The Weight Loss Drug Saxenda (Liraglutide)

Saxenda (liraglutide) is one of eight FDA-approved drugs used for weight management. Saxenda is administered via injection with the Saxenda pen and works by decreasing hunger and appetite.

While Saxenda is highly effective for weight loss, it does come with a list of potential side effects and safety warnings. As such, it may not be right for certain people, particularly those with a history of thyroid or kidney problems.

This article discusses the benefits and risks of Saxenda, along with how it is administered, and who it is right for. It also covers the potential side effects and safety concerns to be aware of.

What Is Saxenda (Liraglutide)?

Saxenda is an injection that is already available in a lower dose as another drug, Victoza, which in turn is used for the treatment of type 2 diabetes.

Liraglutide belongs to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. This class of drugs lowers weight by slowing down your gut so that you feel fuller longer and less hungry overall.

Another drug in this class includes Byetta (exenatide). While all are used for diabetes, liraglutide (in its higher dose as Saxenda) is the first to receive FDA approval specifically for weight management.

How Saxenda Is Administered

Saxenda is administered by injecting the Saxenda pen subcutaneously (into the skin). It can be administered into the abdomen, thigh, or upper arm. Both the injection site and the timing of the injection can be changed without having to adjust the dose.

With Saxenda, the timing of meals does not matter. In other words, you are free to take Saxenda any time you would like—but only once per day. Saxenda must not be injected intravenously (into a vein), or intramuscularly (into a muscle).

Your healthcare provider should deliver the first injection in-office and show you how to do it properly. It's also important to read the Saxenda "Instructions for Use Guide" that comes with the pen.

To administer Saxenda:

1. Remove the dark blue pen cap straight off.
2. Check that the Saxenda medication in the pen is clear and colorless.
3. Take a new needle and pull off the paper tab.
4. Push the needle straight onto the pen and turn it until it is tight.
5. Pull off both needle caps.
6. Turn the flow selector to select the flow check symbol, marked by two dots with a line.
7. Hold the pen with the needle pointing up.
8. Press and hold the dose button until the dose counter returns to zero. The zero must line up with the dose pointer.
9. Make sure that a drop of medication appears at the needle tip. If no drop appears, repeat step 9 up to six times until a drop appears. If there is still no drop, switch out the needle for a new one and repeat the steps from the beginning.
10. If a drop of Saxenda does not appear, do not use the pen. Contact your healthcare provider for next instructions. If a drop does appear, proceed to the next step.
11. Turn the dose selector forward or backward to select the right dose (.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg).
12. Making sure you can see the dose counter, aim the needle at a 90-degree angle to your skin.
13. Insert the needle into the skin then press and hold the dose button until the dose counter switches to zero.
14. Keep the needle in the skin and count slowly to six to make sure the full dose is delivered.
15. Remove the needle from the skin.
16. Carefully remove the needle from the pen by twisting off the white cap. Always remove the needle from your pen to prevent contamination or infection.
17. Dispose of the needle in a hard plastic container.
18. Put the pen cap back on.

Using an injector for the first time can feel a little intimidating. If you feel nervous or want extra instruction, don't hesitate to give your healthcare provider a call. You can also watch a video tutorial on the Saxenda website.

How Effective Is Saxenda?

Three clinical trials have evaluated the safety and effectiveness of Saxenda. These trials enrolled approximately 4,800 people with obesity or overweight in total.

In one clinical trial involving adults with a body mass index (BMI) between 27 and 29.9 and at least one weight-related medical condition, about 34% of people using Saxenda lost at least 5% of body weight.

In another trial involving adults with an average BMI of 38, 63% of people using liraglutide lost at least 5% of their body weight.

The research is promising but ongoing and will need to be continued long-term to evaluate the safety and effectiveness of Saxenda years down the line.

Who Should Use Saxenda?

Saxenda has been approved for use in:

• Adults with a BMI of 30 or greater
• Adults with a BMI of 27 or greater who have at least one other weight-related disorder, such as diabetes, high blood pressure, or high cholesterol
• Children with obesity ages 12 and older who have a body weight above 60 kilograms

Contraindications

Saxenda is meant to be used as an adjunct to diet and exercise for chronic weight management in adults. It is not meant to replace diet and exercise.

Due to the theoretical risk of thyroid tumors, Saxenda should not be taken by people who have a rare endocrine disorder known as multiple endocrine neoplasia syndrome type 2 (MEN-2), or by people who have a personal or family history of a type of thyroid cancer known as medullary thyroid carcinoma (MTC).

