FREQUENTLY ASKED QUESTIONS
You asked, we answered
Some of the most common questions healthcare professionals ask about Vyleesi
What are the most common adverse reactions for Vyleesi?
A: In clinical trials, the most common adverse reactions for Vyleesi, occurring in more than 4% of patients, were nausea, flushing, injection site reactions, headache, and vomiting. Other adverse reactions occurring in more than 2% of patients were cough, fatigue, hot flush, paresthesia, dizziness, and nasal congestion. The majority of events were reported to be mild to moderate in intensity and transient.1
Can my patient drink alcohol while taking Vyleesi?
A: Yes. In a study to assess the safety of a single intranasal dose (20 mg) of bremelanotide coadministered with alcohol in 24 healthy male and female subjects, alcohol consumption had no effect on the pharmacokinetic profile of bremelanotide, did not lead to an increased frequency of adverse events, and no participants discontinued due to adverse events. Small, transient increases in blood pressure were observed following co-administration of bremelanotide and alcohol, consistent with those observed in Vyleesi clinical studies.1
What are the most important things my patient needs to know before taking Vyleesi?
A: Your patient should use effective birth control while taking Vyleesi (if pregnancy is suspected, discontinue treatment), may take no more than one dose every 24 hours and should not exceed 8 doses per month. Taking Vyleesi more frequently or too close together may lead to increases in blood pressure and increased cardiovascular risk. Advise patients that focal hyperpigmentation may occur when Vyleesi is used intermittently, particularly in patients with darker skin. Incidence may increase with daily use. She may also experience mild to moderate nausea, which usually resolves within 2 hours.1
How can I manage patients’ nausea?
A: You can prescribe an antiemetic or antinauseant if needed.1
Does my patient need to be on birth control?
A: Advise your patients to use effective contraception while taking Vyleesi, and discontinue Vyleesi as soon as pregnancy is suspected.1
What happens if my patient gets pregnant while on Vyleesi?
A: There are no studies of Vyleesi in pregnant women to inform whether there is a drug-associated risk, or if there is a potential for fetal harm. Advise your patients to use effective contraception while taking Vyleesi, and discontinue Vyleesi as soon as pregnancy is suspected.1
How can I quickly diagnose HSDD?
A: Use the Decreased Sexual Desire Screener (DSDS), a simple, validated diagnostic tool to help you identify and discuss hypoactive sexual desire disorder (HSDD).2
My patient is still having sex. Could she benefit from Vyleesi?
A: Changes in sexual desire are not always accompanied by observable changes in sexual behavior or frequency. Women with low sexual desire still engage in sexual activity, but it’s infrequent or initiated by a partner.3-5
How many doses of Vyleesi can my patient take a month?
A: Your patient can take up to 8 doses of Vyleesi a month.1
How should I code HSDD?
A: HSDD is miscoded over one-third of the time. If you’re using the ICD-10-CM, HSDD should be billed to F52.0. If you’re using ICD-11, the code for HSDD is HA00.2. Using the correct code can prevent the need for prior authorization.6-8
How should the Vyleesi autoinjector be stored and handled?
A: The Vyleesi autoinjector does not need refrigeration, but should be protected from light and stored at or below 25°C (77°F). Do not freeze. The single-dose autoinjector is patient-administered and must be disposed of correctly in a sharps container.1
Can I request a sample of Vyleesi?
A: Samples of Vyleesi are not available at this time, but please sign up for updates to stay in the know.
Has Vyleesi been studied in postmenopausal women?
A: The RECONNECT trials studied Vyleesi in premenopausal women only. Vyleesi is not indicated for the treatment of HSDD in postmenopausal women or in men.1
My patient is taking depression medication. Can she take Vyleesi?
A: In the drug interaction studies, there were no clinically relevant interactions with Vyleesi and concomitant antidepressants; there was also no dose adjustment needed with select selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. Note that patients with a history of depression and antidepressant use were excluded from the clinical trials to eliminate potential confounding factors such as sexual dysfunction due to antidepressant use.1,9
How it Works
How does Vyleesi work?
A: Vyleesi is a melanocortin receptor agonist that nonselectively activates several receptor subtypes, the most relevant of which are MC1R and MC4R. The exact mechanism by which Vyleesi improves HSDD in women is unknown.1
VYLEESI 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 with the relationship, or
- The effects of a medication or drug substance.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Limitations of Use
- VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
- VYLEESI is not indicated to enhance sexual performance.
IMPORTANT SAFETY INFORMATION
VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.
WARNINGS AND PRECAUTIONS
Transient Increase in Blood Pressure and Decrease in Heart Rate: VYLEESI transiently increases blood pressure and reduces heart rate after each dose. Advise patients that these changes usually resolve within 12 hours. VYLEESI is not recommended in patients at high risk for cardiovascular disease. Consider the patient’s cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. To minimize the risk of more pronounced blood pressure effects, patients should not take more than one VYLEESI dose within 24 hours. Patients should not use more than 8 VYLEESI doses per month.
Focal Hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Patients are at higher risk of developing focal hyperpigmentation if they have darker skin and with daily dosing. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI. Consider discontinuing VYLEESI if hyperpigmentation develops.
Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Nausea improves for most patients with the second dose. Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea.
Most common adverse reactions (incidence >4%) are nausea, flushing, injection site reactions, headache, and vomiting.
VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction.
Advise patients to discontinue VYLEESI if pregnancy is suspected. Advise patients to use effective contraception while taking VYLEESI.
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at 1-800-972-5220.
Please see full Prescribing Information.
References: 1. VYLEESI [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2019. 2. Clayton AH, Goldfischer ER, Goldstein I, DeRogatis L, Lewis-D’Agostino DJ, Pyke R. Validation of the decreased sexual desire screener (DSDS): a brief diagnostic instrument for generalized acquired female hypoactive sexual desire disorder (HSDD). J Sex Med. 2009;6(3):730-738. 3. Parish SJ, Goldstein AT, Goldstein SW, et al. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions—part II. J Sex Med. 2016;13(12):1888-1906. 4. Leiblum SR, Koochaki PE, Rodenberg CA, Barton IP, Rosen RC. Hypoactive sexual desire disorder in postmenopausal women: US results from the Women’s International Study of Health and Sexuality (WISHeS). Menopause. 2006;13(1):46-56. 5. Bancroft J, Loftus J, Long JS. Distress about sex: a national survey of women in heterosexual relationships. Arch Sex Behav. 2003;32(3):193-208. 6. Data on file; publication pending. AMAG Pharmaceuticals, Inc. 2018. 7. World Health Organization. International statistical classification of diseases and related health problems. 10th revision, 5th ed. Geneva, Switzerland: World Health Organization. 8. World Health Organization. International classification of diseases for mortality and morbidity statistics. 11th revision, Chapter 17, Conditions related to sexual health, Sexual dysfunctions. https://icd.who.int/browse11/l-m/en#/http%3A%2F%2Fid.who.int%2Ficd%2Fentity%2F711380687. Accessed August 8, 2019. 9. Data on File, AMAG Pharmaceuticals, Inc.; Study BMT-301 OLE.