CC Nov 2015 Flibanserin (Addyl)

echoecho's version from 2015-11-02 13:58


Question Answer
After twice previously rejecting approval due to what, in 8-2015 the FDA approved this drug?unfavorable risk-benefit profile
What is Flibanserin (Addyl)?it is the first medication for acquired, generalized, hypoactive sexual desire disorder (HSDD) in women
Of the definition of Addyl, what does the "acquired" mean?that the pt had normal sexual desire in the past
Of the definition of Addyl, what does the "generalized" mean?it means that the decreased sexual desire occurs regardless of the partner, situation, or the type of sexual activity
Of the definition of Addyl, what does the "disorder" mean?it means that the low sexual desire causes marked distress or difficulty with interpersonal relationships and is not caused by medical or psychiatric conditions, problems in the relationship or due to a medication or substance
What drug category is Addyl in?it is a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT (2A) receptor antagonist
What is the mechanism of action?its exact mechanism of action is unkonw, its affinity for 5-HT receptors suggests modulation of serotonin and/or dopamine activity
Addyl is FDA-approved for the use in prememnopausal and postmenopausal women, true or false?true
Why has approval of Addyl ("pink pill") met with controversy while it is the first drug to address decreased sexual desire in women and levels the playing field (referring to meds for male ED)?there are some serious concerns regarding safety
*** What two side effects does Addyl have? It's effect is exacerbated with concomitan use of what substance?1) severe hypotension and syncope 2) alcohol (therefore, consumptiong of alcohol while using this medication is contraindicated)
The product prescribing information indicates that patients must abstain from what substance? And that the prescriber must ascertain whether the patient is likely to abstain?alcohol
What organ dysfunction and certain medications can also increase the risk of hypotension and syncope?1) hepatic 2) Moderate or strong CYP3A4 inhibitors increases risk (Strong = ketoconazole (Nizoral), itraconazole (Sporanox), Clarithromycin (Biaxin), ritonavir (Norvir), saquinavir (Invirase)). (Moderate = ciprofloxacin (Cipro), diltiazem (Cardizem), verapamil (Calan), erythromycin, fluconazole (Diflucan) 3) Weak CYP3A4 inhibitors (may increase risk) = oral contraceptives, cimetidine (Tagamet), fluoxetine (Prozac), ranitidine (Zantac) 4) Strong CYP2C19 inhibitors (may increase risk) = proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), benzadiazepines
Use of Addyl taking what inhibitors or with what organ impairment is contraindicated?1) moderate or strong CYP3A4 inhibitors OR 2) with hepatic impairment
The concomitant use of Addyl with what other medications can further increase CNS depression?1) CNS depressants (hypnotics, opioids, benzodiazepines, diphenhydramine (Benadryl)
What is the dose of Addyl?100 mg q hs
Comment on the studies demonstrating what benefit with use of this drug?1) moderate benefit (increase in the number of satisfying sexual events per month by 0.5-1 compared to placebo with small improrvments in sexual desire scores and distress scores 2) about 10% more treated patients reported significant improvement compared to placebo
Lack of response at ____ weeks should prompt discontinuation?8
Addyl was approved with a risk evaluation mitigation strategy (REMS), what is this?1) physicians electing to prescribe the med must be certified through REMS by enrolling and completing training 2) the use of a patient provider agreement form is mandatory 3) only certified pharmacists can dispense this med, and they are required to consel the patietn regarding concomitant alcohol use as well
*** SUMMARY = What is flibanser (Addyl) indicated for?acquired, generalized hypoactive sexual desire (HSDD) in women
*** SUMMARY = Patients must abstain from consuming what substance while on the medication because of what 2 side effects?1) alcohol 2) hypotension and syncope
*** SUMMARY = The use of flibanserin in patients taking moderate to strong ______ inhibitors or with _____ organ impairment is contraindicated?1) CYP3A4 2) hepatic