Others who should not take Saxenda include:

• Children younger than 12
• Women who are pregnant or breastfeeding
• Anyone who has ever had a serious hypersensitivity reaction to liraglutide or to any of the product components of Saxenda

Saxenda Safety Warnings

The FDA considers Saxenda generally safe and effective for the treatment of overweight and obesity. But, Saxenda does come with several safety warnings:

• Gastrointestinal disorders, such as nausea, diarrhea, constipation, and gastritis (inflammation of the stomach lining), occurred in 68% of people using Saxenda during clinical trials.
• Thyroid tumors were observed in rats and mice during Saxenda clinical trials. It is unknown if Saxenda will cause thyroid thyroid cancer in humans. For this reason, people who have a family history of thyroid carcinoma should not use Saxenda.
• Breast cancer was confirmed in .7% of people using Saxenda during clinical trials. If you have a family history of breast cancer, ask your healthcare provider if Saxenda is right for.
• Acute pancreatitis, or inflammation of the pancreas, has been observed in people using liraglutide. Unless treated promptly, pancreatitis can be fatal. Look out for signs of pancreatitis, such as persistent, severe abdominal pain that sometimes radiates to the back, and vomiting.
• Acute gallbladder disease, including gallstones and gallbladder inflammation, has been observed in people using liraglutide, some of which required gallbladder removal surgery (cholecystectomy).
• Hypoglycemia, or low blood sugar, may occur in some people with type 2 diabetes being treated with Saxenda. Know the signs of hypoglycemia, such as shaking, sweating, and dizziness, and contact your healthcare provider right away if you experience them.
• Tachycardia, or increased heart rate, has been observed in people using Saxenda. Tachycardia can be serious if left untreated. Let your healthcare provider know if you develop a fast heart rate that persists while you are at rest.
• Kidney impairment, Acute kidney failure, including in people with no history of kidney problems, and worsening of chronic kidney failure have been reported in people using Saxenda. Kidney impairment appears to occur more frequently in Saxenda users who experience nausea, vomiting, or diarrhea.
• Allergic reactions can occur in some people using Saxenda, as with any injection or medication. Some allergic reactions can be very serious or life-threatening. If you develop any signs of anaphylaxis, such as dizziness or difficulty breathing, get immediate medical attention.
• Suicidal behavior and ideations have been observed in people using Saxenda. If you develop any signs of depression, suicidal thoughts or behaviors, or unusual mood changes, stop using Saxenda and contact a healthcare provider immediately. If you have a history of suicidal thoughts or behaviors, do not use Saxenda.

Saxenda isn't right for everyone. While discussing Saxenda with your healthcare provider, don't be afraid to raise questions about the possibility of these risks.

Side Effects of Saxenda

The FDA has issued a boxed warning on Saxenda, stating that tumors of the thyroid gland have been observed in studies on rodents, but that it is unknown whether or not Saxenda can cause these tumors in humans.

The most common side effects reported in people taking Saxenda include:

• Nausea
• Diarrhea
• Constipation
• Vomiting
• Redness, itching, or rash at the injection site
• Headache
• Low blood sugar (hypoglycemia)
• Fatigue

If you experience any concerning or uncomfortable side effects while taking Saxenda, contact your healthcare provider right away for advice.

Ongoing Research

The FDA is conducting ongoing research to evaluate reports of suicidal thoughts or actions in people using Saxenda and other GLP-1 RAs. The FDA claims that it did not find an association between GLP-1 RAs and suicidal thoughts or actions during its initial evaluations. However, a small number of suicidal thoughts or actions in people using Saxenda and other GLP-1 RAs have been reported.

During Saxenda clinical trials, 17 out of 2,379 people using Saxenda developed breast cancer. In a separate trial, eight out of 3,291 people using Saxenda developed thyroid cancer. Although it is unclear to researchers whether the cancers were related to Saxenda, the FDA will continue to evaluate what link, if any, there is and how it can be avoided.

According to a 2023 study published in The American Journal of Managed Care, nearly 50% of people taking GLP-1 RAs to control blood sugar stop the medication within one year. The rate of discontinuation among GLP-1 RAs is high compared to other diabetes medications. Considering the importance of treatment adherence, researchers want to understand why.

Researchers believe the high rate of discontinuation among GLP-1 RAs may be attributed to the gastrointestinal side effects these drugs can cause, such as nausea, vomiting, and diarrhea. The research highlights the need for ongoing communication between people who use GLP-1 RAs like Saxenda, and prescribing healthcare providers.

Summary

Saxenda is one of eight FDA-approved medications for weight management. It is administered via a daily injection that can be taken with or without meals. While considered generally safe and effective by the FDA, Saxenda commonly causes nausea, diarrhea, constipation, and other gastrointestinal side effects. The FDA is evaluating reports of thyroid and breast cancers, kidney failure, and suicidal ideation in people who used Saxenda. It's important to discuss these potential health risks with your healthcare provider to determine if this effective weight loss drug is right for you.