Alcohol use is contraindicated in patients taking flibanserin, because concomitant use increases the risk of severe hypotension and syncope. 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, and counsel patients who are prescribed flibanserin about the importance of abstaining from alcohol use. Flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program. Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment due to risk of severe hypotension and syncope .
Central Nervous System Agent
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.
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:
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.
Flibanserin should never be used in children for HSDD.
Flibanserin is not recommended for use in the elderly. Safety and efficacy have not been established.
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.
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.
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.
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.
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.
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:
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.
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.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
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 if you are also using 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®).
Do not drink alcohol while you are using flibanserin. 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.
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.
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.
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.
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:
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:
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.