Counseling for Patients of Reproductive Potential^*

Qsymia can cause fetal harm.

Advise patients of reproductive potential that labeling recommends:

• Pregnancy testing prior to beginning Qsymia and monthly during therapy. Specific documentation of the result is not required at the pharmacy level.
• Use of effective contraception consistently during Qsymia therapy because Qsymia can cause certain kinds of birth defects (oral clefts). Even patients who believe they cannot become pregnant should use effective contraception while taking Qsymia due to the potential for increased fertility associated with weight loss.
• If a patient becomes pregnant while taking Qsymia, Qsymia should be discontinued immediately and the patient advised to notify their healthcare provider.

^*Patients of reproductive potential are patients who have NOT had a hysterectomy, bilateral oophorectomy, or medically documented spontaneous ovarian failure, and have not gone through menopause. Menopause should be clinically confirmed by an individual's healthcare provider.

Advise nursing mothers not to use Qsymia. Qsymia may be present in human milk because topiramate and amphetamines (phentermine has pharmacologic activity and a chemical structure similar to amphetamines) are excreted in human milk.