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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.
How common is peripheral edema with ONSWIK™ (insulin efsitora alfa-gobe)?
Peripheral edema is a common adverse drug reaction with efsitora, reported in 1.6% of participants in the integrated phase 3 type 2 diabetes safety dataset. Thiazolidinediones combined with insulin increase the risk of edema and heart failure.
Content Overview
- How often was peripheral edema reported with efsitora?
- How were cases of peripheral edema managed in the phase 3 trials with efsitora?
- Is there an increased risk of edema with concomitant thiazolidinediones?
- Enclosed Prescribing Information
- References
How often was peripheral edema reported with efsitora?
The efficacy and safety of efsitora were evaluated in 4 phase 3 studies in adults with type 2 diabetes, known collectively as the QWINT (Once Weekly Insulin Therapy) clinical program.1-4
Across the 4 QWINT studies, peripheral edema was reported as a common adverse drug reaction, occurring in 1.6% of the 1883 efsitora-treated adults with type 2 diabetes.5
Peripheral edema is a composite term. It comprises the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms edema peripheral, edema, generalized edema, swelling, and peripheral swelling.6
How were cases of peripheral edema managed in the phase 3 trials with efsitora?
The QWINT-1 to -4 study protocols did not provide guidance about the management of peripheral edema. During the studies, investigators used local standards of care to make treatment recommendations.1-4
Eli Lilly and Company cannot provide treatment recommendations for peripheral edema. The treating health care provider may use the information provided, the patient's prior medical history and concomitant medications, and other individual factors in developing a treatment plan. The treating health care provider should consider potential risks and benefits of treatment options and monitor appropriately.
Is there an increased risk of edema with concomitant thiazolidinediones?
Thiazolidinediones (TZDs), which are peroxisome proliferator activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure.5
Enclosed Prescribing Information
ONSWIK™ (insulin efsitora alfa-gobe) injection, for subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med. 2025;393(4):325-335. https://doi.org/10.1056/NEJMoa2502796
- Wysham C, Bajaj HS, Del Prato S, et al; QWINT-2 Investigators. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med. 2024;391:2201-2211. https://www.nejm.org/doi/full/10.1056/NEJMoa2403953
- Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2279-2289. https://doi.org/10.1016/S0140-6736(25)01044-X
- Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2290-2301. https://doi.org/10.1016/S0140-6736(25)01069-4
- Onswik [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: September 10, 2026