Safety

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Vyleesi Injection: Uses, Dosage, Side Effects, Precautions and Alternates

· 6 min read

Vyleesi Injection: Uses, Dosage, Side Effects, Precautions and Alternates
Generic namebremelanotide
Drug classMelanocortin receptor agonist
FormsSolution for injection (prefilled autoinjector/injection pen), 1.75 mg/0.3 mL
Vyleesi Injection: Uses, Dosage, Side Effects, Precautions and Alternates product

Quick overview

Vyleesi Injection (bremelanotide) is a melanocortin receptor agonist given as an injectable prescription medicine. It is used to treat low sexual desire, known as hypoactive sexual desire disorder (HSDD), in premenopausal women. It is used on an as-needed basis before anticipated sexual activity rather than on a daily schedule. It is not intended for men, postmenopausal women, or low desire caused by relationship, health, or mental health issues.

What is Vyleesi Injection

Vyleesi is an injectable prescription medicine used to treat low sexual desire in women who have not gone through menopause.

Vyleesi Injection uses

  • Treats low sexual desire (hypoactive sexual desire disorder or HSDD) in premenopausal women that occurs with any type of sexual activity, situation, or partner
  • Not for low sexual desire caused by relationship problems, health problems, mental illness, or medication/drug use
  • Not for use in men or in women who have gone through menopause
  • Not meant to improve sexual performance

Benefits of Vyleesi Injection

  • Helps treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
  • Can help increase sexual desire and interest
  • May reduce distress associated with persistently low sexual desire
  • Provides an on-demand, non-hormonal treatment option used before anticipated sexual activity

How Vyleesi Injection works

Vyleesi may work by activating certain receptors in the brain that affect mood and sexual desire.

Vyleesi Injection dosage

Use exactly as directed by your doctor and follow all instructions on your prescription label and any medication guides. It is injected under the skin (subcutaneously), usually in the abdomen or thigh; a healthcare provider may teach you how to give the injection yourself. Use the injection at least 45 minutes before you expect to have sexual activity. Do not use more than one injection in a 24-hour period, and do not use more than 8 injections in one month.

Prepare an injection only when you are ready to give it; do not use if the liquid looks cloudy, has changed color, or has particles in it. Clean the injection site with rubbing alcohol before each dose, and change the injection site each time to reduce injury under the skin. Do not inject into skin that is irritated, sore, bruised, red, hard, or scarred. Avoid rubbing the injection site after the shot to reduce bruising.

Use a prefilled injection pen only once, then dispose of it in a puncture-proof sharps container according to local rules. Tell your doctor if your symptoms do not improve after 8 weeks of use. Since this medicine is used as needed rather than on a daily schedule, there is no missed-dose schedule to follow.

Age groupDose
Under 18 yearsNot indicated; safety and effectiveness not established
18+ years – Premenopausal women with HSDD1.75 mg subcutaneously as needed, at least 45 minutes before anticipated sexual activity
Maximum per 24 hours1 dose (1.75 mg)
Maximum monthly useNo more than 8 doses per month
65+ yearsNot indicated for postmenopausal women

Available forms and strengths

  • Solution for injection (prefilled autoinjector/injection pen), 1.75 mg/0.3 mL

Side effects of Vyleesi Injection

Common

  • Nausea, vomiting
  • Flushing or hot flashes (sudden warmth, redness, or tingly feeling)
  • Cough, stuffy nose
  • Headache, tiredness, dizziness
  • Pain, bruising, redness, itching, bleeding, numbness, or tingling where the injection was given
  • Joint pain, muscle pain, diarrhea, restless leg feelings, upper abdominal pain, flu-like symptoms

Serious

  • Severe allergic reaction: hives, difficult breathing, swelling of face, lips, tongue, or throat
  • Severe or ongoing nausea
  • Slow heartbeats
  • High blood pressure symptoms: severe headache, blurred vision, pounding in neck or ears
  • Darkening of the skin color (especially on the face, gums, or breasts), which may be permanent
  • Liver problems (hepatitis)
  • Increased creatine kinase levels

