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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.
Can ONSWIK™ (insulin efsitora alfa-gobe) be used in patients with renal impairment?
Additional dose adjustment should not be necessary for patients with renal impairment; however, as with all insulin products, glucose monitoring should be intensified and the efsitora dosage adjusted on an individual basis.
Content Overview
•Are dose adjustments of efsitora needed in patients with renal impairment?
•Does impaired renal function impact the pharmacokinetics of efsitora?
•Were patients with renal impairment included in the efsitora phase 3 studies?
•Can efsitora be used in patients with a renal transplant or who are undergoing dialysis?
Are dose adjustments of efsitora needed in patients with renal impairment?
Additional dose adjustment should not be necessary for patients with renal impairment.1
However, as with all insulin products, glucose monitoring should be intensified and the efsitora dosage adjusted on an individual basis in patients with renal impairment.1
Does impaired renal function impact the pharmacokinetics of efsitora?
No clinically relevant differences in the pharmacokinetics of efsitora were observed across the different renal impairment subgroups.1
No clinically significant differences in the pharmacokinetics of efsitora were observed based on renal function (based on race-free CKD-EPI 2021 category).1
The protracted time-action profile of efsitora results from reduced renal clearance due to its relatively large molecular size, inhibition of degradation due to binding to the neonatal Fc receptor, and reduced affinity for the insulin receptor relative to human insulin, which decreases receptor-mediated clearance.1
Following a 100-unit subcutaneous bolus injection of efsitora, the geometric mean (CV%) clearance (CL) was 0.02 L/h (24%). The geometric mean (CV%) elimination half-life at steady-state is approximately 17 days (26%), independent of dose.1
Were patients with renal impairment included in the efsitora phase 3 studies?
The QWINT (Once Weekly [QW] Insulin Therapy) clinical program assessed the efficacy and safety of efsitora as treatment for patients with diabetes.2
Patients with renal impairment were enrolled in the QWINT studies. Baseline renal function of efsitora-treated participants is presented in Table 1.
Table 1. Baseline eGFR Category of Efsitora-Treated Participants in QWINT-1, QWINT-2, and QWINT-43,4,6
eGFR, mL/min/1.73 m² |
QWINT-1 (N=397) |
QWINT-2 (N=466) |
QWINT-4 (N=365) |
|---|---|---|---|
<30 |
2 (0.5) |
2 (0.4) |
NA |
≥30 to <60 |
20 (5.0) |
42 (9.0) |
NA |
<60 |
NR |
NR |
48 (13) |
≥60 to <90 |
117 (29.5) |
170 (36.5) |
122 (33) |
≥90 |
258 (65.0) |
252 (54.1) |
195 (53) |
Abbreviations: eGFR = estimated glomerular filtration rate; NA = not applicable; NR = not reported.
Note: Data are presented as n (%). Participants were excluded from QWINT-4 if they had an eGFR <30 mL/min/1.73 m², so no participants fell into the <30 category. QWINT-1 and QWINT-2 reported the <30 and ≥30 to <60 categories separately; QWINT-4 reported a single <60 category. Baseline renal function category was not reported for QWINT-3.
During the QWINT studies, no dose adjustments were required for patients with mild to moderate renal impairment (eGFR 30-60 mL/min/1.73 m²).3-6
However, since renal impairment can increase the risk of hypoglycemia, intensified glucose monitoring may be necessary based on clinical discretion.7
Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.1
Clinical experience with efsitora in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) is limited. Patients were excluded from the efsitora trials if they had an eGFR <20 mL/min/1.73 m².1 In the individual study protocols, the renal exclusion threshold was an eGFR <20 mL/min/1.73 m² in QWINT-1, QWINT-2, and QWINT-3, and <30 mL/min/1.73 m² in QWINT-4.3-6
Can efsitora be used in patients with a renal transplant or who are undergoing dialysis?
No clinical data are available on the use of efsitora in patients with a history of renal transplantation or those undergoing renal dialysis, as these populations were excluded from the QWINT clinical trials.3-6
The effect of hemodialysis with kidney failure on the pharmacokinetics of efsitora is unknown.1
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).
- Onswik [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- 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
- 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://doi.org/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
- Galindo RJ, Beck RW, Scioscia MF, et al. Glycemic monitoring and management in advanced chronic kidney disease. Endocr Rev. 2020;41(5):756-774. https://doi.org/10.1210/endrev/bnaa017
Date of Last Review: August 14, 2026