Women should not use Vyleesi if they have high blood pressure that is not controlled (uncontrolled hypertension) or known heart (cardiovascular) disease.
Vyleesi is not for the treatment of HSDD in women who have gone through menopause or in men.
Vyleesi is not for use to improve sexual performance. Vyleesi is not for use in children.
Before using Vyleesi, tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if Vyleesi will harm your unborn baby. Women who can become pregnant should use effective birth control during treatment with Vyleesi.
Patients should avoid using Vyleesi with an orally administered naltrexone-containing product intended to treat alcohol and opioid addiction due to the severe consequence of naltrexone treatment failure.
What is HSDD?
That’s the abbreviation for hypoactive sexual desire disorder. It’s a common, treatable medical condition characterized by ongoing low sexual desire that women find frustrating (“hypoactive” means “low”).
If you’re diagnosed with “acquired, generalized” HSDD, it means you haven’t had low sexual desire in the past, but you now have low sexual desire no matter the sexual activity, situation, or sexual partner.
If you’ve never heard of HSDD, you’re not alone. One survey showed that 72% of premenopausal women weren’t aware of HSDD,* even though about 10% of premenopausal women in the US have it.
*Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Womens Health. 2014;23(10):817-823.
What’s Vyleesi?
Vyleesi (bremelanotide injection) is the first and only FDA-approved as-needed treatment for women experiencing low libido associated with HSDD (hypoactive sexual desire disorder). It was approved by the FDA on June 21, 2019.
Vyleesi is for 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
Do not use if you have:
high blood pressure that is not controlled (uncontrolled hypertension)
Vyleesi can cause serious side effects, including:
Temporary increase in blood pressure and decrease in heart rate: an increase in blood pressure and decrease in heart rate can happen shortly after you inject Vyleesi. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use Vyleesi more often than prescribed by your healthcare professional.
Darkening of the skin on certain parts of the body (focal hyperpigmentation), including the face, gums (gingiva), and breast. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if Vyleesi is used every day. Darkening of the skin may not go away, even after you stop using Vyleesi. Tell your healthcare professional if you have any concerns about changes to your skin.
Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first Vyleesi injection but can also happen after any dose of Vyleesi. The nausea usually lasts for about 2 hours but can last longer in some people. The nausea usually goes away by itself. Tell your healthcare professional if you have nausea that is severe or does not go away. Your healthcare professional may prescribe an anti-nausea medicine for you.
The most common side effects of Vyleesi include:
nausea
flushing
vomiting
hot flush
nasal congestion
injection site reactions
cough
tingling
headache
fatigue
dizziness
These are not all the possible side effects of Vyleesi.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What do you mean Vyleesi can be taken “as needed”?
It means that if you have a prescription for Vyleesi, you can decide when is the best time to take it, any time of day, based on your own experience, as long as you administer Vyleesi at least 45 minutes before anticipated sexual activity. Do not administer more than one dose within 24 hours or more than 8 doses per month.
(PS: Vyleesi has no alcohol restriction.)
Please use Vyleesi exactly as prescribed by your healthcare professional.
A specialty pharmacy handles medications that have special storage, delivery, or administration requirements. When you get a medication through a specialty pharmacy, you don’t go there to pick it up; it’s shipped directly to you. They also work to verify your insurance and help with any co-pay assistance that may be available to you. Vyleesi is handled by special pharmacies only. So if your healthcare professional prescribes Vyleesi for you, this is how you’ll get it:
Step 1: Vyleesi gets prescribed and submitted.
Your healthcare provider sends your Vyleesi prescription to BlinkRx specialty pharmacy. With our partnership with BlinkRx, you can be sure you are getting the lowest price using all available discounts.
Step 2: BlinkRx sends you a text.
BlinkRx texts you a link on the same day. You pay online or by phone and get home delivery at no additional cost. They’ll let you know about the copay, help with any approvals, and apply savings offers.
Step 3: Vyleesi is delivered to your door.
BlinkRx will arrange for your Vyleesi to be delivered to your home. Have questions? Just give BlinkRx a call at 1(833) 799-5028or visit blinkrx.com.
PS: If you already have a prescription, you can contact BlinkRx directly at 1 (833) 799-5028or visit www.blinkrx.comfor more information on how to get Vyleesi for the lowest price with FREE SHIPPING.
Here’s what two identically designed clinical trials with more than 1,200 women with HSDD who had not gone through menopause* showed:
Vyleesi increased sexual desire and reduced related distress.
Women who took Vyleesi experienced continued meaningful improvement of HSDD symptoms, with nearly 80% of women who completed the clinical study volunteering for an additional one-year extension.
The most common side effects are nausea, flushing, injection site reactions, headache, and vomiting.†
*The effectiveness and safety of Vyleesi were studied in two identical trials in over 1,200 women with HSDD who had not gone through menopause for at least six months. Ages ranged from 19-56 years old, with an average age of 39 years old; 86% were White and 12% were Black. The trials had two phases: a 24-week Core Study Phase (24-week placebo-controlled, double-blind treatment period) and an uncontrolled 52-week Open-label Extension Study Phase in which nearly 700 patients received Vyleesi. Most people who received Vyleesi used it two to three times per month and no more than once a week.