Warnings and precautions

  • Do not use this medicine if you have heart problems or untreated or uncontrolled high blood pressure.
  • This medicine is not approved for anyone younger than 18 years old.
  • This medicine can cause nausea, which can be severe, especially with the first dose. Your doctor may give you other medicine to help prevent it.
  • After each dose, blood pressure may rise and heart rate may slow down; these changes are usually small and go away within 12 hours but may cause serious problems in people with heart disease.
  • This medicine can darken the color of the gums or skin, especially on the face or breasts. People with darker skin may be more likely to develop this, and the change may be permanent.
  • This medicine may slow digestion and reduce how well your body absorbs other medicines you take by mouth, especially antibiotics, pain medicine, or naltrexone used for alcohol or opioid addiction.
  • Bremelanotide may harm an unborn baby. Use effective birth control while using this medicine. If you become pregnant, stop using it and tell your doctor right away. You may be asked to join a pregnancy registry that tracks outcomes in women exposed to this medicine during pregnancy.
  • It is not known if this medicine passes into breast milk. It may not be safe to breastfeed while using it, so ask your doctor about the risks.
  • Tell your doctor if you have ever had kidney disease before using this medicine. Tell your doctor if you have ever had liver disease before using this medicine.
  • It is not known if alcohol affects this medicine, but drinking alcohol while using it may increase the risk of side effects such as dizziness.
  • This medicine may cause dizziness and could affect your ability to safely drive or operate machinery. Use caution until you know how it affects you.

Storage

  • Store in a refrigerator at 2–8°C (36–46°F); it may also be stored at 20–25°C (68–77°F) for up to 30 days.
  • Keep the autoinjector in its original carton to protect it from light.
  • Do not freeze; do not use if the medicine has been frozen.
  • Protect from excessive heat and direct sunlight and follow the labeled expiration/storage period.
  • Keep out of reach and sight of children and pets.

When to see a doctor

  • Get emergency medical help if you have signs of a severe allergic reaction: hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
  • Call your doctor right away if you have severe or ongoing nausea, slow heartbeats, or signs of high blood pressure such as severe headache, blurred vision, or pounding in your neck or ears.
  • If your blood pressure reading shows the top number at 180 or higher or the bottom number at 120 or higher, get medical attention right away.
  • Tell your health care provider right away if you have chest pain, feel lightheaded or faint, feel confused, feel weak or unusually tired, notice a slow or skipped heartbeat, or have shortness of breath.
  • Get medical help right away if you or someone else has used too much of this medicine.
  • Tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Alternatives

  • Addyi (Flibanserin)
  • Flibanserin
  • Bupropion
  • Buspirone

Watch the video

Video: Vyleesi Injection: Uses, Dosage, Side Effects, Precautions and Alternates

FAQs

What is Vyleesi Injection used for?

Vyleesi is an injectable prescription medicine used to treat low sexual desire, known as hypoactive sexual desire disorder (HSDD), in premenopausal women.

How is Vyleesi Injection used?

It is injected under the skin, usually in the abdomen or thigh, at least 45 minutes before anticipated sexual activity. Do not use more than one injection in 24 hours or more than 8 injections per month.

What are the common side effects of Vyleesi Injection?

Common side effects include nausea, vomiting, flushing or hot flashes, cough, stuffy nose, headache, tiredness, dizziness, and pain, bruising, or redness at the injection site.

Who should not use Vyleesi Injection?

It should not be used by men, postmenopausal women, anyone under 18, or people with heart problems or untreated or uncontrolled high blood pressure. It is also not meant for low desire caused by relationship, health, or mental health issues.

Can Vyleesi Injection cause skin darkening?

Yes, it can darken the color of the skin or gums, especially on the face or breasts, and this change may be permanent, particularly in people with darker skin.

General information, not medical advice

Your prescriber and the leaflet in your pack know your situation. This page does not.

  • Follow your prescriber and the leaflet
  • Don't start, stop, or change a dose on your own
  • Doses and warnings differ by country and product
Facts checked by a personSourcesFull disclaimer

Sources

  1. https://www.drugs.com/vyleesi.html#faq
  2. https://www.webmd.com/drugs/vyleesi-bremelanotide
  3. https://www.healio.com/clinical-guidance/drugs/vyleesi