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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 hypersensitivity reactions have been reported with ONSWIK™ (insulin efsitora alfa-gobe)?
Efsitora is contraindicated in patients with hypersensitivity to efsitora or its excipients. Severe generalized allergy, including anaphylaxis, can occur. Hypersensitivity was reported in 4.9% of efsitora-treated participants in phase 3 trials.
Content Overview
- Can efsitora cause serious allergic reactions?
- How are hypersensitivity reactions with efsitora managed?
- How often were hypersensitivity reactions reported with efsitora?
- What hypersensitivity events were reported in each phase 3 study?
- Enclosed Prescribing Information
- References
Can efsitora cause serious allergic reactions?
Efsitora is contraindicated in patients with hypersensitivity to efsitora or one of its excipients.1
Severe, life-threatening generalized allergy, including anaphylaxis, can occur with insulins, including efsitora.1
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.2-5 Hypersensitivity findings from each of these studies are described below under What hypersensitivity events were reported in each phase 3 study?
How are hypersensitivity reactions with efsitora managed?
If hypersensitivity reactions occur, discontinue efsitora; treat per standard of care and monitor until symptoms and signs resolve.1
The QWINT-1 to QWINT-4 study protocols stated that participants who experienced a systemic hypersensitivity reaction be treated per national and international guidelines. Study sites were to have appropriately trained medical staff and appropriate medical equipment available when participants were receiving study intervention.2-5
If the investigator determined that a systemic hypersensitivity reaction related to study intervention administration had occurred, the participant could be permanently discontinued from study intervention, and the sponsor-designated medical monitor was to be notified.2-5
Eli Lilly and Company cannot provide treatment recommendations for hypersensitivity reactions. 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.
How often were hypersensitivity reactions reported with efsitora?
Across the 4 QWINT studies, hypersensitivity was reported as a common adverse drug reaction, occurring in 4.9% of the 1883 efsitora-treated adults with type 2 diabetes.1,6 Hypersensitivity was identified using the narrow Medical Dictionary for Regulatory Activities (MedDRA) Standardized Medical Query.6
What hypersensitivity events were reported in each phase 3 study?
Hypersensitivity events reported in each of the 4 phase 3 type 2 diabetes studies are shown in Table 1. The studies differed in treatment duration, prior insulin experience, and comparator, so results should not be compared across studies.
Study |
Treatment |
Hypersensitivity Events |
|---|---|---|
QWINT-1, 52 weeks2 |
Efsitora (N=397) |
6 (1.5) |
|
Insulin glargine U100 (N=398) |
10 (2.5) |
QWINT-2, 52 weeks3 |
Efsitora (N=466) |
42 (9.0) |
|
Insulin degludec (N=462) |
31 (6.7) |
QWINT-3, 78 weeks4 |
Efsitora (N=655) |
34 (5.0) |
|
Insulin degludec (N=331) |
16 (5.0) |
QWINT-4, 26 weeks5 |
Efsitora (N=365) |
11 (3.0) |
|
Insulin glargine U100 (N=365) |
4 (1.0) |
In QWINT-2, hypersensitivity events in the efsitora group were mild in 30 participants (6.4%) and moderate in 12 participants (2.6%), and in the insulin degludec group were mild in 25 participants (5.4%) and moderate in 6 participants (1.3%).3
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.
- 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
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: October 09, 2026