Mounjaro and Xultophy Comparison

Mounjaro®(tirzepatide)	Xultophy®(insulin degludec / liraglutide)
Prescription Only Mounjaro (tirzepatide) is prescribed for adults with type 2 diabetes to effectively lower blood sugar levels (blood glucose). Administered as a once-weekly injection, Mounjaro is...	Prescription Only Xultophy is an injection pen combining insulin degludec and liraglutide. Insulin degludec provides long-acting glucose control, while liraglutide assists in regulating blood...
Administration
Subcutaneous . Learn more.	Subcutaneous. Learn more.
Dosing
2.5 mg injected subcutaneously once weekly * After 4 weeks, increase to 5 mg injected SC once weekly Increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. if needed. Max dosage is 15 mg weekly.. Learn more.	Administer XULTOPHY® 100/3.6 by subcutaneous injection once-daily at the same time each day with or without food. See complete table for starting dose and titration schedule in the PI.. Learn more.
Latin Shorthand
Start: 2.5 mg SC weekly Wk 4: Increase to 5 mg SC weekly If more control needed, ↑ by 2.5 mg after ≥4 wks Max: 15 mg SC weekly Weekly dosing, any time, w/wo meals SC injection: abd, thigh, upper arm. Learn more.	Administer XULTOPHY® 100/3.6 by SC injection qd at the same time each day with or without food.. Learn more.
Out-Of-Pocket Costs With Copay Card
$25. Learn more.	Insurance Specific Copay. Learn more.
Annual Cap
$1800. Learn more.	Learn more.
Assistance Expiration
12/31/2023. Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are: nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.. Learn more.	• Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection. • Immunogenicity-related events, including urticaria, were more common among liraglutide-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.
Mechanism of Actions (MoA)
GLP-1 Receptor Agonists. Learn more.	GLP-1 Receptor Agonists. Learn more.
Special Populations
What are the risks associated with MOUNJARO use during pregnancy? Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data). The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. What are the clinical considerations regarding pregnancy and MOUNJARO use? Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. What animal data is available regarding MOUNJARO use during pregnancy? In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide (0.03-, 0.07-, and 0.5-fold the MRHD of 15 mg once weekly based on AUC) during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg. In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically-mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F1 pups from F0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females. What are the risks associated with MOUNJARO use during lactation? There are no data on the presence of tirzepatide in animal or human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MOUNJARO and any potential adverse effects on the breastfed infant from MOUNJARO or from the underlying maternal condition. How does MOUNJARO use affect oral hormonal contraceptives? Use of MOUNJARO may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with MOUNJARO. Is MOUNJARO safe and effective for pediatric patients? Safety and effectiveness of MOUNJARO have not been established in pediatric patients (younger than 18 years of age). Are there age-related differences in MOUNJARO use for geriatric patients? In the pool of seven clinical trials, 1539 (30.1%) MOUNJARO-treated patients were 65 years of age or older, and 212 (4.1%) MOUNJARO-treated patients were 75 years of age or older at baseline. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Is dosage adjustment necessary for patients with renal impairment using MOUNJARO? No dosage adjustment of MOUNJARO is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in tirzepatide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function when initiating or escalating doses of MOUNJARO in patients with renal impairment reporting severe adverse gastrointestinal reactions. Is dosage adjustment necessary for patients with hepatic impairment using MOUNJARO? No dosage adjustment of MOUNJARO is recommended for patients with hepatic impairment. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide PK was observed.	Is there a risk to the fetus from exposure to liraglutide during pregnancy? Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. XULTOPHY® 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Are there available data on the use of XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women? There are no available data with XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy. What are the findings from animal reproduction studies for insulin degludec during pregnancy? For insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. No adverse outcomes were observed for pregnant animals and offspring. What are the findings from animal reproduction studies for liraglutide during pregnancy? For liraglutide, animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day. What is the estimated background risk of major birth defects and miscarriage in the general population and in women with pre-gestational diabetes? In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA1c >10. What are the disease-associated maternal and/or embryo/fetal risks related to poorly controlled diabetes in pregnancy? Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. Are there data on the presence of liraglutide or insulin degludec in human milk, their effects on the breastfed infant, or effects on milk production? There are no data on the presence of liraglutide or insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. In lactating rats, insulin degludec and liraglutide, the two components of XULTOPHY® 100/3.6, were present in milk. What are the safety and effectiveness considerations for pediatric use of XULTOPHY® 100/3.6? Safety and effectiveness of XULTOPHY® 100/3.6 have not been established in pediatric patients. Are there age-related differences in safety and effectiveness for geriatric patients using XULTOPHY® 100/3.6? No overall differences in safety or effectiveness of XULTOPHY® 100/3.6 were observed between patients 65 years of age and older and younger patients. Age had no clinically relevant effect on the pharmacokinetics of XULTOPHY® 100/3.6. What are the considerations for XULTOPHY® 100/3.6 use in patients with renal impairment? There is limited experience with XULTOPHY® 100/3.6 in patients with mild and moderate kidney impairment and when used in these patients, additional glucose monitoring and XULTOPHY® 100/3.6 dose adjustments may be required on an individual basis. XULTOPHY® 100/3.6 has not been studied in patients with severe kidney impairment. Are there any differences in insulin degludec pharmacokinetics in patients with kidney impairment? No clinically relevant difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with kidney impairment, including subjects with end stage kidney disease. What is the effect of liraglutide on kidney impairment? The safety and efficacy of liraglutide was evaluated in a 26-week clinical study that included patients with moderate kidney impairment. There is limited experience with liraglutide in patients with end stage kidney disease. Are there considerations for XULTOPHY® 100/3.6 use in patients with hepatic impairment? XULTOPHY® 100/3.6 has not been studied in patients with hepatic impairment. Are there any differences in insulin degludec pharmacokinetics in patients with hepatic impairment? No clinically relevant difference in the pharmacokinetics of insulin degludec, one of the components of XULTOPHY® 100/3.6, was identified in a study comparing healthy subjects and subjects with hepatic impairment. What is the effect of liraglutide on hepatic impairment? There is limited experience in patients with mild, moderate, or severe hepatic impairment with liraglutide, one of the components of XULTOPHY® 100/3.6. Does liraglutide, a component of XULTOPHY® 100/3.6, have an impact on gastric emptying? Liraglutide, one of the components of XULTOPHY® 100/3.6, slows gastric emptying. XULTOPHY® 100/3.6 has not been studied in patients with pre-existing gastroparesis.

