PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
• BELVIQ 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 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 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
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.
• Men who have an erection lasting greater than 4 hours, whether painful
or not, should immediately discontinue the drug and seek emergency
medical attention.
• Patients should be instructed to avoid pregnancy or breastfeeding while
undergoing BELVIQ therapy and to talk to their prescribing physician
should they get pregnant or decide to breastfeed.
• 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.