Classes
DEA Class; Rx
Common Brand Names; Victoza, Saxenda
- Antidiabetics, Glucagon-like Peptide-1 Agonists
Description
Subcutaneous incretin mimetic (GLP-1 receptor agonist); used once daily; not a first-line therapy due to the boxed warning regarding rodent C-cell tumors and the uncertain risk to humans
Victoza product is used in adult and pediatric patients 10 years and older with type 2 diabetes mellitus (DM) and to reduce the risk of non-fatal and fatal cardiovascular events (e.g., myocardial infarction or stroke) in adults, if these patients also have cardiovascular disease
Separate product (Saxenda) used for weight reduction and maintenance in obese pediatric patients 12 years and older and obese adults or overweight adults with at least 1 weight-related comorbidity
Indications
Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.
Contraindications
Hypersensitivity to liraglutide or its components
Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
Saxenda only: Pregnancy
Adverse Effects
- Nausea (26%)
- Diarrhea (17%)
- Vomiting (11%)
- Nausea (39.3%)
- Hypoglycemia in T2DM (23%)
- Diarrhea (20.9%)
- Constipation (19.4%)
- Vomiting (15.7%)
- Headache (13.6%)
- Constipation (10%)
- Headache (9%)
- Antiliraglutide antibodies (7%)
- Injection-site reactions (2%)
- Decreased appetite (10%)
- Dyspepsia (9.6%)
- Fatigue (7.5%)
- Dizziness (6.9%)
- Abdominal pain (5.4%)
- Increased lipase (5.3%)
- Upper abdominal pain (5.1%)
- Gastroesophageal reflux disease (4.7%)
- Gastroenteritis (4.7%)
- Abdominal distension (4.5%)
- Eructation (4.5%)
- Urinary tract infection (4.3%)
- Flatulence (4%)
- Viral gastroenteritis (2.8%)
- Injection site erythema (2.5%)
- Injection site reaction (2.5%)
- Insomnia (2.4%)
- Dry mouth (2.3%)
- Asthenia (2.1%)
- Anxiety (2%)
- Urticaria
- Upper respiratory tract infection
- UTI
- Dizziness
- Sinusitis
- Nasopharyngitis
- Back pain
- Hypertension
- Hypoglycemia (mostly in combination therapy)
- Pancreatitis
- Papillary thyroid carcinoma
- Thyroid C-cell hyperplasia
Warnings
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed; studied in a limited number of patients with a history of pancreatitis; unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis
Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and postmarketing; if cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up indicated
May cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice; if serum calcitonin is elevated, evaluate further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated
Renal Impairment reported in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis; altered renal function has been reversed in many of reported cases with supportive treatment and discontinuation of potentially causative agents; use caution when initiating or escalating doses of in these patients
There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions, angioedema)
Never share pen between patients even if needle is changed
Pregnancy and Lactation
Victoza
- Based on animal reproduction studies, there may be risks to the fetus from exposure during pregnancy
- Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Saxenda
- Contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm
- There are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage
There are no data on the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production
Maximum Dosage
1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.
1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.
1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.
12 years: 1.8 mg/day subcutaneously for the treatment of type 2 diabetes mellitus; 3 mg/day subcutaneously for the treatment of obesity.
10 to 11 years: 1.8 mg/day for the treatment of type 2 diabetes mellitus; safety and efficacy for the treatment of obesity have not been established; however, doses up to 3 mg/day have been used off-label.
7 to 9 years: Safety and efficacy have not been established; however, doses up to 3 mg/day have been used off-label for the treatment of obesity.
1 to 6 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Liraglutide
SC solution multidose pen
- 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8mg
- 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg