Saxenda (liraglutide) is an injectable prescription medicine approved for chronic weight management in adults with obesity or overweight (excess weight) who also have weight-related medical problems, and children aged 12-17 years with a body weight above 132 pounds (60kg) and obesity to help them lose weight and keep the weight off. It contains liraglutide, an analog of human GLP-1, acting as a GLP-1 receptor agonist. This medication is formulated as a sterile, aqueous, clear, colorless solution for subcutaneous use, with each milliliter containing 6 mg of liraglutide. The pre-filled pen delivers a total of 18 mg of liraglutide.
This article provides a detailed overview of Saxenda, including its efficacy, usage, potential side effects, and considerations based on user reviews and clinical data.
How Saxenda Works
Liraglutide, the active ingredient in Saxenda, is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a neuropeptide and an incretin secreted by the intestinal L cells and the brain stem (nucleus tractus solitarus). GLP-1 receptors are found in the stomach, pancreas, and intestine as well as in the central nervous system (CNS), including the hypothalamus and the brain stem. GLP-1 has a multitude of functions depending on its location. It mimics a naturally occurring hormone in the body, helping to control appetite and regulate blood sugar levels. Specifically, liraglutide regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption. It also stimulates the release of insulin from the pancreas, increases the volume of beta cells, and regulates and controls the release of glucagon.
Clinical Trials and Efficacy
The effectiveness of liraglutide has been evaluated in several clinical trials, including the Liraglutide Effect and Action in Diabetes (LEAD) and the Satiety and Clinical Adiposity, Liraglutide Evidence (SCALE) programs.
LEAD Program
The LEAD program included various arms to study the efficacy and safety of liraglutide used alone and in combination with commonly used oral antidiabetic drugs (e.g., sulfonylurea, metformin) versus placebo. Though the series was not intended to study weight loss, the LEAD trials concluded that liraglutide was associated with weight reduction (3%), and, in most instances, the reduction from baseline was significantly greater than that seen with comparators.
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SCALE Series
SCALE Diabetes
Davies et al reported the results of SCALE Diabetes, a 56-week randomized, double-blind, placebo-controlled, parallel-group trial with 12-week observational off-drug follow-up period. About half of individuals on 3.0mg liraglutide lost five percent or more of their body their weight at the end of the trial, compared to 35.6 percent in the liraglitude 1.8mg group and 13.8 percent on placebo.
SCALE Obesity and Prediabetes
The SCALE Obesity and Prediabetes trial included more than four times the amount of participants of the SCALE Diabetes Trial. Like SCALE Diabetes, this was a 56-week randomized, double-blind, placebo-controlled trial. Pi-Sunyer et al studied a total of 3,731 patients without T2DM that fell into the following BMI catergories: 1) BMI of 30kg/m2 or more or 2) BMI of 27kg/m2 or more and treated or untreated dyslipidemia or hypertension.
SCALE Maintenance
They found that 81.4 percent of participants receiving liraglutide maintained the five percent or more run-in weight loss, compared with 48.9 percent of those receiving placebo. Additionally, about half of the participants in the liraglutide group went on to lose more weight.
SCALE Sleep Apnea
The researchers found that the mean reduction in apnea-hypopnea index (AHI) was greater with liraglutide than with placebo (P=0.0150), thus confirming that weight loss improves OSA-related parameters.
Additional Research
Research conducted outside of the LEAD and SCALE programs show similar weight loss efficacy results. Astrup et al evaluated short-term weight loss and safety/tolerability with liraglutide in a randomized, double-blind, placebo-controlled 20-week trial among individuals with obesity (body-mass index 30-40kg/m2) without T2DM. They found that participants on liraglutide lost significantly more weight than did those on placebo.
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Dosage and Administration
The recommended dose of Saxenda is 3mg subcutaneously once daily, injected into the abdomen, thigh, or upper arm. Treatment is initiated at a dose of 0.6 mg daily for 1 week, after which the daily dose is escalated at weekly increments of 0.6 mg over 4 weeks to reach the recommended daily maintenance dose of 3 mg daily. Patients may also consider delaying dose escalation for approximately one additional week if they find they cannot tolerate an increased dose during the escalation period. According to prescribing information, physicians should evaluate patients after 16 weeks on Saxenda.
Administration Instructions
This medication is for injection under the skin of your upper leg, stomach area, or upper arm. You will be taught how to prepare and give this medication. Use exactly as directed. Take your medication at regular intervals. Do not take it more often than directed. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.
Missed Dose
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you miss your dose for 3 days or more, call your care team to talk about how to restart this medicine.
Storage
Store unopened pen in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medication has been frozen. Protect from light and excessive heat. After you first use the pen, it can be stored at room temperature between 15 and 30 degrees C (59 and 86 degrees F) or in a refrigerator. Throw away your used pen after 30 days or after the expiration date, whichever comes first. Do not store your pen with the needle attached. If the needle is left on, medication may leak from the pen.
Potential Side Effects
Like all medications, Saxenda can cause side effects. The most common side effects observed across all clinical trials were nausea, diarrhea, constipation, vomiting, hypoglycemia, and decreased appetite.
