Saxenda is the next obesity drug approved by the FDA

 In Blog, Medical Conditions related to Obesity, Weight Loss

saxenda-pen-300x114Another medication has been approved by the FDA to be used to help overweight or obese patients lose weight. The medication, Liraglutide, is already being used in the treatment of type 2 diabetes. The brand name for the obesity version of the drug will be Saxenda.

Saxenda is given as a once daily injection into the skin, in a similar manner to an insulin injection. It is delivered through a pen injector which makes it both easy to do and almost painless, due to the very small size of the needle.  However, this new drug isn’t really new at all. It’s been on the market for type 2 diabetics and is known as Victoza, which is part of a drug class called incretin mimetics. The other drug on the market that essentially does the same thing is called Byetta, or exenatide.

This class of drugs activates something called glucagon-like-peptide-1 (or GLP-1), a chemical released by the digestive system which does several things. It increases insulin secretion (which lowers blood sugar), it decreases glucagon secretion (which lowers blood sugar), and it delays gastric emptying (slows down digestion). The most common side effect of Victoza, Byetta, and now the new drug Saxenda (which is nothing more than a higher dose of Victoza) decreases your appetite through the above mentioned mechanisms, especially the delayed gastric emptying. If the food you eat takes longer to move through your digestive system, you should feel fuller longer. Unfortunately, that exact mechanism can also cause the person taking the medication to feel bloated or nauseated. This is the most common side effect of the medication and the most likely reason someone might discontinue it. However, if you don’t have significant nausea, this can be a wonderful drug to aid in weight loss.

This is the 5th available obesity drug in the United States which is a victory for physicians specializing in obesity, as it gives us one more tool in our toolbox. Of course, many of our patients lose weight without taking any medication, so while it’s one way, it’s not the only way.

Dr. Pinto is experienced using this drug in it’s approved diabetic dosing and is ready to start using it for patient’s to lose weight.

Indications and Usage

  • Saxenda® (liraglutide [rDNA origin] injection) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)

Limitations of Use

  • Saxenda® is not indicated for the treatment of type 2 diabetes.
  • Saxenda® should not be used in combination with any other GLP-1 receptor agonist.
  • Saxenda® should not be used with insulin.
  • The effects of Saxenda® on cardiovascular morbidity and mortality have not been established.
  • The safety and efficacy of coadministration with other products for weight loss have not been established.
  • Saxenda® has not been studied in patients with a history of pancreatitis.
Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

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 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 and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).  Counsel patients regarding the risk of MTC with use of Saxenda® and inform them of symptoms of thyroid tumors (e.g., 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 Saxenda®.

Contraindications

Saxenda® is contraindicated in the following conditions:

  • Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Patients with a prior serious hypersensitivity reaction to liraglutide or to any of the product components
  • Pregnancy

Warnings and Precautions

  • Acute Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide. After initiation of Saxenda® observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Saxenda® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Saxenda® should not be restarted.
  • Acute Gallbladder Disease: Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Saxenda®-treated patients than in placebo-treated patients even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
  • Serious Hypoglycemia: When Saxenda® is used with an insulin secretagogue (e.g., a sulfonylurea) serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.
  • Heart Rate Increase:  For patients who experience a sustained increase in resting heart rate while taking Saxenda®, Saxenda® should be discontinued.
  • Renal Impairment: Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Saxenda® in patients with renal impairment.
  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported during postmarketing use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda® and promptly seek medical advice.
  • Suicidal Behavior and Ideation: Patients treated with Saxenda® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Saxenda® in patients who experience suicidal thoughts or behaviors. Avoid Saxenda® in patients with a history of suicidal attempts or active suicidal ideation.

Adverse Events

  • The most common adverse reactions, reporting in ≥5% are:  nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase.

Use in Specific Populations

  • Nursing mothers should either discontinue Saxenda® or discontinue nursing.
  • Safety and effectiveness of Saxenda® have not been established in pediatric patients and is not recommended for use in pediatric patients.
More information on the medication can be found here.