Liraglutide

Liraglutide is a prescription medication used as:

• an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (Victoza)
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (Victoza)
• adjunctive therapy to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of 30 kg/m2 and more (obese) or a BMI of 27 kg/m2 and more (overweight) who have at least 1 weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia) [Saxenda]

Liraglutide is available under the following different brand names: Saxenda, Victoza

Dosages of Liraglutide:

Adult and Pediatric dosage

SC solution multidose pen

• 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8 mg
• 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg 

Type 2 Diabetes Mellitus

Victoza only

Adults

• 0.6 mg SC daily for 1 week initially, then increase to 1.2 mg once daily
• If glycemic control is not achieved, can increase to 1.8 mg once daily
• The initial dose of 0.6mg SC daily is only the decreased GI adverse effects and does not provide glycemic control

Pediatric

• Children 10 years of age or older with type 2 diabetes mellitus
• 0.6mg SC once daily for 1 week, may increase the dose to 1.2 mg/day if additional glycemic control is required
• If additional glycemic control is required, may increase to 1.8 mg once daily after at least 1 week after 1.2 mg once daily dose

Obesity

Saxenda only

Adults

• Initiate at 0.6 mg SC once daily for 1 week; increase by 0.6 mg per day in weekly intervals until a dose of 3 mg per day is achieved
• If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for  approximately 1 additional week
• Discontinue if a patient cannot tolerate the 3-mg dose, as efficacy has not been established at lower doses (eg, 0.6, 1.2, 1.8, 2.4 mg)
• Evaluate change in body weight 16 weeks after initiating Saxenda
• Discontinue Saxenda if the patient has not lost at least 4% of baseline body weight

Pediatric

• Adolescents aged 12 years and older with a weight of 60 kg and more and a BMI of 30 kg/m2 and more

• Initiate at 0.6mg SC once daily for 1 week; increase by 0.6 mg/day in weekly intervals until a dose of 3 mg/day achieved

• Recommended maintenance dose is 3 mg/day; if unable to tolerate, may reduce to 2.4 mg/day; discontinue if 2.4 mg is not tolerated

• If pediatric patients do not tolerate an increased dose during dose escalation, may lower the dose to the previous level; dose escalation for pediatric patients may take up to 8 weeks

• Evaluate change in BMI after 12 weeks on maintenance dose

• Discontinue saxenda if the patient has not reduced BMI by at least 1% from baseline, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Liraglutide include:

• low blood sugar, 
• nausea, 
• vomiting, 
• stomach discomfort, 
• loss of appetite, 
• diarrhea, 
• constipation, 
• rash, 
• headache, 
• dizziness, and 
• tiredness

Serious side effects of Liraglutide include:

• hives, 
• fast heartbeats, 
• dizziness, 
• trouble breathing, 
• difficulty swallowing, 
• swelling of the face, lips, tongue, or throat, 
• racing or pounding heartbeats, 
• sudden changes in mood or behavior, 
• thoughts of self-harm, 
• feeling very thirsty or hot, 
• being unable to urinate, 
• heavy sweating, 
• hot and dry skin, 
• headache, 
• hunger, 
• sweating, 
• irritability, 
• dizziness, 
• anxiety, 
• shakiness, 
• sudden and severe pain in the upper stomach that may spread to the back, 
• nausea, 
• vomiting, 
• fever, 
• yellowing of the skin or eyes (jaundice), 
• swelling or a lump in the neck, 
• hoarse voice, and
• shortness of breath

Rare side effects of Liraglutide include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Liraglutide has severe interactions with no other drugs.
• Liraglutide has serious interactions with no other drugs.
• Liraglutide has moderate interactions with at least 111 other drugs.
• Liraglutide has minor interactions with the following drugs:
  • acetaminophen
  • acetaminophen IV
  • digoxin
  • lovastatin

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

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 types 2 (MEN 2)
• Saxenda only: Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Liraglutide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Liraglutide?”

Cautions

• 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 posted marketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions, angioedema)
• Never share pen between patients even if the needle is changed
• Pulmonary aspirations
  • Therapy delays gastric emptying there have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations
  • Available data are insufficient to inform recommendations to mitigate risk of pulmonary aspiration during general anesthesia or deep sedation in patients receiving therapy, including whether modifying preoperative fasting recommendations or temporarily discontinuing therapy could reduce the incidence of retained gastric contents; instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are receiving this therapy
• Acute kidney injury
  • This drug has not been found to be directly nephrotoxic in animal studies or clinical trials; there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in treated patients
  • Some of these events were reported in patients without known underlying renal disease; a majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration
  • Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status; altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including this drug; use caution when initiating or escalating doses of this drug in patients with renal impairment
• January 11, 2024, FDA MedWatch Alert
  • FDA has evaluated reports of suicidal thoughts or actions in patients treated with GLP-1 agonists
  • Preliminary evaluation has shown no evidence suggesting the use of GLP-1 agonists causes suicidal thoughts or actions
  • FDA reviews of clinical trials, including large outcome studies and observational studies, did not find an association between the use of GLP1 agonists and the occurrence of suicidal thoughts or actions
  • Owing to the small number of suicidal thoughts or actions observed in both treated patients and in comparative control groups, the FDA cannot definitively rule out that a small risk may exist; therefore, the FDA is continuing to investigate this issue
  • Instruct patients not to stop taking GLP-1 agonists without first consulting a healthcare professional, as stopping these medicines may worsen their condition
  • Patients should contact their healthcare professional if new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior develops
  • Call or text 988 or go to https://988lifeline.org/, which provides free support for people in distress 24 hours a day, 7 days a week

Saxenda only

• Resting heart rate may increase by 2-3 bpm; up to 10-20 bpm increases also reported
• Suicidal ideation; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior; discontinue in patients who experience suicidal thoughts or behaviors; avoid in patients with a history of suicidal attempts or active suicidal ideation

Drug interactions overview

• May cause a delay of gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications; exercise caution when oral medications are concomitantly administered with liraglutide
• Risk for Hypoglycemia with Concomitant Use of Antidiabetic Therapy
• The risk for hypoglycemia is increased when Saxenda is used in combination with insulin secretagogues (ie, sulfonylureas) or insulin in patients with type 2 Diabetes Mellitus
• In patients with type 2 diabetes, monitor blood glucose before starting therapy and during treatment
• Therefore, patients may require a lower dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin in this setting
• Victoza only: In pediatric patients 10 years of age or older, the risk of hypoglycemia was higher regardless of concomitant antidiabetic therapies

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
• If a patient wishes to become pregnant, or pregnancy occurs, discontinue treatment
• A minimum weight gain, and no weight loss, recommended for all pregnant women, including those who are already overweight or obese, due to necessary weight gain that occurs in maternal tissues during pregnancy

Clinical Considerations

• Disease-associated maternal and/or embryo/fetal risk
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
• Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
• There are no data on the presence of drugs in human milk, the effects on the breastfed infant, or the effects on milk production
• Present in the milk of lactating rats