WEGOVY

2 DOSAGE AND ADMINISTRATION In patients with diabetes, monitor blood glucose prior to starting and during WEGOVY treatment. ( 2.1 ) WEGOVY Injection • Administer WEGOVY injection once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals. ( 2.1 ) • Inject subcutaneously in the abdomen, thigh, or upper arm. ( 2.1 ) • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule in Table 1, titrating every 4 weeks to achieve the maintenance dosage. ( 2.2 ) • The usual recommended maintenance dosage of WEGOVY injection is 2.4 mg once weekly. Refer to the full PI for maintenance dosages based on the indication. ( 2.2 ) WEGOVY Tablets • Take WEGOVY tablets orally once-daily on an empty stomach in the morning with water (up to 4 ounces). Do not take with other liquids besides water ( 2.1 ). • Swallow tablets whole. Do not split, crush, chew or dissolve. ( 2.1 ) • After taking WEGOVY tablet wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • Initiate WEGOVY tablet with a dosage of 1.5 mg once daily for 30 days. Then follow the dosage escalation schedule, titrating every 30 days to achieve the maintenance dosage. ( 2.2 ) • The recommended maintenance dosage of WEGOVY tablets is 25 mg orally once daily for cardiovascular risk reduction and weight reduction in adults. ( 2.3 ) 2.1 Important Monitoring and Administration Instructions In patients with diabetes mellitus, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment [see Warnings and Precautions (5.4 )] . Administer WEGOVY in combination with a reduced-calorie diet and increased physical activity. WEGOVY Injection • Prior to initiation of WEGOVY injection, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Visually inspect the WEGOVY injection prior to each administration. Only use if the solution is clear, colorless, and contains no particles. • Administer WEGOVY injection once weekly, on the same day each week, at any time of day, with or without meals. • Inject WEGOVY subcutaneously in the abdomen, thigh, or upper arm. The time of day and the injection site can be changed without the need for a dosage modification. WEGOVY Tablets • Take one WEGOVY tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces). Do not take WEGOVY tablets with other liquids besides water [see Clinical Pharmacology ( 12.3 )] . • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. • After taking a WEGOVY tablet, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage for WEGOVY Injection 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 Weeks Once-weekly Subcutaneous Injection Dosage Starting Dosage 1 through 4 0.25 mg Dosage Escalation 5 through 8 0.5 mg 9 through 12 1 mg 13 through 16 1.7 mg Maintenance Dosage 17 and onward See the indication below for the recommended maintenance dosage(s) 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), 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 )] . 2.3 Recommended Dosage of WEGOVY Tablets Recommended Dosage of WEGOVY Tablets for Cardiovascular Risk Reduction or Weight Reduction in Adults • The recommended starting dosage of WEGOVY tablets is 1.5 mg taken orally once daily. Follow the dosage escalation in Table 2 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. • The recommended maintenance dosage of WEGOVY tablets is 25 mg orally once daily. • If patients do not tolerate the 25 mg once daily maintenance dosage, consider switching to WEGOVY injection 1.7 mg once weekly [see Dosage and Administration ( 2.5 )] . Table 2. Recommended Dosage of WEGOVY Tablets for Cardiovascular Risk Reduction or Weight Reduction in Adults Days Once Daily Tablet Dosage Starting Dosage 1 through 30 1.5 mg Dosage Escalation 31 through 60 4 mg 61 through 90 9 mg Maintenance Dosage 91 and onward 25 mg 2.4 Recommendations Regarding Missed Dose(s) WEGOVY Injection • If one dose of WEGOVY injection is missed and the next scheduled dose is: o More than 2 days away, administer WEGOVY injection as soon as possible. o Less than 2 days away do not administer the WEGOVY injection dose. Resume dosing on the regularly scheduled day of the week. • If 2 or more consecutive doses of WEGOVY injection are missed, resume dosing as scheduled or, if needed, reinitiate WEGOVY injection and follow the dosage escalation schedule, which may reduce the occurrence of gastrointestinal adverse reactions associated with reinitiation of treatment [see Dosage and Administration ( 2.2 )]. WEGOVY Tablets If a dose of WEGOVY tablets is missed, skip the missed dose and take the next dose the following day. 2.5 Switching Between WEGOVY Injection and WEGOVY Tablets Switching from WEGOVY Injection to WEGOVY Tablets • Patients taking WEGOVY 2.4 mg injection for cardiovascular risk reduction or weight reduction in adults may switch to WEGOVY 25 mg tablets. • One week after discontinuing WEGOVY 2.4 mg injection, initiate 25 mg of WEGOVY tablets orally once daily. Switching from WEGOVY Tablets to WEGOVY Injection • Patients may switch from WEGOVY 25 mg tablets to WEGOVY injection. • The day after discontinuing WEGOVY tablets 25 mg once daily, initiate WEGOVY 2.4 mg subcutaneous injection once weekly. For patients who do not tolerate WEGOVY 25 mg tablets, consider switching to WEGOVY 1.7 mg injection. • If additional weight reduction is needed in patients with type 2 diabetes mellitus treated with WEGOVY 25 mg tablets, consider switching to WEGOVY 1.7 mg injection and follow the recommended dosage escalation for WEGOVY injection [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )].

See official label

1 INDICATIONS AND USAGE 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.