WARNINGS
Serious side effects may happen in people who take SAXENDA®, including:
Possible thyroid tumors, including cancer. 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. 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 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 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).
you have had a serious allergic reaction to liraglutide or any of the ingredients in SAXENDA. See the section ADDITIONAL INFORMATION below for a complete list of ingredients in SAXENDA. See the section SIDE EFFECTS below for symptoms of a serious allergic reaction.
USES
SAXENDA® is an injectable prescription medicine used for adults with obesity or overweight (excess
weight) who also have weight related medical problems, and children aged 12 to 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® is not recommended for people who also take liraglutide or other medicines called glucagon-like peptide-1 (GLP-1) receptor agonists.
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.
HOW TO USE
Read the Instructions for Use that comes with SAXENDA®.
Use SAXENDA® exactly as your healthcare provider tells you to.
Your healthcare provider should show you how to use SAXENDA® before you use it for the first time.
Use SAXENDA® with a reduced-calorie diet and increased physical activity.
SAXENDA® is injected under the skin (subcutaneously) in your stomach area (abdomen), upper leg (thigh), or upper arm. Do not inject into a muscle (intramuscularly) or vein (intravenously).
SAXENDA® is injected 1 time each day, at any time during the day.
Start SAXENDA® with 0.6 mg per day in your first week. In your second week, increase your daily dose to 1.2 mg. In the third week, increase your daily dose to 1.8 mg. In the fourth week, increase
your daily dose to 2.4 mg and in the fifth week onwards, increase your daily dose to the full dose of 3 mg. After that, do not change your dose unless your healthcare provider tells you to. Children may reduce their dose to 2.4 mg daily if the maximum dose is not tolerated.
If you miss your daily dose of SAXENDA®, just 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.
SAXENDA® may be taken with or without food.
Change (rotate) your injection site with each injection. Do not use the same site for each injection.
Do not share your SAXENDA® pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
If you take too much SAXENDA®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Throw away the used SAXENDA® pen after 30 days.
SAXENDA® may cause serious side effects, including:
See “What is the most important information I should know about SAXENDA®?”
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.
increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes, especially those who also take medicines to treat type 2 diabetes mellitus such as an insulin or a sulfonylureas and in children who are 12 years of age and older without type 2 diabetes mellitus. Low blood sugar in patients with adults with type 2 diabetes and in children without type 2 diabetes mellitus who receive SAXENDA® can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar. You should check your blood sugar before you start taking SAXENDA® and while you take SAXENDA®.
Signs and symptoms of low blood sugar may include:
dizziness or light-headedness
blurred vision
anxiety, irritability, or mood changes
sweating
slurred speech
hunger
confusion or drowsiness
shakiness
weakness
headache
fast heartbeat
feeling jittery
Talk to your healthcare provider about how to recognize and treat low blood sugar. 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 healthcare provider should check your heart rate while you take SAXENDA®. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
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.
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
problems breathing or swallowing
very rapid heartbeat
severe rash or itching
gallbladder problems. SAXENDA® 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)
yellowing of your skin or eyes (jaundice)
fever
clay-colored stools
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.
food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). SAXENDA® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking SAXENDA® before you are scheduled to have surgery or other procedures.
The most common side effects of SAXENDA® in adults include:
nausea
injection site reaction
tiredness (fatigue)
diarrhea
low blood sugar (hypoglycemia)
dizziness
constipation
headache
stomach pain
vomiting
upset stomach (dyspepsia)
change in enzyme (lipase) levels in your blood
Additional common side effects in children are fever and gastroenteritis. Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SAXENDA®. 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.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SAXENDA® for a condition for which it was not prescribed. Do not give SAXENDA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SAXENDA® that is written for health professionals.
What are the ingredients in SAXENDA® ?
Active ingredients: 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.
OVERDOSE
If you take too much SAXENDA®, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
MISSED DOSE
If you miss your daily dose of SAXENDA®, just 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.
STORAGE
Store your new, unused Saxenda® pens in the refrigerator at 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
Store your pen in use for 30 days at 59-degrees F to 86-degrees F (15-degrees C to 30-degrees C) or in a refrigerator at 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
NOTES
Medication Guide: revision date 05/2025
Prescribing Information: revision date 10/2025
SAXENDA® causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with SAXENDA®.
have or have had problems with your pancreas.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
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 healthcare provider should decide if you will use SAXENDA® or breastfeed.
Tell your healthcare provider about all the medicines you take including prescription over-the-counter medicines, vitamins, and herbal supplements. SAXENDA® may affect the way some medicines work and some other medicines may affect the way SAXENDA® works.
Tell your healthcare provider if you take diabetes medicines, especially insulin and sulfonylurea
medicines. Talk with your healthcare provider if you are not sure if you take any of these medicines.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacy when you get a new medicine.
