Mounjaro vs ZEPBOUND

Full label qualifications: 1 INDICATIONS AND USAGE MOUNJARO ® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 ) to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 ) Selected products: Mounjaro — 0002-1506; Mounjaro — 0002-1495; Mounjaro — 0002-1484; Mounjaro — 0002-1471; Mounjaro — 0002-1460; Mounjaro — 0002-1457; Mounjaro — 0002-1152; Mounjaro — 0002-1243; Mounjaro — 0002-2214; Mounjaro — 0002-2340; Mounjaro — 0002-2423; Mounjaro — 0002-3002; Mounjaro — 0002-4052; Mounjaro — 0002-4103; Mounjaro — 0002-4210; Mounjaro — 0002-4304; Mounjaro — 0002-4523; Mounjaro — 0002-4612; Mounjaro KwikPen — 0002-3466; Mounjaro KwikPen — 0002-3455; Mounjaro KwikPen — 0002-3444; Mounjaro KwikPen — 0002-3433; Mounjaro KwikPen — 0002-3422; Mounjaro KwikPen — 0002-3411 Form scope: INJECTION, SOLUTION Formulation qualification: 2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or have another person inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to the Full Prescribing Information for additional important administration instructions about MOUNJARO presentations. ( 2.2 ) 2.1 Recommended Dosage Follow the starting dosage recommendation and dosage escalation schedule below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )]. Recommended Starting Dosage and Escalation The recommended starting dosage of MOUNJARO is 2.5 mg injected subcutaneously once weekly [see Dosage and Administration ( 2.2 )] . If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. The maximum dosage of MOUNJARO is: 15 mg injected subcutaneously once weekly in adults. 10 mg injected subcutaneously once weekly in pediatric patients. Recommendations Regarding Missed Doses If a dose is missed, instruct patients to administer MOUNJARO 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). 2.2 Important Administration Instructions Inform patients and their caregiver(s) which MOUNJARO presentation (e.g., vial, pre-filled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed MOUNJARO 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 MOUNJARO presentation [see Instructions for Use] . After training, a patient may self-inject MOUNJARO if the healthcare provider determines that it can be properly administered, except for the following: MOUNJARO KwikPen is not recommended for self-administration by pediatric patients. MOUNJARO KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using MOUNJARO 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. Administer MOUNJARO once weekly, any time of day, with or without meals. Inject MOUNJARO subcutaneously in the abdomen, thigh, or have another person inject MOUNJARO in the back of the upper arm. Rotate injection sites with each dose. Inspect MOUNJARO visually before use. It should appear clear and colorless to slightly yellow. Do not use MOUNJARO if particulate matter or discoloration is seen. When using MOUNJARO with insulin, administer as separate injections and never mix. It is acceptable to inject MOUNJARO and insulin in the same body region, but the injections should not be adjacent to each other. Full label qualifications: 1 INDICATIONS AND USAGE MOUNJARO ® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 ) to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 ) Selected products: Mounjaro — 0002-1506; Mounjaro — 0002-1495; Mounjaro — 0002-1484; Mounjaro — 0002-1471; Mounjaro — 0002-1460; Mounjaro — 0002-1457; Mounjaro — 0002-1152; Mounjaro — 0002-1243; Mounjaro — 0002-2214; Mounjaro — 0002-2340; Mounjaro — 0002-2423; Mounjaro — 0002-3002; Mounjaro — 0002-4052; Mounjaro — 0002-4103; Mounjaro — 0002-4210; Mounjaro — 0002-4304; Mounjaro — 0002-4523; Mounjaro — 0002-4612; Mounjaro KwikPen — 0002-3466; Mounjaro KwikPen — 0002-3455; Mounjaro KwikPen — 0002-3444; Mounjaro KwikPen — 0002-3433; Mounjaro KwikPen — 0002-3422; Mounjaro KwikPen — 0002-3411 Form scope: INJECTION, SOLUTION Formulation qualification: 2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or have another person inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to the Full Prescribing Information for additional important administration instructions about MOUNJARO presentations. ( 2.2 ) 2.1 Recommended Dosage Follow the starting dosage recommendation and dosage escalation schedule below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.1 )]. Recommended Starting Dosage and Escalation The recommended starting dosage of MOUNJARO is 2.5 mg injected subcutaneously once weekly [see Dosage and Administration ( 2.2 )] . If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. The maximum dosage of MOUNJARO is: 15 mg injected subcutaneously once weekly in adults. 10 mg injected subcutaneously once weekly in pediatric patients. Recommendations Regarding Missed Doses If a dose is missed, instruct patients to administer MOUNJARO 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). 2.2 Important Administration Instructions Inform patients and their caregiver(s) which MOUNJARO presentation (e.g., vial, pre-filled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed MOUNJARO 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 MOUNJARO presentation [see Instructions for Use] . After training, a patient may self-inject MOUNJARO if the healthcare provider determines that it can be properly administered, except for the following: MOUNJARO KwikPen is not recommended for self-administration by pediatric patients. MOUNJARO KwikPen is not recommended for self-administration by those who are visually impaired. Instruct patients using MOUNJARO 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. Administer MOUNJARO once weekly, any time of day, with or without meals. Inject MOUNJARO subcutaneously in the abdomen, thigh, or have another person inject MOUNJARO in the back of the upper arm. Rotate injection sites with each dose. Inspect MOUNJARO visually before use. It should appear clear and colorless to slightly yellow. Do not use MOUNJARO if particulate matter or discoloration is seen. When using MOUNJARO with insulin, administer as separate injections and never mix. It is acceptable to inject MOUNJARO and insulin in the same body region, but the injections should not be adjacent to each other.

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.

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

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