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Saxenda® Important Safety Information | WW USA

Important Saxenda® Safety Information

Most Important Safety Information

  • In rats and mice, liraglutide caused thyroid C-cell tumors, including medullary thyroid cancer. It is not known if Saxenda will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. 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.
  • Do not use Saxenda if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Saxenda if you have had a serious allergic reaction to liraglutide or any of the ingredients in Saxenda.

What is the FDA-approved use of Saxenda?

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced calorie diet and increased physical activity, for people 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 (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use:

  • Saxenda should not be used in combination with other liraglutide-containing products or any other GLP-1 receptor agonist.
  • The safety and efficacy of coadministration with other products for weight loss have not been established

What should I tell my provider before using Saxenda?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Tell your provider if you are taking medicines to treat diabetes including insulin which could increase your risk of low blood sugar. Tell your provider if you are taking other GLP-1 receptor agonists.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • Type 1 or type 2 diabetes
  • Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Pancreatitis
  • Gallbladder Issues
  • Severe problems with your stomach, including gastroparesis or problems digesting food
  • Kidney disease
  • Diabetic retinopathy
  • History of Eating Disorders
  • Depression
  • Suicidal thoughts or behavior, or other mental health issues
  • History of a suicide attempt

Whether you are 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.

If planning pregnancy: Discontinue Saxenda at least 2 months before a planned pregnancy since the drug is not recommended for women who are actively planning pregnancy.

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 drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Insulin
  • Sulfonylureas (these can cause blood sugar levels to drop dangerously low when combined with Saxenda)
  • Other GLP-1 receptor agonist medications such as liraglutide, dulaglutide, or semaglutide.
  • Other products for weight loss, including dietary supplements
  • Other oral medications: Saxenda causes a delay in gastric emptying, so it can impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on managing other medications.
  • You should limit your alcohol intake while taking this drug because alcohol can lower blood sugar. Combining alcohol with Saxenda may cause blood sugars to fall too fast, leading to fainting and dizziness.

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 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 Tumors: In rats and mice, liraglutide 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. 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. Do not use Saxenda if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Acute Kidney Injury: Use of Saxenda has been associated with gastrointestinal side effects, sometimes severe, which can lead to dehydration. If severe, dehydration could cause acute kidney injury. It is important for you to drink plenty of water to help reduce your chance of dehydration.
  • Acute Gallbladder Disease: Saxenda and other GLP-1 receptor agonists are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
  • Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
  • Allergic Reactions: Stop using Saxenda right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
  • Low Blood Sugar (Hypoglycemia): Saxenda lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Increased heart rate: Saxenda can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding and it lasts for several minutes.
  • Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
  • Never Share a Pen: Pen-sharing poses a risk of infection.

These common side effects can occur with Saxenda.

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Headache
  • Fatigue
  • Upset Stomach
  • Dizziness
  • Belching
  • Hypoglycemia in patients with type 2 diabetes
  • Flatulence
  • Heartburn

You are encouraged to report negative side effects of prescription products:

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Saxenda® is a registered trademark of Novo Nordisk.