Zepbound single-dose pen and single-dose vial Instructions for Use revised

Eli Lilly issued revised Instructions for Use (IFU) documents for two Zepbound (tirzepatide) presentations: the single-dose pen (document ZEP-0003-PEN-IFU-20260422) and the single-dose vial (document ZEP-0002-VL-IFU-20260422) ^[3]. Both documents are dated April 22, 2026, and are approved by the U.S. Food and Drug Administration ^[2][3].

The vial IFU spells out what patients need on hand for an injection: one single-dose vial, a syringe and needle supplied separately, an alcohol swab, gauze, and a sharps container ^[2]. It notes explicitly that "the needle and syringe are not included" and gives a 1 mL syringe as an example of what a healthcare provider might recommend ^[2]. The document also walks through preparing the injection, including pulling air into the syringe up to the 0.5 mL line, pushing that air into the vial, and drawing the dose back out while tapping the syringe to clear air bubbles before injecting ^[2].

The pen IFU includes a commonly-asked-questions section addressing three things patients often notice during injection, according to the source summary: that air bubbles in the pen are normal, that it is not necessary to warm the pen to room temperature before use, and that a soft click before the final loud click is part of normal pen operation. The full text of the pen IFU was not included in the sources reviewed for this article, so further detail on that document is not yet known.

These IFU updates arrived alongside other Zepbound labeling activity. The full prescribing information for Zepbound lists a "Recent Major Changes" table showing a Dosage and Administration update in January 2026, a Warnings and Precautions update on severe gastrointestinal adverse reactions in February 2026, and a diabetic retinopathy complications warning added in August 2026, among other changes, with the label revised as of August 2026 ^[1]. A separate FDA approval letter for Mounjaro, tirzepatide's version marketed for type 2 diabetes, references "Instructions for Use - single dose vial (version previously approved April 22, 2026)" and "Instructions for Use - single dose pen (version previously approved April 22, 2026)" as enclosures tied to labeling supplements approved in August 2026, confirming the same April 22, 2026 IFU revision date applies across the shared tirzepatide labeling ^[3].

Why it matters for patients

Instructions for Use documents are not the same as prescribing information; they are the practical, step-by-step guide patients read before injecting a medication. This revision does not change the drug itself, the approved doses, or the boxed warning about thyroid C-cell tumor risk that remains part of Zepbound's label ^[1]. Instead, it appears to add reassurance-style guidance for people already using the pen, confirming that air bubbles, no need to warm the pen, and a soft click before the loud click are all expected during normal use, based on the source summary describing the pen IFU's commonly-asked-questions section.

For people using the single-dose vial, the IFU is explicit that the syringe and needle must be obtained separately from a pharmacy or provider, since they do not come packaged with the vial ^[2]. The document also details storage requirements, including refrigeration at 36°F to 46°F, an option to store unopened vials at room temperature up to 86°F for a maximum of 21 days, and instructions never to freeze the medication or reuse an opened vial ^[2]. Patients switching between the pen and vial forms, or those newly starting on either, may find the updated documents useful for confirming what is normal versus what might warrant a call to their pharmacist or prescriber.

What happens next

The vial and pen IFU revisions carry an April 22, 2026, approval date ^[2][3]. Separately, FDA approved broader labeling supplements for tirzepatide's diabetes indication (Mounjaro) in August 2026, covering a new cardiovascular risk-reduction indication and updated dosing guidance for ongoing glycemic control ^[3]. Whether additional IFU updates specific to Zepbound will follow those broader changes is not stated in the sources reviewed.