Saxenda Prescribing Information, Explained Section by Section
The Saxenda label carries a boxed warning for thyroid c-cell tumors, 9 other warnings and 2 drug interaction lines. It is approved for 1 use.
- Boxed warning
- C-cell tumors in the thyroid
- Approved uses
- 1
- Warnings
- 9
- First approved
- 2014
Saxenda: key facts
The half-life is about 13 hours. After 13 hours, half is gone, and about 3% remains after five half-lives (2.7 days).
SCALE Obesity and Prediabetes, 56 weeks: body weight loss was 7.4%, compared with 3% on placebo.
Sources: FDA label (DailyMed).
Boxed warning for Saxenda
Boxed warning: Saxenda caused thyroid C-cell tumors in rodents, but it is not known whether it causes them in people. Do not use it if you or a family member has had medullary thyroid cancer (MTC), or if you have MEN 2.
What the label says
“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 SAXENDA causes”
Source: FDA label (DailyMed).
Indications
It helps adults and children 12 and older who weigh over 60 kg and have obesity lose weight and keep it off over the long term, along with diet and activity. It also helps adults who have overweight plus a weight-related condition.
What the label says
“SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term”
Source: FDA label (DailyMed).
Contraindications
Either medullary thyroid cancer (MTC) in your personal or family history, or MEN 2.
What the label says
“personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
Source: FDA label (DailyMed).
A serious allergic reaction in the past to liraglutide or any product ingredient.
What the label says
“a serious hypersensitivity reaction to liraglutide or to any of the excipients in SAXENDA. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported”
Source: FDA label (DailyMed).
Cautions and warnings
C-cell tumors in the thyroid. Saxenda caused thyroid C-cell tumors in rodents, but it is not known whether it causes them in people. Do not use it if you or a family member has had medullary thyroid cancer (MTC), or if you have MEN 2.
What the label says
“Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice [see Nonclinical Toxicology”
Source: FDA label (DailyMed).
Pancreatitis. It can cause inflammation of the pancreas. If severe stomach pain does not go away, stop taking it and get care. The pain may spread to your back.
What the label says
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including liraglutide [see Adverse Reactions”
Source: FDA label (DailyMed).
Disease of the gallbladder. You may develop gallstones and inflammation of the gallbladder. Report any fever, yellow skin or eyes, and pain in the upper right belly.
What the label says
“In SAXENDA clinical trials in adults, 2.2% of SAXENDA-treated patients reported adverse events of cholelithiasis versus 0.8% of placebo-treated patients. The incidence of cholecystitis was”
Source: FDA label (DailyMed).
Blood sugar that is too low. Low blood sugar is more likely alongside insulin or a sulfonylurea, so the doses of those drugs may need lowering.
What the label says
“Adult patients with type 2 diabetes mellitus on an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia with use of”
Source: FDA label (DailyMed).
Increased heart rate.It can increase your resting heart rate. Tell your doctor if your heartbeat races or pounds while you are at rest.
What the label says
“Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in SAXENDA-treated adult patients compared”
Source: FDA label (DailyMed).
Fluid loss can cause kidney injury. Vomiting or diarrhea may cause fluid loss that leads to kidney injury. Drink fluids, and report any heavy fluid loss.
What the label says
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with liraglutide [see Adverse Reactions (6.2)]. The majority”
Source: FDA label (DailyMed).
Severe stomach and gut side effects. Side effects in the stomach and gut are common and may be severe. It is not recommended for people with severe gastroparesis.
What the label says
“Use of GLP-1 receptor agonists, including liraglutide, has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In SAXENDA clinical trials, severe”
Source: FDA label (DailyMed).
Allergic reactions that are serious. Reports include serious allergic reactions with swelling of the face, lips or throat. If they occur, stop it and get help right away.
What the label says
“There have been reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with SAXENDA [see Contraindications (4), Adverse Reactions (6.1, 6.2)].”
Source: FDA label (DailyMed).
Food reaching your lungs while you are under anesthesia or sedation. Food may stay in your stomach longer, and that matters during anesthesia or deep sedation. Let the care team know before any procedure.
What the label says
“SAXENDA delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Table of adverse reactions
The label trials list the side effects that appeared most often, grouped by dose and set beside the placebo column.
| Side effect | Placebo | Saxenda Saxenda | More than placebo |
|---|---|---|---|
| Nausea | 13.8% | 39.3% | +25.5 points |
| Diarrhea | 9.9% | 20.9% | +11 points |
| Constipation | 8.5% | 19.4% | +10.9 points |
| Vomiting | 3.9% | 15.7% | +11.8 points |
| Injection Site Reaction | 10.5% | 13.9% | +3.4 points |
| Headache | 12.6% | 13.6% | +1 points |
| Hypoglycemia in T2DM | 6.6% | 12.6% | +6 points |
| Dyspepsia | 2.7% | 9.6% | +6.9 points |
| Fatigue | 4.6% | 7.5% | +2.9 points |
| Dizziness | 5% | 6.9% | +1.9 points |
| Abdominal Pain | 3.1% | 5.4% | +2.3 points |
| Increased Lipase | 2.2% | 5.3% | +3.1 points |
Source: Saxenda label (DailyMed).
Interactions with other drugs
Stomach emptying slows, which may affect how your body absorbs other pills.
What the label says
“SAXENDA causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials,”
Source: FDA label (DailyMed).
With type 2 diabetes, taking insulin or a sulfonylurea alongside it brings a higher chance of low blood sugar.
What the label says
“risk of hypoglycemia with use of SAXENDA, including severe hypoglycemia.”
Source: FDA label (DailyMed).
Pregnancy and breast feeding
Losing weight brings no benefit when you are pregnant, and animal studies point to a possible risk for a baby.
What the label says
“Based on animal reproduction studies, there may be risks to the fetus from exposure to SAXENDA during pregnancy. SAXENDA should be used during pregnancy only”
Source: FDA label (DailyMed).
Whether it passes into human breast milk is not known.
What the label says
“There are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or effects on milk production. Liraglutide was”
Source: FDA label (DailyMed).
Patient counselling and storage
Put new pens in the fridge; once you have used a pen, it can sit at room temperature, or stay in the fridge, for 30 days.
What the label says
“After initial use of the SAXENDA pen, the pen can be stored for 30 days at controlled room temperature 59°F to 86°F (15°C to 30°C)”
Source: FDA label (DailyMed).
Comparing this label with other GLP-1 labels
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
 Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
 Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Birth control pills, Strong CYP3A4 inhibitors and Strong CYP3A4 inducers, Simvastatin |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
| Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Warfarin and narrow-range drugs, plus Birth control pills and antibiotics |
Sources: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the complete Saxenda label
You can find the complete prescribing information on DailyMed, the National Library of Medicine label site.