Saxenda® (liraglutide) injection 3 mg

How Does Saxenda Work?  Saxenda works in the brain as an appetite suppressant.

The drug is designed for adults with obesity (body mass index (BMI) >30) or overweight (BMI >27) and also affected with one obesity-related condition such as type 2 diabetes, cardiovascular disease, hypertension or high cholesterol.

In April 2020, a supplemental indication for the drug received approval from the FDA for chronic weight management in obese patients aged 12 years and older.

In March 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended the use of the drug for treating obesity in adolescents aged 12-17 years.

How Is Saxenda Dosed?

Saxenda is an injectable medication you take once a day. You may inject it at the most convenient time for you (e.g., before breakfast, lunch, dinner, or bedtime), but it should be taken at approximately the same time each day. Saxenda comes in a prefilled multidose pen, and the dose is usually increased according to the following schedule. However, if you have side effects, your doctor may slow down the dose increases to give your body time to get used to the medication.

Week 1   0.6 mg

Week 2   1.2 mg

Week 3   1.8 mg

Week 4   2.4 mg

Week 5 and afterward   3.0 mg

Is Saxenda a Controlled Substance? No, Saxenda is not a controlled substance.

Who Should Not Use Saxenda?

• Women who are pregnant, nursing, or planning to become pregnant

• People who have been diagnosed with medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or have a close family member with those diseases

 Which Medications Should Not Be Used with Saxenda? Mediations used to treat type 2 diabetes called GLP1 receptor agonists or DPP4 inhibitors work similarly to Saxenda and should not be used together with Saxenda.

Common Side Effects of Saxenda?

 • Nausea

• Headache

 • Dizziness

 • Diarrhea

 • Vomiting

 • Upset stomach

 • Constipation

Note: Nausea is most common when first starting Saxenda, but it tends to decrease over time as the body gets used to the medication.

Possible Serious Side Effects of Saxenda :

 Possible Thyroid Tumors, Including Cancer.  Tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda and medicines that work like Saxenda caused thyroid tumors, including thyroid cancer. It is not known if Saxenda will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Gallbladder Problems Saxenda may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your doctor if you develop pain in your upper abdomen, yellowing of your skin or eyes, fever, or clay-colored stools.

Pancreatitis (Inflammation of the Pancreas) Some people who have used Saxenda have developed inflammation of the pancreas. If you develop new stomach pain or back pain while using the medication, stop the medication and call your doctor. Low Blood Sugar (Hypoglycemia)

Saxenda can cause low blood sugar in people with type 2 diabetes who also take medicines used to treat type 2 diabetes (such as sulfonylureas or insulin). In some people, the blood sugar may get so low that they need another person to help them. If you take a sulfonylurea or insulin, the dose may need to be lowered while you use Saxenda. People taking these medications should check their blood sugars regularly during Saxenda treatment.

Studies :

The first SCALE clinical trial was a randomised, double-blind, placebo-controlled study. It enrolled 3,731 patients with obesity. The second study enrolled 635 patients with type 2 diabetes who were either overweight or obese, while the third study enrolled 422 patients with obesity.

Patients were given 3mg of Saxenda daily or a placebo for 56 weeks and received counselling about lifestyle changes they needed to adopt related to a low-calorie diet and regular physical exercise.

The primary efficacy parameters of the first and second SCALE clinical studies included the mean percentage change in body weight and the percentages of patients achieving greater than or equal to 5% and 10% weight loss from baseline to week 56.