WEGOVY vs ZEPBOUND

Full label qualifications: 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. • 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. • 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. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. 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. ( 1 ) • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • 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. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) 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. ( 1 ) • 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. ( 1 ) 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. ( 1 ) Selected products: WEGOVY — 0169-4525; WEGOVY — 0169-4505; WEGOVY — 0169-4501; WEGOVY — 0169-4517; WEGOVY — 0169-4524; WEGOVY — 0169-4572; WEGOVY — 0169-1602; WEGOVY — 0169-1605; WEGOVY — 0169-1610; WEGOVY — 0169-1617; WEGOVY — 0169-1624; WEGOVY — 0169-4915 Form scope: INJECTION, SOLUTION Formulation qualification: 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 • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • 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. • Rotate injection sites with each dose. 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. • Do not take more than one tablet per day. • 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), 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 )] . 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, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Adverse Reactions (6.1)]. 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 )]. Label table context (read with the full qualifications): | 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) Label table context (read with the full qualifications): | 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 Full label qualifications: 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. • 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. • 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. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. 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. ( 1 ) • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • 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. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) 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. ( 1 ) • 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. ( 1 ) 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. ( 1 ) Selected products: WEGOVY — 0169-4525; WEGOVY — 0169-4505; WEGOVY — 0169-4501; WEGOVY — 0169-4517; WEGOVY — 0169-4524; WEGOVY — 0169-4572; WEGOVY — 0169-1602; WEGOVY — 0169-1605; WEGOVY — 0169-1610; WEGOVY — 0169-1617; WEGOVY — 0169-1624; WEGOVY — 0169-4915 Form scope: INJECTION, SOLUTION Formulation qualification: 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 • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • 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. • Rotate injection sites with each dose. 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. • Do not take more than one tablet per day. • 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), 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 )] . 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, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Adverse Reactions (6.1)]. 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 )]. Label table context (read with the full qualifications): | 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) Label table context (read with the full qualifications): | 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 Full label qualifications: 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. • 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. • 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. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. 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. ( 1 ) • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • 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. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) 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. ( 1 ) • 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. ( 1 ) 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. ( 1 ) Selected products: WEGOVY — 0169-4525; WEGOVY — 0169-4505; WEGOVY — 0169-4501; WEGOVY — 0169-4517; WEGOVY — 0169-4524; WEGOVY — 0169-4572; WEGOVY — 0169-1602; WEGOVY — 0169-1605; WEGOVY — 0169-1610; WEGOVY — 0169-1617; WEGOVY — 0169-1624; WEGOVY — 0169-4915 Form scope: INJECTION, SOLUTION Formulation qualification: 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 • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • 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. • Rotate injection sites with each dose. 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. • Do not take more than one tablet per day. • 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), 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 )] . 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, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Adverse Reactions (6.1)]. 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 )]. Label table context (read with the full qualifications): | 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) Label table context (read with the full qualifications): | 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 Full label qualifications: 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. • 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. • 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. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. 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. ( 1 ) • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • 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. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) 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. ( 1 ) • 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. ( 1 ) 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. ( 1 ) Selected products: WEGOVY — 0169-4404; WEGOVY — 0169-4415; WEGOVY — 0169-4409; WEGOVY — 0169-4425 Form scope: TABLET Formulation qualification: 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 • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • 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. • Rotate injection sites with each dose. 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. • Do not take more than one tablet per day. • 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), 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 )] . 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, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Adverse Reactions (6.1)]. 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 )]. Label table context (read with the full qualifications): | 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) Label table context (read with the full qualifications): | 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 Full label qualifications: 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. • 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. • 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. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist. 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. ( 1 ) • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. ( 1 ) o adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) • 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. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. ( 1 ) 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. ( 1 ) • 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. ( 1 ) 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. ( 1 ) Selected products: WEGOVY — 0169-4404; WEGOVY — 0169-4415; WEGOVY — 0169-4409; WEGOVY — 0169-4425 Form scope: TABLET Formulation qualification: 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 • Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. • Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired. • 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. • Rotate injection sites with each dose. 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. • Do not take more than one tablet per day. • 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), 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 )] . 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, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Adverse Reactions (6.1)]. 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 )]. Label table context (read with the full qualifications): | 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) Label table context (read with the full qualifications): | 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

