Bremelanotide Injection

Bremelanotide injection is used to treat women with hypoactive sexual desire disorder (HSDD; a low sexual desire that causes distress or interpersonal difficulty) who have not experienced menopause (change of life; the end of monthly menstrual periods); who have not had problems with low sexual desire in the past; and whose low sexual desire is not due to a medical or mental health problem, a relationship problem, or medication or other drug use. Bremelanotide injection should not be used for the treatment of HSDD in women who have gone through menopause, in men, or to improve sexual performance. Bremelanotide injection is in a class of medications called melanocortin receptor agonists. It works by activating certain natural substances in the brain that control mood and thinking.

Bremelanotide injection comes as a solution (liquid) in a prefilled automatic injection device to inject subcutaneously (under the skin). It is usually injected as needed, at least 45 minutes before sexual activity. You and your doctor will determine the best time for you to inject bremelanotide injection based on how well the medication works for you and the side effects you experience. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use bremelanotide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not inject more than one dose of bremelanotide injection within 24 hours. Do not inject more than 8 doses of bremelanotide injection within a month.

Before you use bremelanotide injection yourself the first time, carefully read the manufacturer's instructions. Ask your doctor or pharmacist to show you how to inject it. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication.

Use a new prefilled automatic injection device each time you inject your medication. Do not reuse or share automatic injection devices. Discard used automatic injection devices in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to discard the puncture-resistant container.

You should inject bremelanotide injection into the skin of the stomach area or the front of the thigh. Avoid giving your injection within the 2-inch area around your belly button. Do not inject into areas where the skin is irritated, sore, bruised, red, hard, or scarred. Do not inject through your clothes. Choose a different site each time you give yourself an injection.

Always look at your bremelanotide solution before you inject it. It should be clear and free of particles. Do not use bremelanotide solution if it is cloudy, colored, or contains particles.

If your symptoms do not improve after 8 weeks of treatment, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using bremelanotide injection,

• tell your doctor and pharmacist if you are allergic to bremelanotide, any other medications, or any of the ingredients in bremelanotide injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antibiotics taken by mouth, indomethacin (Indocin, Tivorbex), and naltrexone taken by mouth (in Contrave, in Embeda). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have high blood pressure that is not able to be controlled by medication or heart disease. Your doctor will probably tell you not to use bremelanotide injection.
• tell your doctor if you have or have ever had high blood pressure, any type of heart problems, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Use effective birth control during your treatment with bremelanotide injection. If you become pregnant while using bremelanotide injection, call your doctor.
• you should know that bremelanotide injection may cause darkening of the skin on certain parts of the body including the face, gums, and breasts. The chance of darkening skin is higher in people with darker skin color and in people who used bremelanotide injection for eight days in a row. Darkening of the skin may not go away, even after you stop using bremelanotide injection. Talk to your doctor about any changes to your skin while using this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Bremelanotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea (most common after the first dose and usually lasts for about 2 hours)
• vomiting
• headache
• flushing
• nasal stuffiness
• cough
• tiredness
• dizziness
• pain, redness, bruising, itching, numbness, or tingling in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor:

• increase in blood pressure and decrease in heart rate that may last for up to 12 hours after a dose

Bremelanotide injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator or at room temperature and away from light, excess heat and moisture (not in the bathroom). Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vyleesi^®