Skip to main content
Lyumjev home
  • Prescribing Information
  • Patient Information
  • Instructions for Use
Menu closed
Lyumjev home
  • Prescribing Information
  • Patient Information
  • Instructions for Use
Globe Loading... Reveal available languages
  • House For Healthcare Professionals
    • Novel Formulation
      • Adult Efficacy
      • CGM Substudy
      • Adult Safety
      • Pediatric Efficacy & Safety
      • Challenges for Children with Diabetes
    • Dosing
    • Savings
  • For Consumers
Ask Lilly

We're here to help.

Phone Call:
1-800-LillyRx
(1-800-545-5979)
Link Visit Lilly Medical (HCP)
Question Submit a Question
Question Sample/Sales Inquiry
Expand contact lilly
doctor with smiling adult and child patients

Lyumjev is indicated to improve glycemic control in adults and children with diabetes mellitus.1

Lyumjev demonstrated noninferior A1c change compared with Humalog in pediatric patients with diabetes.1

Lyumjev and Postmeal Lyumjev* achieved A1c noninferiority vs Humalog in a treat-to-target trial: PRONTO-Peds

*Lyumjev = dosed immediately (0 to 2 minutes) prior to each meal. Postmeal Lyumjev = dosed at or within 20 minutes of starting the meal

A1C mean of Lyumjev compared to Humalog

*At randomization

At week 26, treatment with mealtime Lyumjev provided a mean change in A1c that met the prespecified noninferiority margin (0.4%) compared to mealtime Humalog. In addition, postmeal Lyumjev met the prespecified noninferiority margin (0.4%) compared to mealtime Humalog.

In treat-to-target trials in diabetes, each treatment arm aims to achieve the same ranges of glycemic control to allow for comparison of clinical measures.

Select Important Safety Information for Lyumjev and Humalog

Lyumjev and Humalog are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.

PRONTO-Peds

Study design: A Phase 3, 26-week, randomized, active-controlled, treat-to-target, multinational trial that evaluated the efficacy of Lyumjev and Humalog in 716 pediatric patients (age 3 to age 17) with type 1 diabetes (T1D) using multiple-daily-injection. Key inclusion criteria included: T1D for ≥6 months, A1c ≤9.9%, weight ≥16 lbs, and total daily dose of insulin 0.3 to ≤1.9 U/kg. Following a 4-week lead-in period, patients were randomized (2:2:1) in a double-blind manner to either Lyumjev (n=280), Humalog (n=298), or open-label postmeal Lyumjev (n=138), all in combination with basal insulin (insulin glargine, insulin degludec or insulin detemir). Lyumjev and Humalog were injected 0 to 2 minutes before the meal and postmeal Lyumjev was injected within 20 minutes after starting the meal. The primary objective was noninferiority of Lyumjev to Humalog on change in A1c from baseline to week 26.

Noninferiority of postmeal Lyumjev to Humalog was a multiplicity controlled secondary objective. An additional secondary objective, change from baseline to Week 26 in 7-point SMBG values for Lyumjev and postmeal Lyumjev compared to Humalog, was not multiplicity controlled.

7-point SMBG values for Lyumjev and Humalog at Week 26 in PRONTO-Peds2

chart of SMBG values for Lyumjev and Humalog at Week 26 in PRONTO-Peds

Data shown are LSM At Week 26 Prior to Discontinuation of Investigational Product.LSM = Least Squares Mean

HumalogLyumjevPostmeal Lyumjev
: Fasting Humalog: 157.4 mg/dL Lyumjev: 153.0 mg/dL Postmeal Lyumjev: 150.5 mg/dL
: Morning 1-hr Postmeal Humalog: 179.1 mg/dL Lyumjev: 164.4 mg/dL Postmeal Lyumjev: 172.5 mg/dL
: Midday Premeal Humalog: 161.5 mg/dL Lyumjev: 167.1 mg/dL Postmeal Lyumjev: 158.6 mg/dL
: Midday 1-hour Postmeal Humalog: 167.5 mg/dL Lyumjev: 161.4 mg/dL Postmeal Lyumjev: 165.1 mg/dL
: Evening Premeal Humalog: 178.7 mg/dL Lyumjev: 182.3 mg/dL Postmeal Lyumjev: 178.0 mg/dL
: Evening 1-hour Postmeal Humalog: 179.6 mg/dL Lyumjev: 166.6 mg/dL Postmeal Lyumjev: 168.8 mg/dL
: Bedtime Humalog: 170.2 mg/dL Lyumjev: 169.9 mg/dL Postmeal Lyumjev: 169.5 mg/dL

Limitation: Caution should be exercised in the interpretation of SMBG in this study as it was not multiplicity adjusted.

Lyumjev is designed to be absorbed quickly. It can be administered at the start of a meal or within 20 minutes after starting a meal.1

Learn more about dosing

Select Important Safety Information for Lyumjev and Humalog

Never share a Lyumjev or Humalog prefilled pen, cartridge, syringe, or Humalog reusable pen compatible with Lilly 3 mL cartridges between patients, even if the needle is changed.

