BELVIQ XR Extended Release Extended Release (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

BELVIQ XR 20-mg tablets are supplied as orange-colored, round, biconvex, film-coated tablets debossed with “A” on one side and “20” on the other side and are available as follows:

  • NDC 62856-535-30 Bottle of 30

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP controlled room temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • BELVIQ XR is indicated for chronic weight management only in conjunction with a reduced-calorie diet and increased physical activity.
  • Patients should be instructed to discontinue use of BELVIQ XR if they have not achieved 5% weight loss by 12 weeks of treatment.
  • Patients should be informed of the possibility of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions with the combined use of BELVIQ XR with other serotonergic drugs, including selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), triptans, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dietary supplements such as St. John’s Wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.
  • Patients who develop signs or symptoms of valvular heart disease, including dyspnea or dependent edema should seek medical attention.
  • Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ XR therapy does not affect them adversely.
  • Patients should be instructed to seek medical attention in the event of emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • Patients should be cautioned not to increase their dose of BELVIQ XR.
  • Men who have an erection lasting greater than 4 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention.
  • Pregnancy: Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider with a known or suspected pregnancy [ see Contraindications (4), Use in Specific Populations (8.1)].
  • Lactation: Advise women to avoid use of BELVIQ XR while breastfeeding [see Use in Specific Populations (8.2)].
  • Patients should tell their healthcare provider about all the medications, nutritional supplements and vitamins (including any weight loss products) that they may take while taking BELVIQ XR.

BELVIQ XR is a registered trademark of Arena Pharmaceuticals GmbH, Zofingen, Switzerland

Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

PATIENT INFORMATION BELVIQ XR ® (BEL-VEEK E KS -A RE ) (lorcaserin hydrochloride) Extended Release Tablets
What is BELVIQ XR ? BELVIQ XR is a prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.BELVIQ XR should be used with a reduced calorie diet and increased physical activity.It is not known if BELVIQ XR is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.It is not known if BELVIQ XR changes your risk of heart problems or stroke or of death due to heart problems or stroke.It is not known if BELVIQ XR is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).It is not known if BELVIQ XR is safe and effective in children under 18 years old.
BELVIQ XR is a federally controlled substance (CIV) because it contains lorcaserin hydrochloride and may be abused or lead to drug dependence. Keep your BELVIQ XR in a safe place, to protect it from theft. Never give your BELVIQ XR to anyone else, because it may cause harm to them. Selling or giving away this medicine is against the law.
Do not take BELVIQ XR if you: ● are pregnant or planning to become pregnant. BELVIQ XR may harm your unborn baby.● are allergic to lorcaserin hydrochloride or any of the ingredients in BELVIQ XR. See the end of this leaflet for a complete list of ingredients in BELVIQ XR.
Before you take BELVIQ XR , tell your healthcare provider about all of your medical conditions, including if you: ● have or have had heart problems including: ○ congestive heart failure ○ heart valve problems ○ slow heart beat or heart block ● have diabetes● have a condition such as sickle cell anemia, multiple myeloma, or leukemia● have a deformed penis, Peyronie’s disease, or ever had an erection that lasted more than 4 hours● have kidney problems● have liver problems● are pregnant or plan to become pregnant. ● are breastfeeding or plan to breastfeed. It is not known if BELVIQ XR passes into your breast milk. You and your healthcare provider should decide if you will take BELVIQ XR or breastfeed. You should not do both.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BELVIQ XR may affect the way other medicines work, and other medicines may affect how BELVIQ XR works. Especially tell your healthcare provider if you take medicines for depression, migraines or other medical conditions such as: ● triptans, used to treat migraine headache ● medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin uptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or antipsychotics ● cabergoline ● linezolid, an antibiotic● tramadol ● dextromethorphan, an over-the-counter medicine used to treat the common cold or cough● over-the-counter supplements such as tryptophan or St. John’s Wort● medicines to treat erectile dysfunctionAsk your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know all the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take BELVIQ XR ? • Take BELVIQ XR exactly as your healthcare provider tells you to take it.• Your healthcare provider will tell you how much BELVIQ XR to take and when to take it. ○ Take 1 tablet 1 time each day. Do not increase your dose of BELVIQ XR. ○ BELVIQ XR can be taken with or without food. ○ Take the whole tablet. Do not chew, crush, or divide the tablet.• Your healthcare provider should start you on a diet and exercise program when you start taking BELVIQ XR. Stay on this program while you are taking BELVIQ XR.• Your healthcare provider should tell you to stop taking BELVIQ XR if you do not lose a certain amount of weight within the first 12 weeks of treatment. • If you take too much BELVIQ XR or overdose, call your healthcare provider or go to the nearest emergency room right away.
What should I avoid while taking BELVIQ XR ? Do not drive a car or operate heavy machinery until you know how BELVIQ XR affects you. BELVIQ XR can slow your thinking.
What are the possible side effects of BELVIQ XR ? BELVIQ XR may cause serious side effects, including: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions. BELVIQ XR and certain medicines for depression, migraine, the common cold, or other medical problems may affect each other causing serious or life-threatening side effects. Call your healthcare provider right away if you start to have any of the following symptoms while taking BELVIQ XR: ○ mental changes such as agitation, hallucinations, confusion, or other changes in mental status ○ coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes) ○ restlessness ○ racing or fast heart beat, high or low blood pressure ○ sweating or fever ○ nausea, vomiting, or diarrhea ○ muscle rigidity (stiff muscles) Valvular heart disease. Some people taking medicines like BELVIQ XR have had problems with the valves in their heart. Call your healthcare provider right away if you have any of the following symptoms while taking BELVIQ XR: ○ trouble breathing ○ swelling of the arms, legs, ankles, or feet ○ dizziness, fatigue, or weakness that will not go away ○ fast or irregular heartbeat Changes in your attention or memory. Mental problems. Taking BELVIQ XR in high doses may cause psychiatric problems such as: ○ hallucinations ○ feeling high or in a very good mood (euphoria) ○ feelings of standing next to yourself or out of your body (disassociation)
  • Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
  • Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking BELVIQ XR and while you take BELVIQ XR.
  • Painful erections (priapism). The medicine in BELVIQ XR can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using BELVIQ XR and call your healthcare provider or go to the nearest emergency room right away.
  • Slow heart beat. BELVIQ XR may cause your heart to beat slower. Tell your healthcare provider if you have a history of your heart beating slow or heart block.
  • Decreases in your blood cell count. BELVIQ XR may cause your red and white blood cell count to decrease. Your healthcare provider may do tests to check your blood cell count while you are taking BELVIQ XR.
  • Increase in prolactin. The medicine in BELVIQ XR may increase the amount of a certain hormone your body makes called prolactin. Tell your healthcare provider if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.
The most common side effects of BELVIQ XR include: headache nausea cough○ dizziness○ dry mouth○ low blood sugar (hypoglycemia) in patients with diabetes○ fatigue○ constipation○ back painThese are not all the possible side effects of BELVIQ XR. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store BELVIQ XR ? Store BELVIQ XR at room temperature between 59°F to 86°F (15°C to 30°C). Safely throw away medicine that is out of date or no longer needed. Keep BELVIQ XR and all medicines out of the reach of children.
General information about the safe and effective use of BELVIQ XR . Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BELVIQ XR for a condition for which it was not prescribed. Do not give BELVIQ XR to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about BELVIQ XR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BELVIQ XR that is written for health professionals.
What are the ingredients in BELVIQ XR ? Active ingredient: lorcaserin hydrochlorideInactive ingredients: microcrystalline cellulose NF; mannitol USP; hypromellose 2208 USP; ethylcellulose dispersion Type B NF; hypromellose 2910 USP; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C yellow #6/sunset yellow FCF; aluminum lake; iron oxide yellow NF; iron oxide red NF; and magnesium stearate NFManufactured by: Manufactured by Arena Pharmaceuticals GmbH, Untere Brϋhlstrasse 4, CH-4800, Zofingen, Switzerland Distributed by Eisai Inc., Woodcliff Lake, NJ 07677For more information, go to www.BELVIQXR.com or call 1-888-274-2378.

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: July 2016

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