Vyleesi 1.75 mg/0.3 mL subcutaneous auto-injector

Generic name:
Bremelanotide - subcutaneous injection

Pronunciation
(BRE-me-LAN-oh-tide)

Brand name(s)
Vyleesi

This medication is used to treat women who have not gone through menopause who have low sexual desire and are concerned about it.

Bremelanotide should not be used to treat low sexual desire caused by a medical or mental/mood disorder, problems in a relationship, or the effects of other drugs. This medication should not be used by women who have gone through menopause, or by men. Bremelanotide is not used to enhance sexual performance.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using bremelanotide and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually as needed. The injection is given in the abdomen or thigh. Use each injection at least 45 minutes before you think you will begin sexual activity. Do not use more than 1 dose in 24 hours. Do not use more than 8 doses each month. Doing so may increase your risk of side effects (such as darkening of the skin, high blood pressure).

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is irritated, sore, bruised, red, hard, or scarred. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition does not get better or if it gets worse.

Nausea, vomiting, flushing, headache, or dizziness may occur. Redness/irritation/pain at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If you have severe nausea that does not go away, your doctor may prescribe an anti-nausea medicine for you.

This medication may cause darkening of the skin on certain areas of your body (such as the face, gums, and breast). People with darker skin color may be at higher risk. It is unknown if this effect is permanent. Tell your health care provider if you have any concerns about changes to your skin.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause a temporary increase in blood pressure and decrease in heart rate after each injection. This effect will usually go away within 12 hours after the dose. Check your blood pressure regularly and tell your doctor if the results are high.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using bremelanotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood pressure
• heart problems
• kidney problems
• liver problems

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure) should be done while you are using this medication. Keep all medical and lab appointments.

Not applicable.

Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.