Flibanserin

Flibanserin is a prescription drug indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty.

Flibanserin is available under the following different brand names: Addyi.

Tablet

• 100 mg

Dosage Considerations – Should be Given as Follows:

Hypoactive Sexual Desire Disorder

• Indicated for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not caused by a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance
• 100 mg orally once daily at bedtime
• Dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system depression
• Discontinued after 8 weeks if no improvement

• Missed dose
  • If a dose is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day
  • Instruct the patient to not double the next dose
• CYP3A4 inhibitors
  • Coadministration with moderate or strong CYP3A4 inhibitors is contraindicated
  • If initiating flibanserin following moderate or strong CYP3A4 inhibitor use, start flibanserin 2 weeks after the last dose of the CYP3A4 inhibitor
  • If initiating a moderate or strong CYP3A4 inhibitor following flibanserin use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of flibanserin

Pediatric:

• Not indicated for pediatric use

Dosing Considerations

• Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire
• Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner
• Limitations of use
  • Not indicated for HSDD in postmenopausal women or in men
  • Not indicated to enhance sexual performance

Common side effects of flibanserin include:

• abdominal pain
• abnormal bleeding from the uterus
• anxiety
• central nervous system depression
• constipation
• dizziness
• dry mouth
• fainting
• fatigue
• insomnia
• low blood pressure
• nausea
• rash
• sedation
• sleepiness
• spinning sensation (vertigo)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Flibanserin has severe interactions with 57 different drugs.
• Serious interactions of flibanserin include:
  • venetoclax
• Flibanserin has moderate interactions with 202 different drugs.
• Flibanserin has no known minor interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

Contraindicated with alcohol.

• Use with alcohol increases risk of severe hypotension and syncope; therefore, alcohol use is contraindicated
• Before prescribing flibanserin, assess the likelihood of the patient abstaining from alcohol, taking into account the patient's current and past drinking behavior, and other pertinent social and medical history
• Counsel patients who are prescribed flibanserin about the importance of abstaining from alcohol use
• Because of the increased risk of hypotension and syncope is due to an interaction with alcohol, flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program

Contraindicated with moderate or strong CYP3A4 inhibitors

• Coadministration with moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope
• Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated

Contraindicated in patients with liver impairment

• Contraindicated for use with any degree of liver impairment
• Flibanserin exposure increased 4.5-fold in patients with liver impairment, compared with those with normal liver function, increasing the risk of hypotension, syncope, and central nervous system depression

This medication contains flibanserin. Do not take Addyi if you are allergic to flibanserin or any ingredients contained in this drug

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Use with alcohol
• Coadministration with moderate or strong CYP3A4 inhibitors
• Any degree of liver impairment

Effects of Drug Abuse

• Avoid using with alcohol.

Short-Term Effects

• See "What Are Side Effects Associated with Using Flibanserin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Flibanserin?"

Cautions

• Coadministration with alcohol increases the risk of severe hypotension and syncope (also see Contraindications and Warnings)
• Coadministration with moderate or strong CYP3A4 inhibitors is significantly increases flibanserin concentrations, which can lead to low blood pressure (hypotension) and fainting (syncope) (also see Contraindications, Warnings, and Dosing)
• Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (ginkgo, resveratrol) or nonprescription drugs (cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope
• Causes central nervous system depression (somnolence, sedation); risk of central nervous system depression is increased if taken during waking hours, or with alcohol or other central nervous system depressants, or with medications that increase flibanserin concentrations (CYP3A4 inhibitors)
• Hypotension and syncope can also occur with flibanserin taken alone
• The use in patients with any degree of liver impairment is contraindicated; liver impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope

Pregnancy and Lactation

• There are no studies in pregnant women to inform whether there is a drug-associated risk in humans.
• Animal data
  • In animals, fetal toxicity only occurred in the presence of significant maternal toxicity, including reductions in weight gain and sedation
  • Adverse reproductive and developmental effects consisted of decreased fetal weight, structural anomalies, and increases in fetal loss at exposures greater than 15 times exposures achieved with the recommended human dosage

Unknown if distributed in human breast milk and it is unknown whether flibanserin has effects on the breastfed infant or if it affects milk production.

Flibanserin is excreted in rat milk.

Because of the potential for serious adverse reactions, including sedation, in a breastfed infant, breastfeeding is not recommended during treatment.