Classes
DEA Class; Rx
Common Brand Names; Xultophy
- Antidiabetics, Glucagon-like Peptide-1 Agonists;
- Antidiabetics, Insulins;
- Antidiabetics, Long-Acting Insulins
Description
Subcutaneous injection with a basal insulin (insulin degludec) and a GLP-1 RA (liraglutide); given once daily
Used in adults for type 2 diabetes mellitus; may be added to metformin in patients naive to basal insulin
Liraglutide is not a first-line therapy due to the boxed warning regarding rodent C-cell tumors and the uncertain risk to humans
Indications
Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.
Contraindications
Patients with a personal or family history of MTC and in patients with MEN
During episodes of hypoglycemia
Hypersensitivity to either of the active drugs or any excipients; serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with liraglutide
Adverse Effects
- Nasopharyngitis (9.6 %)
- Headache (9.1%)
- Nausea (7.8%)
- Diarrhea (7.5%)
- Increased lipase (6.7%)
- Upper respiratory tract infection (5.7%)
- Mildly elevated serum bilirubin concentrations (4%)
- Injection site reactions (2.6%)
- Cholelithiasis (0.3%)
- Cholecystitis (0.2%)
- Hypoglycemia
- Weight gain
- Peripheral edema
- Increased pulse 2-3 bpm
- Lipodystrophy at injection site
- Systemic allergy
- Immunogenicity
Warnings
Do not share insulin pens between patients
No clinical studies have established conclusive evidence of macrovascular risk reduction with any antidiabetic drugs
The product contains two drugs, insulin degludec, and liraglutide; daily administration of more than 50 units of this drug combination can result in overdose of the liraglutide component; do not exceed the 1.8 mg maximum recommended dose of liraglutide or use with other glucagon-like peptide-1 receptor agonists
Accidental mix-ups between insulin products reported; to avoid medication errors between this drug combination (an insulin-containing product) and other insulin products, instruct patients to always check the label before each injection
Acute gallbladder disease, such as cholelithiasis or cholecystitis reported with liraglutide, a component of this drug combination; majority of events required hospitalization or cholecystectomy; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up are indicated
All insulin-containing products cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia; untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death; monitor potassium levels in patients at risk for hypokalemia if indicated (eg, patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations)
Pregnancy and Lactation
Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
There are no available data with insulin degludec or liraglutide in pregnant women to inform a drug-associated risk for major birth defects or miscarriage
There are no data on presence of liraglutide or insulin degludec in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
Insulin degludec 50 units/day with liraglutide 1.8 mg/day subcutaneously.
Insulin degludec 50 units/day with liraglutide 1.8 mg/day subcutaneously.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
Liraglutide/insulin degludec
SC injection
- 3.6mg/100units per mL
- Available as a 3-mL single-use pen