Saxenda

Generic name: Liraglutide
Dosage form: Subcutaneous injection
Drug class: Incretin mimetics

Usage of Saxenda

Saxenda (liraglutide) is used for weight loss and to help keep weight off once weight has been lost, it is used for obese adults or overweight adults who also have weight-related medical problems. Saxenda can be used in children aged 12 to 17 years who with obesity and who have a bodyweight above 132 pounds (60 kg). Saxenda is used together with a healthy diet and exercise.

Saxenda is an injection given once a day under the skin (suBC UTAneous) from a multi-dose injection pen.

Saxenda contains the same active ingredient (liraglutide) as Victoza. The difference between Saxenda and Victoza is they are different strengths and they are FDA approved for different conditions.

Saxenda is not for treating type 1 or type 2 diabetes. 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.

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:

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

increased heart rate;

diarrhea, constipation;

headache, dizziness; or

feeling tired.

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.

Before taking 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

diabetic ketoacidosis (call your doctor for treatment).

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 problems with your pancreas or gallbladder; 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 affect the nursing baby. Tell your doctor if you are breast-feeding.

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

Relate drugs

How to use Saxenda

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-If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

Saxenda should not be used in combination with any other GLP-1 receptor agonist.

The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

Evaluate weight loss at 16 weeks; if 4% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management 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).

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.

Usual Pediatric Dose for Weight Loss:

12 years and older:

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed if necessary based on tolerability; dose escalation may take up to 8 weeks:

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:

2.4 or 3 mg subcutaneously once a day

If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.

Comments:

Saxenda should not be used in combination with any other GLP-1 receptor agonist.

Evaluate weight loss at 12 weeks on the maintenance dose; if 1% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment and this drug should be discontinued.

Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in pediatric patients with a body weight above 60 kg and an initial BMI of 30 kg/m2 or greater.

Warnings

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, diabetic ketoacidosis, or are pregnant.

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.

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.

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