Liraglutide (saxenda) (new)

<body><h2>Description</h2> Liraglutide, sold under the brand name Victoza among others, is a medication used to treat diabetes mellitus type 2 and obesity. In diabetes it is a less preferred agent. Its effects on long term health outcomes like heart disease and life expectancy are unclear. In obesity if after 12 weeks less than 5% of body weight is lost it is recommended the medication be stopped. It is given by injection under the skin. The Victoza brand of liraglutide is used together with diet and exercise to improve blood sugar control in adults and children at least 10 years old who have type 2 diabetes mellitus. Victoza is also used to help reduce the risk of serious heart problems such as heart attack or stroke in adults who have type 2 diabetes and heart disease. Victoza is not for treating type 1 diabetes. The Saxenda brand of liraglutide is used together with diet and exercise to help people lose weight when they have certain health conditions. Saxenda is not for treating type 1 or type 2 diabetes. Saxenda is not a weight-loss medicine or appetite suppressant. Liraglutide may also be used for purposes not listed in this medication guide. <h2>History</h2> Liraglutide was approved for medical use in Europe in 2009 and in the United States in 2010. A month supply in the United Kingdom costs the NHS about £78.50 as of 2019. In the United States the wholesale cost of this amount is about US$98.30. In 2016, it was the 188th most prescribed medication in the United States with more than 3 million prescriptions. <h2>Cautions</h2> Do not use Saxenda and Victoza together. You should not use liraglutide if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer. In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath. You should not use liraglutide if you are allergic to it, or if you have: multiple endocrine neoplasia type 2 (tumors in your glands); or a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer).Tell your doctor if you have ever had: stomach problems causing slow digestion; kidney or liver disease; high triglycerides (a type of fat in the blood); heart problems; problems with your pancreas or gallbladder; or (if you use Saxenda) depression or suicidal thoughts. In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk. Do not use Saxenda if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight. Stop using Saxenda and tell your doctor right away if you become pregnant. Follow your doctor’s instructions about using Victoza if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester. It may not be safe to breastfeed while using liraglutide. Ask your doctor about any risk. <h2>How to use and store</h2> Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Do not use Saxenda and Victoza together. Liraglutide is injected under the skin at any time of the day, with or without a meal. A healthcare provider may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions. Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine. Call your doctor if you are sick with vomiting or diarrhea. You can easily become dehydrated while using liraglutide. This can lead to kidney failure. You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda). Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency. Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination. Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule. Storing unopened injection pens: Refrigerate and use until the expiration date. Storing after your first use: Store the pen in a refrigerator or at room temperature and use within 30 days. Do not freeze liraglutide, and throw away the medicine if it has become frozen. Use a needle only once and then place it in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.Side Effects Common side effects include low blood sugar, nausea, dizziness, abdominal pain, and pain at the site of injection. Other serious side effects may include medullary thyroid cancer, angioedema, pancreatitis, gallbladder disease, and kidney problems. Use in pregnancy and breastfeeding is of unclear safety. Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 receptor agonist) also known as incretin mimetics. It works by increasing insulin release from the pancreas and decreases excessive glucagon release. <h2>Thyroid cancer:</h2> At exposures eight times greater than those used in humans, liraglutide caused a statistically significant increase in thyroid tumors in rats. The clinical relevance of these findings is unknown. In clinical trials, the rate of thyroid tumors in patients treated with liraglutide was 1.3 per 1000 patient (4 people) compared to 1.0 per 1000 patients (1 person) in comparison groups. The sole person in the comparator group and four of the five persons in the liraglutide group had serum markers (elevated calcitonin) suggestive of pre-existing disease at baseline. The FDA said serum calcitonin, a biomarker of medullary thyroid cancer, was slightly increased in liraglutide patients, but still within normal ranges, and it required ongoing monitoring for 15 years in a cancer registry. <h2>Pancreatitis:</h2> In 2013, a group at Johns Hopkins reported an apparently statistically significant association between hospitalization for acute pancreatitis and prior treatment with GLP-1 derivatives (such as exenatide) and DPP-4 inhibitors (such as sitagliptin). In response, the United States FDA and the European Medicines Agency conducted a review of all available data regarding the possible connection between incretin mimetics and pancreatitis or pancreatic cancer. In a joint 2014 letter to the New England Journal of Medicine, the agencies concluded that “A pooled analysis of data from 14,611 patients with type 2 diabetes from 25 clinical trials in the sitagliptin database provided no compelling evidence of an increased risk of pancreatitis or pancreatic cancer” and “Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data. The FDA and the EMA have not reached a final conclusion at this time regarding such a causal relationship. Although the totality of the data that have been reviewed provides reassurance, pancreatitis will continue to be considered a risk associated with these drugs until more data are available; both agencies continue to investigate this safety signal. <h2>Dosage for weight loss</h2> Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed by 1 additional week if necessary:Week 1: Inject 0.6 mg subcutaneously once a dayWeek 2: Inject 1.2 mg subcutaneously once a dayWeek 3: Inject 1.8 mg subcutaneously once a dayWeek 4: Inject 2.4 mg subcutaneously once a dayWeek 5: Inject 3 mg subcutaneously once a dayMAINTENANCE dose: 3 mg subcutaneously once a day-If maintenance dose is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses. - Saxenda and Victoza both contain liraglutide; Saxenda is indicated for use in chronic weight management and should not be used for the treatment of type 2 diabetes mellitus.- Saxenda has not been studied in combination with insulin.- Evaluate weight loss at 16 weeks; if 4% or more of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Use: As an adjunct to a reduced-caloried diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/m2 or greater (obese) or an initial BMI of 27 kg/m2 (overweight) or greater in the presence of at least 1 weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling. <h2>Availability</h2> Liraglutide is marketed under the brand name Victoza in the U.S., U.K. UAE, Kuwait, India, Iran, Canada, Europe and Japan. It has been launched in Germany, Italy, Denmark, the Netherlands, the United Kingdom, Ireland, Sweden, Japan, Canada, the United States, France, Malaysia and Singapore. Liraglutide is also known to be marketed as Saxenda in Australia, Iran, Israel, Canada, Brazil, and the U.S. Liraglutide was approved by the FDA in 2014 and by the European Medicines Agency in 2015, for adults with a body mass index (BMI) of 30 or greater (obesity) or a BMI of 27 or greater (overweight) who have at least one weight-related condition. Liraglutide was approved by the FDA in 2019 for treatment of children 10 years or older with type 2 diabetes, making it the first non-insulin drug approved to treat type 2 diabetes in children since metformin was approved in 2000. Novo Nordisk stated that it plans to use 500 of its 3,000-strong sales force in the United States to promote Saxenda in 2015, because it is considered to have the potential for sales of $1 billion a year within 8–10 years of launch around the world. Analysts at Citi Research concur, assuming that the drug will reach less than 0.5 percent of the 107 million people in the United States classified as obese, and a daily price of $30 over 6 to 12 months’ use. The company estimates that it has spent about $1 billion over ten years to take Saxenda from research to marketing. </body>