†Serious adverse reactions were reported in 1.1% of Vyleesi-treated patients and 0.5% of placebo-treated patients.
How do I take Vyleesi?
Vyleesi is simple and intuitive. Our step-by-step guide is here to walk you through your first dose of desire.
Please use Vyleesi exactly as prescribed by your healthcare professional.
Do I have to avoid alcohol while taking Vyleesi?
Vyleesi has no alcohol restriction, so you can “cheers” to your desire!
Please use Vyleesi exactly as prescribed by your healthcare professional.
Vyleesi’s impact on pregnancy is unknown. Stop using Vyleesi and tell your healthcare professional right away if you become pregnant or think you might be pregnant during treatment with Vyleesi.
Women who can become pregnant should use effective birth control while taking Vyleesi—talk to your healthcare professional about choices that may be right for you.
Please use Vyleesi exactly as prescribed by your healthcare professional.
Telemedicine allows you to get Vyleesi without having to visit the doctor’s office. Just connect with a healthcare professional about your symptoms online from the comfort of home. Then, if prescribed, your Vyleesi will get delivered right to your door for free. Plus, it’s just $29 for the consultation!
What does Vyleesi cost, and is there help to pay for it?
Here’s how to get your Vyleesi prescription:
Vyleesi is only available through BlinkRx specialty pharmacy.
Vyleesi is affordable; most commercially insured patients pay $0 for Vyleesi.*
BlinkRx helps all patients get Vyleesi for the lowest price with FREE SHIPPING!
If you already have a prescription for Vyleesi, you can contact BlinkRx directly at 1 (833) 799-5028 or visit www.blinkrx.com. They can answer any questions you may have.
*Depending on your insurance coverage, most eligible patients may pay as little as $0. Each patient’s eligibility is evaluated on an individual basis. Patients must be 18 or older to qualify. These programs and any assistance provided may be discontinued or modified at any time based on eligibility, state and local laws, and program availability. Patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible.
Financial assistance applies to the patient’s co-pay, coinsurance, or deductible for patients receiving Vyleesi. Cosette contributions against patient deductible and/or out-of-pocket maximums are subject to possible health plan restrictions. Cosette co-pay assistance will only apply to 2 fills every 30 days. Enrollment into the program cannot be retroactive.
See the detailed Instructions for Use that comes with Vyleesi for information on how to prepare and inject a dose of Vyleesi. Talk to your healthcare professional or pharmacist if you have any questions.
Use Vyleesi exactly as prescribed by your healthcare professional.
Vyleesi comes in an autoinjector that you or your caregiver may use at home to give injections.
Vyleesi is given as an injection under the skin (subcutaneous injection), in your thighs or stomach area.
Inject Vyleesi at least 45 minutes before you think that you will begin sexual activity.
Do not inject more than 1 dose of Vyleesi within 24 hours of your last dose.
Do not inject more than 8 doses of Vyleesi within a month.
Tell your healthcare professional if your symptoms of HSDD have not improved after you have used Vyleesi for 8 weeks.
Low libido associated with HSDD, is experienced by an estimated 1 in 10 women in the US. It’s the most common medical condition to cause sex-related distress for women, affecting self-esteem and putting a strain on relationships. However, most susceptible women—around 72%*— aren’t aware of it. And those experiencing low libido associated with HSDD often don’t discuss it with their doctors or seek treatment. Now, you can help change the conversation by starting it.
Learn more about low libido associated with HSDD and FDA-approved treatment, Vyleesi. It’s time to get back to your desire!
*Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Womens Health. 2014;23(10):817-823.
Important Safety Information
Do not use Vyleesi if you have:
high blood pressure that is not controlled (uncontrolled hypertension)
known heart (cardiovascular) disease
Book Virtual Appointment
with a healthcare provider now.
Important Safety Information
Do not use Vyleesi if you have:
high blood pressure that is not controlled (uncontrolled hypertension)
known heart (cardiovascular) disease
Before using Vyleesi, tell your healthcare provider about all of your medical conditions, including if you:
have high blood pressure. have heart problems. have kidney problems. have liver problems. are pregnant or plan to become pregnant. It is not known if Vyleesi will harm your unborn baby.
Women who can become pregnant should use effective birth control during treatment with Vyleesi.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Vyleesi may affect the way other medicines work, and other medicines may affect the way Vyleesi works.
How should I use Vyleesi?
Inject Vyleesi at least 45 minutes before you think that you will begin sexual activity. Do not inject more than 1 dose of Vyleesi within 24 hours of your last dose. Do not inject more than 8 doses of Vyleesi within a month.
