Zepbound label revised in August 2026 lays out starting, maintenance and maximum doses

The US prescribing information for Zepbound (tirzepatide) was revised in August 2026, and its dosing section sets out a single step-up schedule for both of the drug's uses: 2.5 mg injected under the skin once weekly for four weeks, then increases of 2.5 mg no sooner than every four weeks until a maintenance dose is reached ^[1].

The label states plainly that 2.5 mg is for treatment initiation and is not approved as a maintenance dose ^[1]. After the first four weeks, the recommended next step is 5 mg once weekly, with further 2.5 mg increases allowed after at least four more weeks at the current dose. The label says the choice of maintenance dose should take treatment response and tolerability into account, and that a lower maintenance dose can be considered for patients who do not tolerate a higher one ^[1].

Maintenance doses differ by indication

For weight reduction and long-term maintenance, the recommended maintenance doses are 5 mg, 10 mg or 15 mg once weekly. For moderate to severe obstructive sleep apnea in adults with obesity, the recommended maintenance doses are 10 mg or 15 mg once weekly ^[1]. The maximum recommended dose for all indications is 15 mg once weekly ^[1].

Zepbound is indicated, alongside a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight who have at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity ^[1]. The label says combining Zepbound with another tirzepatide product or with any GLP-1 receptor agonist is not recommended ^[1].

Four device types, each holding a set number of doses

The label lists four presentations. Single-dose pens and single-dose vials come in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg per 0.5 mL. Multi-dose vials and the single-patient-use KwikPen each contain 2.4 mL at one strength, and that volume holds four doses: 10 mg/2.4 mL for four 2.5 mg doses, up to 60 mg/2.4 mL for four 15 mg doses ^[1].

The label directs that patients and caregivers be told which presentation they will receive and be trained for that specific device, and be retrained if the prescribed presentation changes ^[1].

Missed doses and schedule changes

The label says a missed dose should be given as soon as possible within four days, or 96 hours. If more than four days have passed, the patient skips that dose and takes the next one on the usual day, then resumes the regular weekly schedule. The day of the week for dosing can be changed as long as at least three days, or 72 hours, separate two doses ^[1].

Rec nt label updates

The highlights list several recent major changes: Dosage and Administration, 01/2026; a warning never to share a Zepbound KwikPen between patients, 01/2026; an update on severe gastrointestinal adverse reactions, 02/2026; removal of the suicidal behavior and ideation warning, 02/2026; and an update on diabetic retinopathy complications in patients with type 2 diabetes mellitus, 08/2026 ^[1].

Zepbound carries a boxed warning that tirzepatide causes thyroid C-cell tumors in rats and that it is unknown whether the drug causes such tumors, including medullary thyroid carcinoma, in humans. The drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. Adverse reactions reported in at least 5% of patients include nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection site reactions, fatigue, hypersensitivity reactions, belching, hair loss and gastroesophageal reflux disease ^[1]. The label also states that Zepbound may cause fetal harm and should be discontinued when pregnancy is recognized, and advises women using oral contraceptives to switch to a non-oral method or add a barrier method for four weeks after starting and after each dose increase ^[1].

Why it matters for patients

The starting dose and the maintenance dose are not the same thing, and the label's four-week minimum between increases means a full step-up to a maintenance dose takes time. For someone with obstructive sleep apnea, the label's maintenance options begin at 10 mg, higher than the lowest weight-management maintenance dose ^[1].

Because the multi-dose vial and KwikPen each hold four doses of one strength, a change in dose generally means a different device or vial, and the label ties training to the specific presentation a patient receives ^[1]. The KwikPen carries an explicit instruction that it must not be shared between patients, even if the needle is changed ^[1].

The label's missed-dose window is four days, not the full week, and skipping is the stated option after that point ^[1]. The most recent listed label change, dated 08/2026, concerns diabetic retinopathy monitoring in patients with type 2 diabetes, and the label directs monitoring for people with a history of that condition ^[1]. The label notes that routine calcitonin monitoring or thyroid ultrasound is of uncertain value for early detection of medullary thyroid carcinoma in patients taking Zepbound ^[1].

What happens next

The label does not disclose any pending updates, and no future filing or revision dates are stated in the document ^[1].