Medication Guide

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 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).

What is SAXENDA?

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.

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SAXENDA should be used with a reduced calorie diet and increased physical activity.

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SAXENDA and VICTOZA have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines.

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It is not known if SAXENDA is safe and effective when taken with other prescription, over-the-counter medicines, or herbal weight loss products.

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It is not known if SAXENDA is safe and effective in children under 12 years of age.

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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:

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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).

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you have had a serious allergic reaction to liraglutide or any of the ingredients in SAXENDA. See the end of this Medication Guide for a complete list of ingredients in SAXENDA. Symptoms of a serious allergic reaction include:

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swelling of your face, lips, tongue or throat

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problems breathing or swallowing

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severe rash or itching

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fainting or feeling dizzy

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very rapid heartbeat

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are pregnant or plan to become pregnant. SAXENDA may harm your unborn baby.

Before taking SAXENDA, tell your healthcare provider about all of your medical conditions, including if you:

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are taking certain medicines called GLP-1 receptor agonists.

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have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

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have or have had problems with your pancreas, kidneys or liver.

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have or have had depression or suicidal thoughts, or mental health issues.

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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 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 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.

How should I use SAXENDA?

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Read the Instructions for Use that comes with SAXENDA.

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Use SAXENDA exactly as prescribed by your healthcare provider.

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Your healthcare provider should show you how to use SAXENDA before you use it for the first time.

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Use SAXENDA exactly as prescribed by your healthcare provider. Your dose should be increased after using SAXENDA for 1 week until you reach the 3 mg dose.

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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.

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SAXENDA is injected 1 time each day, at any time during the day.

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Inject your dose of SAXENDA under the skin (subcutaneously) 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.

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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.

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If you take too much SAXENDA, call your healthcare provider right away. Taking too much SAXENDA may cause severe nausea, severe vomiting, and low blood sugar (hypoglycemia).

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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.

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You can take SAXENDA with or without food.

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Throw away the used SAXENDA pen after 30 days.

Your healthcare provider should start you on a reduced calorie diet and increased physical activity when you start taking SAXENDA. Stay on this program while you are taking SAXENDA.

What are the possible side effects of SAXENDA?

SAXENDA may cause serious side effects, including:

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See “What is the most important information I should know about SAXENDA?”

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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.

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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:

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pain in your upper stomach (abdomen)

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fever

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yellowing of your skin or eyes (jaundice)

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clay-colored stools

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increased risk of low blood sugar (hypoglycemia) in adults with type 2 diabetes mellitus who also take medicines to treat type 2 diabetes mellitus such as sulfonylureas or insulin.

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risk of low blood sugar (hypoglycemia) in children who are 12 years of age and older without type 2 diabetes mellitus

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Signs and symptoms of low blood sugar may include:

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shakiness

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sweating

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headache

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drowsiness

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weakness

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dizziness

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confusion

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irritability

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hunger

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fast heartbeat

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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.

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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.

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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.

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serious allergic reactions. Stop using SAXENDA, and get medical help right away if you have any symptoms of a serious allergic reaction including:

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swelling of your face, lips, tongue, or throat

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fainting or feeling dizzy

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very rapid heartbeat

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problems breathing or swallowing

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severe rash or itching

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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.

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The most common side effects of SAXENDA in adults include:

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nausea

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diarrhea

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constipation

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vomiting

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injection site reaction

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low blood sugar (hypoglycemia)

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headache

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upset stomach (dyspepsia)

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tiredness (fatigue)

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dizziness

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stomach pain

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change in enzyme (lipase) levels in your blood

 

Additional common side effects in children are fever and gastroenteritis

 

Tell 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.

General information about the safe and effective use of SAXENDA.

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.