Generic name: bremelanotide [ BRE-me-LAN-oh-tide ]
Brand name: Vyleesi
Dosage form: subcutaneous solution (1.75 mg/0.3 mL)
Drug class: Melanocortin receptor agonists
What is bremelanotide?
Bremelanotide is used to treat low sexual desire in women who have not gone through menopause and have not had low sexual desire in the past.
bremelanotide should be used only to treat low sexual desire that occurs with any type of sexual activity, in any sexual situation, or with any sexual partner.
Bremelanotide should not be used to treat low sexual desire that is caused by relationship problems, health problems, mental illness, or by using certain drugs or medications.
Bremelanotide is not for use in men, or in women who have gone through menopause. Bremelanotide should not be used to improve sexual performance.
Bremelanotide may also be used for purposes not listed in this medication guide.
You should not use bremelanotide if you have heart problems or if you have untreated or uncontrolled high blood pressure.
Before taking this medicine
You should not use bremelanotide if you are allergic to it, or if you have:
heart disease; or
untreated or uncontrolled high blood pressure.
Bremelanotide is not approved for use by anyone younger than 18 years old.
Tell your doctor if you have ever had:
high blood pressure;
kidney disease; or
Bremelanotide may harm an unborn baby. Use effective birth control to prevent pregnancy. Stop using the medicine and tell your doctor right away if you become pregnant.
If you do use bremelanotide during pregnancy, your name may be listed on a pregnancy registry to track the effects of bremelanotide on the baby.
It may not be safe to breastfeed while using bremelanotide. Ask your doctor about any risk.
How should I use bremelanotide?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Bremelanotide is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Use the bremelanotide injection at least 45 minutes before sexual activity.
Do not use more than 1 bremelanotide injection every 24 hours. Do not use more than 8 total injections within 1 month.
Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Bremelanotide can cause nausea, which may be severe. Use this medicine exactly as your doctor has prescribed.
Call your doctor if your symptoms do not improve after 8 weeks.
Store at cool room temperature, away from heat and light. Do not freeze. Keep unused injection pens in their original carton.
Use a prefilled injection pen only once and then place it in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
What happens if I miss a dose?
Since bremelanotide is used when needed, it does not have a daily dosing schedule.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using bremelanotide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Bremelanotide side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Bremelanotide may cause serious side effects. Call your doctor at once if you have:
severe or ongoing nausea;
slow heartbeats; or
high blood pressure--severe headache, blurred vision, pounding in your neck or ears.
Your blood pressure and heart rate should return to normal within 12 hours after an injection. Tell your doctor if these side effects last longer that 12 hours.
Bremelanotide may darken the color of your gums or your skin (especially on the face or breasts). People with darker skin color may be more likely to develop this side effect. These skin changes may be permanent, even after you stop using bremelanotide. Talk with your doctor about your own risk.
Common side effects of bremelanotide may include:
flushing (sudden warmth, redness, or tingly feeling);
cough, stuffy nose;
headache, tiredness, dizziness; or
pain, bruising, redness, itching, bleeding, numbness, or tingling where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Bremelanotide dosing information
Usual Adult Dose for Hypoactive Sexual Desire Disorder:
1.75 mg subcutaneously as needed 45 minutes before anticipated sexual activity
-No more than 1 dose should be administered within 24-hour period
-Administering more than 8 doses/month is not recommended
-Hypoactive sexual desire disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty.
-Acquired HSDD means the patient has previously had no problems with sexual desire.
-Generalized HSDD means the condition occurs regardless of the type of stimulation, situation, or partner.
-This drug is not for the treatment of HSDD in postmenopausal women or in men; it is not indicated to enhance sexual performance.
-This drug should be discontinued if there is no improvement in symptoms after 8 weeks.
Use: For the treatment of acquired, generalized HSDD in premenopausal women not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.
What other drugs will affect bremelanotide?
Bremelanotide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.
Tell your doctor about all your other medicines, especially:
pain medicine; or
naltrexone (to treat alcohol or opioid addiction).
This list is not complete. Other drugs may affect bremelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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