Saxenda

Saxenda (liraglutide) is a prescription injection used for weight loss and weight management in adults and children aged 12 and older who have obesity or are overweight. It works by reducing appetite and slowing digestion to help lower calorie intake. It should be used together with a reduced-calorie diet and increased physical activity.

Saxenda is given as a once-daily injection under the skin (subcutaneous) using a multi-dose injection pen.

Saxenda contains the same active ingredient as Victoza (liraglutide), but the two medicines have different strengths and are FDA-approved for different conditions. Victoza is approved for type 2 diabetes; Saxenda is approved for weight management.

Saxenda is not approved for treating type 1 or type 2 diabetes.

Saxenda is FDA-approved for chronic weight management in adults and children aged 12 and older. It is used alongside a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight loss long term.

Saxenda is approved for:

Adults

• Adults with obesity (BMI of 30 kg/m² or greater)
• Adults who are overweight (BMI of 27 kg/m² or greater) and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol

Children aged 12 and older

• Adolescents with obesity who weigh more than 60 kg (132 pounds)

Limitations of use

• Saxenda should not be used together with other medicines that contain liraglutide, such as Victoza, or with any other GLP-1 receptor agonist, such as Ozempic, Wegovy, or Trulicity
• The safety and effectiveness of Saxenda in children aged 12 to 17 years who have type 2 diabetes have not been established.

Saxenda belongs to a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. It works by mimicking a naturally occurring hormone in the body that helps regulate appetite, blood sugar, and digestion.

Saxenda helps with weight loss in three main ways:

• It reduces appetite, so you feel less hungry
• It slows the emptying of your stomach, so you feel full for longer
• These effects together help lower your overall calorie intake

Saxenda is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use Saxenda and Victoza together. These two brands contain the same active ingredient but they should not be used together.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Saxenda is injected under the skin at any time of the day, with or without a meal. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Saxenda comes in a prefilled injection pen. Ask your pharmacist which type of needles are best to use with your pen.

Your care provider will show you the best places on your body to inject Saxenda. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not use Saxenda if it has changed colors or if it has particles in it. Call your pharmacist for new medicine.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Saxenda is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Storing unopened injection pens: Store in the refrigerator. Do not freeze Saxenda, and throw away the medication if it has become frozen. Do not use an unopened injection pen if the expiration date on the label has passed.

Storing after your first use: You may keep "in-use" injection pens in the refrigerator or at room temperature. Protect the pens from moisture, heat, and sunlight. Use within 30 days. Remove the needle before storing an injection pen, and keep the cap on the pen when not in use.

BOXED WARNING: Risk of thyroid tumors

Based on animal studies, liraglutide (the active ingredient in Saxenda) caused thyroid C-cell tumors in rats and mice. It is not known whether Saxenda causes thyroid C-cell tumors, including a type called medullary thyroid carcinoma (MTC), in humans.

Saxenda is contraindicated (must not be used) in people with:

• A personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a genetic condition that increases the risk of certain hormone-related tumors

Tell your doctor immediately if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

This is the most serious warning issued by the FDA. Talk to your doctor about whether Saxenda is appropriate for you.

Pancreatitis (inflammation of the pancreas)

Cases of pancreatitis have been reported in people taking GLP-1 receptor agonists, including Saxenda. Stop taking Saxenda and contact your doctor immediately if you develop persistent severe abdominal pain, which may radiate to your back, with or without vomiting. These can be signs of pancreatitis.

Gallbladder problems

Saxenda may increase the risk of gallstones (cholelithiasis) or gallbladder inflammation (cholecystitis). Tell your doctor if you experience sudden pain in your upper right abdomen, nausea, or fever, as these may be signs of a gallbladder problem. Your doctor may order gallbladder tests if a problem is suspected.

Low blood sugar (hypoglycemia)

Low blood sugar can occur in adults who take Saxenda together with insulin or an insulin secretagogue, such as a sulfonylurea. Your doctor may lower your dose of insulin or sulfonylurea to reduce this risk. Low blood sugar has also been reported in children and adolescents taking Saxenda, even without type 2 diabetes. Signs of low blood sugar include dizziness, shakiness, sweating, confusion, and rapid heartbeat. Make sure you know how to recognize and respond to low blood sugar before starting Saxenda.

Increased heart rate

Saxenda can cause an increase in resting heart rate. Your doctor should check your heart rate at regular appointments while you are taking Saxenda. Tell your doctor if you notice your heart racing or pounding at rest.

Kidney problems

Saxenda can cause nausea, vomiting, and diarrhea, which may lead to dehydration and, in some cases, acute kidney injury. Stay well hydrated, particularly when you first start treatment or when your dose is increased. Contact your doctor if you experience a significant decrease in urination or signs of dehydration.

Severe gastrointestinal reactions

Saxenda is associated with gastrointestinal side effects including nausea, vomiting, and diarrhea, which can sometimes be severe. Saxenda is not recommended for people with severe gastroparesis (delayed stomach emptying), as it further slows the movement of food through the stomach.

