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saxenda

Saxenda contains liraglutide, the same active ingredient contained in the type 2 diabetes medicine Victoza.

The U.S. Food and Drug Administration (FDA) has approved Saxenda (liraglutide 3 mg), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity. It is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30 kg/m2 ) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease.

Medication Guide

Read this Medication Guide and Patient Instructions for Use that come with your prescription before you start using this medicine and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions after reading this information, ask your healthcare provider or pharmacist.

Important information

Saxenda may cause serious side effects including:

Possible thyroid tumors, including cancer. During the drug testing process, liraglutide caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if this medicine will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.
- Before you start taking this medicine, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take this medicine if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Saxenda.
- While taking this medicine, tell your healthcare 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.
Inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before taking this medicine, tell your healthcare provider if you have had:
- pancreatitis
- stones in your gallbladder (gallstones)
- a history of alcoholism
- high blood triglyceride levels
These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Saxenda.

While taking Saxenda:

Stop taking Saxenda and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

What is Saxenda?

Saxenda is an injectable prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.
It is a medicine that should be used with a reduced calorie diet and increased physical activity.
Saxenda is not for the treatment of type 2 diabetes mellitus. Saxenda and Victoza? have the same active ingredient, liraglutide. These medicines should not be used together.
Saxenda should not be used with other GLP-1 receptor agonist medicines.
It should not be used together with insulin.
It is not known if it is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.
It is not known if it changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if it can be used safely in people who have had pancreatitis.
It is not known if it safe and effective in children under 18 years of age. Saxenda is not recommended for use in children.

Who should not use Saxenda?

Do not use this medicine if:

you or any of your family members have a history of medullary thyroid cancer.
you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
you are allergic to liraglutide or any of the ingredients in Saxenda. See the end of this Medication Guide for a complete list of ingredients.
Symptoms of a serious allergic reaction may include:
- swelling of your face, lips, tongue, or throat
- fainting or feeling dizzy
- very rapid heartbeat
- problems breathing or swallowing
- severe rash or itching
Talk with your healthcare provider if you are not sure if you have any of these conditions.
are pregnant or planning to become pregnant. Saxenda may harm your unborn baby.

Before using Saxenda

Before using this medicine, tell your healthcare provider if you:

have any of the conditions listed in the section Important information.
are taking certain medications called GLP-1 receptor agonists.
are allergic to liraglutide or any of the other ingredients in Saxenda. See the end of this Medication Guide for a list of ingredients.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
have or have had kidney or liver problems.
have or have had depression or suicidal thoughts.
have any other medical conditions.
are pregnant or plan to become pregnant. Saxenda may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
If you are pregnant you should stop using Saxenda.
are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your healthcare provider should decide if you will take Saxenda or breastfeed. You s hould not do both without talking with your healthcare provider first.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription 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 vice versa. Tell your healthcare provider if you take other diabetes medicines, especially sulfonylurea medicines or insulin.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use Saxenda?

Use this medicine exactly as prescribed by your healthcare provider. Your dose should be increased after using Saxenda for one week until you reach the 3 mg dose. After that, do not change your dose unless your healthcare provider tells you to.
Saxenda is injected one time each day, at any time during the day.
You can take the dose with or without food.
Your doctor should start you on a diet and exercise program when you start treatment and you should stay on this program for the duration of your treatment.
Saxenda comes in a prefilled pen.
Your healthcare provider must teach you how to inject a dose before you use it for the first time.

If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.

See the Patient Instructions for Use that come with your prescription for detailed information about the right way to use your pen.

Pen needles are not included. Use the Saxenda pen with Novo Nordisk disposable needles. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.
When starting a new prefilled Saxenda pen, you must follow the “Check the Saxenda flow with each new pen” (see the detailed Patient Instructions for Use that comes with your prescription). You only need to do this once with each new pen. You should also do this if you drop your pen. If you do the check before each injection, you will run out of medicine too soon.
Inject your dose under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your healthcare provider. Do not inject into a vein or muscle.
If you overdose, call your healthcare provider right away. Too much Saxenda may cause severe nausea and vomiting.
If you miss your daily dose, administer it as soon as you remember. Then take your next daily dose as usual on the following day. Do not take an extra dose or increase your dose on the following day to make up for your missed dose. If you miss your dose for three days or more, call your healthcare provider to talk about how to restart your treatment.
Never share your pen or needles with another person. You may give an infection to them, or get an infection from them.

Saxenda side effects

Serious side effects include:

possible thyroid tumors, including cancer. See Important information.
inflammation of the pancreas (pancreatitis). See Important information.
gallbladder problems. This medicine 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)
- clay-colored stools
low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat type 2 diabetes mellitus. Saxenda can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as sulfonylureas). In some people, the blood sugar may get so low that they need another person to help them. If you take a sulfonylurea medicine, the dose may need to be lowered while you use Saxenda. Signs and symptoms of low blood sugar may include:
- shakiness
- confusion
- sweating
- irritability
- headache
- hunger
- drowsiness
- fast heartbeat
- weakness
- feeling jittery
- dizziness
Talk to your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people who are around you a lot know how to recognize and treat low blood sugar. You should check your blood sugar before you start, and while you are using Saxenda.
increased heart rate. Saxenda can increase your heart rate while you are at rest. Your healthcare provider should check your heart rate during treatment. Tell your healthcare provider 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 healthcare 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. Serious allergic reactions can happen with Saxenda. Stop treatment, and get medical help right away if you have any symptom s of a se rious allergic reaction. See Who should not use Saxenda?
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 healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Common side effects include:

nausea
diarrhea
constipation
low blood sugar (hypoglycemia)
vomiting
headache
decreased appetite
upset stomach
tiredness
dizziness
stomach pain
changes in enzyme (lipase) levels in your blood

Nausea is most common when first starting treatment, but decreases over time in most people as their body gets used to the medicine. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the side effects associated with Saxenda. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep your Saxenda pen, pen needles, and all medicines out of the reach of children.

See also: Side effects (in more detail)

General information

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information you should know about using Saxenda. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.