Full label qualifications: 1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with 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 in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with 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 in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. Selected products: ZEPBOUND — 0002-2506; ZEPBOUND — 0002-2495; ZEPBOUND — 0002-2484; ZEPBOUND — 0002-2471; ZEPBOUND — 0002-2460; ZEPBOUND — 0002-2457; Zepbound — 0002-0152; Zepbound — 0002-0243; Zepbound — 0002-1214; Zepbound — 0002-1340; Zepbound — 0002-1423; Zepbound — 0002-2002; Zepbound — 0002-6052; Zepbound — 0002-6103; Zepbound — 0002-6210; Zepbound — 0002-6304; Zepbound — 0002-6523; Zepbound — 0002-6612; Zepbound KwikPen — 0002-3566; Zepbound KwikPen — 0002-3555; Zepbound KwikPen — 0002-3544; Zepbound KwikPen — 0002-3533; Zepbound KwikPen — 0002-3522; Zepbound KwikPen — 0002-3511 Form scope: INJECTION, SOLUTION Formulation qualification: 2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 ) 2.1 Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration ( 2.2 )] . Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage. 2.2 Recommended Maintenance and Maximum Dosage Recommended Maintenance Dosage Weight Reduction and Long-Term Maintenance The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg, injected subcutaneously once weekly. OSA The recommended maintenance dosage is 10 mg or 15 mg injected subcutaneously once weekly. Maximum Recommended Dosage The maximum dosage of ZEPBOUND for all indications is 15 mg injected subcutaneously once weekly. 2.3 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours). 2.4 Important Administration Instructions Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use ] . After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following: ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection. Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen. Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity. Administer ZEPBOUND once weekly at any time of day, with or without meals. Inject ZEPBOUND subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. Full label qualifications: 1 INDICATIONS AND USAGE ZEPBOUND ® is indicated in combination with 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 in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with 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 in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. Selected products: ZEPBOUND — 0002-2506; ZEPBOUND — 0002-2495; ZEPBOUND — 0002-2484; ZEPBOUND — 0002-2471; ZEPBOUND — 0002-2460; ZEPBOUND — 0002-2457; Zepbound — 0002-0152; Zepbound — 0002-0243; Zepbound — 0002-1214; Zepbound — 0002-1340; Zepbound — 0002-1423; Zepbound — 0002-2002; Zepbound — 0002-6052; Zepbound — 0002-6103; Zepbound — 0002-6210; Zepbound — 0002-6304; Zepbound — 0002-6523; Zepbound — 0002-6612; Zepbound KwikPen — 0002-3566; Zepbound KwikPen — 0002-3555; Zepbound KwikPen — 0002-3544; Zepbound KwikPen — 0002-3533; Zepbound KwikPen — 0002-3522; Zepbound KwikPen — 0002-3511 Form scope: INJECTION, SOLUTION Formulation qualification: 2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4 ) 2.1 Recommended Dose Escalation Schedule The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks. The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage. Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] . After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration ( 2.2 )] . Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage. 2.2 Recommended Maintenance and Maximum Dosage Recommended Maintenance Dosage Weight Reduction and Long-Term Maintenance The recommended maintenance dosage is 5 mg, 10 mg, or 15 mg, injected subcutaneously once weekly. OSA The recommended maintenance dosage is 10 mg or 15 mg injected subcutaneously once weekly. Maximum Recommended Dosage The maximum dosage of ZEPBOUND for all indications is 15 mg injected subcutaneously once weekly. 2.3 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours). 2.4 Important Administration Instructions Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation. Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use ] . After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following: ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection. Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen. Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity. Administer ZEPBOUND once weekly at any time of day, with or without meals. Inject ZEPBOUND subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose.

SEMAGLUTIDE: 0.25 mg / 0.5 mL; SEMAGLUTIDE: 0.5 mg / 0.5 mL; SEMAGLUTIDE: 1.0 mg / 0.5 mL; SEMAGLUTIDE: 1.7 mg / 0.75 mL; SEMAGLUTIDE: 2.4 mg / 0.75 mL; SEMAGLUTIDE: 7.2 mg / 0.75 mL; SEMAGLUTIDE: 0.5 mg / 1 mL; SEMAGLUTIDE: 1 mg / 1 mL; SEMAGLUTIDE: 2 mg / 1 mL; SEMAGLUTIDE: 2.27 mg / 1 mL; SEMAGLUTIDE: 3.2 mg / 1 mL; SEMAGLUTIDE: 4 mg / 1 1; SEMAGLUTIDE: 1.5 mg / 1 1; SEMAGLUTIDE: 9 mg / 1 1; SEMAGLUTIDE: 25 mg / 1 1

tirzepatide: 2.5 mg / 0.5 mL; tirzepatide: 5 mg / 0.5 mL; tirzepatide: 7.5 mg / 0.5 mL; tirzepatide: 10 mg / 0.5 mL; tirzepatide: 12.5 mg / 0.5 mL; tirzepatide: 15 mg / 0.5 mL; tirzepatide: 4.17 mg / 1 mL; tirzepatide: 8.33 mg / 1 mL; tirzepatide: 12.5 mg / 1 mL; tirzepatide: 16.7 mg / 1 mL; tirzepatide: 20.8 mg / 1 mL; tirzepatide: 25 mg / 1 mL