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Common Side Effects
- Nausea
- Diarrhea
- Constipation
- Vomiting
- Upset stomach
- Loss of appetite
Serious Side Effects
- Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Inflammation of the pancreas (pancreatitis). Stop using Saxenda and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting.
- Increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes especially those who also take medicines to treat type 2 diabetes such as sulfonylureas or insulin
- Risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older without type 2 diabetes. Signs and symptoms of low blood sugar may include: dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery. You should check your blood sugar before you start taking Saxenda and while you take Saxenda
- Increased heart rate. Saxenda can increase your heart rate while you are at rest. Your health care provider should check your heart rate while you take Saxenda. Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes
- Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Saxenda. Tell your healthcare provider if you have stomach problems that are severe or will not go away
- Serious allergic reactions. Stop using Saxenda and get medical help right away if you have any symptoms of a serious allergic reaction including swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, or severe rash or itching
- Gallbladder problems. Saxenda may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your healthcare provider if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), or clay-colored stools
- Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care provider right away if you have any mental changes that are new, worse, or worry you
- Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Saxenda may increase the chance of food getting into your lungs during surgery or other procedures.
When to Seek Medical Attention
Report the following side effects to your care team as soon as possible:
- Allergic reactions-skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Dehydration-increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
- Fast or irregular heartbeat
- Gallbladder problems-severe stomach pain, nausea, vomiting, fever
- Kidney injury-decrease in the amount of urine, swelling of the ankles, hands, or feet
- Pancreatitis-severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
- Thyroid cancer-new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness
Contraindications and Warnings
Saxenda is contraindicated in patients with a personal or family history of MTC (medullary thyroid carcinoma) and in patients with MEN II (multiple endocrine neoplasia syndrome type 2). The boxed warning states the following: Liraglutide causes dose-dependent and treatment duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of race and mice. It is unknown whether Saxenda causes thyroid C- cell tumors including medullary thyroid carcinoma (MTC) in humans, as human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.
Precautions
Before taking Saxenda, inform your care team if you have any of the following conditions:
- Gallbladder disease
- History of depression
- History of pancreatitis
- Scheduled surgery
- Kidney disease
- Liver disease
- Personal or family history of MEN 2
- Personal or family history of thyroid cancer
- Stomach or intestine problems
- Suicidal thoughts, plans, or attempt
- Allergic reaction to liraglutide or other medications
- Pregnant or trying to get pregnant
- Breastfeeding
Interactions
Saxenda may interact with insulin and other medications for diabetes. Provide your health care provider with a list of all medicines, herbs, non-prescription drugs, or dietary supplements you use. Also, inform them if you smoke, drink alcohol, or use illegal drugs.
User Reviews and Experiences
User reviews provide valuable insights into the real-world experiences of individuals taking Saxenda. Many users report successful appetite control, leading to significant weight loss. For example, one user shared, "Starting my 5th week on this today. I have lost 10.4 lbs so far. I am very happy with it. It helps reduce my appetite and I get full faster. I have had virtually no side effects either. This has given me hope! Started at 198…"
However, it's important to note that experiences can vary. Some users report gastrointestinal side effects such as nausea, while others do not experience any significant side effects.
One patient, Ivy (37), shared her experience: "I'm screaming about it from the top of my lungs. It's a game changer that people should really know more about." She also mentioned that the medication helped reduce her cravings for unhealthy treats and wine.
Considerations for Treatment
Physicians generally trust Saxenda’s safety, with an average safety rating of 4.4. Saxenda is widely recognized for its efficacy in weight loss, achieving high ratings from physicians (average 4.5/5). However, healthcare providers should evaluate patients after 16 weeks on Saxenda to determine if the medication is effective. A clinically meaningful weight loss is typically considered to be between 5% and 10% of total body weight.
Lifestyle Modifications
Saxenda is most effective when combined with a reduced-calorie diet and increased physical activity. It should be used as an adjunct to lifestyle intervention.
Long-Term Management
Weight management is a long-term process. Patients may need to continue treatment to sustain weight loss. The clinical expert considered that it would be reasonable to consider pharmacotherapy in patients with a BMI between 27 kg/m2 and 30 kg/m2 without comorbidity as second-line after lifestyle changes, although this would be beyond the Health Canada-approved indication. The expert felt that patients would regain the weight they had lost if pharmacologic treatment for weight management was discontinued; therefore, such treatments would need to be continued in the long-term, even in patients whose BMI dropped below 30 kg/m2 (or 27 kg/m2 in patients with weight-related comorbidities).
Obesity: A Public Health Problem
Obesity has been declared a public health problem as well as a global epidemic. The WHO (WHO) defines overweight and obesity as abnormal or excessive fat accumulation that presents a risk to health. In 2019, overweight and obesity rates among adults aged 18 years to 79 years in Canada were 35.5% and 24.3%, respectively. It is estimated that median survival is reduced by 2 years to 4 years for those with a BMI of 30 kg/m2 to 35 kg/m2 and by 8 years to 10 years for those with a BMI of 40 kg/m2 to 50 kg/m.
Multi-Component Interventions
Successful nonsurgical treatment of obesity involves a multidisciplinary approach that includes nutrition, behavioral modification, exercise, and medical management. The treatment of choice to manage overweight and obesity is a multi-component interventions approach with respect to provider discipline, as well as length and format of treatment.