Mounjaro®(tirzepatide)

Xultophy®(insulin degludec / liraglutide)

Prescription Only

Mounjaro (tirzepatide) is prescribed for adults with type 2 diabetes to effectively lower blood sugar levels (blood glucose). Administered as a once-weekly injection, Mounjaro is...

Prescription Only

Xultophy is an injection pen combining insulin degludec and liraglutide. Insulin degludec provides long-acting glucose control, while liraglutide assists in regulating blood...

Dosage & Administration

Administration

Subcutaneous . Learn more.

Subcutaneous. Learn more.

Dosing

2.5 mg injected subcutaneously once weekly * After 4 weeks, increase to 5 mg injected SC once weekly *Increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. if needed. * Max dosage is 15 mg weekly.. Learn more.

Administer XULTOPHY® 100/3.6 by subcutaneous injection once-daily at the same time each day with or without food. See complete table for starting dose and titration schedule in the PI.. Learn more.

Latin Shorthand

Start: 2.5 mg SC weekly Wk 4: Increase to 5 mg SC weekly If more control needed, ↑ by 2.5 mg after ≥4 wks Max: 15 mg SC weekly Weekly dosing, any time, w/wo meals SC injection: abd, thigh, upper arm. Learn more.

Administer XULTOPHY® 100/3.6 by SC injection qd at the same time each day with or without food.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$25. Learn more.

Insurance Specific Copay. Learn more.

Annual Cap

$1800. Learn more.

Learn more.

Assistance Expiration

12/31/2023. Learn more.

Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are: nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.. Learn more.

• Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection. • Immunogenicity-related events, including urticaria, were more common among liraglutide-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.. Learn more.

Mechanism of Actions (MoA)

GLP-1 Receptor Agonists. Learn more.

Special Populations

What are the risks associated with MOUNJARO use during pregnancy?

Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. MOUNJARO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data). The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

What are the clinical considerations regarding pregnancy and MOUNJARO use?

Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

What animal data is available regarding MOUNJARO use during pregnancy?

In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide (0.03-, 0.07-, and 0.5-fold the MRHD of 15 mg once weekly based on AUC) during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg. In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically-mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F1 pups from F0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females.

What are the risks associated with MOUNJARO use during lactation?

