Saxenda Weight-Loss Pen

WHAT IS SAXENDA (liraglutide) ?

Saxenda, also known as liraglutide, is a daily injectable prescription medication. It is a glucagon-like peptide 1 (GLP-1) receptor agonist used for chronic weight management in addition to diet and exercise. Saxenda has proven efficacy and safety in those who are:

• Adult patients with an initial body mass index (BMI) of
  • ? 30 kg/m² (obese), or
  • ? 27 kg/m² (overweight) with at least one weight-related comorbid condition such as type 2 diabetes mellitus (T2DM), hypertension, or dyslipidemia)
• Pediatric patients aged 12 years and older with:
  • A weight greater than 60 kg and
  • A BMI corresponding to 30 kg/m² for adults (obese) by international cut-offs

Saxenda has a few limitations to its use. These include:

• Co-administration with other GLP-1 receptor agonists or other products containing liraglutide
• Pediatric patients with T2DM, as safety and efficacy has not been confirmed in this population
• Combination with other weight loss medications, as safety and efficacy has not been confirmed when used with other products

HOW DOES SAXENDA WORK?

Saxenda is a GLP-1 receptor agonist, making it a mediator of calorie intake and appetite. The GLP-1 receptor appears throughout various parts of the brain that contribute to appetite regulation. In animal models, Saxenda administration produced liraglutide in areas of the brain that regulate appetite, including the hypothalamus.

SIDE EFFECTS

Common side effects of Saxenda include:

• Nausea
• Diarrhea
• Constipation
• Vomiting
• Injection site reactions
• Headache
• Dyspepsia
• Hypoglycemia
• Fatigue
• Stomach pain
• Dizziness
• Alterations to serum lipase levels

WARNINGS AND PRECAUTIONS

Thyroid C-Cell Tumors

Saxenda has been shown to cause thyroid C-cell tumors in rats. Liraglutide has demonstrated medullary thyroid carcinoma (MTC) in post-marketing data; though causality cannot be determined at this time.

Currently, it is not known if Saxenda can induce thyroid C-cell tumors, but those with a history of MTC should avoid use of Saxenda. Patients should look out for MTC symptoms, such as a neck mass, dysphagia, hoarseness, or dyspnea. If these signs are present, patients should be evaluated for thyroid disease. Signs include if a patients serum calcitonin is markedly elevated or if a neck mass is present.

Acute Pancreatitis

Both fatal and non-fatal hemorrhagic or necrotizing acute pancreatitis cases have been reported in post-marketing data. Patients should be monitored for pancreatitis signs, such as abdominal pain or vomiting. If these symptoms occur, Saxenda should be stopped immediately and the pancreatitis should be managed appropriately. Therapy with Saxenda should not be reinitiated in the presence of true pancreatitis.

Hypoglycemia

Saxenda can cause hypoglycemia when used in combination with other products that lower blood glucose, such as insulin. Dose adjustments to insulin may be required to prevent development of hypoglycemia. Patients should be made aware of other drugs that can potentiate the glycemic effects of Saxenda and cause hypoglycemia. Patients should also be counseled on typical signs and symptoms of low blood sugar.

Acute Gallbladder Disease

Liraglutide has been shown to cause acute occurrences of gallbladder disease, such as cholelithiasis or cholecystitis. If gallbladder disease is suspected, providers should provide appropriate clinical interventions and monitoring.

Increased Heart Rate

In studies, Saxenda has been shown to increase resting heart rate up to 2 to 3 beats per minute (bpm). Other patients demonstrated increases between 10 to 20 bpm, with at least one person having a heart rate over 100 bpm. Consequently, Saxenda is thought to cause tachycardia. A patient’s heart rate should be monitored routinely while on Saxenda. In patients who experience a fast heart rate at rest for a long period of time, Saxenda should be stopped.

Renal Impairment

Saxenda has been shown to cause acute renal failure or worsening of existing renal failure. Some cases have needed treatment with hemodialysis. Some cases occurred in those with known renal disease. Most cases were accompanied by symptoms of nausea, diarrhea, or vomiting, causing volume depletion. Certain cases included patients who were on other medications that can influence renal function and volume status. Most cases of renal impairment were reversed after discontinuing causative agents, such as Saxenda, and initiating supportive treatment. If a patient has renal impairment, providers should use caution when starting Saxenda or increasing the dose.

Hypersensitivity Reactions

Saxenda has been shown to cause severe hypersensitivity reactions, including anaphylaxis and angioedema. Patients with a history of hypersensitivity reactions with other GLP-1 receptor agonists should be closely observed for allergic reactions. If anaphylaxis or angioedema occur, Saxenda should be stopped and the patient should seek medical attention.

Suicidal Ideation and Behavior

In clinical trials, 0.3% of patients on Saxenda experienced suicidal ideation compared to the 0.1% in the placebo group. One patient in the Saxenda arm attempted suicide. In pediatric studies, one patient (0.8%) died by suicide. It is currently unknown if there is a causal relationship between Saxenda and suicidal ideation. Patients should be monitored for new and worsening signs of depression and suicidal behavior. If patients exhibit these symptoms, Saxenda should be stopped. If patients have a history of depression or suicidal behavior, Saxenda should be avoided.

DRUG INTERACTIONS

Orally Administered Drugs

Saxenda reduces the rate of gastric emptying, potentially causing Saxenda to slow the absorption rate of other oral drugs. Providers should take caution when patients are taking oral medications concomitantly with Saxenda, as a decreased oral absorption rate may reduce clinical effectiveness of important medications.

FREQUENTLY ASKED QUESTIONS