Bremelanotide injection

What is this medication?

BREMELANOTIDE (BRE mel AN oh tide) is used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had 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 a low sexual desire that is troubling to them, and is not due to a medical or mental health problem, problems in the relationship, medicines, or drug abuse.

This medicine is not for HSDD in women who have gone through menopause. This medicine is not for men. This medicine not for use to improve sexual performance.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): VYLEESI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• high blood pressure
• an unusual or allergic reaction to bremelanotide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Do not take your medicine more often than directed.

It is important that you put your used autoinjector in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine is not for regular use.

What may interact with this medication?

• naltrexone products for drug or alcohol addiction

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor if your symptoms have not improved after you have taken this medicine for 8 weeks.

Do not become pregnant while taking this medicine. Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects and harm to an unborn child. Talk to your healthcare professional for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• high blood pressure
• severe nausea that does not go away
• skin discoloration, such as dark spots on the face, gums, or breast

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• cough
• dizziness
• flushing
• headache
• hot flashes
• nausea, vomiting
• pain, redness or irritation at site where injected
• stuffy nose
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store unopened autoinjectors at or below 25 degrees C (77 degrees F). Do not freeze. Protect from light. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.