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Generic Name: liraglutide (LIR a GLOO tde)
Brand Names: Saxenda, Victoza

What is Saxenda?

Saxenda (liraglutide) is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

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 used together with diet and exercise.

Saxenda is not a weight-loss medicine or appetite suppressant.

Important information

The Victoza brand of liraglutide is used together with diet and exercise to treat type 2 diabetes. Do not use Saxenda and Victoza together.

You should not use Saxenda if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin)

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

Before using Saxenda

You should not use Saxenda if you are allergic to liraglutide, or if you have:

  • multiple endocrine neoplasia type 2 (tumors in your glands);

  • a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

You should not use Saxenda if you also use insulin or other medicines like liraglutide (albiglutide, dulaglutide, exenatide, Byetta, Bydureon, Tanzeum, Trulicity).

To make sure Saxenda is safe for you, tell your doctor if you have:

  • stomach problems causing slow digestion;

  • kidney or liver disease;

  • high triglycerides (a type of fat in the blood);

  • heart problems;

  • a history of pancreatitis;

  • a history of gallstones;

  • a history of alcoholism; or

  • a history of depression or suicidal thoughts.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

It is not known whether Saxenda will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether liraglutide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Saxenda is not approved for use by anyone younger than 18 years old.

How should I use Saxenda?

Do not use Saxenda and Victoza together. These two brands contain the same active ingredient but they should not be used together.

Use Saxenda exactly as prescribed by your healthcare provider. Your dose should be increased after 1 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 once per day, at any time during the day.

  • You can use Saxenda with or without food.

  • Your doctor should start you on a diet and exercise program when you start taking Saxenda. Stay on this program while you are using this medicine.

  • Saxenda comes in a prefilled pen.

  • Your healthcare provider must teach you how to inject Saxenda 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 this Medication Guide 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 pen, you must follow the “Check the Saxenda flow with each new pen” (see the detailed Patient Instructions for Use that comes with this Medication Guide). You only need to do this 1 time with each new pen. You should also do this if you drop your pen. If you do the “Check the Saxenda flow with each new pen” 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 take too much Saxenda, call your healthcare provider right away. Too much of this medicine may cause severe nausea and vomiting.

  • Never share your pen or needles with another person. You may give an infection to them, or get an infection from them.

Storing unopened injection pens: Store in the refrigerator. Do not freeze Saxenda, and throw away the medication if it has become frozen. Do not use an unopened injection pen if the expiration date on the label has passed.

Storing after your first use: You may keep "in-use" injection pens in the refrigerator or at room temperature. Protect the pens from moisture, heat, and sunlight. The Saxenda pen you are using should be thrown away after 30 days, even if it still has medicine left in it. Remove the needle before storing an injection pen, and keep the cap on the pen when not in use.

Saxenda dosing information

Usual Adult Dose for Weight Loss:

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed by 1 additional week if necessary:
Week 1: Inject 0.6 mg subcutaneously once a day
Week 2: Inject 1.2 mg subcutaneously once a day
Week 3: Inject 1.8 mg subcutaneously once a day
Week 4: Inject 2.4 mg subcutaneously once a day
Week 5: Inject 3 mg subcutaneously once a day
Maintenance dose: 3 mg subcutaneously once a day

-Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia; conversely when discontinuing use in a patient with type 2 diabetes, monitor for an increase in blood glucose.
-If a dose of 3 mg once daily is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.
-Evaluate weight loss at 16 weeks; if at least 4% of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Use: In adult patients with an initial BMI of 30 kg/m2 or greater (obese) or an initial BMI of 27 kg/m2 (overweight) or greater in the presence of at least 1 weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia), this drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

If you miss your daily dose of Saxenda, use Saxenda as soon as you remember. Then 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Saxenda?

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Saxenda side effects

Get emergency medical help if you have signs of an allergic reaction to Saxenda: hives; fast heartbeats; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • racing or pounding heartbeats;

  • sudden changes in mood or behavior, suicidal thoughts;

  • severe ongoing nausea, vomiting, or diarrhea;

  • signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;

  • gallbladder problems - fever, upper stomach pain, clay-colored stools, jaundice (yellowing of your skin or eyes);

  • symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;

  • severely low blood sugar - extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or

  • kidney problems - little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common Saxenda side effects may include:

  • low blood sugar;

  • nausea (especially when you start using liraglutide), vomiting, stomach pain;

  • upset stomach, loss of appetite;

  • headache, dizziness, tiredness; or

  • diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Saxenda?

Saxenda can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • insulin; or

  • oral diabetes medicine - Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others.

This list is not complete. Other drugs may interact with liraglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Saxenda.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Saxenda only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 6.02. Revision Date: 2016-05-25, 2:31:33 PM.