What are the guidelines for dispensing Flibanserin (Addyi) in a drug store?

Flibanserin Dispensing Guidelines in Drug Stores

Flibanserin (Addyi) must be dispensed in its original packaging with the FDA-mandated Medication Guide provided to each patient, as this medication carries a boxed warning and is part of a Risk Evaluation and Mitigation Strategy (REMS) program. 1

Critical Dispensing Requirements

Packaging and Documentation

• Dispense flibanserin only in the original manufacturer packaging - do not repackage into standard pharmacy vials 1
• Provide the FDA-approved Medication Guide with every prescription, including refills 1
• The medication is available as 100 mg tablets in 30-tablet bottles 1

Patient Counseling Points (Required by REMS)

Alcohol Contraindication (Boxed Warning)

• Absolute contraindication with alcohol consumption - patients must avoid alcohol within 2 hours before bedtime when taking flibanserin 1, 2
• Concurrent alcohol use significantly increases risk of severe hypotension, syncope (loss of consciousness), and CNS depression 1, 3
• This contraindication is based on FDA-mandated alcohol challenge studies that demonstrated serious safety concerns 2

Timing of Administration

• Must be taken at bedtime only - never during waking hours 1
• Taking during waking hours substantially increases risk of hypotension, syncope, and sedation 1
• Patients should not drive, operate machinery, or perform activities requiring alertness for at least 6 hours after dosing 1

Drug and Supplement Interactions

• Grapefruit juice is contraindicated - increases risk of severe hypotension and syncope 1
• Avoid herbal supplements: St. John's Wort, ginkgo, and resveratrol 1
• Avoid cimetidine (over-the-counter H2 blocker) without physician consultation 1
• These interactions increase risk of hypotension, syncope, and excessive sleepiness 1

Common Adverse Events to Discuss

The most frequently reported adverse events (occurring in ≥10% of patients) include 4, 3:

• Dizziness (11.4%)
• Somnolence/sleepiness (11.2%)
• Nausea (10.4%)
• Fatigue (9.2%)
• Insomnia (4.9%)
• Dry mouth (2.4%)

Dosing and Duration Guidance

Standard Dosing

• 100 mg once daily at bedtime 5, 6, 1
• No dose adjustments for age alone, though caution in elderly patients 1

Treatment Duration Assessment

• Discontinue if no improvement after 8 weeks - this is an FDA recommendation that should be communicated to prescribers 1, 3
• The medication shows modest efficacy of approximately 1 additional satisfying sexual event every 2 months compared to placebo 5, 6

Storage Requirements

• Store at room temperature between 68°F to 77°F (20°C to 25°C) 1
• Keep in original packaging until dispensed 1

Special Populations

Patients on Antidepressants

• Flibanserin can be safely used with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) 7
• No increased safety concerns when added to stable antidepressant regimens 7
• The adverse event profile is similar to other serotonergic medications 2

Critical Safety Pitfalls

Common Dispensing Errors to Avoid

• Never dispense without the Medication Guide - this violates REMS requirements 1
• Never repackage from original container - must remain in manufacturer packaging 1
• Ensure patients understand the absolute alcohol contraindication, not just a warning 1, 2
• Emphasize bedtime-only dosing - daytime use significantly increases adverse event risk 1

Red Flags for Pharmacist Intervention

• Patient reports taking medication in the morning or during the day 1
• Patient mentions consuming alcohol regularly 1
• Patient is taking cimetidine or contraindicated herbal supplements 1
• Prescription continues beyond 8 weeks without documented benefit 1, 3