Flibanserin

What is Flibanserin?

• Flibanserin (ADDYI) is used to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

What are the uses of this medicine?

This medicine is used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:

• a medical or mental health problem
• problems in the relationship
• medicine or other drug use

Limitations of Use:

• ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
• ADDYI is not indicated to enhance sexual performance.

How does this medicine work?

• Flibanserin (flib an' ser in) is a serotonergic mixed agonist and antagonist that was initially developed as an antidepressant when it was found to have possible effects on sexual desire and drive.
• In vitro, flibanserin acts predominantly as a serotonin (5-HT) 1A receptor agonist, but it also has antagonist activity against other serotonin receptors, such as 5-HT 2C and 2B, as well as less defined activity at dopamine D4 receptors.
• Flibanserin also has variable regional activities, increasing or decreasing serotonin, dopamine and norepinephrine in different brain areas.
• While its exact mechanism of action is unclear, flibanserin was found to improve subjective measures of sexual desire and satisfaction in multiple large clinical trials done mostly in premenopausal women who fulfilled the clinical criteria for hypoactive sexual desire disorder.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• concomitant use with moderate or strong CYP3A4 inhibitors
• hepatic impairment

What drug interactions can this medicine cause?

• The coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone.
• The concomitant use of ADDYI with CNS depressants (Diphenhydramine, opioids, hypnotics, benzodiazepines) may increase the risk of CNS depression (e.g., somnolence) compared to the use of ADDYI alone.
• The concomitant use of ADDYI with moderate(Examples of moderate CYP3A4 inhibitors :Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice) or strong CYP3A4 inhibitors is contraindicated. (eg: Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan)
• The concomitant use of ADDYI with strong CYP2C19 inhibitors(eg: Proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals) may increase flibanserin exposure which may increase the risk of hypotension, syncope, and CNS depression.
• The concomitant use of ADDYI with CYP3A4 inducers (eg: Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort) is not recommended.
• The concomitant use of ADDYI with digoxin, a drug that is transported by P-glycoprotein (P-gp), increases the digoxin concentration.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage of ADDYI is 100 mg administered orally once per day at bedtime.
• If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor.
• If initiating a moderate or strong CYP3A4 inhibitor following ADDYI use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI.
• ADDYI is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation).

Administration

• Take ADDYI exactly as your doctor tells you to take it.
• Take 1 ADDYI tablet one time a day at bedtime.
• Take ADDYI only at bedtime. Taking ADDYI at a time other than bedtime can increase your risk of low blood pressure, fainting (loss of consciousness), accidental injury, and sleepiness.
• If you drink alcohol, see "What is the most important information I should know about ADDYI?"
• If you skip a dose of ADDYI, take your next dose at bedtime the next day.
• If you miss a dose of ADDYI, skip your missed dose. Take your next dose at bedtime the next day. Do not take ADDYI the next morning or double your next dose. If you take too much ADDYI, call your doctor.
• Tell your doctor if your symptoms of HSDD have not improved after you have taken ADDYI for 8 weeks.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg

This medicine is available in fallowing brand namesː

• ADDYI

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• nausea
• tiredness
• difficulty falling asleep or staying asleep
• dry mouth

ADDYI can cause serious side effects, including:

• Sleepiness
• Low blood pressure and fainting (loss of consciousness)

What special precautions should I follow?

• Do not drink alcohol close to the time you take your ADDYI dose because this increases your risk of severe low blood pressure and fainting (loss of consciousness).
• Do not drive, operate machinery, or do things that require clear thinking until at least 6 hours after you take ADDYI and until you know how ADDYI affects you.
• Do not drink grapefruit juice if you take ADDYI. Drinking grapefruit juice during your treatment with ADDYI increases your risk of severe low blood pressure and fainting (loss of consciousness).
• You should not take the herbal supplements St. John’s Wort, ginkgo, or resveratrol or certain over-the-counter medicines such as cimetidine until you talk to your doctor. Taking ADDYI with these herbal supplements and over-the-counter medicine may increase your risk of low blood pressure, fainting (loss of consciousness), and sleepiness.
• After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day.
• The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors significantly increases flibanserin concentrations, which can lead to hypotension and syncope . The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated.
• ADDYI can cause CNS depression (e.g., somnolence, sedation). Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them.
• The use of ADDYI is contraindicated in patients with hepatic impairment.

What to do in case of emergency/overdose?

• Overdosage of ADDYI may cause an increase in the incidence or severity of any of the reported adverse reactions.

Management for overdosage:

• In the event of overdosage, treatment should address the symptoms and supportive measures, as needed.
• There is no known specific antidote for flibanserin.

Can this medicine be used in pregnancy?

• There are no studies of ADDYI in pregnant women to inform whether there is a drug-associated risk in humans.

Can this medicine be used in children?

• ADDYI is not indicated for use in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: flibanserin
• Inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, talc, macrogol, and the coloring agents, titanium dioxide and iron oxide.

Who manufactures and distributes this medicine?

• Packager: Sprout Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store ADDYI at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Flibanserin
• FDA Flibanserin

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