.3 )] .
• Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )].
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )].
• Hypokalemia [see Warnings and Precautions ( 5.6 )] .
• Adverse reactions associated with Insulin Lispro include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
• ( 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 designs, the adverse reaction rates reported in one clinical trial may not be easily compared with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
• Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% of patients treated with Insulin Lispro or regular human insulin.
• The frequencies of adverse reactions during Insulin Lispro clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
• Table 1:
• Adverse Reactions That Occurred in ≥5% in Patients with Type 1 Diabetes Mellitus Insulin Lispro (%) (n=81) Regular human insulin (%) (n=86) Flu syndrome 34.6
• 32.6 Pharyngitis 33.3
• 33.7 Rhinitis 24.7
• 29.1 Headache 29.6
• 22.1 Pain 19.8
• 16.3 Cough increased 17.3
• 17.4 Infection 13.6
• 20.9 Nausea 6.2
• 15.1 Accidental injury 8.6
• 11.6 Surgical procedure 6.2
• 14.0 Fever 6.2
• 11.6 Abdominal pain 7.4
• 8.1 Asthenia 7.4
• 8.1 Bronchitis 7.4
• 7.0 Diarrhea 8.6
• 5.8 Dysmenorrhea 6.2
• 7.0 Myalgia 7.4
• 5.8 Urinary tract infection 6.2
• 4.7 Table 2:
• Adverse Reactions That Occurred in ≥5% in Patients with Type 2 Diabetes Mellitus Insulin Lispro (%) (n=714) Regular human insulin (%) (n=709) Headache 11.6
• 9.3 Pain 10.8
• 10.0 Infection 10.1
• 7.6 Pharyngitis 6.6
• 8.2 Rhinitis 8.1
• 6.6 Flu syndrome 6.2
• 8.2 Surgical procedure 7.4
• 6.8 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.
• Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Insulin Lispro.
• Lipodystrophy Long-term use of insulin, including Insulin Lispro, can cause lipodystrophy at the site of repeated insulin injections or infusion.
• Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption [see Dosage and Administration ( 2.2 )] .
• Weight gain Weight gain can occur with insulins, including Insulin Lispro, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
• Peripheral Edema Insulins, including Insulin Lispro, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
• Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for Insulin Lispro and regular human insulin treated patients ( see Table 3 ).
• Table 3:
• Catheter Occlusions and Infusion Site Reactions Insulin Lispro (n=38) Regular human insulin (n=39) Catheter occlusions/month 0.09
• 0.10 Infusion site reactions 2.6% (1/38) 2.6% (1/39) In a randomized, 16-week, open-label, parallel design study of pediatric patients with type 1 diabetes, adverse reactions related to infusion-site reactions were similar for Insulin Lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively).
• In both groups, the most frequently reported infusion site reactions were infusion site erythema and infusion site reaction.
• Allergic Reactions Local Allergy — As with any insulin, patients taking Insulin Lispro may experience redness, swelling, or itching at the site of the injection.
• These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of Insulin Lispro.
• Systemic Allergy — Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including Insulin Lispro.
• Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
• In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving Insulin Lispro (n=2944).
• Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in Insulin Lispro [see Contraindications ( 4 )] .
• Antibody Production In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and Insulin Lispro (including patients previously treated with human insulin and naive patients).
• As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy.
• The antibody levels peaked by 12 months and declined over the remaining years of the study.
• These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose.
• There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.
• 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.
• Medication errors in which other insulins have been accidentally substituted for Insulin Lispro have been identified during post-approval use.
• 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.

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 an Insulin Lispro Prefilled Pen or Syringe Between Patients Advise patients that they must never share an Insulin Lispro prefilled pen with another person, even if the needle is changed.
• Advise patients using Insulin Lispro 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 Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of Insulin Lispro 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 container label before each injection to
• avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] .
• Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with Insulin Lispro.
• Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] .
• Instructions For Patients Using Continuous Subcutaneous Insulin Pumps 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.
• This Insulin Lispro product can be used with continuous subcutaneous insulin infusion pumps labeled for use with Humalog (insulin lispro) – refer to the insulin pump user manual to see if Humalog can be used.
• See recommended reservoir and infusion sets in the insulin pump user manual.
• Instruct patients to replace insulin in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers' user manual.
• 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).
• The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat.
• 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 )] .
• Manufactured by:
• Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 Humalog ® and KwikPen ® are registered trademarks of Eli Lilly and Company.
• Copyright © 1996, 2023, Eli Lilly and Company.
• All rights reserved.
• LIS-0008-USPI-20230921

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 KwikPen prefilled pen 3 mL single-patient-use Junior KwikPen prefilled pen Injection:
• 100 units/mL (U-100) is available as:
• ( 3 ) 10 mL multiple-dose vial 3 mL single-patient-use KwikPen ® prefilled pen 3 mL single-patient-use Junior KwikPen ® prefilled pen

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

What it looks like and how it is packed

• 16.1 How Supplied Insulin Lispro injection is a clear and colorless solution available as:
• Insulin Lispro Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7737-01 1 vial U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8222-59 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7752-05 5 pens The KwikPen dials in 1-unit increments.
• The Junior KwikPen dials in 0.5-unit increments.
• Each Insulin Lispro prefilled pen is for single-patient-use only.
• Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed.
• Patients using Insulin Lispro vials must never share needles or syringes with another person.
• 16.2 Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use.
• Protect from direct heat and light.
• Do not freeze and do not use if it has been frozen.
• See table below for storage information:
• * When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time.
• Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) In-Use (Opened) (see temperature below*) 10 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL single-patient-use Insulin Lispro KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Insulin Lispro Junior KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 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 Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )] .
• Do not dilute Insulin Lispro used in an external insulin pump.
• Storage of Intravenous Infusion Preparations with Insulin Lispro Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C).
• The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .
• Insulin Lispro injection is a clear and colorless solution available as:
• Insulin Lispro Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7737-01 1 vial U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8222-59 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7752-05 5 pens The KwikPen dials in 1-unit increments.
• The Junior KwikPen dials in 0.5-unit increments.
• Each Insulin Lispro prefilled pen is for single-patient-use only.
• Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed.
• Patients using Insulin Lispro vials must never share needles or syringes with another person.

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

How to store it

• Dispense in the original sealed carton with the enclosed Instructions for Use.
• Protect from direct heat and light.
• Do not freeze and do not use if it has been frozen.
• See table below for storage information:
• * When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time.
• Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) In-Use (Opened) (see temperature below*) 10 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL single-patient-use Insulin Lispro KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Insulin Lispro Junior KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 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 Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )] .
• Do not dilute Insulin Lispro used in an external insulin pump.
• Storage of Intravenous Infusion Preparations with Insulin Lispro Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C).
• The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .

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

What is in it

• Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli .
• Insulin lispro 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 5.808 kDa, both identical to that of human insulin.
• Insulin lispro has the following primary structure:
• Insulin Lispro injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use.
• Each mL of Insulin Lispro contains 100 units of insulin lispro, and the inactive ingredients:
• dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP.
• Insulin Lispro has a pH of 7.0 to 7.8.
• Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH.
• 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.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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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.

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