What are the possible side effects of Vyleesi?Vyleesi can cause serious side effects, including:
Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject Vyleesi. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use Vyleesi more often than prescribed by your healthcare provider. Darkening of the skin on certain parts of the body (focal hyperpigmentation), including the face, gums (gingiva), and breast. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if Vyleesi is used every day. Darkening of the skin may not go away, even after you stop using Vyleesi. Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first Vyleesi injection but can also happen after any dose of Vyleesi. The nausea usually lasts for about 2 hours but can last longer in some people. The nausea usually goes away by itself. Tell your healthcare provider if you have nausea that is severe or does not go away.
The most common side effects of Vyleesi include: flushing, injection site reactions, headache, vomiting, cough, fatigue, hot flush, tingling, dizziness, and nasal congestion. These are not all the possible side effects of Vyleesi.
Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
INDICATIONWhat is Vyleesi?
Vyleesi 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
Vyleesi is not for the treatment of HSDD in women who have gone through menopause or in men.
Vyleesi is not for use to improve sexual performance.
Vyleesi is not for use in children.
Quick Question
Are you a healthcare professional in the United States?
This website is intended for US healthcare professionals only.
Terms & Conditions
*Depending on your insurance coverage, most eligible patients may pay as little as $0. Each patient’s eligibility is evaluated on an individual basis. Patients must be 18 or older to qualify. These programs and any assistance provided may be discontinued or modified at any time based on eligibility, state and local laws, and program availability. Patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible.
Financial assistance applies to the patient’s copay, coinsurance, or deductible for patients receiving Vyleesi. Cosette contributions against patient deductible and/or out-of-pocket maximums are subject to possible health plan restrictions. Cosette copay assistance will only apply to 2 fills every 30 days. Enrollment into the program cannot be retroactive.
Get a diagnosis
If your healthcare provider suspects that you may have HSDD, he or she will likely ask you 5 questions from the Decreased Sexual Desire Screener (DSDS). Here’s what to expect:
1.In the past, was your level of sexual desire or interest good and satisfying to you? 2.Has there been a decrease in your level of sexual desire or interest? 3.Are you bothered by your decreased level of sexual desire or interest? 4.Would you like your level of sexual desire or interest to increase? 5.Please circle any of the factors that you feel may be contributing to your current decrease in sexual desire or interest:
An operation, depression, injuries, or other medical condition
Medications, drugs, or alcohol you are currently taking
Pregnancy, recent childbirth, or menopausal symptoms
Other sexual issues you may be having (pain, decreased arousal or orgasm)
Your partner’s sexual problems
Dissatisfaction with your relationship or partner
Stress or fatigue
None of the above
Exciting offer!
Your online visit is just $49$29.
Connect with a licensed physician to see if Vyleesi is right for you.
By clicking here, you will go to our third-party telemedicine provider.
Terms & Conditions
*Depending on your insurance coverage, most eligible patients may pay as little as $0. Each patient’s eligibility is evaluated on an individual basis. Patients must be 18 or older to qualify. These programs and any assistance provided may be discontinued or modified at any time based on eligibility, state and local laws, and program availability. Patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible.
Financial assistance applies to the patient’s copay, coinsurance, or deductible for patients receiving Vyleesi. Cosette contributions against patient deductible and/or out-of-pocket maximums are subject to possible health plan restrictions. Cosette copay assistance will only apply to 2 fills every 30 days. Enrollment into the program cannot be retroactive.
Get a diagnosis
If your healthcare provider suspects that you may have HSDD, he or she will likely ask you 5 questions from the Decreased Sexual Desire Screener (DSDS). Here’s what to expect:
In the past, was your level of sexual desire or interest good and satisfying to you?
Has there been a decrease in your level of sexual desire or interest?
Are you bothered by your decreased level of sexual desire or interest?
Would you like your level of sexual desire or interest to increase?
Please check any of the factors that you feel may be contributing to your current decrease in sexual desire or interest:
Quick Question
Are you a healthcare professional in the United States?
You are now leaving Vyleesi.com to go to our telemedicine partner’s site (Prescribery)
Cosette is not affiliated with healthcare providers, does not make any recommendations of specific healthcare providers, and is not responsible for information you share with them. Any prescription is the decision of the healthcare provider alone, based on the patient’s needs. Cosette does not accept any responsibility for the care, treatment, or advice received from any healthcare provider.
*View complete eligibility terms & conditions
Terms & Conditions
‡Depending on your insurance coverage, most eligible patients may pay as little as $0. Each patient’s eligibility is evaluated on an individual basis. Patients must be 18 or older to qualify. These programs and any assistance provided may be discontinued or modified at any time based on eligibility, state and local laws, and program availability. Patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible.
Financial assistance applies to the patient’s copay, coinsurance, or deductible for patients receiving Vyleesi. Cosette contributions against patient deductible and/or out-of-pocket maximums are subject to possible health plan restrictions. Cosette copay assistance will only apply to 2 fills every 30 days. Enrollment into the program cannot be retroactive.
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