Flibanserin (Oral Route)

Descriptions:

Flibanserin is used to treat hypoactive sexual desire disorder (HSDD) in women who have not gone through menopause. This medicine should only be used by women who have low sexual desire that is troubling to them and is not caused by a medical or mental problem, problems in the relationship, or medicine or other drug use.

Women who have gone through menopause and men should not use flibanserin. Do not use this medicine to improve sexual performance.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric:
Flibanserin should never be used in children for HSDD.

Geriatric:
Flibanserin is not recommended for use in the elderly. Safety and efficacy have not been established.

Breastfeeding:
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir
Aprepitant
Atazanavir
Boceprevir
Ciprofloxacin
Clarithromycin
Colchicine
Conivaptan
Diltiazem
Dronedarone
Erythromycin
Fluconazole
Fosamprenavir
Fosaprepitant
Imatinib
Indinavir
Itraconazole
Ketoconazole
Letermovir
Levoketoconazole
Lopinavir
Nefazodone
Nelfinavir
Nirmatrelvir
Posaconazole
Ritonavir
Saquinavir
Telaprevir
Telithromycin
Verapamil
Voriconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acepromazine
Adagrasib
Afatinib
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aripiprazole
Asciminib
Asenapine
Avacopan
Baclofen
Benperidol
Benzhydrocodone
Berotralstat
Betrixaban
Bromazepam
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Carbinoxamine
Carisoprodol
Carphenazine
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clozapine
Codeine
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daridorexant
Dexmedetomidine
Diazepam
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Doxylamine
Droperidol
Enasidenib
Enflurane
Enzalutamide
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fedratinib
Fentanyl
Fexinidazole
Fluphenazine
Flurazepam
Fluspirilene
Fosnetupitant
Fospropofol
Gabapentin
Gabapentin Enacarbil
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyzine
Isoflurane
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Lanreotide
Lefamulin
Lemborexant
Lenacapavir
Levocetirizine
Levorphanol
Lofexidine
Lonafarnib
Lorazepam
Lorlatinib
Loxapine
Magnesium Oxybate
Mavacamten
Mavorixafor
Meclizine
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Metoclopramide
Midazolam
Mitotane
Mobocertinib
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Netupitant
Nicomorphine
Nirogacestat
Nitrazepam
Nitrous Oxide
Octreotide
Olanzapine
Oliceridine
Omaveloxolone
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Palbociclib
Papaveretum
Paregoric
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Pirtobrutinib
Potassium Oxybate
Pralsetinib
Prazepam
Pregabalin
Primidone
Prochlorperazine
Promazine
Promethazine
Propofol
Quazepam
Quetiapine
Ramelteon
Relugolix
Remifentanil
Remimazolam
Remoxipride
Repotrectinib
Ribociclib
Rimegepant
Ritlecitinib
Ropeginterferon Alfa-2b-njft
Secobarbital
Selpercatinib
Sertindole
Sirolimus Protein-Bound
Sodium Oxybate
Sotorasib
Sparsentan
Sufentanil
Sulpiride
Suvorexant
Tapentadol
Taurursodiol
Temazepam
Tenofovir Alafenamide
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tilidine
Tizanidine
Tocilizumab
Tolonium Chloride
Topiramate
Topotecan
Tovorafenib
Tramadol
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trofinetide
Tucatinib
Ubrogepant
Venetoclax
Vincristine
Vincristine Sulfate Liposome
Vonoprazan
Zaleplon
Zolpidem
Zopiclone
Zotepine
Zuranolone
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Digoxin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Depression or mental illness, history of or
Drug or alcohol abuse, or history of or
Hypotension (low blood pressure)—Use with caution. May make these conditions worse.
Liver problem—Should not be used in patients with this condition.

Proper Use:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

The medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take flibanserin only at bedtime. Taking this medicine at a time other than bedtime may increase risk of low blood pressure, fainting, accidental injury, or sleepiness.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
For treatment of hypoactive sexual desire disorder:
Adults—100 milligrams (mg) once a day at bedtime.
Children—Use is not recommended.
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage:
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not use this medicine together with amprenavir, atazanavir (Reyataz®), boceprevir (Victrelis®), ciprofloxacin (Cipro®), clarithromycin (Biaxin®), conivaptan (Vaprisol®), diltiazem (Cardizem®), erythromycin (Ery-Tab®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone, nelfinavir (Viracept®), posaconazole (Noxafil®), ritonavir (Norvir®), saquinavir (Invirase®), telaprevir, telithromycin (Ketek®), or verapamil (Calan®). Using these medicines together may increase risk for low blood pressure and fainting.

Lightheadedness, dizziness, or fainting may occur when you take flibanserin within 2 hours of drinking alcohol. It is recommended to wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks (eg, one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot) before taking flibanserin at bedtime, or you may skip your dose if you drink 3 or more standard alcoholic drinks in the evening. If you have taken flibanserin at bedtime, do not drink alcohol until the following day.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using flibanserin.

If your condition does not improve within 8 weeks, or if it become worse, check with your doctor.

This medicine may cause you to feel dizzy, drowsy, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert for at least 6 hours after you take this medicine and until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Blurred vision
confusion
dizziness, fainting, or lightheadedness, especially when getting up suddenly from a lying or sitting position
sleepiness or unusual drowsiness
sweating
unusual tiredness or weakness
Less common
Feeling of constant movement of self or surroundings
sensation of spinning
Rare
Bloating
fever
nausea
severe cramping
stomach or lower abdominal pain
vomiting
Incidence not known
Chest tightness
cough
difficulty swallowing
dizziness
fast heartbeat
hives, itching, skin rash
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Constipation
dry mouth
nervousness
normal menstrual bleeding occurring earlier, possibly lasting longer than expected
trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.