Home Drug Guide Flibanserin

Drug Guide

Generic Name

Flibanserin

Brand Names Addyi

Classification

Therapeutic: Aphrodisiac for Hypoactive Sexual Desire Disorder in Women

Pharmacological: Serotonin Receptor Modulator

FDA Approved Indications

Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women

Mechanism of Action

Flibanserin acts as a serotonin 5-HT1A receptor agonist and 5-HT2A receptor antagonist, which helps to rebalance the levels of neurotransmitters involved in sexual desire, possibly increasing sexual desire and reducing distress associated with HSDD.

Dosage and Administration

Adult: The recommended dose is 100 mg once daily at bedtime.

Pediatric: Not indicated for pediatric use.

Geriatric: No specific dosage adjustment recommended based solely on age, but caution due to potential increased sensitivity.

Renal Impairment: No specific dose adjustment recommended; however, caution is advised.

Hepatic Impairment: Contraindicated in patients with Hepatic impairment; evaluate liver function prior to therapy.

Pharmacokinetics

Absorption: Rapidly absorbed with peak plasma concentrations within 30 minutes to 2 hours.

Distribution: Widely distributed; plasma protein binding approximately 98%.

Metabolism: Primarily hepatic metabolism via CYP3A4 and CYP2C19 enzymes.

Excretion: Excreted mainly in feces (around 84%), with minor urinary excretion.

Half Life: Approximately 11 hours.

Contraindications

Hypersensitivity to flibanserin or any component.
Use with alcohol or CYP3A4 inhibitors (due to risk of severe hypotension and syncope).
Concurrent use with moderate to strong CYP3A4 inhibitors.
History of hepatic impairment.

Precautions

Risk of hypotension and syncope, especially during the initial weeks of therapy.
Caution in hepatic impairment, use only if liver function is normal, and contraindicated if abnormal.

Adverse Reactions - Common

Dizziness (Common)
Somnolence (Common)
Nausea (Common)
Fatigue (Common)

Adverse Reactions - Serious

Severe hypotension and syncope (Less Common)
Hypersensitivity reactions (Rare)
Insomnia, depression, suicidal ideation (Rare)

Drug-Drug Interactions

Alcohol (avoid due to increased risk of hypotension, syncope, CNS depression)
CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) - increase risk of adverse effects

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Assess baseline sexual desire disorder, liver function, and concomitant medications.

Diagnoses:

Risk for injury related to hypotension or syncope.
Risk for ineffective tissue perfusion.

Implementation: Administer at bedtime. Monitor for signs of hypotension, dizziness, and CNS effects.

Evaluation: Assess changes in sexual desire and safety profile regularly.

Patient/Family Teaching

Do not consume alcohol during therapy.
Report immediately if experiencing dizziness, fainting, or adverse symptoms.
Take medication at bedtime to reduce side effects.
Follow up on liver function tests as recommended.

Special Considerations

Black Box Warnings:

Hypotension and syncope, especially in patients using alcohol or CYP3A4 inhibitors.
Use only in women with HSDD after excluding other causes.

Genetic Factors: Metabolism affected by CYP3A4 activity.

Lab Test Interference: No significant interference reported.

Overdose Management

Signs/Symptoms: Severe hypotension, loss of consciousness.

Treatment: Supportive care, monitor vital signs, consider activated charcoal if ingestion is recent, but no specific antidote.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable up to the expiration date on the package.