Description

Saxenda (liraglutide) injection 3 mg is an injectable prescription medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Saxenda should be used with a reduced-calorie meal plan and increased physical activity. Saxenda often gets confused with products that have similar functions such as Ozempic and Adlyxin. Saxenda should not be confused for any insulin product, such as pens, vials or cartridges.

Speak to your doctor or healthcare provider if you are interested in being prescribed Saxenda.

Tell your health care provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, herbal supplements and any time of insulin (ie, isophane and degludec)

Saxenda slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Saxenda may affect the way some medicines work and some other medicines may affect the way Saxenda works. Tell your health care provider if you take diabetes medicines, especially insulin and sulfonylurea medicines.

Saxenda is not for the treatment of type 2 diabetes nor should be combined with insulin. There is no specific diet with Saxenda but it would be beneficial to understand the foods to avoid.

Additional information

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Warnings & Precautions

Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda 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.

Saxenda is contraindicated in patients with a personal or family history of MTC or patients with Multiple Endocrine Neoplasia syndrome type 2. Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Saxenda contains liraglutide and should not be co-administered with other liraglutide-containing products or any other GLP-1 receptor agonist.

The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established.

The safety and efficacy of Saxenda in combination with other products intended for weight loss have not been established.

Saxenda and Victoza have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines.

It is unknown if Saxenda is safe and effective when taken with other prescriptions, over-the-counter medicines, or herbal weight-loss products. It is also not known if it is safe and effective in children under 12.

Severe Side Effects

As with all medication, Saxenda may cause common or severe side effects with usage. Please speak to your healthcare provider in determining if Saxenda is suitable for you. A few of the side effects should be taken seriously, as they can result in death.

Thyroid Tumors

Saxenda may cause possible thyroid tumors, including cancer.  Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and carcinomas) at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda will cause 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. Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

Pancreatitis

It may also cause inflammation of the pancreas (pancreatitis). Stop using Saxenda and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your waist to your back. On spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide.

Gallbladder Disease

Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was more significant in Saxenda-treated patients than in placebo-treated patients even after accounting for the degree of weight loss.

Hypoglycemia

Adult patients with type 2 diabetes mellitus on an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia using Saxenda, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.

Increase in Heart Rate

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 to placebo in clinical trials. In a clinical pharmacology trial that monitored heart rate continuously for 24 hours, Saxenda treatment was associated with a heart rate that was 4 to 9 bpm higher than that observed with a placebo.

Renal Impairment

In patients treated with GLP-1 receptor agonists, including Saxenda, reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. Altered renal function has been reversed in many reported cases with supportive treatment and discontinuation of potentially causative agents, including liraglutide.

Hypersensitivity Reactions

There have been reports of severe hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with liraglutide. If a hypersensitivity reaction occurs, you should discontinue Saxenda and other suspect medications and promptly seek medical advice.

Suicidal Behavior and Ideation

In Saxenda adult clinical trials, 9 (0.3%) of 3384 Saxenda- treated patients and 2 (0.1%) of the 1941 placebo-treated patients reported suicidal ideation; one of these Saxenda-treated patients attempted suicide. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and any unusual changes in mood or behavior. Please discontinue medication if you experience suicidal thoughts or behaviors. Avoid any medicines in patients with a history of suicidal attempts or active suicidal ideation.

Common Side Effects

Common side effects of Saxenda include nausea, diarrhea, constipation, headache, vomiting, low blood sugar (hypoglycemia), decreased appetite, upset stomach, tiredness, dizziness, stomach pain, and changes in enzyme (lipase) levels in your blood. Nausea is most common when first starting Saxenda but decreases over time in most people as their body gets used to the medicine.

Tell your healthcare professional if you have any side effect that bothers you or does not go away.

Allergic Reactions

Please speak to your doctor of any allergies, as this medication may cause an allergic reaction.

The active ingredient in this medication is liraglutide. The inactive ingredients are disodium phosphate dihydrate, propylene glycol, phenol, and water for injection.

Pregnancy

Saxenda is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. There are no available data with liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Saxenda should not be used during pregnancy. 

Overdose

Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdosage, appropriate supportive treatment should be initiated and, if needed, visit the nearest health facility. 

Disposing

After your injection is complete, carefully remove the needle from the pen. To avoid needlesticks, do not put the needle cap back on the needle. Immediately place the needle in a sharps container to reduce the risk of needlesticks. Put the pen cap back on your pen after each use to protect Saxenda from light.

Do not throw away used needles in household trash or recycling bins.

Storage

Store new, unused Saxenda pens in the refrigerator between 36°F and 46°F (2°C to 8°C). After first use, store in a refrigerator or at room temperature between 59°F and 86°F (15°C to 30°C).

Don’t freeze Saxenda. Saxenda that has been frozen must not be used.

Pens in use should be thrown away after 30 days even if they still have Saxenda left in them.