Changes in insulin regimen (eg, insulin strength, manufacturer, type, injection site, or method of administration) may affect glycemic control and predispose patients to hypoglycemia and hyperglycemia. Make changes cautiously with increased frequency of blood glucose monitoring.

Lyumjev Pediatric Safety Results

Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Pediatric Patients with Type 1 Diabetes

chart of Lyumjev Pediatric Safety Results

Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% of patients and at the same rate or greater for Lyumjev-treated patients than Humalog® (insulin lispro) injection 100 units/mL-treated patients.

In Study PRONTO-Peds, injection site-related reactions* occurred in 6.2% of 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.3

*Denotes rash, redness, inflammation, pain, bruising, or itching.

Select Important Safety Information for Lyumjev

Lyumjev-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to Lyumjev-treated adults. 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. 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.

Adverse reactions associated with Lyumjev include hypoglycemia, hypokalemia, allergic reactions, injection- or infusion-site reactions, lipodystrophy, localized cutaneous amyloidosis, pruritus, rash, weight gain, and peripheral edema.

Incidence of severe hypoglycemia for Lyumjev, postmeal Lyumjev*, and Humalog

* Lyumjev dosed immediately (0 to 2 minutes) prior to each meal. Postmeal Lyumjev = dosed at or within 20 minutes of starting the meal

Incidence of Severe† Hypoglycemia (%) in PRONTO-Peds 1,3

Incidence of Severe Hypoglycemia in PRONTO-Peds

In PRONTO-Peds, 1.1% (3/280) of patients on mealtime Lyumjev, 0% (0/138) of patients on postmeal Lyumjev, and 1.0% (3/298) of patients on Humalog experienced severe hypoglycemia.1,3

†Severe is defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.1

The PRONTO-Peds trial was not designed to evaluate the relative safety between Lyumjev and Humalog.

Comparison of incidence of adverse reactions is not an adequate basis for comparison between products.

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.

Select Important Safety Information for Lyumjev

Severe hypoglycemia may be life threatening and can cause unconsciousness, seizures, or death. Hypoglycemia is the most common adverse effect of Lyumjev therapy. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.

Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

References

  1. Lyumjev. Prescribing Information. Lilly USA, LLC.
  2. Data on File, Lilly USA, LLC, DOF-UR-US-0038.
  3. Data on File, Lilly USA, LLC, DOF-UR-US-0036.

IMPORTANT SAFETY INFORMATION

Contraindications - Lyumjev and Humalog are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.

Warnings and Precautions

Never Share a Lyumjev or Humalog Prefilled Pen, Cartridge, Syringe, or Humalog Reusable Pen Compatible with Lilly 3 mL Cartridges Between Patients, even if the needle is changed. Patients using Lyumjev or Humalog vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.


Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Use caution and close medical supervision when making any changes in insulin regimen and increase the frequency of blood glucose monitoring. Due to reports of hyperglycemia and hypoglycemia, 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 blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.

Hypoglycemia: Severe hypoglycemia may be life threatening, may lead to unconsciousness, and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Lyumjev and Humalog. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, coadministered medications, meal pattern, or physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness.

Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors. Do not transfer Lyumjev U-200 from the Lyumjev KwikPen® to a syringe and do not transfer Humalog U-200 from the Humalog KwikPen® to a syringe as overdose and severe hypoglycemia can occur.

Hypokalemia: Hypokalemia may be life threatening. Insulins, including Lyumjev and Humalog, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (e.g., patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).

Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Lyumjev and Humalog. If hypersensitivity reactions occur, discontinue the use of Lyumjev or Humalog and treat per standard of care until signs and symptoms resolve.

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Lyumjev and Humalog. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.

Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Pump or infusion set malfunctions and insulin degradation can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification is necessary. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.


Adverse Reactions

Adverse reactions associated with Lyumjev and Humalog include hypoglycemia, hypokalemia, allergic reactions, injection- or infusion-site reactions, lipodystrophy, localized cutaneous amyloidosis, pruritus, rash, weight gain, and peripheral edema.

Drug Interactions

Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Pediatric Use

Lyumjev-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to Lyumjev-treated adults. 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. 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.

UR HI HCP ISI 14OCT2022

INDICATIONS

Lyumjev is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.


Humalog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Visit LillyMedical.com
Terms of Use
Privacy Statement
Sitemap
Accessibility
  • Terms of Use
  • Privacy Statement
  • Sitemap
  • Accessibility
 To speak to customer support:
Call (800) 545-5979

This site is intended for US healthcare professionals.

PP-UR-US-0001 12/2022 ©Lilly USA, LLC 2022. All rights reserved .

Lyumjev®, Humalog® and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
TRICARE® is a registered trademark of the Department of Defense (DoD), DHA.

Facebook YouTube
Terms of Use Privacy Statement Sitemap Accessibility
Lilly footer Logo