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Onswik ™ (insulin efsitora alfa-gobe) injection
500 units/mL (U-500), 1,000 units/mL (U-1,000)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is known about lipodystrophy with ONSWIK™ (insulin efsitora alfa)?
In clinical trials in adults with type 2 diabetes mellitus, lipodystrophy was reported in 0.3% of patients treated with efsitora. Rotating injection sites and not injecting into affected areas can reduce the risk of lipodystrophy.
Content Overview
- What is the frequency of lipodystrophy reported with efsitora?
- How can the risk of lipodystrophy be reduced with efsitora?
- Enclosed Prescribing Information
- References
What is the frequency of lipodystrophy reported with efsitora?
The QWINT (Once Weekly [QW] Insulin Therapy) phase 3 clinical program evaluated the efficacy and safety of efsitora for the treatment of adults with diabetes.1
The safety of efsitora was evaluated in four clinical trials involving 1,883 adults with type 2 diabetes mellitus exposed to efsitora, with a mean exposure duration of 372 days.2
Long-term use of insulin, including efsitora, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption. Lipodystrophy was reported in 0.3% of adults with type 2 diabetes mellitus treated with efsitora.2
How can the risk of lipodystrophy be reduced with efsitora?
Inject efsitora subcutaneously into the abdomen, upper arm, thigh, or buttocks.2
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.2
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in 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 for hypoglycemia.2
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- Bergenstal RM, Philis-Tsimikas A, Wysham C, et al. Once-weekly insulin efsitora alfa: design and rationale for the QWINT phase 3 clinical development programme. Diabetes Obes Metab. 2024;26(8):3020-3030. https://doi.org/10.1111/dom.15604
- ONSWIK [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: August 24, 2026