Important Safety Information for Saxenda (liraglutide) injection
Warning: Risk of Thyroid C-Cell Tumors
Saxenda® may cause serious side effects, including: 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. In studies with rats and mice, Saxenda and medicines that work like Saxenda caused thyroid tumors, including thyroid cancer. It is not known if Saxenda will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Saxenda if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Saxenda?
Saxenda (liraglutide) injection 3 mg is an injectable prescription medicine used for adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30), and children aged 12-17 years with a body weight above 132 pounds (60 kg) and obesity to help them lose weight and keep the weight off. Saxenda should be used with a reduced calorie diet and increased physical activity.
Limitations of Use:
- Saxenda and Victoza have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines
- It is not known if Saxenda is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight-loss products
- It is not known if Saxenda is safe and effective in children under 12 years of age
- It is not known if Saxenda is safe and effective in children aged 12 to 17 years with type 2 diabetes
Who should not use Saxenda?
Do not use Saxenda if:
- you or any of your family have ever had MTC or if you have MEN 2
- you have had a serious allergic reaction to liraglutide or any of the ingredients in Saxenda.
- you are pregnant or plan to become pregnant. Saxenda may harm your unborn baby
How should I take Saxenda?
Read the Instructions for Use that comes with Saxenda. Inject your dose of Saxenda under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care provider. Do not inject into a vein or muscle. Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection
You should not change your dosing regimen or stop taking Saxenda as prescribed without discussing with your provider first. If you take too much Saxenda, call your healthcare provider or seek medical advice promptly.
What should I discuss with my Ivím provider before using Saxenda?
- Saxenda has certain drug interactions. It’s important to tell your Ivím provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
- Your healthcare provider should show you how to use Saxenda before you use it for the first time. You should also discuss if you have medical conditions including:
- have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
- have or have had problems with your pancreas, kidneys or liver
- have or have had depression or suicidal thoughts, or mental health issues
- are breastfeeding or plan to breastfeed. It is not known if Saxenda passes into your breast milk. You and your health care provider should decide if you will use Saxenda or breastfeed
Some medications to watch out for include:
- Medications for diabetes: Other medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Other oral medications: Saxenda causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
- Hormonal birth control: Other GLP-1 medications have been shown to potentially decrease the efficacy of oral birth control pills. If you are using an oral hormonal contraceptive (birth control), Saxenda may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Saxenda and for 4 weeks after each dose escalation, until you reach a maintenance dose.
- Other GLP-1 medications: Including Zepbound, Mounjaro, Wegovy, Ozempic, Victoza, Byetta, Bydureon, or compound GLP-1 formularies. These medications should not be taken with Saxenda.
- Other products for weight loss: Including dietary supplements
- It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Gastrointestinal disease
- Kidney disease
- Diabetic retinopathy
- Suicidal thoughts or behavior
- Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Saxenda should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Saxenda during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female reproductive potential: Saxenda may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
- If you are breastfeeding: It is not known if Saxenda passes into breast milk. Talk to your provider first about the benefits and risks of using Saxenda while breastfeeding.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Saxenda?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with Saxenda. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors: In rats, Saxenda caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Saxenda causes thyroid C-cell tumors in humans. Saxenda is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Severe Gastrointestinal Disease: Saxenda is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
- Inflammation of the pancreas (pancreatitis): Stop using Saxenda and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your stomach area (abdomen) to your back
- Gallbladder problems: Saxenda may cause gallbladder problems, including gallstones. Some gallbladder problems need surgery. Call your health care 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.
- Increased risk of low blood sugar (hypoglycemia): in adults with type 2 diabetes who also take medicines to treat type 2 diabetes such as sulfonylureas or insulin. Increased 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: shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, 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
- Kidney problems (kidney failure): Saxenda may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth
- 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
- 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
- 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.
- Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Saxenda.
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
- Never Share a Pen: Pen-sharing poses a risk of infection.
What are the most common side effects of Saxenda?
- Stomach pain
- Injection site reactions
- Feeling tired (fatigue)
- Allergic reactions
- Hair loss
- Gastroesophageal reflux disease (heartburn)
- Hypoglycemia (low blood sugar)
- Change in enzyme (lipase) levels
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.