FDA approves Lyumjev? (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps
INDIANAPOLIS,?Aug. 16, 2021?/PRNewswire/ --?The?U.S.?Food and Drug Administration?(FDA) has approved an expanded label for?Eli Lilly and Company's?(NYSE: LLY) rapid-acting insulin, Lyumjev??(insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream?and reduce A1C levels, was approved by the FDA in?June 2020. As a rapid-acting mealtime insulin, Lyumjev helps control blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes.
"Insulin pumps are an important delivery option for people with diabetes ? many of whom struggle with high postmeal blood sugar levels," said?Leonard Glass M.D., F.A.C.E., vice president of Medical Affairs,?Lilly. "The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes. It is an exciting development for pump users seeking to manage their blood sugar levels and reduce postmeal spikes."
The approval was based on results from PRONTO-PUMP-2, a phase 3 treat-to-target study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog. Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared to Humalog.1
Lyumjev is available in the?U.S.?and in several global markets, including?Japan?and the?European Union, where it is also approved for use in insulin pumps. People with diabetes should seek guidance from their healthcare providers and refer to the insulin pump maker instructions to see if Lyumjev U-100?can be used with their pump.
Lilly?offers several solutions to help eligible people who need assistance accessing their?Lilly?insulin, including Lyumjev, at the?Lilly?Diabetes Solution Center at (833) 808-1234 and?www.insulinaffordability.com. People who have commercial insurance can visit?www.Lyumjev.com?to access the Lyumjev Savings Card. Lyumjev is also included in the?Lilly?Insulin Value Program for people with commercial insurance or no insurance at all, as well as in the Seniors Savings Model for people in the Medicare Part D program?allowing them to fill their monthly prescription of Lyumjev for?$35. Other restrictions may apply.
About the PRONTO-PUMP-2 Study
PRONTO-PUMP-2 was a phase 3, 16-week, randomized (1:1), active controlled, double-blind treat-to-target multinational study that evaluated the efficacy and safety of Lyumjev versus Humalog (insulin lispro injection) 100 units/mL?in 432 adult patients with type 1 diabetes (T1D) using insulin pumps. Following a 2-week lead-in period, patients were randomized in a double-blind manner to either Lyumjev (n=215) or Humalog (n=217), both 100 units/mL. Patients were instructed to deliver bolus doses 0-2 minutes before meals. The primary objective was noninferiority (noninferiority margin [NIM]=0.4% for A1C) of Lyumjev to Humalog on change in A1C from baseline to week 16. Key multiplicity-adjusted secondary objectives included superiority of Lyumjev to Humalog at week 16 for 1- and 2-hour postprandial glucose during a meal test?and duration of time in range (70-180 mg/dL) during daytime and over a 24-hour period.1
PURPOSE and SAFETY SUMMARY
Important Facts About?LYUMJEV??(LOOM-jehv) and?Humalog??(HU-ma-log)
Other most common side effects with Humalog include swelling of your hands or feet.
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:
- Lyumjev is also known as insulin lispro-aabc injection. Humalog is also known as insulin lispro injection.
- Lyumjev is a fast-acting insulin. Lyumjev is used to control high blood sugar in adults with diabetes. Humalog is a fast-acting insulin. Humalog is used to control high blood sugar in adults and children with diabetes. Lyumjev and Humalog are available only with a prescription.
- Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). Lyumjev U-200 contains?2 times as much insulin?in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. The dose window of the pen shows the number of insulin units to be delivered.
- It is not known if Lyumjev is safe and effective for children. It is not known if Humalog is safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes as there were no studies done with Humalog in these groups of children. If your doctor decides to give your child any insulin products, he or she may give you special instructions.
- symptoms of low blood sugar (hypoglycemia)
- an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog.
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with?Lilly?3mL cartridges available for Humalog
- needles
- syringes
- Low blood sugar.?This can cause:
???? dizziness or lightheadedness | ???? sweating | ???? confusion | |||
???? headache | ???? blurred vision | ???? slurred speech | |||
???? shakiness | ???? fast heartbeat | ???? anxiety | |||
???? irritability | ???? mood change | ???? hunger |
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.
- Low potassium in your blood.?This can lead to severe breathing problems, irregular heartbeat, and death.
- Severe allergic reaction. Get emergency help right away if you have:
???? a rash over your whole body | ???? trouble breathing | ???? a fast heartbeat | |||
???? sweating | ???? a faint feeling | ???? shortness of breath | |||
???? extreme drowsiness | ???? dizziness | ???? confusion | |||
???? swelling of your face, tongue, or throat |
- Heart failure.?Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with Lyumjev or Humalog 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 Lyumjev or Humalog. 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.
- Sudden onset of high blood sugar and high amounts of ketones in your blood or urine.?You can have these serious side effects when your insulin pump or infusion set is not working the right way, if there are handling errors, or if your insulin is no longer effective. For these reasons, you may not get the right amount of insulin, so always keep extra insulin and injection supplies with you.
???? low blood sugar | ???? allergic reactions |
???? reactions or pain at the injection or infusion site with insulin pump use | ???? skin thickening or pits at the injection or infusion site |
???? itching | ???? rash |
???? weight gain |
- 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.
- 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 reuse 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.
- Inject Lyumjev under your skin at the beginning of a meal or within 20 minutes after you start eating a meal.
- Inject Humalog under your skin within 15 minutes before or right after you eat a meal.
- mix Lyumjev with other insulins or liquids
- drive or use heavy machinery until you know how your Lyumjev or Humalog affects you.
- drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog.
- Warren, Mark, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes, Obesity and Metabolism. 2021; 23(7): 1552-1561.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020.?Atlanta, GA:?Centers for Disease Control and Prevention,?U.S. Dept. of Health and Human Services; 2020.
- International Diabetes Federation. IDF Diabetes Atlas, 9th edn.?Brussels, Belgium:?International Diabetes Federation, 2019. Available at:?http://diabetesatlas.org.