"Advise patients of the following:
Qsymia is indicated for chronic weight management in conjunction with a reduced-calorie diet and increased physical activity.
Access to Qsymia
Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. Advise patients on how to access Qsymia through certified pharmacies. Additional information may be obtained via the website www.QsymiaREMS.com or by telephone at 1-888-998-4887.
Concomitant Use with Other Products
Advise patients to tell healthcare provider(s) about all medications, nutritional supplements, and vitamins (including any weight loss products) that are being taken or may be taken while on Qsymia.
Females of Reproductive Potential
Qsymia can cause fetal harm and patients should avoid getting pregnant while taking Qsymia [see Warnings and Precautions (5.1)]
Pregnancy testing is recommended before starting Qsymia and monthly thereafter during therapy.
Advise patients about effective methods of contraception, as well as the importance of using effective contraception consistently during Qsymia therapy. Advise females who become pregnant during Qsymia therapy to stop Qsymia immediately and tell their healthcare provider(s).
Either discontinue nursing or discontinue Qsymia [see Use in Specific Populations (8.3)].
Elevation in Heart Rate
Qsymia can increase resting heart rate [see Warnings and Precautions (5.2)].
Advise patients to report symptoms of sustained periods of heart pounding or racing while at rest to their health care provider(s)
Suicidal Behavior and Ideation; Changes in Mood or Depression
Qsymia can increase the risk of mood changes, depression, and suicidal ideation [see Warnings and Precautions (5.5)].
Advise patients to tell their healthcare provider(s) immediately if mood changes, depression, and suicidal ideation occur.
Acute Angle Closure Glaucoma
Qsymia can increase the risk of acute myopia and secondary angle closure glaucoma [see Warnings and Precautions (5.4)].
Advise patients to report symptoms of severe and persistent eye pain or significant changes in their vision to their healthcare provider(s).
Cognitive Adverse Reactions
Qsymia can cause dizziness, confusion, concentration and word-finding difficulties, or visual changes [see Warnings and Precautions (5.6)].
Advise patients to tell their healthcare provider(s) about any changes in attention, concentration, memory, and/or difficulty finding words.
Advise patients not to drive or operate machinery until they have gained sufficient experience on Qsymia to gauge whether it adversely affects their mental performance, motor performance, and/or vision.
Qsymia can increase the risk of metabolic acidosis [see Warnings and Precautions (5.7)].
Advise patients to tell their healthcare provider(s) about any factors that can increase the risk of acidosis (e.g. prolonged diarrhea, surgery, and high protein/low carbohydrate diet, and/or concomitant medications such as carbonic anhydrase inhibitors).
Hypoglycemia in Patients with Type 2 Diabetes Mellitus on Anti-diabetic Therapy
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas) [see Warnings and Precautions (5.9)].
Advise patients with type 2 diabetes mellitus on anti-diabetic therapy to monitor their blood glucose levels and report symptoms of hypoglycemia to their healthcare provider(s)
CNS Depression with Concomitant CNS Depressants including Alcohol
The concomitant use of alcohol or central nervous system (CNS) depressant drugs (e.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression or other centrally mediated effects of these agents, such as dizziness, cognitive adverse reactions, drowsiness, light-headedness, impaired coordination and somnolence [see Warnings and Precautions (5.11)].
Advise patients not to drink alcohol while taking Qsymia.
Potential Seizures with Abrupt Withdrawal of Qsymia
Abrupt withdrawal of topiramate, a component of Qsymia, has been associated with seizures in individuals without a history of seizures or epilepsy.
Advise patients not to abruptly stop Qsymia without first talking to their healthcare provider(s) [see Dosage and Administration (2.1)]
Use of Qsymia has been associated with kidney stone formation [see Warnings and Precautions (5.15) and Adverse Reactions (6.1)].
Advise patients to increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation.
Advise patients to report symptoms of severe side or back pain, and/or blood in their urine to their healthcare provider(s).
Oligohidrosis and Hyperthermia
Oligohidrosis (decreased sweating) has been reported in association with the use of topiramate, a component of Qsymia. Decreased sweating and an elevation in body temperature above normal characterized these cases.
Advise patients to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather."