Lilly is reducing the list price of insulins by:

• Cutting the list price of its non-branded insulin, Insulin Lispro Injection 100 units/mL, to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog^® vial in 1999.
• Cutting the list price of Humalog^® (insulin lispro injection) 100 units/mL¹, Lilly's most commonly prescribed insulin, and Humulin^® (insulin human) injection 100 units/mL² by 70%, effective in Q4 2023.
• Launching Rezvoglar^TM (insulin glargine-aglr) injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus^® (insulin glargine) injection, for $92 per five pack of KwikPens^®, a 78% discount to Lantus, effective April 1, 2023.

"While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," said David A. Ricks, Lilly's Chair and CEO. "The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap."

In addition to reducing the list price of its insulins, Lilly is making it easier for more people with diabetes to get Lilly insulins:   

• Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.³
• People who don't have insurance can continue to go to InsulinAffordability.com and immediately download the Lilly Insulin Value Program savings card to receive Lilly insulins for $35 per month.

"We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don't use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable," continued Ricks. "For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won't stop until all people with diabetes are in control of their disease and can get the insulin they need."

Today's announcement builds on years of efforts by Lilly to close the gaps in the U.S. healthcare system that keep some people with diabetes from accessing affordable insulin. In recent years, Lilly has introduced multiple insulin affordability solutions that have made a real impact, including launching low-list-price, non-branded insulins in 2019, implementing the Lilly Insulin Value Program in 2020 and committing all of our insulins to the Medicare Part D Senior Savings Model in 2021. Because of these efforts, the average out-of-pocket cost for Lilly insulins has dropped to $21.80 over the last five years.

In the coming weeks, Lilly will launch a nationwide public awareness campaign to help ensure all Lilly insulin users understand how to access the company's industry-leading affordability solutions. For more information, go to Lilly.com/insulin.

PURPOSE and SAFETY SUMMARY

Important Facts About Humalog^® (HU-ma-log) and Insulin Lispro Injection

• Humalog is also known as insulin lispro injection.
• Humalog and Insulin Lispro Injection are fast-acting insulins. They are used to control high blood sugar in adults and children with diabetes. They are available only with a prescription.
• Humalog comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). The Humalog U-200 prefilled pen contains 2 times as much insulin per 1 milliliter as standard (U-100) insulin. The dose window on the pen shows your insulin dose.
• It is not known if Humalog or Insulin Lispro Injection are safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes. There were no studies done with these insulins in these groups of children. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

Important Facts about Humalog^® Mix50/50™, Humalog^® Mix75/25™, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25

• Humalog Mix50/50 and Humalog Mix75/25 are known as insulin lispro protamine and insulin lispro injectable suspension.
• Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are mixed U-100 insulins. This means they contain a mix of fast-acting and intermediate-acting insulins. They are used to control high blood sugar in people with diabetes. They are available only with a prescription.
• It is not known if Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are safe and effective for children younger than 18 years of age. There were no studies done with these insulins in children younger than 18. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

All Humalog and Insulin Lispro Injection products contain insulin lispro. Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 contain insulin lispro protamine mixed with insulin lispro.

Warnings

Do not take Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 if you have:

• symptoms of low blood sugar (hypoglycemia)
• an allergy to insulin lispro products or any of their ingredients.

Do not reuse needles or share your insulin injection supplies with other people. This includes your: 

• prefilled pen for use by a single patient
• cartridges
• reusable pen that works with Lilly 3mL cartridges
• needles
• syringes

You or the other person can get a serious infection. This can happen even if you change the needle. 

Do not change the type of insulin you take or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious. 

Do not use a syringe to remove Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.

Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 may cause serious side effects. Some of these can lead to death. The possible serious side effects are:

• Low blood sugar. This can cause:

If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream.

• Severe allergic reaction.
  Get emergency help right away if you have:

• Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
• Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with insulin lispro products may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with these insulin lispro products. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include: shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.
• High blood sugar and ketoacidosis. You can have these serious problems when your insulin pump or infusion set stops working. They can also happen if your insulin is no longer effective. For these reasons, always keep extra insulin injection supplies with you.

Common side effects

The most common side effects of Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are:

These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:

• about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
• about any other prescription medicines you take, especially ones called TZDs.
• about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.
• if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.

How to take

Read the Instructions for Use that come with your Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. Be sure to take your insulin lispro product and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.

Before injecting your insulin lispro product

You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:

• Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.
• Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
• Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.

When you are ready to inject

• If you are taking Humalog or Insulin Lispro Injection, inject it under your skin within 15 minutes before or right after you eat a meal.
• If you are taking Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, inject it under your skin within 15 minutes before you eat a meal.

Staying safe while taking your insulin lispro product

To stay safe while taking your insulin, be sure to never inject Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 in your vein, muscle, or with an insulin pump. Also be sure not to:

• mix Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 with other insulins or liquids.
• drive or use heavy machinery until you know how your insulin lispro product affects you.
• drink alcohol or use other medicines that contain alcohol when taking your insulin lispro product.