Lilly issues Instructions for Use for Zepbound multi-dose vial with 30-day discard rule

Eli Lilly issued FDA-approved Instructions for Use for the Zepbound multi-dose vial on Jan. 7, 2026, setting a 0.6 mL injection volume and a rule that a vial must be discarded after 30 days at room temperature, 30 days after first use, or four weekly doses — whichever comes first, even if medicine remains ^[1]. The document is identified as ZEP-0001-MDV-IFU-20260107 ^[1].

Zepbound is tirzepatide, a GIP and GLP-1 receptor agonist approved in the U.S. in 2022 to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight plus at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity ^[1].

The multi-dose vial holds 2.4 mL and is built for four doses of 0.6 mL each, according to the prescribing information's list of dosage forms and strengths ^[1]. It comes in six strengths:

• 10 mg/2.4 mL (4.17 mg/mL) for four 2.5 mg doses
• 20 mg/2.4 mL (8.33 mg/mL) for four 5 mg doses
• 30 mg/2.4 mL (12.5 mg/mL) for four 7.5 mg doses
• 40 mg/2.4 mL (16.7 mg/mL) for four 10 mg doses
• 50 mg/2.4 mL (20.8 mg/mL) for four 12.5 mg doses
• 60 mg/2.4 mL (25 mg/mL) for four 15 mg doses ^[1]

The same listing pairs the multi-dose vial with the single-patient-use KwikPen and separates both from the single-dose pen and single-dose vial, which deliver 0.5 mL per injection ^[1]. So the per-injection volume differs by presentation: 0.6 mL from the multi-dose vial, 0.5 mL from the single-dose products ^[1].

The prescribing information's recent major changes table dates the Dosage and Administration section on administration instructions to 01/2026, and adds a warning that a Zepbound KwikPen must never be shared between patients, even if the needle is changed ^[1]. The KwikPen is described as single-patient-use ^[1].

Why it matters for patients

Tracking the discard date is now a labeling question rather than a preference. Four 0.6 mL doses at one dose per week line up with the 30-day window, but the rule is written as whichever limit comes first ^[1]. A skipped week, a delayed refill, or a dose held before a procedure can leave medicine in the vial that the instructions say to throw away ^[1].

The limit applies to the multi-dose vial no matter how much is left in it. The labeling does not explain whether the limit reflects sterility, potency, or both. Whether refrigeration extends the 30-day window has not been reported.

Zepbound's labeled schedule is one subcutaneous injection per week: 2.5 mg for four weeks to start, then increases of 2.5 mg after at least four weeks until a maintenance dose is reached ^[1]. Labeled maintenance doses are 5 mg, 10 mg, or 15 mg once weekly for weight reduction and long-term maintenance, and 10 mg or 15 mg once weekly for obstructive sleep apnea, with a maximum recommended dosage of 15 mg once weekly ^[1]. Coadministration with another tirzepatide-containing product or any GLP-1 receptor agonist is not recommended ^[1].

The prescribing information carries a boxed warning that tirzepatide causes thyroid C-cell tumors in rats and that it is unknown whether Zepbound causes such tumors, including medullary thyroid carcinoma, in humans ^[1]. Zepbound is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. The label also lists warnings for severe gastrointestinal reactions, acute kidney injury from volume depletion, gallbladder disease, pancreatitis, serious hypersensitivity reactions, hypoglycemia when used with insulin or an insulin secretagogue, diabetic retinopathy progression in people with type 2 diabetes, and pulmonary aspiration during general anesthesia or deep sedation ^[1]. Common adverse reactions reported in at least 5% of patients include nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease ^[1].

Whether the multi-dose vial costs less than other Zepbound presentations, and whether pharmacies will walk patients through the discard date at pickup, has not been reported.