We will be using this on a case by case basis, but with some serious caveats.
The medication has been shown to be helpful in losing weight and burning fat first! But there are some precautions that need to be taken with this medication most notably the risk of birth defects. VIVUS has a healthcare provider information letter that all doctors looking to use this medication should read here!
If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qysmia 7.5 mg/46 mg dose.
ALL women, except those who have gone through menopause or undergone surgical sterilization, should be advised to consistently use effective contraception, even women who have had difficulty getting pregnant in the past.
It is important to have this conversation with all patients. It is important to know whether a patient is:
- Trying to get pregnant and not using contraception, in which case do not prescribe Qsymia
- Sexually active and what contraception she is using, in which case reinforce the importance of consistent use of effective contraception
- Surgically sterilized or has gone through menopause that has been clinically confirmed, in which case no contraception is required
It is important to have this conversation with all patients, so that if there is a female of reproductive potential in the house, the patient knows to keep Qsymia in a secure location and not share it with anyone else.
If a woman believes she might be pregnant, she should stop taking Qsymia immediately and contact her healthcare provider.
Dispensing by certified mail order pharmacies
Qsymia is available only through certified mail order pharmacies that provide a Qsymia Medication Guide and Risk of Birth Defects with Qsymia patient brochure with every prescription and refill as required by the REMS. The list of certified mail order pharmacies can be found at www.QsymiaREMS.com.
Reporting adverse events
Healthcare providers should report all suspected adverse events associated with the use of Qsymia. If you become aware of a patient experiencing an adverse event while taking Qsymia, please contact VIVUS Medical Information at 1-888-998-4887 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If you have any questions you can always come in the office or call.