Usual Adult Dose for Hypoactive Sexual Desire Disorder

100 mg orally once a day at bedtime

Comments:

• For patients with no improvement in hypoactive sexual desire disorder (HSDD) after 8 weeks, this drug should be discontinued.
• This drug is not indicated for the treatment of HSDD in postmenopausal women or in men.
• This drug is not indicated to enhance sexual performance.

Use: Treatment of premenopausal women with acquired, generalized HSDD characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition; problems within the relationship; or the effects of a medication or other drug substance.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Contraindicated

Dose Adjustments

Concomitant use with Moderate or Strong CYP450 3A4 Inhibitors: Contraindicated

• Flibanserin should not be started until 2 weeks after the last dose of a moderate or strong CYP450 3A4 inhibitor
• Strong or moderate CYP450 3A4 inhibitors should not be started for 2 days after the last flibanserin dose
• Use caution with multiple weak CYP450 3A4 inhibitors

Concomitant Use with Alcohol:

• To reduce the potential interaction with alcohol, patients consuming 3 or more standard alcoholic drinks should skip their daily (bedtime) dose; patients consuming 1 or 2 standard alcoholic drinks should wait at least 2 hours before dosing
• A standard alcoholic drink contains 14 g of pure alcohol and is equivalent to one 12-ounce regular beer (5% alcohol), 5-ounces wine (12% alcohol), or 1.5 ounces of distilled spirits/shot (40% alcohol).
• Once a patient has taken their bedtime dose, alcohol should not be consumed until the following day

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Addyi. It includes a medication guide. For additional information: www.fda.gov/REMS

US BOXED WARNINGS: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS:

• Interaction with Alcohol: Use of this drug close in time with alcohol increases the risk of severe hypotension and syncope. Counsel patients to wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking this drug at bedtime or skip their dose if they have consumed 3 or more standard alcoholic drinks that evening.
• Contraindicated with Strong or Moderate CYP450 3A4 Inhibitors: Concomitant use of this drug with strong or moderate CYP450 3A4 inhibitors increases the concentration of this drug, which can cause severe hypotension and syncope.
• Contraindicated in Patients with Hepatic Impairment: The concentration of this drug is increased when used in patients with hepatic impairment, which can result in severe hypotension and syncope.

CONTRAINDICATIONS:

• Concomitant use with moderate or strong CYP450 3A4 inhibitors
• Hepatic impairment
• Known hypersensitivity to this drug or any of its components; anaphylaxis consistent with angioedema, pruritus, and urticaria have been reported

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:

• Take orally once a day at bedtime
• Missed dose: If a dose is missed, skip the missed dose and resume dosing the next day at bedtime

General:

• This drug should be only be taken at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and CNS depression (e.g., somnolence and sedation).
• If no improvement in HSDD is achieved in 8 weeks, this drug should be discontinued.

Monitoring:

• Monitor for hypotension
• Monitor for somnolence, sedation, and fatigue

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should understand that this drug may cause hypotension and syncope particularly when taken close in time with alcohol, grapefruit juice, or a number of different medications or herbal supplements; patients should discuss all medication and herbal use with their healthcare professional.
• Patients should understand that alcohol use should be limited, they should understand the limitations to avoid the risk of hypotension and syncope.
• Patients should be instructed to lie down if they experience lightheadedness; they should seek medical help promptly if symptoms persist.
• Patients should be instructed not to drive or engage in hazardous tasks until at least 6 hours after their last dose, and until they understand how this drug affects them.

Frequently asked questions

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