There are no data on the presence of tirzepatide in animal or human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MOUNJARO and any potential adverse effects on the breastfed infant from MOUNJARO or from the underlying maternal condition.

How does MOUNJARO use affect oral hormonal contraceptives?

Use of MOUNJARO may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation with MOUNJARO.

Is MOUNJARO safe and effective for pediatric patients?

Safety and effectiveness of MOUNJARO have not been established in pediatric patients (younger than 18 years of age).

Are there age-related differences in MOUNJARO use for geriatric patients?

In the pool of seven clinical trials, 1539 (30.1%) MOUNJARO-treated patients were 65 years of age or older, and 212 (4.1%) MOUNJARO-treated patients were 75 years of age or older at baseline. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Is dosage adjustment necessary for patients with renal impairment using MOUNJARO?

No dosage adjustment of MOUNJARO is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in tirzepatide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function when initiating or escalating doses of MOUNJARO in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Is dosage adjustment necessary for patients with hepatic impairment using MOUNJARO?

No dosage adjustment of MOUNJARO is recommended for patients with hepatic impairment. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide PK was observed.

Is there a risk to the fetus from exposure to liraglutide during pregnancy?

Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. XULTOPHY® 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Are there available data on the use of XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women?

There are no available data with XULTOPHY® 100/3.6, insulin degludec, or liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy.

What are the findings from animal reproduction studies for insulin degludec during pregnancy?

For insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 U/kg/day. No adverse outcomes were observed for pregnant animals and offspring.

What are the findings from animal reproduction studies for liraglutide during pregnancy?

For liraglutide, animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day.

What is the estimated background risk of major birth defects and miscarriage in the general population and in women with pre-gestational diabetes?

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20 to 25% in women with a peri-conceptional HbA1c >10.

What are the disease-associated maternal and/or embryo/fetal risks related to poorly controlled diabetes in pregnancy?

Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

Are there data on the presence of liraglutide or insulin degludec in human milk, their effects on the breastfed infant, or effects on milk production?

There are no data on the presence of liraglutide or insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production. In lactating rats, insulin degludec and liraglutide, the two components of XULTOPHY® 100/3.6, were present in milk.

What are the safety and effectiveness considerations for pediatric use of XULTOPHY® 100/3.6?

Safety and effectiveness of XULTOPHY® 100/3.6 have not been established in pediatric patients.

Are there age-related differences in safety and effectiveness for geriatric patients using XULTOPHY® 100/3.6?

No overall differences in safety or effectiveness of XULTOPHY® 100/3.6 were observed between patients 65 years of age and older and younger patients. Age had no clinically relevant effect on the pharmacokinetics of XULTOPHY® 100/3.6.

What are the considerations for XULTOPHY® 100/3.6 use in patients with renal impairment?

There is limited experience with XULTOPHY® 100/3.6 in patients with mild and moderate kidney impairment and when used in these patients, additional glucose monitoring and XULTOPHY® 100/3.6 dose adjustments may be required on an individual basis. XULTOPHY® 100/3.6 has not been studied in patients with severe kidney impairment.

Are there any differences in insulin degludec pharmacokinetics in patients with kidney impairment?

No clinically relevant difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with kidney impairment, including subjects with end stage kidney disease.

What is the effect of liraglutide on kidney impairment?

The safety and efficacy of liraglutide was evaluated in a 26-week clinical study that included patients with moderate kidney impairment. There is limited experience with liraglutide in patients with end stage kidney disease.

Are there considerations for XULTOPHY® 100/3.6 use in patients with hepatic impairment?

XULTOPHY® 100/3.6 has not been studied in patients with hepatic impairment.

Are there any differences in insulin degludec pharmacokinetics in patients with hepatic impairment?

No clinically relevant difference in the pharmacokinetics of insulin degludec, one of the components of XULTOPHY® 100/3.6, was identified in a study comparing healthy subjects and subjects with hepatic impairment.

What is the effect of liraglutide on hepatic impairment?

There is limited experience in patients with mild, moderate, or severe hepatic impairment with liraglutide, one of the components of XULTOPHY® 100/3.6.

Does liraglutide, a component of XULTOPHY® 100/3.6, have an impact on gastric emptying?

Liraglutide, one of the components of XULTOPHY® 100/3.6, slows gastric emptying. XULTOPHY® 100/3.6 has not been studied in patients with pre-existing gastroparesis.

Mounjaro® Alternatives