Saxenda Selected Important Safety Information

Do not share your Saxenda pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is the most important information I should know about Saxenda?

Serious side effects may happen in people who take Saxenda, 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 Saxenda (liraglutide) injection 3 mg?

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.

• 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

Saxenda Important Safety Information

Do not share your Saxenda pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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. See symptoms of serious allergic reactions in “What are the possible side effects of Saxenda?”

• you are pregnant or plan to become pregnant. Saxenda may harm your unborn baby

Before taking Saxenda, tell your health care provider about all of your medical conditions, including if you:

• are taking certain medicines called GLP-1 receptor agonists

• 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

Tell your health care provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Saxenda slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda may affect the way some medicines work and some other medicines may affect the way Saxenda injection works. Tell your health care provider if you take diabetes medicines, especially insulin and sulfonylurea medicines.

How should I use Saxenda Injection?

• 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