Xultophy
(insulin degludec / liraglutide)Xultophy 100/3.6 in 3 ML Pen Injector
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Xultophy FAQs
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.
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