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Indications and Usage
- Saxenda® (liraglutide) injection 3 mg is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
- Saxenda® is not indicated for the treatment of type 2 diabetes
- Saxenda® and Victoza® both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda® should not be used in combination with any other GLP-1 receptor agonist
- Saxenda® has not been studied in patients taking insulin. Saxenda® and insulin should not be used together
- The safety and efficacy of Saxenda® in combination with other products for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established
Important Safety Information
Saxenda® is contraindicated in:
- Patients with a personal or family history of MTC or MEN 2
- Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components
Warnings and Precautions
- Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated
- Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Saxenda® promptly and if pancreatitis is confirmed, do not restart
- Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in patients treated with Saxenda® than with placebo even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
- Risk of Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: When Saxenda® is used with an insulin secretagogue (eg, a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia. Monitor blood glucose parameters prior to starting Saxenda® and during treatment and adjust anti-diabetic drugs as needed
- Heart Rate Increase: Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed in patients treated with Saxenda®. Monitor heart rate at regular intervals and inform patients to report palpitations or feelings of a racing heartbeat while at rest during treatment with Saxenda®. Discontinue Saxenda® in patients who experience a sustained increase in resting heart rate
- Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported, usually in association with nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Saxenda® in patients with renal impairment
- Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported in patients treated with liraglutide. If a hypersensitivity reaction occurs, patients should stop taking Saxenda® and promptly seek medical advice
- Suicidal Behavior and Ideation: In clinical trials, 9 (0.3%) of 3,384 patients treated with Saxenda® and 2 (0.1%) of the 1,941 treated with placebo reported suicidal ideation; one of the patients treated with Saxenda® attempted suicide. Monitor patients on Saxenda® for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue treatment if patients experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation
- The most common adverse reactions, reported in ≥5% are: nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase
- Saxenda® causes a delay of gastric emptying, and has the potential to impact the absorption of concomitantly administered oral medications. Monitor for potential consequences of delayed absorption of oral medications concomitantly administered with Saxenda®
Use in Specific Populations
- There are no data on the presence of liraglutide in human breast milk; liraglutide was present in the milk of lactating rats
- Saxenda® has not been studied in patients below 18 years of age and is not recommended for use in pediatric patients
- Saxenda® slows gastric emptying. Saxenda® has not been studied in patients with preexisting gastroparesis
Please click here for Prescribing Information, including Boxed Warning.
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Short-Term Side Effects
There are several short-term side effects that are most evident at the beginning of therapy, particularly when patients commence the diet with an initial fast.
Hypoglycemia is a common side effect in this instance, and noticeable signs may include:
- Excessive thirst
- Frequent urination
- Confusion, anxiety and/or irritability
- Lightheadedness and shakiness
- Sweating and chills
Additionally, patients may also experience some constipation and low-grade acidosis. These effects tend to improve when the diet is continued, as the body adapts to the new diet and adjust the ways in which it sources energy.
Alteration in Blood Composition
As a result of the changes in dietary consumption and the body’s adaptive mechanisms to cope with the reduced carbohydrate intake, there are several changes in the blood composition of individuals following the ketogenic diet.
In particular, the levels of lipids and cholesterol in the blood are commonly higher than what is considered to be normal. More than 60% of patients have raised lipid levels and more than 30% have high levels of cholesterol.
If these changes are profound and there is some concern about the health of the child, slight changes to the diet can be made for the individual patient. For example, saturated fat sources can be substituted for polyunsaturated fats. In some cases, it may be necessary to lower the ketogenic ratio and reduce the proportion of fat to carbohydrate and protein in the diet.
When the ketogenic diet is continued for extended periods of time, there are other adverse effects that become more evident and have a greater impact on individuals.
Kidney stones, also known as nephrolithiasis, are a common complication for children following the diet, with approximately 5% of patients suffering from the condition. It is, however, treatable and the current recommendations suggest that the diet should be continued. The formation of kidney stones is believed to be linked to hypocitraturia and hypercalciuria, when acidosis causes the bone to demineralize. Additionally, low pH in the urine can encourage the formation of crystals and, eventually, kidney stones.
There is some evidence that supplementation with potassium citrate reduces the incidence of kidney stones, as it binds to and reduces the level of calcium in the bloodstream. More research on this is required, however.
Additionally, patients have an increased risk of bone fractures. This arises from the altered levels of insulin-like growth factor 1 and the effects of acidosis. Acidosis leads to the erosion of bone, weakening the bones and leaving them prone to fractures.
In order to manage these side effects, supplementation of vitamins and minerals are routinely administered to patients following the ketogenic diet. This commonly comprises of a multivitamin, calcium and vitamin D supplements.
Side Effects in Adults
For adults following the ketogenic diet, the most common complications include weight loss, constipation and increased levels of cholesterol and triglycerides. Women may also experience amenorrhea or other disruptions to the menstrual cycle.
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