WOODCLIFF LAKE, NJ, June 7, 2013 /PRNewswire/ — Eisai Inc. announced today that BELVIQ (pronounced BEL-VEEK) will be available to eligible patients by prescription in the United States beginning June 11.
BELVIQ was approved by the U.S. Food and Drug Administration on June 27, 2012 to be used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m² or greater (obese), or BMI of 27 kg/m² or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes your risk of heart problems or stroke, or of death due to heart problems or stroke.
“BELVIQ is a new treatment option for the medical management of patients who are obese and who have not been able to sustain long-term weight loss by altering their diets or increasing exercise alone,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “Eisai is committed to making BELVIQ available to appropriate patients as part of our human health care corporate mission of keeping patients’ medical needs at the forefront of all that we do.”
BELVIQ will be available in U.S. pharmacies only with a prescription. Patients are cautioned not to buy BELVIQ from parties offering BELVIQ without a valid prescription from their doctor. Eisai will market and distribute BELVIQ in the United States and Arena Pharmaceuticals will manufacture and supply the finished commercial product from its facility in Switzerland.
“BELVIQ provides appropriate patients with a new treatment option that along with diet and exercise can help them lose weight and keep the weight off,” said Ken Fujioka, M.D., Director of the Center for Weight Management at the Scripps Clinic. “Obesity needs to be recognized and treated as a chronic disease. The availability of BELVIQ is a significant milestone in the medical management of overweight and obesity as we work to slow this epidemic in the United States.”
About BELVIQ (lorcaserin HCl) CIV Tablets
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence. For more information about BELVIQ, click here for the full Product Information or visit www.BELVIQ.com
Important Safety Information
- Pregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby, as weight loss offers no potential benefit to a pregnant woman.
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles.
- Valvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems.
- Changes in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you.
- Mental problems: Taking too much BELVIQ may cause hallucinations, feeling high or in a very good mood, or feelings of standing outside of your body.
- Depression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide.
- Low blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops.
- Painful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop using BELVIQ and call your doctor or go to the nearest emergency room right away.
- Slow heart beat: BELVIQ may cause your heart to beat slower.
- Decreases in blood cell count: BELVIQ may cause your red and white blood cell count to decrease.
- Increase in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid or if you are a male and your breasts begin to increase in size.
- Most common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation.
- Most common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue.
- Nursing: BELVIQ should not be taken while breastfeeding.
- Drug Interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines or other medical conditions such as: triptans, medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic), tramadol, dextromethorphan (an over-the-counter (OTC) common cold/cough medicine), OTC supplements such as tryptophan or St. John’s Wort, or erectile dysfunction medicines.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About Arena Pharmaceuticals
Arena is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs. BELVIQ® (lorcaserin HCl), Arena’s internally discovered drug, is approved in the United States and is under review for regulatory approval in additional territories. Arena’s US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena’s website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
Contacts: Eisai Inc.
Type Press Release
Date Released June 07, 2013