KLG asked
I have been taking Qsymia for about 75 days and it has been working. I am up to the 7.5mg/46 mg dose. I am leaving the country on May 1 for 6 months for work (but will be home for a break in the middle). My doctor wrote me a 90 day Rx but I have just been told by my pharmacy that due to FDA regulations, Qsymia can only be dispensed every 30 days. Since it will take about two weeks for mail to reach me outside the country, a vacation override of a few days is not sufficient. Is my only option to quit taking Qsymia? This would be very unfortunate has I feel like it is working for me.
Answer
It is true that Qsymia can only be dispensed as a 30 day supply at one time, per federal regulations.
Qsymia Restrictions
Qsymia (phentermine hydrochloride/topiramate) is a combination medication that is commonly prescribed to suppress appetite to assist with chronic weight loss in addition to diet and exercise.
Qsymia cannot be taken while pregnant due to the risk of causing fetal harm. There is an increased risk of a child being born with oral clefts and metabolic acidosis when taking topiramate, a component in Qsymia, while pregnant. It is for this reason that the FDA requires a Risk Evaluation Mitigation Strategy (REMS) for Qsymia.
A REMS is required for potentially dangerous medications, to ensure that the benefits of a medication outweigh the risks associated with them. REMS medications usually require additional monitoring by doctors and have specific dispensing requirements. Patients will receive additional counseling when being prescribed a REMS medication to ensure that the risks are understood.
Females of child bearing age are required to have a negative pregnancy test before starting the Qsymia and then every month while taking the medication. Qsymia can only be dispensed by approved pharmacies that have completed a Qsymia training program. This is to ensure that all of the pharmacy staff is educated about the risks associated with Qsymia and are documenting each prescription correctly.
Due to the monthly pregnancy testing that is required, Qsymia can only be dispensed one month at a time after the negative test is logged with the FDA. Only then is the pharmacy eligible to dispense another months supply.
It is important to use protection during intercourse while taking Qsymia to prevent pregnancy. Females who become pregnant should stop taking Qsymia immediately.
