Indication and Important Safety Information, including Boxed Warning
Addyi® (flibanserin) tablets is a prescription medicine 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
Addyi is not for the treatment of HSDD in women who have gone through menopause or in men, or to improve sexual performance. Addyi is not for use in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Addyi?
Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take Addyi and:
- drink alcohol. Do not drink alcohol if you take Addyi.
- take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking Addyi until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking Addyi.
- have liver problems. Do not take Addyi if you have liver problems.
If you take Addyi and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can.
Addyi is only available through the Addyi Risk Evaluation and Mitigation Strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get Addyi from pharmacies that are enrolled in the Addyi REMS Program.
Who should not take Addyi?
Do not take Addyi if you:
- drink alcohol
- take certain other medicines. Taking Addyi with certain other medicines can increase the amount of Addyi in your blood and cause severe low blood pressure, fainting (loss of consciousness), and sleepiness.
- Do not take Addyi if you are taking any of the following medicines:
- certain medicines used to treat HIV-1 infection
- certain medicines that you take by mouth used to treat fungal infections
- certain antibiotics, including:
- ciprofloxacin (CIPRO, CIPRO XR)
- telithromycin (KETEK)
- erythromycin (ERY-TAB, ERYC, PCE)
- clarithromycin (BIAXIN)
- certain medicines used to treat Hepatitis C infection
- certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems
- nefazodone: a medicine used to treat depression
Ask your doctor or pharmacist if you are not sure if you take any of these types of medicines. These are examples of the types of medicines that you should not take if you are taking Addyi. Tell your doctor about all of the medicines you take before you start taking Addyi.
- have liver problems
What should I tell my doctor before taking Addyi?
Before you take Addyi, tell your doctor about all of your medical conditions, including if you:
- drink alcohol, use drugs or have a history of alcohol or drug abuse
- have ever had depression or other mental health problems
- have low blood pressure or a medical condition that can cause low blood pressure
- are pregnant or plan to become pregnant. It is not known if Addyi will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Addyi passes into your breast milk.
- You and your doctor should decide if you will take Addyi or breastfeed. You should not do both.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Addyi can affect the way other medicines work, and other medicines can affect the way Addyi works, and can cause serious side effects.
How should I take Addyi?
- 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.
What should I avoid while taking Addyi?
- 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).
What are the possible side effects of Addyi?
Addyi can cause serious side effects, including:
- Sleepiness is a common side effect of Addyi and can be serious. Taking Addyi can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements.
- Low blood pressure and fainting (loss of consciousness) can happen when you take Addyi even if you do not drink alcohol or take other medicines or herbal supplements. Your risk of low blood pressure and fainting (loss of consciousness) is increased if Addyi is taken during waking hours, if you drink alcohol, or if you take certain medicines or herbal supplements.
The most common side effects of Addyi include:
- dry mouth
- difficulty falling asleep or staying asleep
These are not all of the possible side effects of Addyi. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for FULL PRESCRIBING INFORMATION, including BOXED WARNING regarding risk of severe low blood pressure and fainting, and Medication Guide for Addyi.
1. U.S. Census Bureau, 2014; Shifren JL, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-8
2. Arnow BA, Millheiser L, Garrett A, et al. Women with hypoactive sexual desire disorder compared to normal females: A functional magnetic resonance imaging study. Neuroscience. 2009; 158:484-502.
3. Woodard TL, Nowak NT, Balon R, Diamond MP. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: A cross-sectional pilot study. Fertil Steril. 2013; 100(4): 1068-1076.