Victoza

Question 1

What are the considerations regarding the use of VICTOZA® during pregnancy?

Accepted Answer

Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA® during pregnancy. VICTOZA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. The estimated background risk of major birth defects for women with uncontrolled pre-gestational diabetes is 6 to 10%. Clinical considerations include the increased risk of maternal and fetal complications associated with poorly controlled diabetes.

Question 2

What are the considerations regarding the use of VICTOZA® during lactation?

Accepted Answer

There are no data on the presence of VICTOZA® in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in the milk of lactating rats. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VICTOZA® and any potential adverse effects on the breastfed infant from VICTOZA® or from the underlying maternal condition.

Question 3

What is known about the safety and effectiveness of VICTOZA® in pediatric patients?

Accepted Answer

The safety and effectiveness of VICTOZA® as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. Use of VICTOZA® for this indication is supported by clinical trials. The risk of hypoglycemia was higher with VICTOZA® in pediatric patients. VICTOZA® has not been established in pediatric patients less than 10 years of age.

Question 4

Are there any age-related differences in the safety and effectiveness of VICTOZA®?

Accepted Answer

In clinical trials, no overall differences in safety or effectiveness for VICTOZA® have been observed between patients 65 years of age and older and younger patients.

Question 5

How should VICTOZA® be used in patients with renal impairment?

Accepted Answer

No dose adjustment of VICTOZA® is recommended for patients with renal impairment. The safety and efficacy of VICTOZA® was evaluated in patients with moderate renal impairment. In clinical trials, no overall differences in safety or efficacy were seen in patients with renal impairment compared to patients with normal renal function. Use caution in patients who experience dehydration.

Question 6

What are the recommendations for using VICTOZA® in patients with hepatic impairment?

Accepted Answer

There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, VICTOZA® should be used with caution in this patient population. No dose adjustment of VICTOZA® is recommended for patients with hepatic impairment.

Question 7

How does VICTOZA® affect patients with gastroparesis?

Accepted Answer

VICTOZA® slows gastric emptying. VICTOZA® has not been studied in patients with pre-existing gastroparesis.

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