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SEPT 20-23, 2022 / WASHINGTON, DC
AAFP’S FAMILY MEDICINE EXPERIENCE (FMX)
The AAFP’s Family Medicine Experience is for family physicians and industry leaders. Each year, FMX draws thousands of family physicians together to explore the best education, the latest patient and practice solutions, and networking opportunities. FMX also provides messages from today’s thought leaders, resources to help physicians enhance their delivery of care, and gatherings with peers and solution providers to advance the specialty of family medicine.
SEPT 29-OCT 2, 2022 / HOUSTON, TX
NURSE PRACTITIONERS IN WOMEN’S HEALTH (NPWH) ANNUAL WOMEN’S HEALTHCARE CONFERENCE
The 25th Annual NPWH Women’s Healthcare Conference is the premier continuing education, networking, clinical, and business meeting for WHNPs and other advanced practice registered nurses specializing in women’s and gender-related healthcare.
OCT 12-15, 2022 / ATLANTA, GA
NORTH AMERICAN MENOPAUSE SOCIETY (NAMS) ANNUAL MEETING
The North American Menopause Society Annual Meeting is a must-attend event for anyone involved with midlife women’s health issues. Attendees will hear from world-renowned speakers, learn the latest discoveries from important clinical trials, and network with colleagues from North America and around the world.
OCT 27-30, 2022 / MIAMI, FL
SEXUAL MEDICINE SOCIETY OF NORTH AMERICA (SMSNA) ANNUAL FALL SCIENTIFIC MEETING
This year’s joint 23rd Annual Fall Scientific Meeting of SMSNA and the 23rd ISSM Scientific Meeting will contain lectures, debates, and panel discussions by leaders in their respective fields and many renowned experts within the society and the ISSM itself. Feature sessions will cover the gamut including surgery, pharmacotherapy, epidemiology, mental health, hormones, basic science, and issues in gender identity and sexual orientation. The abstract sessions spark spirited but collegial discussion and debate among members.
NOV 17-20, 2022 / SCOTTSDALE, AZ
INTERNATIONAL SOCIETY FOR THE STUDY OF WOMEN’S SEXUAL HEALTH (ISSWSH) FALL COURSE
Whether you are a return attendee or brand new to the International Society for the Study of Women’s Sexual Health this year’s course will provide a new and exciting experience for you to learn about women’s sexual health and connect with colleagues from all over. This course is relevant for all women’s healthcare providers, including MDs, NPs, PAs, PTs, CNMs, and all types of mental health providers. Trainees and those with decades in their respective fields are welcome as this course can contribute to almost any practitioner.
Stay Up To Date on the Latest Addyi Info
Indication and Important Safety Information including Boxed Warning regarding hypotension and syncope in certain settings
Important Safety Information including Boxed Warning regarding hypotension and syncope in certain settings
- Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
- Hepatic impairment
- Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported.
Warnings and Precautions
- Hypotension and Syncope Due to an Interaction with Alcohol: Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime. Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
- Hypotension and Syncope with CYP3A4 Inhibitors: Moderate or strong CYP3A4 inhibitors significantly increase ADDYI concentrations, which can lead to hypotension and syncope. Concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.
- Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone and is exacerbated by other CNS depressants including alcohol, and in settings where flibanserin concentrations are increased such as CYP3A4 inhibitors. The risk of CNS depression is also increased if ADDYI is taken during waking hours. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them.
- Hypotension and Syncope with ADDYI Alone: The use of ADDYI – without other concomitant medications known to cause hypotension or syncope – can cause hypotension and syncope. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken. Consider the benefits of ADDYI and the risks of hypotension and syncope in patients with pre-existing conditions that predispose to hypotension. Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.
- Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. ADDYI is contraindicated in patients with hepatic impairment.
- Hypersensitivity Reactions: Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs.
- Alcohol: coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone. Patients should wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening.
- CNS Depressants: (i.e., diphenhydramine, opioids, hypnotics, benzodiazepines, etc.) Concomitant use with ADDYI may increase the risk of CNS depression compared to use of ADDYI alone.
- Moderate or Strong CYP3A4 Inhibitors: ADDYI is contraindicated in women taking moderate (e.g., fluconazole, etc.) or strong (e.g., ketoconazole, etc.) CYP3A4 inhibitors
- Oral Contraceptives and Other Weak CYP3A4 Inhibitors: In combination with ADDYI may increase the risk of adverse reactions
- Strong CYP2C19 Inhibitors: (i.e., proton pump inhibitors, SSRI’s, benzodiazepines, antifungals, etc.) Increase flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression
- CYP3A4 Inducers: (i.e., carbamazepine, phenobarbital, etc.) Concomitant use substantially decreases flibanserin exposure compared to the use of ADDYI alone and is not recommended.
- Digoxin or other P-glycoprotein (P-gp) substrates: Increases digoxin concentration, which may lead to digoxin toxicity. Increase monitoring of drugs transported by P-gp that have a narrow therapeutic index.
Most Common Adverse Reactions
- Most common adverse reactions (ADDYI incidence ≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.
ADDYI (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
- A co-existing medical or psychiatric condition,
- Problems within the relationship, or
- The effects of a medication or other drug substance.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problem with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.
Limitations of Use:
- ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
- ADDYI is not indicated to enhance sexual performance.