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  1. Who shouldn’t take Vyleesi?

    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.

  2. 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.

    Think you have symptoms of HSDD? Check it out.


    *Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Womens Health. 2014;23(10):817-823.

  3. What’s Vyleesi?

    Vyleesi (bremelanotide injection) is the first and only FDA-approved as-needed treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It was approved by the FDA on June 21, 2019.

    Do not use if you have:

    • high blood pressure that is not controlled (uncontrolled hypertension)
    • known heart (cardiovascular) disease

    See clinical trials info.

  4. 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 professional.

    See How should I use Vyleesi?

    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.

    For more information about using Vyleesi, please read the Vyleesi Patient Information.

  5. 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.

    Watch our video, “How to take Vyleesi.”

  6. What’s a specialty pharmacy and how does it work?

    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 up, it’s shipped directly to you. They also work to verify your insurance and help with any copay 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: Your prescription gets submitted
    Your healthcare professional will send your prescription to a specialty pharmacy, either Avella™ or BioPlus®. Specialty pharmacies handle medications that have special storage, delivery, or administration requirements.

    Step 2: You get a call (or text)
    Be on the lookout for a text and/or phone call from Avella™ or BioPlus®. It may be a couple of days after your appointment. They are contacting you to process your prescription by:

    • Verifying  insurance
    • Helping with copay assistance
    • Arranging your delivery of Vyleesi (you may be able to schedule your delivery online)

    Step 3. You get your Vyleesi!
    The specialty pharmacy will ship your Vyleesi directly to you, with overnight or two-day shipping. You can track your package, if you like, and it will be delivered quickly and discreetly to your door.

    PS: both Avella™ and BioPlus® have on-call pharmacists that will answer your questions.

    Talk to a healthcare professional now, from the comfort and privacy of your own home.

  7. Does Vyleesi work?

    Here’s what two identically designed clinical trials with over 1,200 premenopausal women with HSDD* 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 premenopausal women with acquired, generalized HSDD 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.

  8. How do I administer Vyleesi to myself?

    We have a video that’s about just that.

    Have a look…

    Please use Vyleesi exactly as prescribed by your healthcare professional.

  9. Do I have to avoid alcohol while taking Vyleesi?

    Nope. Vyleesi has no alcohol restriction.

    Please use Vyleesi exactly as prescribed by your healthcare professional.

    For more information about using Vyleesi, please read the Vyleesi Patient Information.

  10. Can I take Vyleesi if I’m pregnant?

    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.

    For more information about using Vyleesi, please read the Vyleesi Patient Information.

  11. What’s telemedicine?

    Basically, it’s a way for you to talk to a healthcare professional about your symptoms without having to be in their physical presence. You can book and have your appointment online, from the privacy of your own home—or wherever. You can even get a prescription for Vyleesi this way.

    Interested? Get the details.

  12. What does Vyleesi cost, and is there help to pay for it?

    It’s simple: pay a $0 copay for your first Vyleesi prescription. Then, pay no more than $99 for each eligible refill of 4 single-dose autoinjectors.*

    This applies to eligible commercially insured patients, or patients paying cash—whether they’re uninsured or their insurance doesn’t cover Vyleesi.

    *Each patient’s eligibility is evaluated on an individual basis. In compliance with federal regulations, patients insured by a government-funded program (Medicaid, TRICARE, etc.) are not eligible. 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.

    Financial assistance applies to the patient’s copay, coinsurance, or deductible for patients receiving Vyleesi. AMAG contributions against patient deductible and/or out-of-pocket maximums are subject to possible health plan restrictions. AMAG Pharmaceuticals will help lower the out-of-pocket cost to a $0 copay for the patient’s first prescription. AMAG will also provide copay assistance to lower the out of pocket cost for refills to a maximum copay of $99 per 4-pack. AMAG copay assistance will only apply to 2 fills every 30 days. Enrollment into the program cannot be retroactive.

    Save on Vyleesi.

  13. How should I use Vyleesi?

    Watch our video or 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.

    For more information about using Vyleesi, please read the Vyleesi Patient Information.

  14. How common is hypoactive sexual desire disorder (HSDD)?

    It’s pretty common. Consider: it’s estimated that about one in ten premenopausal women in the US has HSDD. That’s millions of women. But even though HSDD has been a recognized medical condition for decades, one survey showed that 72% of premenopausal women weren’t aware of it.* So if you hadn’t heard of HSDD before you got here, don’t be too tough on yourself. You know now. And now you know this, too: Vyleesi can treat it!

    Learn more about Vyleesi.


    *Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Womens Health. 2014;23(10):817-823.

Don't forget this part.
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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. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION
What 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.