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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, to 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.
Saxenda is not for treating type 1 or type 2 diabetes.
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.
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.
Saxenda is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not use Saxenda and Victoza together. These two brands contain the same active ingredient but they should not be used together.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Saxenda is injected under the skin at any time of the day, with or without a meal. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Saxenda comes in a prefilled injection pen. Ask your pharmacist which type of needles are best to use with your pen.
Your care provider will show you the best places on your body to inject Saxenda. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
Do not use Saxenda if it has changed colors or looks cloudy, or if it has particles in it. Call your pharmacist for new medicine.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Saxenda is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
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. Use within 30 days. Remove the needle before storing an injection pen, and keep the cap on the pen when not in use.
Usual Adult Dose of Saxenda 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
Comments:
-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.
If you miss your daily dose of Saxenda, use the dose 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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.
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.
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.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Saxenda (www.drugs.com/saxenda.html).
Note: This document contains side effect information about liraglutide. Some of the dosage forms listed on this page may not apply to the brand name Saxenda.
Applies to liraglutide: subcutaneous solution
Subcutaneous route (Solution)
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.Liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide and inform them of symptoms of thyroid tumors (eg a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide.
Along with its needed effects, liraglutide (the active ingredient contained in Saxenda) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking liraglutide:
More common
Less common
Rare
Incidence not known
Some side effects of liraglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to liraglutide: subcutaneous solution
Chronic Weight Management:
Very common (10% or more): Nausea (39.3%), diarrhea (20.9%), constipation (19.4%), vomiting (15.7%),
Common (1% to 10%): Dyspepsia, abdominal pain, upper abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence, dry mouth, gastroenteritis, viral gastroenteritis, increased lipase
Uncommon (0.1% to 1%): Acute pancreatitis, acute gallbladder disease
Type 2 Diabetes Mellitus:
Very common (10% or more): Nausea (up to 28.4%), diarrhea (up to 17.1%), vomiting (up to 10.9%)
Common (1% to 10%): Constipation, dyspepsia, abdominal pain, gastritis, flatulence, abdominal discomfort, toothache, elevated lipase, elevated amylase
Rare (less than 0.1%): Intestinal obstruction
Postmarketing reports: Acute hemorrhagic or necrotizing pancreatitis, including fatalities
Chronic Weight Management:
-The percentage of patients reporting nausea declined as treatment continued. Most gastrointestinal events were mild or moderate and did not lead to discontinuation.
-Acute pancreatitis occurred in 0.3% (9/3291) of liraglutide-treated patients and 0.1% (1/1843) of placebo patients in clinical trials. Three additional cases occurred in liraglutide-treated patients, 2 in patients who prematurely withdrew from the trial and 1 during an off-treatment follow-up period.
-Acute gallbladder disease was reported more frequently in liraglutide-treated patients (1.5% versus 0.5%) during clinical trials. Substantial or rapid weight loss can increase the risk of cholelithiasis, but even after accounting for the degree of weight loss, the incidence of acute gallbladder disease was greater in liraglutide-treated patients.
Type 2 Diabetes Mellitus
-Postmarketing reports of acute hemorrhagic or necrotizing pancreatitis, including fatalities have been reported. During clinical trials, 13 cases of pancreatitis were received among liraglutide treated patients, 9 acute and 4 chronic compared with 1 case in the comparator (glimepiride) group; some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse.
-Serum amylase and lipase were routinely measure in the LEADER trial; elevations of 3 times the upper limit of normal were reported in 1% and 7.5% of liraglutide treated patients compared with 0.7 % and 4.5% of placebo, respectively.
-In the LEADER trial, 3.1% of liraglutide treated patients reported an acute event of gallbladder disease such as cholelithiasis or cholecystitis.
Chronic Weight Management:
Very common (10% or more): Hypoglycemia in type 2 diabetes (23%)
Common (1% to 10%): Decreased appetite
Type 2 Diabetes Mellitus:
Very common (10% or more): Hypoglycemia (when used in combination with a sulfonylurea)
Common (1% to 10%): Hypoglycemia, anorexia, decreased appetite
Uncommon (0.1% to 1%): Dehydration
Postmarketing reports: Dehydration resulting from nausea, vomiting and diarrhea
Chronic Weight Management:
In patients with type 2 diabetes mellitus receiving this drug for chronic weight management, severe hypoglycemia occurred in 0.7% (3/422) of liraglutide-treated patients, each of these patients was also receiving a sulfonylurea. Among all patients receiving this drug in combination with a sulfonylurea, symptomatic hypoglycemia occurred in 43.6% (48/110) of patients. The dose of sulfonylurea had been reduced by 50% at the start of the trial. Among patients not taking a sulfonylurea, symptomatic hypoglycemia occurred in 15.7% (49/312) of patients.
Type 2 Diabetes Mellitus:
Major episodes of hypoglycemia have not been reported in clinical trials in which liraglutide was used as monotherapy, however, when used in combination with a sulfonylurea, hypoglycemia was very commonly reported.
Very common (10% or more): Headache (up to 13.6%)
Common (1% to 10%): Dizziness
Frequency not reported: dysgeusia
Type 2 Diabetes Mellitus:
Common (1% to 10%): Nasopharyngitis, bronchitis, upper respiratory infection
The most commonly reported adverse events for this drug when used for weight management have included nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.
