Ozempic

Question 1

What is the risk of using OZEMPIC® during pregnancy?

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

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

Accepted Answer

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.

Question 6

What is known about semaglutide exposure during lactation?

Accepted Answer

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.

Question 7

Should OZEMPIC® be discontinued in women planning a pregnancy?

Accepted Answer

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

Question 8

Is OZEMPIC® safe for pediatric use?

Accepted Answer

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

Question 9

Is OZEMPIC® safe for geriatric use?

Accepted Answer

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.

Question 10

Is OZEMPIC® safe for patients with renal impairment?

Accepted Answer

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.

Question 11

Is OZEMPIC® safe for patients with hepatic impairment?

Accepted Answer

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.