Qsymia™: a new diet pill approved by the FDA
In July 2012, the FDA approved Qsymia, which is considered to be the most effective of the weight weight loss medications considered by the FDA in recent years.
Here is the official FDA announcement of Qsymia.
Qsymia was previously known as Qnexa but Vivus was asked by the FDA to change the name to avoid confusion with other medication.
What is Qsymia™ and who can use it?
Qsymia is a combination of the appetite suppressant phentermine (the safe half of the diet drug Fen-Phen) and the anti-seizure/migraine medication, Topiramate Extended-Release.
Qsymia is recommended for obese adults (BMI>30) or for overweight adults who have an additional complication (type 2 diabetes, high blood pressure, etc.)
Qsymia is not a "miracle" new diet pill. If you want to see real results, you will need to follow a reduced-calorie diet and increase your physical activity. By the way, this is recommended for all diet pills currently on the market, no exception.
No study has been done to see the effect of Qsymia with other dietary supplements, so if your doctor prescribes you Qsymia, follow his dosage indications.
Qsymia has not been tested (and approved) for patients under 18 years old (17% of children in the USA are obese).
How should I pronounce the name of this medication?
Qsymia is pronounced cue-SIM-ee-uh.
How does Qsymia™ work?
Qsymia™ is a 'combo' medication made of 2 main ingredients:
Phentermine is the well-known appetite suppressant and main active ingredient of Qsymia™
Topiramate, also known under the trademark Topamax, was originaly prescribed as an anticonvulsant and migraine medication. It can aid in weight loss by increasing the feeling of being full, making foods taste less appealing and increasing calorie expenditure.
Qsymia™ release date
On Sep 18, 2012, Vivus announced the availability of Qsymia™ in the USA. The product is not yet approved outside the USA.
Qsymia™ is only available by mail order through certified pharmacies in the Qsymia Home Delivery Network.
What are the limitations?
- Patients may receive their Qsymia™ every 30 days
- Patients may receive up to 5 refills
What is the "Qsymia™ Home Delivery Network"?
It is composed of the following Certified Pharmacies:
- Express Scripts
So this means that you will not be able to get Qsymia from your local pharmacy if it is not part of the Qsymia Home Delivery Network.
If you are a retail pharmacist and receive a prescription for Qsymia™, you must redirect the patient to a certified pharmacy.
Qsymia Prescribing Information
Qsymia Risk Evaluation and Mitigation Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for Qsymia.
The purpose of the Qsymia REMS is to inform prescribers and females of reproductive potential about:
- The increased risk of congenital malformation in children exposed to Qsymia™during the first 3 months of pregnancy.
- The importance of pregnancy prevention for women of reproductive potential receiving Qsymia
- The need to stop Qsymia immediately in case of pregnancy.
Vivus, the manufacturer of Qsymia™ has prepared a Healthcare Provider Training Program (pdf).
Dosage forms and strengths
Qsymia exists in capsules in 4 different dosage forms.
Vivus 3.75 mg/23 mg
Strength: phentermine hydrochloride 3.75 mg (base) / topiramate extended-release 23 mg
Imprint: VIVUS 3.75/23
Vivus 7.5 mg/46 mg
Strength: phentermine hydrochloride 7.5 mg (base) / topiramate extended-release 46 mg
Imprint: VIVUS 7.5/46
Color: Purple / Yellow
Vivus 11.25 mg/69 mg
Strength: phentermine hydrochloride 11.25 mg (base) / topiramate extended-release 69 mg
Imprint: VIVUS 11.25/69
Vivus 15 mg/92 mg
Strength: phentermine hydrochloride 15 mg (base) / topiramate extended-release 92 mg
Imprint: VIVUS 15/92
Color: Yellow / White
Dosage and administration
- One capsule daily in the morning. Do not take in the evening (risk of insomnia)
- Start with Qsymia 3.75 mg/23 mg daily for 14 days; then increase to 7.5 mg/46 mg daily
Change in dosage:
If after 12 weeks on Qsymia 7.5 mg/46 mg, 3% of weight loss is not reached, discontinue or increase dose.
If after 12 weeks on Qsymia 15 mg/92 mg, which is the maximum daily dose, 5% of weight loss is not reached, discontinue.
To avoid possible seizure, discontinue Qsymia 15 mg/92 mg gradually.
For patients with kidney impairment or moderate hepatic impairment, Qsymia 7.5 mg/46 mg is recommended.
Who makes Qsymia?
Qsymia is manufactured by:
1172 Castro Street
Mountain View, CA 94040
Phone:1 (888) 998-4887