The most commonly reported adverse events for this drug when used to treat type 2 diabetes mellitus have included nausea, diarrhea, vomiting, constipation, dyspepsia, and decreased appetite.
Chronic Weight Management:
Very common (10% or more): Increases in mean resting heart rate
Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Cardiac conduction disorder, tachycardia
Type 2 Diabetes Mellitus:
Common (1% to 10%): Increased heart rate
Chronic Weight Management:
Cardiac conduction disorders were reported as first degree atrioventricular block, right bundle branch block, or left bundle branch block.
Increases in mean resting heart rate of 2 to 3 beats per minute (bpm) were observed in clinical trials. Increases of 10 and 20 bpm at 2 consecutive visits were 34% and 5% in liraglutide-treated patients versus 19% and 2% in the placebo group, respectively. Resting heart rate exceeding 100 bpm was recorded for 6% of liraglutide-treated patients versus 4% of placebo patients. Tachycardia was reported in 0.6% of liraglutide-treated patients compared with 0.1% of placebo patients. Monitoring heart rate over 24-hours found that liraglutide treatment was associated with a 4 to 9 bpm higher heart rate than placebo. The clinical significance of this is unknown.
Common (1% to 10%): Urinary tract infection
Common (1% to 10%): Injection site erythema, injection site reaction
The most common injection site reactions were erythema, pruritus, and rash at the injection site.
Frequency not reported: Development of anti-liraglutide (the active ingredient contained in Saxenda) antibodies
Uncommon (0.1% to 1%): Urticaria
Postmarketing reports: Serious hypersensitivity reactions (e.g. anaphylactic reactions and angioedema), allergic reactions (rash and pruritus)
While this drug has not been found to be directly nephrotoxic in animal studies or clinical trials, postmarketing reports of acute renal failure and worsening of chronic renal failure sometimes requiring dialysis have been received. A majority of reports occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.
Type 2 Diabetes Mellitus:
Uncommon (0.1% to 1%): Renal impairment, acute renal failure
Postmarketing reports: Acute renal failure and worsening of chronic renal failure, sometimes requiring dialysis, increased serum creatinine
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Urticaria, pruritus
Common (1% to 10%): Increased blood calcitonin levels
Uncommon (0.1% to 1%): Goiter
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia, malaise
Chronic Weight Management:
Fatigue and asthenia were most commonly reported within the first 12 weeks and were often co-reported with gastrointestinal events.
Chronic Weight Management:
In clinical trials, 0.2% (6/3384) patients receiving liraglutide (the active ingredient contained in Saxenda) reported suicidal ideation and 1 attempted suicide. There were no reports in patients receiving placebo.
Chronic Weight Management:
Common (1% to 10%): Insomnia, anxiety
Uncommon (0.1% to 1%): Suicidal ideation
Very rare (less than 0.01%): Suicide attempt
Chronic Weight Management:
Uncommon (0.1% to 1%): ALT increased
Frequency not reported: AST increased
Type 2 Diabetes Mellitus:
Postmarketing reports: Elevations of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis
Chronic Weight Management:
Breast Cancer: During clinical trials, 0.6% (4/2379) of liraglutide-treated patients were diagnosed with breast cancer compared with 0.2% (3/1300) of placebo patients. There were too few cases to determine if these were related to drug treatment and insufficient data to determine whether this drug had an effect on preexisting breast neoplasia.
Papillary Thyroid Cancer: During clinical trials, 0.2% (7/3291) of the liraglutide-treated patients were diagnosed with papillary thyroid carcinoma compared with no cases in 1843 placebo patients.
Colorectal Neoplasms: During clinical trials, 0.5% (17/3291) of the liraglutide-treated patients had benign colorectal neoplasms compared with 0.2% (4/1843) of placebo patients. Malignant colorectal carcinoma was diagnosed in 2 liraglutide-treated patients.
Type 2 Diabetes Mellitus:
In clinical trials, 6 cases of thyroid C-cell hyperplasia were reported among liraglutide-treated patients and 2 cases in the comparator-treated group (1.3 vs 1 case per 1000 patient-years). Medullary thyroid carcinoma was diagnosed in 1 patient in the comparator group who had pretreatment serum calcitonin concentrations greater than 1000 ng/L suggesting preexisting disease. The study required protocol-specified serum calcitonin measurements. All cases of thyroid C-cell hyperplasia were diagnosed after thyroidectomy which was done due to abnormal calcitonin levels. Of the 6 patients with thyroid C-cell hyperplasia, 5 had elevated calcitonin concentrations at baseline and throughout the trial. One patient in both the liraglutide-treated group and the comparator group developed elevated calcitonin concentrations while on treatment.
Chronic Weight Management:
Uncommon (0.1% to 1%): Benign colorectal neoplasms, papillary thyroid cancer, breast cancer, malignant colorectal carcinoma
Type 2 Diabetes Mellitus:
Uncommon (0.1% to 1%): Thyroid neoplasms
Frequency not reported: Thyroid C-cell hyperplasia
Postmarketing reports: Medullary Thyroid Cancer
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Saxenda (www.drugs.com/saxenda.html).
June 23, 2016
August 6, 2020
August 6, 2020
August 6, 2020
August 6, 2020
August 6, 2020
