Wegovy injection

WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity:

• • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
• • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. o adults with overweight in the presence of at least one weight-related comorbid condition.
  • o adults and pediatric patients aged 12 years and older with obesity.
  • o adults with overweight in the presence of at least one weight-related comorbid condition.
• • for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14.4)]. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.

WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity:

• • to reduce the risk of major adverse CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight.
• • to reduce excess body weight and maintain weight reduction long term in adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use

Concomitant use of WEGOVY (semaglutide) tablets or WEGOVY (semaglutide) injection with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Injection: clear, colorless solution available as follows:

Tablets: available as:

Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications

• • The recommended starting dosage of WEGOVY injection is 0.25 mg administered subcutaneously once weekly.
• • Follow the dosage escalation in Table 1 to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.6), Adverse Reactions (6.1)].
• • If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks.

Table 1. Recommended Starting Dosage and Dosage Escalation of WEGOVY Injection for All Approved Indications in Adults and Pediatric Patients Aged 12 Years and Older

Recommended Maintenance Dosage of WEGOVY Injection for All Approved Indications

Cardiovascular Risk Reduction in Adults

• • The maintenance dosage of WEGOVY injection for cardiovascular risk reduction in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
• • Consider treatment response and tolerability when selecting the maintenance dosage [see Adverse Reactions (6.1), Clinical Studies (14.1)].

Weight Reduction in Adults

• • The maintenance dosage of WEGOVY for weight reduction in adults is either 1.7 mg or 2.4 mg (recommended) injected subcutaneously once weekly.
• • For patients who tolerate the 2.4 mg dosage for at least 4 weeks and additional weight reduction is clinically indicated, the dosage may be increased to a maximum dosage of 7.2 mg subcutaneously once weekly.
• • Consider treatment response and tolerability when selecting the maintenance dosage [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.2 )].

Weight Reduction in Pediatric Patients Aged 12 Years and Older

• • The maintenance dosage of WEGOVY injection for weight reduction in pediatric patients aged 12 years and older is either 2.4 mg (recommended), or 1.7 mg once weekly.
• • Consider treatment response and tolerability when selecting the maintenance dosage [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.3 )] .

Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis in Adults

• • The recommended maintenance dosage of WEGOVY injection for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis in adults is 2.4 mg injected subcutaneously once weekly. If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.4 )] .

WEGOVY Injection

How Supplied

WEGOVY injection is a clear, colorless solution available in cartons containing 4 single-dose pens, 4 single-dose syringes with integrated needles, or 1 single-patient-use pen (WEGOVY FlexTouch) as follows:

Recommended Storage

• •Do not store WEGOVY in the freezer or directly adjacent to the refrigerator cooling element.
• •Do not freeze WEGOVY and do not use if it has been frozen.

Single-dose Pen or Single-dose Syringe Storage

Store the WEGOVY prefilled single-dose pen or single-dose syringe in the refrigerator from 2°C to 8°C (36°F to 46°F). If needed, prior to the pen or syringe cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Protect WEGOVY injection from light. WEGOVY injection must be kept in the original carton until time of administration. Discard the WEGOVY pen or syringe after use.

Single-patient-use Pen (WEGOVY FlexTouch) Storage

Prior to first use, store WEGOVY FlexTouch single-patient-use penin a refrigerator between 2°C to 8°C (36°F to 46°F). After first use, WEGOVY FlexTouch single-patient-use pencan be stored for 56 days between 15°C to 30°C (59°F to 86°F) or in a refrigerator 2°C to 8°C (36°F to 46°F). WEGOVY FlexTouch single-patient-use penshould be protected from excessive heat and light. Keep the pen cap on when not in use. Always remove and safely discard the needle after each injection. Store the WEGOVY FlexTouch single-patient-use pen without an injection needle attached. Always use a new needle for each injection.

WEGOVY Tablets

How Supplied

WEGOVY tablets are available as:

Recommended Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense WEGOVY tablets in the original bottle. Store WEGOVY tablet in the original bottle until use to protect tablets from moisture. Store WEGOVY tablets in a dry place away from moisture.