Mounjaro and Zepbound labels add warning against sharing a KwikPen
Mounjaro and Zepbound labels now say a multi-dose KwikPen must not be shared between patients even with a new needle, to prevent infections from shared injection equipment.
The prescribing labels for Mounjaro and Zepbound now warn that a KwikPen must never be shared between patients, even if the pen needle is changed [1][2]. Both labels list the new language as Warnings and Precautions section 5.10 and date the change to 01/2026 [1][2].
Mounjaro and Zepbound both contain tirzepatide and are made by Eli Lilly and Company [1][2][3]. Mounjaro is indicated for type 2 diabetes in adults and in children 10 years of age and older, and to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk for those events [2]. Zepbound is indicated to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight plus at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity [1]. Both products were first approved in the United States in 2022 [1][2].
The KwikPen is a multi-dose pen that both labels describe as single-patient-use [1][2]. It is sold in six strengths, from 10 mg/2.4 mL to 60 mg/2.4 mL, and each pen provides four doses [1][2]. The Zepbound label states: "Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed" [1]. The Mounjaro label carries the same instruction under section 5.10 [2]. The labels give the reason for the warning as the risk of transmitting bloodborne pathogens when injection equipment is shared [1][2].
FDA records for the Zepbound application, NDA 217806, list a supplement called SUPPL-2 with an action date of 01/20/2026 that covered the package insert, the medication guide, and container and carton labels [3]. The Zepbound label was most recently updated on August 28, 2026, and the Mounjaro label on August 27, 2026 [1][2]. Neither label states whether any infections have been reported in connection with pen sharing, and no case counts, specific pathogens, or dates of patient exposure have been disclosed [1][2].
Why it matters for patients
A KwikPen holds four weekly doses rather than one, which means a two-person household could be tempted to split a pen or a box of pens. The labels rule that out and specifically say that changing the pen needle does not make sharing safe [1][2]. Under the labeling, each person using tirzepatide needs their own pen [1][2]. Single-dose pens and single-dose vials are labeled as single-dose presentations, so the new warning applies to the multi-dose KwikPen rather than those products [1][2].
Zepbound's Limitations of Use also state that taking it with another tirzepatide-containing product, or with any GLP-1 receptor agonist, is not recommended [1]. For households where more than one person uses a GLP-1 medication, that language and the pen-sharing warning both bear on how the drugs are prescribed and dispensed [1][2].
What happens next
The 5.10 warning is dated 01/2026 in both labels [1][2], and the Zepbound supplement covering the package insert carries a January 20, 2026 action date in FDA's records [3]. Both labels have since been updated for other reasons, including diabetic retinopathy monitoring in patients with type 2 diabetes, with the current versions revised in August 2026 [1][2]. Whether the warning will be revised further has not been reported.
Sources
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