Regulation

Wegovy prescribing information now covers both the weekly injection and the daily tablet

One Wegovy label now governs both the injection and the oral tablet, but the two forms do not carry the same approved uses.

By the Semaglutides news desk··Wegovy

Novo Nordisk's Wegovy label now covers both the once-weekly injection and the once-daily tablet in a single prescribing information document, according to the DailyMed listing updated June 18, 2026 [1]. The combined label keeps separate dosing tables for each form, lists different approved uses for each, and includes directions for switching between the two forms in either direction [1].

The injection is given once weekly, on the same day each week, at any time of day and with or without meals, into the abdomen, thigh or upper arm [1]. Treatment starts at 0.25 mg once weekly for four weeks, then increases every four weeks toward a maintenance dose; the usual maintenance dose is 2.4 mg once weekly [1]. The label lists injection strengths of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg in single-dose pens, a 7.2 mg single-dose pen (Wegovy HD), single-dose syringes, and a 9.6 mg/3 mL single-patient-use pen (Wegovy FlexTouch) that delivers four 2.4 mg doses [1].

The tablet is taken once daily in the morning on an empty stomach with up to 4 ounces of water. It cannot be taken with other liquids besides water, must be swallowed whole, and patients must wait at least 30 minutes before eating, drinking or taking other oral medicines [1]. Tablet treatment starts at 1.5 mg once daily for 30 days, then increases every 30 days; the recommended maintenance dose is 25 mg once daily for cardiovascular risk reduction and weight reduction in adults [1]. Tablets come in 1.5 mg, 4 mg, 9 mg and 25 mg strengths [1].

The two forms do not carry identical approved uses [1]. Both are approved to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack or non-fatal stroke — in adults with established cardiovascular disease and either obesity or overweight, and both are approved for long-term weight reduction in adults with obesity or with overweight plus at least one weight-related condition [1]. Only the injection is approved for weight reduction in pediatric patients aged 12 and older, and only the injection is approved for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (stages F2 to F3) in adults [1]. The MASH indication was granted under accelerated approval and may depend on a confirmatory trial [1].

The label carries a boxed warning that semaglutide causes thyroid C-cell tumors in rodents and that it is unknown whether Wegovy causes such tumors, including medullary thyroid carcinoma, in humans; Wegovy is contraindicated in people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 [1]. Other listed warnings include pancreatitis, gallbladder disease, hypoglycemia, acute kidney injury from volume depletion, severe gastrointestinal reactions and hypersensitivity reactions [1]. The label states that Wegovy should not be used with other semaglutide products or with any other GLP-1 receptor agonist [1].

Dated changes listed on the label include indication updates in August 2025 and December 2025, dosage and administration updates in August 2025, December 2025 and March 2026, a June 2026 instruction not to share the Wegovy FlexTouch pen between patients, and removal of a warning about suicidal behavior and ideation in February 2026 [1]. Initial U.S. approval of the drug is listed as 2017 [1].

Why it matters for patients

A single document now holds the instructions for both forms, which matters for anyone who moves from the injection to the tablet or the reverse. The two products are not interchangeable in daily routine: one is weekly, one is daily; escalation for the injection runs in four-week steps, while the tablet escalates in 30-day steps [1].

The tablet's approved uses are narrower than the injection's. A patient who needs a pediatric obesity indication or the MASH indication would not find that use covered by the tablet's labeling [1]. The Food and Drug Administration's reasoning for keeping those uses off the tablet has not been disclosed.

The label's limits also apply across both forms: it does not recommend combining Wegovy with another semaglutide product or any other GLP-1 receptor agonist [1]. Specific step-by-step switching instructions have not been reported in detail.

What happens next

The MASH indication remains under accelerated approval, and continued approval may depend on verifying clinical benefit in a confirmatory trial [1]. No date for that trial has been reported. No other upcoming milestone tied to this labeling change has been announced.

Sources

  1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b

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