Ozempic and Xultophy Comparison

Ozempic®(semaglutide)	Xultophy®(insulin degludec / liraglutide)
Prescription Only Ozempic (semaglutide) is a once-weekly injection that helps improve blood sugar levels in adults with type 2 diabetes mellitus. It also reduces the risk of major cardiovascular...	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
0.25 mg SC injection q/week for 4 weeks. After 4 weeks, increase to 0.5 mg SC q/week. • If more control needed after 4 weeks on 0.5 mg, increase to 1 mg SC q/week • If further control needed after 4 weeks on 1 mg, increase to 2 mg SC q/week (max dose). . 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
0.25 mg SC injection q/week for 4 weeks. After 4 weeks, increase to 0.5 mg SC q/week. • If more control needed after 4 weeks on 0.5 mg, increase to 1 mg SC q/week • If further control needed after 4 weeks on 1 mg, increase to 2 mg SC q/week (max dose). . 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
$150 for 1 month supply; $300 for 2 month supply; $450 for 3 month supply. Learn more.	Learn more.
Assistance Expiration
24 months. 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 OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.. 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 is the risk of using OZEMPIC® during pregnancy? Limited data exist on the use of semaglutide in pregnant women, making it challenging to determine the potential drug-associated risk for adverse developmental outcomes. Poorly controlled diabetes during pregnancy poses risks for both the mother and fetus. OZEMPIC® should be used during pregnancy only if the potential benefits outweigh the potential risks. What are the potential risks to the fetus from exposure to semaglutide during pregnancy? Based on animal studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. In pregnant rats, exposure to semaglutide during organogenesis led to embryofetal mortality, structural abnormalities, and growth alterations. Similar findings were observed in rabbits and cynomolgus monkeys. What is the estimated background risk of birth defects and miscarriage in pregnant women? 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. For women with pre-gestational diabetes, the estimated background risk of major birth defects is 6 to 10% with a peri-conceptional HbA1c >7 and can be as high as 20 to 25% with a peri-conceptional HbA1c >10. What are the disease-associated risks for pregnant women with poorly controlled diabetes? Poorly controlled diabetes during pregnancy increases the risk of hypoglycemia, hyperglycemia, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. It also increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. What do the animal data reveal about the effects of semaglutide exposure during pregnancy? Animal data indicate that exposure to semaglutide during pregnancy in rats, rabbits, and cynomolgus monkeys can result in embryofetal mortality, structural abnormalities, and alterations in growth. These effects were observed at various dose levels and exposures in different animal species. What is known about semaglutide exposure during lactation? There is no information available regarding the presence of semaglutide in human milk or its effects on breastfed infants or milk production. Semaglutide was detected in the milk of lactating rats, but the clinical relevance of these findings is not clear. Should OZEMPIC® be discontinued in women planning a pregnancy? OZEMPIC® should be discontinued in women at least 2 months before planning a pregnancy due to the long washout period required for semaglutide. Is OZEMPIC® safe for pediatric use? Safety and efficacy of OZEMPIC® have not been established in pediatric patients (younger than 18 years). Is OZEMPIC® safe for geriatric use? No overall differences in safety or efficacy have been detected between older and younger patients in clinical trials. However, caution should be exercised in geriatric patients. Is OZEMPIC® safe for patients with renal impairment? No dose adjustment of OZEMPIC® is recommended for patients with renal impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with renal impairment, including end-stage renal disease. Is OZEMPIC® safe for patients with hepatic impairment? No dose adjustment of OZEMPIC® is recommended for patients with hepatic impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with varying degrees of hepatic impairment.	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.

Ozempic®(semaglutide)

Xultophy®(insulin degludec / liraglutide)

Prescription Only

Ozempic (semaglutide) is a once-weekly injection that helps improve blood sugar levels in adults with type 2 diabetes mellitus. It also reduces the risk of major cardiovascular...

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.

Dosing

0.25 mg SC injection q/week for 4 weeks. After 4 weeks, increase to 0.5 mg SC q/week. • If more control needed after 4 weeks on 0.5 mg, increase to 1 mg SC q/week • If further control needed after 4 weeks on 1 mg, increase to 2 mg SC q/week (max dose). . 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

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

$150 for 1 month supply; $300 for 2 month supply; $450 for 3 month supply. Learn more.

Learn more.

Assistance Expiration

24 months. 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 OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.. 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 is the risk of using OZEMPIC® during pregnancy?

Limited data exist on the use of semaglutide in pregnant women, making it challenging to determine the potential drug-associated risk for adverse developmental outcomes. Poorly controlled diabetes during pregnancy poses risks for both the mother and fetus. OZEMPIC® should be used during pregnancy only if the potential benefits outweigh the potential risks.

What are the potential risks to the fetus from exposure to semaglutide during pregnancy?

Based on animal studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. In pregnant rats, exposure to semaglutide during organogenesis led to embryofetal mortality, structural abnormalities, and growth alterations. Similar findings were observed in rabbits and cynomolgus monkeys.

What is the estimated background risk of birth defects and miscarriage in pregnant women?

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. For women with pre-gestational diabetes, the estimated background risk of major birth defects is 6 to 10% with a peri-conceptional HbA1c >7 and can be as high as 20 to 25% with a peri-conceptional HbA1c >10.

What are the disease-associated risks for pregnant women with poorly controlled diabetes?

Poorly controlled diabetes during pregnancy increases the risk of hypoglycemia, hyperglycemia, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. It also increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

What do the animal data reveal about the effects of semaglutide exposure during pregnancy?

Animal data indicate that exposure to semaglutide during pregnancy in rats, rabbits, and cynomolgus monkeys can result in embryofetal mortality, structural abnormalities, and alterations in growth. These effects were observed at various dose levels and exposures in different animal species.

What is known about semaglutide exposure during lactation?

There is no information available regarding the presence of semaglutide in human milk or its effects on breastfed infants or milk production. Semaglutide was detected in the milk of lactating rats, but the clinical relevance of these findings is not clear.

Should OZEMPIC® be discontinued in women planning a pregnancy?

OZEMPIC® should be discontinued in women at least 2 months before planning a pregnancy due to the long washout period required for semaglutide.

Is OZEMPIC® safe for pediatric use?

Safety and efficacy of OZEMPIC® have not been established in pediatric patients (younger than 18 years).

Is OZEMPIC® safe for geriatric use?

No overall differences in safety or efficacy have been detected between older and younger patients in clinical trials. However, caution should be exercised in geriatric patients.

Is OZEMPIC® safe for patients with renal impairment?

No dose adjustment of OZEMPIC® is recommended for patients with renal impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with renal impairment, including end-stage renal disease.

Is OZEMPIC® safe for patients with hepatic impairment?

No dose adjustment of OZEMPIC® is recommended for patients with hepatic impairment. Semaglutide pharmacokinetics have not shown clinically relevant changes in subjects with varying degrees of hepatic impairment.

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.

Ozempic® Alternatives