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BELVIQ XR EXTENDED RELEASE EXTENDED RELEASE- lorcaserin hydrochloride tablet, film coated, extended release

Patient 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[ seeContraindications (4),Use in Specific Populations (8.1)].
  • Lactation: Advise women to avoid use of BELVIQ XR while breastfeeding[seeUse 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 Br hlstrasse 4, CH-4800, Zofingen, Switzerland

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677

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