Xultophy(insulin degludec / liraglutide)
Dosage & Administration
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Xultophy Prescribing Information
Xultophy Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Oct 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Oct 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Oct 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Oct 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Oct 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Oct 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Oct 24, 2024Texas - Uniform Prior Authorization Form
Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form
Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form
Xultophy Financial Assistance Options
Foundation programs
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Overview
- Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
- These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
- Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted
Patient eligibility
- Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
- Patients submit proof of out-of-pocket drug costs to charities for reimbursement
Xultophy PubMed™ News
Xultophy Patient Education
Getting started on Xultophy
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Patient toolkit
Xultophy FAQs
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.
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.
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.
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.
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.
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.
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.
Safety and effectiveness of XULTOPHY® 100/3.6 have not been established in pediatric patients.
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.
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.
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.
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.
XULTOPHY® 100/3.6 has not been studied 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.
There is limited experience in patients with mild, moderate, or severe hepatic impairment with liraglutide, one of the components of XULTOPHY® 100/3.6.
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available