Allergic reactions

Serious allergic reactions, including anaphylaxis and angioedema (severe swelling of the face, lips, throat, or tongue), have been reported with Saxenda since it came to market. Stop taking Saxenda immediately and seek emergency medical help if you experience signs of a serious allergic reaction.

Risk during surgery or procedures requiring anesthesia

GLP-1 receptor agonists, including Saxenda, slow stomach emptying, which increases the risk of pulmonary aspiration (inhaling stomach contents into the lungs) during general anesthesia or deep sedation. Tell all of your healthcare providers, including your surgeon and anesthesiologist, that you are taking Saxenda before any planned surgery or procedure.

Who should not use Saxenda

Do not use Saxenda if you:

• Are allergic to liraglutide or any of the ingredients in Saxenda
• Have a personal or family history of medullary thyroid carcinoma (MTC), a type of thyroid cancer
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a genetic condition that increases the risk of certain hormone-related tumors
• Are currently using another GLP-1 receptor agonist such as Ozempic, Wegovy, or Trulicity, or another liraglutide-containing medicine such as Victoza

Tell your doctor if you have:

Tell your healthcare provider about all of your medical conditions before starting Saxenda, including if you:

• Have or have had problems with your pancreas
• Have severe stomach problems, such as slow stomach emptying (gastroparesis) or difficulty digesting food
• Are scheduled to have surgery or any procedure that uses general anesthesia or deep sedation
• Are pregnant or plan to become pregnant
• Are breastfeeding or planning to breastfeed. It is not known whether Saxenda passes into breast milk. Talk to your doctor about whether to use Saxenda or breastfeed, as both at the same time may not be recommended.

Pregnancy

Saxenda may cause harm to your unborn baby. If you become pregnant, you should tell your healthcare provider and discontinue this medicine.

Breastfeeding

It is not known if this medicine passes into your breast milk. You and your healthcare provider should decide if you should breastfeed while taking Saxenda.

Common Saxenda side effects

The most common side effects of Saxenda are nausea, diarrhea, vomiting, and constipation. These gastrointestinal effects are most likely to occur when you first start Saxenda or after each dose increase, and they often improve as your body adjusts over the first few weeks of treatment.

Other common side effects reported in 5% or more of people in clinical trials include:

Digestive system

• Indigestion (dyspepsia)
• Abdominal pain or upper abdominal pain
• Gastroenteritis (stomach bug)
• Increased lipase levels (a pancreatic enzyme, detected on blood tests)

General

• Headache
• Fatigue (feeling tired)
• Dizziness
• Fever

Other

• Injection site reactions such as redness, irritation, or bruising
• Low blood sugar (hypoglycemia), particularly if you also take insulin or a sulfonylurea

Contact your doctor if any side effects are severe, persistent, or affecting your daily life.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Saxenda: hives; fast heartbeats; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• racing or pounding heartbeats;
• severe ongoing nausea, vomiting, or diarrhea;
• signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;
• gallbladder problems - fever, upper stomach pain, clay-colored stools, jaundice (yellowing of your skin or eyes);
• symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;
• severely low blood sugar - extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or
• kidney problems - little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Pulmonary aspiration during general anesthesia or deep sedation has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Weight Loss:

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed by 1 additional week if necessary:

Week 1: Inject 0.6 mg subcutaneously once a day

Week 2: Inject 1.2 mg subcutaneously once a day

Week 3: Inject 1.8 mg subcutaneously once a day

Week 4: Inject 2.4 mg subcutaneously once a day

Week 5: Inject 3 mg subcutaneously once a day

Maintenance dose:

• 3 mg subcutaneously once a day-If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

• Saxenda should not be used in combination with any other GLP-1 receptor agonist.
• The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Evaluate weight loss at 16 weeks; if 4% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Usual Pediatric Dose for Weight Loss:

12 years and older:

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed if necessary based on tolerability; dose escalation may take up to 8 weeks:

Week 1: Inject 0.6 mg subcutaneously once a day

Week 2: Inject 1.2 mg subcutaneously once a day

Week 3: Inject 1.8 mg subcutaneously once a day

Week 4: Inject 2.4 mg subcutaneously once a day

Week 5: Inject 3 mg subcutaneously once a day

Maintenance dose:

• 2.4 or 3 mg subcutaneously once a day
• If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

• Saxenda should not be used in combination with any other GLP-1 receptor agonist.
• The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• Evaluate weight loss at 12 weeks on the maintenance dose; if 1% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment and this drug should be discontinued.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in pediatric patients with a body weight above 60 kg and an initial BMI of 30 kg/m2 or greater.

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

If you miss your daily dose of Saxenda, use the dose as soon as you remember. Then take your next daily dose as usual on the following day. Do not take an extra dose of Saxenda or increase your dose on the following day to make up for your missed dose.

If you miss your dose of Saxenda for 3 days or more, call your healthcare provider to talk about how to restart your treatment.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or diseases to pass from one person to another.

Do not use Saxenda together with other weight loss products, diet pills, or appetite suppressants.

Saxenda can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin; or
• oral diabetes medicine - Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others.

Saxenda is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists.

This list is not complete. Other drugs may interact with liraglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Active ingredient: liraglutide

Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust the pH.