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Medication Guide
Liraglutide (luh·ra·gluh·tide)
injection, for subcutaneous use
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Read this Medication Guide before you start using liraglutide injection and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
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What is the most important information I should know about liraglutide injection?
Liraglutide injection may cause serious side effects, including:
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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, liraglutide injection and medicines that work like liraglutide injection caused thyroid tumors, including thyroid cancer. It is not known if liraglutide injection will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
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- Do not use liraglutide injection 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).
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What is liraglutide injection?
Liraglutide injection is an injectable prescription medicine used:
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- along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.
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- to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.
Liraglutide injection is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if liraglutide injection is safe and effective to lower blood sugar (glucose) in children under 10 years of age.
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Who should not use liraglutide injection?
Do not use liraglutide injection 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 liraglutide injection. See the end of this Medication Guide for a complete list of ingredients in liraglutide injection. 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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What should I tell my healthcare provider before using liraglutide injection?
Before using liraglutide, tell your healthcare provider if you have any other medical conditions, including if you:
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- have or have had problems with your pancreas, kidneys, or liver.
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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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- are pregnant or plan to become pregnant. It is not known if liraglutide injection will harm your unborn baby. Tell your healthcare provider if you become pregnant while using liraglutide injection.
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- are breastfeeding or plan to breastfeed. It is not known if liraglutide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using LIRAGLUTIDE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Liraglutide injection may affect the way some medicines work and some medicines may affect the way liraglutide injection works.
Before using liraglutide injection, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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How should I use liraglutide injection?
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- Read the Instructions for Use that comes with liraglutide injection.
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- Use liraglutide injection exactly as your healthcare provider tells you to.
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Your healthcare provider should show you how to use liraglutide injection before you use it for the first time.
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Use liraglutide injection 1 time each day, at any time of the day.
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- Liraglutide injection may be taken with or without food.
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- Liraglutide injection is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject liraglutide injection into a muscle (intramuscularly) or vein (intravenously).
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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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Do not mix insulin and liraglutide together in the same injection.
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- You may give an injection of liraglutide injection and insulin in the same body area (such as your stomach area), but not right next to each other.
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- If you miss a dose of liraglutide injection, take the missed dose at the next scheduled dose. Do not take 2 doses of liraglutide injection at the same time.
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- If you take too much liraglutide injection, call your healthcare provider right away. Taking too much liraglutide injection may cause severe nausea, severe vomiting, and low blood sugar (hypoglycemia).
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Do not share your liraglutide injection 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.
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- The liraglutide injection pen you are using should be thrown away 30 days after you start using it.
Your dose of liraglutide injection and other diabetes medicines may need to change because of:
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- change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
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What are the possible side effects of liraglutide injection?
Liraglutide injection may cause serious side effects, including:
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See “What is the most important information I should know about liraglutide injection?”
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inflammation of your pancreas (pancreatitis). Stop using liraglutide injection 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 abdomen to your back.
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low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use liraglutide injection with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with liraglutide injection regardless of use with another medicine that can also lower blood sugar.
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Signs and symptoms of low blood sugar may include:
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- dizziness or light-headedness
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- blurred vision
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- anxiety, irritability, or mood changes
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- sweating
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- slurred speech
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- hunger
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- confusion or drowsiness
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- shakiness
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- weakness
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- headache
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- fast heartbeat
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- feeling jittery
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kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
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serious allergic reactions. Stop using liraglutide injection 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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- problems breathing or swallowing
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- very rapid heartbeat
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- severe rash or itching
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gallbladder problems. Gallbladder problems have happened in some people who take liraglutide injection. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:
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- pain in your upper stomach (abdomen)
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- yellowing of skin or eyes (jaundice)
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- fever
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- clay-colored stools
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The most common side effects of liraglutide injection may include nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation.
Talk to your healthcare provider about any side effects that bothers you or does not go away. These are not all the possible side effects of liraglutide injection.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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General information about the safe and effective use of liraglutide injection.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use liraglutide injection for a condition for which it was not prescribed. Do not give liraglutide injection to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about liraglutide injection that is written for health professionals.
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What are the ingredients in liraglutide injection?
Active ingredient: liraglutide
Inactive ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection, hydrochloric acid or sodium hydroxide may be added to adjust pH
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Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark.
To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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