Wegovy

Question 1

What is the Pregnancy Exposure Registry for Semaglutide (Wegovy)?

Accepted Answer

The Pregnancy Exposure Registry monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women or healthcare providers can contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.

Question 2

What risks are associated with using Wegovy (semaglutide) during pregnancy?

Accepted Answer

Animal studies suggest potential risks to the fetus from semaglutide exposure during pregnancy. Weight loss, induced by Wegovy, offers no benefit during pregnancy and may lead to fetal harm. When pregnancy is identified, patients are advised of the potential fetal risk, and Wegovy treatment is discontinued.

Question 3

What are the known risks of birth defects or miscarriage with Wegovy use during pregnancy?

Accepted Answer

The available data from pharmacovigilance and clinical trials on Wegovy's use in pregnant patients are insufficient to establish its association with major birth defects, miscarriage, or adverse maternal/fetal outcomes. The estimated background risk for major birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively.

Question 4

How does Semaglutide (Wegovy) affect pregnant animals in studies?

Accepted Answer

Studies on pregnant rats, rabbits, and monkeys show that semaglutide exposure during organogenesis caused embryofetal mortality, structural abnormalities, and altered growth at doses below the recommended human dose. In monkeys and rabbits, there were early pregnancy losses and structural abnormalities observed at doses below or equal to the recommended human dose.

Question 5

What clinical considerations are advised for pregnant patients using Wegovy?

Accepted Answer

Pregnant patients, including those with overweight or obesity, should aim for appropriate weight gain due to the necessary weight gain during pregnancy. Wegovy should be discontinued upon pregnancy recognition due to the potential risks to both the mother and fetus.

Question 6

Are there any data on Semaglutide (Wegovy) in lactating mothers?

Accepted Answer

There is no data available on semaglutide or its metabolites in human milk. However, semaglutide was found in the milk of lactating rats. When drugs are present in animal milk, they're likely to be present in human milk.

Question 7

What recommendations are provided for females and males of reproductive potential using Wegovy?

Accepted Answer

To prevent potential fetal harm, discontinue Wegovy in patients planning pregnancy at least 2 months before conception, considering semaglutide's long half-life.

Question 8

Is Wegovy (Semaglutide) safe and effective for pediatric use?

Accepted Answer

Wegovy is deemed safe and effective as an adjunct to a reduced-calorie diet and increased physical activity in pediatric patients aged 12 years and older with a BMI corresponding to ≥95th percentile. However, its safety for children less than 12 years old or with type 2 diabetes is not established.

Question 9

How is Wegovy (Semaglutide) used in geriatric patients?

Accepted Answer

In clinical trials, no notable differences in safety or effectiveness were observed between patients aged 65 and older and younger adults.

Question 10

Does renal or hepatic impairment require dosage adjustments for Wegovy (Semaglutide)?

Accepted Answer

No dosage adjustments are recommended for patients with renal or hepatic impairment based on clinical studies that showed no significant changes in semaglutide pharmacokinetics in these conditions.

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