Medication Guide Dispensing Requirement for QSYMIA
Yes, the medication guide must be dispensed with each dispensing of QSYMIA (phentermine and topiramate extended-release). This is an FDA requirement clearly stated on the drug label. 1
FDA Labeling Requirement
The principal display panel on QSYMIA bottles explicitly states: "DISPENSE WITH MEDICATION GUIDE" 1. This is a mandatory FDA requirement, not an optional recommendation.
Rationale for This Requirement
QSYMIA carries several serious safety concerns that necessitate patient education with every dispensing:
Critical Safety Information Requiring Ongoing Patient Awareness
- Teratogenicity risk - Topiramate component causes birth defects, requiring monthly pregnancy testing at home after initial healthcare professional verification 2
- Cardiovascular effects - Can cause increased heart rate and blood pressure requiring monitoring 2
- Psychiatric and cognitive adverse effects - Including depression, suicidal ideation, concentration/memory impairment, and anxiety 2
- Metabolic acidosis - Requires electrolyte and creatinine monitoring before and during treatment 2
- Acute angle-closure glaucoma - Can cause acute myopia and ocular pain 2
Additional Safety Considerations
- Contraindications with MAOIs - Requires at least 14 days between discontinuation 2
- Kidney stone formation risk - Acute nephrolithiasis can occur 2
- Discontinuation protocol - The 15mg/92mg dose should not be stopped abruptly and requires tapering over at least 1 week 2
- Drug interactions - Altered metabolism of estrogen and progestins can cause menstrual spotting in women taking birth control pills 2
Clinical Practice Implications
- Pharmacists must provide the medication guide with every prescription fill, regardless of whether the patient is a new or continuing user 1
- The medication guide serves as ongoing reinforcement of critical safety information, particularly important given the cognitive impairment that can occur with this medication 2
- Patients need repeated reminders about monthly home pregnancy testing requirements and the absolute contraindication in pregnancy 2