Flibanserin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat hypoactive sexual desire disorder in women who have not reached menopause. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe low blood pressure, fainting, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with MANY other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: serotonin 5-HT1A receptor agonist/5-HT2A receptor antagonist

Generic and brand names: flibanserin, oral; Addyi

What is this medicine used for?

This medicine is taken by mouth to treat hypoactive (low) sexual desire disorder in women who have not reached menopause (when monthly menstrual periods stop). It will not treat low sexual desire caused by:

• A mental health or physical problem
• Problems within the relationship
• Side effects of medicines

You must be enrolled in a special program before you can receive this medicine due to the risk of severe side effects if you take this medicine and use alcohol. Only certain healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. For more information call 844-746-5745 or visit https://www.addyirems.com/AddyiUI/rems/home.action.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression, thoughts of suicide, or other mental health problems
• Low blood pressure
• Liver problems
• Problems with drug or alcohol abuse or if you drink alcohol or have recently stopped drinking alcohol.

Tell your healthcare provider about all prescription medicines, nonprescription medicines, and natural remedies you currently take, plan to take, or have taken within the last 2 weeks. Do not start or stop any medicine or supplement unless you check with your healthcare provider or pharmacist.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding, or plan to breast-feed. It is not known if this medicine will harm an unborn baby. It is not known if this medicine passes into your breast milk. Breastfeeding is not recommended during treatment with this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of this medicine or take it longer than prescribed.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine only at bedtime. Taking this medicine at any other time of day can increase your risk of low blood pressure, fainting, and drowsiness.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed (at bedtime) the next day. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, coma.

What should I watch out for?

This medicine may cause low blood pressure and severe dizziness or fainting. The risk is increased if you also drink alcohol, take certain other medicines, or if you have liver problems. Do NOT drink alcohol while you are taking this medicine. Do not take other medicines while you are taking this medicine unless your healthcare provider approves.

If you have dizziness, lightheadedness, or feel faint, lie down. If the symptoms do not go away or if you faint, get medical help right away. Tell your healthcare provider if you have severe dizziness or fainting while taking this medicine.

This medicine may cause you to fall asleep without warning during daily activities. If you have drowsiness that continues or becomes severe, you may need to stop taking this medicine. Do not drive or operate machinery for at least 6 hours after you take a dose of this medicine, or if you feel drowsy or dizzy. This medicine increases the effects of other medicines that slow down your nervous system. Do not take other medicines unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fainting; unusual drowsiness; severe dizziness.

Other: Mild sleepiness or dizziness, dry mouth, nausea, constipation, stomach pain, tiredness, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), simeprevir (Olysio), and sofosbuvir (Sovaldi)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Dexamethasone
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec), and ranitidine (Zantac)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa), and rivaroxaban (Xarelto)
• Mifepristone (Korlym, Mifeprex)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Naloxegol (Movantik)
• Natural remedies such as gingko, gotu kola, kava, resveratrol, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), dronabinol (Marinol), and promethazine
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)

Do NOT drink alcohol or take other medicines while you are taking this medicine unless your healthcare provider approves.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.