Zepbound multi-dose vial Instructions for Use issued, with a 30-day or four-dose in-use limit

Eli Lilly has issued FDA-approved Instructions for Use for the Zepbound (tirzepatide) multi-dose vial, dated January 7, 2026 and numbered ZEP-0001-MDV-IFU-20260107. The document lays out a firm in-use limit: patients must discard the vial after 30 days at room temperature, 30 days after the first use, or after four weekly doses have been drawn — whichever happens first — even if some medicine remains in the vial ^[1].

The multi-dose vial is a different presentation from the single-dose vial and pen products Lilly already sells. According to the prescribing information's dosage forms section, the multi-dose vial delivers a 0.6 mL injection volume per dose, compared with the 0.5 mL draw from single-dose vials or pens ^[1]. The multi-dose vials come in six strengths — 10 mg/2.4 mL, 20 mg/2.4 mL, 30 mg/2.4 mL, 40 mg/2.4 mL, 50 mg/2.4 mL, and 60 mg/2.4 mL — each formulated to provide four weekly doses ranging from 2.5 mg to 15 mg per 0.6 mL injection ^[1].

The label's "Recent Major Changes" table lists a change to the Dosage and Administration section (2.4, Important Administration Instructions) dated January 2026, which aligns with the new multi-dose vial instructions ^[1]. The same revision history also flags a related update: a new warning that a Zepbound KwikPen must never be shared between patients, even if the needle is changed, which appears in Warnings and Precautions section 5.10 ^[1].

Why it matters for patients

The 0.6 mL per-injection volume is larger than the 0.5 mL volume patients may be used to from single-dose vials or pens, so anyone switching presentations needs to pay attention to which device and volume they're using ^[1]. Mixing up single-dose and multi-dose vial instructions could lead to drawing up the wrong amount.

The 30-day-or-four-dose rule means the multi-dose vial cannot simply be stored and used until it runs dry. Even if a patient misses a dose or ends up with medicine left over near the end of the cycle, the instructions call for discarding the vial once any one of the three limits — 30 days at room temperature, 30 days from first use, or four doses — is reached. This is a stricter and more specific rule than what applies to single-dose vials or pens, which are intended for one use each and don't have this multi-dose in-use countdown ^[1].

For patients who inject weekly, four doses over roughly four weeks lines up closely with the 30-day limit, but the sources do not spell out exactly how storage conditions, missed doses, or delays between injections affect which limit triggers first in practice. Patients should check the actual product labeling and instructions that come with their vial for the precise storage conditions, since the source material does not describe refrigeration requirements before first use or exact wording matching the summary's product code.

The warning against sharing a KwikPen between patients, even with a new needle, is a separate but related safety point included in this same labeling update. It underscores that Lilly is treating device- and vial-specific handling as a current safety priority across Zepbound's presentations ^[1].

What happens next

The prescribing information shows a broader schedule of label updates through 2026, including changes to gastrointestinal warnings in February 2026 and diabetic retinopathy warnings in August 2026, with the full prescribing information listed as revised as of August 2026 ^[1]. It is not yet known from the available sources whether additional guidance specific to the multi-dose vial's storage or handling will be issued before then, or how pharmacies and patients are being notified of the new in-use limit.