Pronunciation:

bre-me-LAN-oh-tide

Brand Names:

• Vyleesi

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Bremelanotide injection is used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women who previously had no problems with sexual desire and that occurs in any type of stimulation, situation, or partner. It should only be used in women who have low sexual desire that is troubling to them and is not caused by a medical or mental health problem, problems in the relationship, or medicine or other drug use.

Women who have gone through menopause and men should not use bremelanotide. Do not use this medicine to improve sexual performance.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bremelanotide injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of bremelanotide injection in the elderly. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Naltrexone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or
• Hypertension (high blood pressure), uncontrolled—Should not be used in patients with these conditions.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Stomach or bowel problem (eg, slow gastric emptying)—Use with caution. May make this condition worse and decrease the absorption of oral medicines.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach or thighs. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Check the liquid in the autoinjector pen. It should be clear or colorless. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

Use a new needle each time you inject your medicine.

You might not use all of the medicine in each autoinjector. Use each autoinjector only one time. Do not save an open autoinjector.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For hypoactive sexual desire disorder:
    • Adults—1.75 milligrams (mg) injected under the skin at least 45 minutes before a sexual activity. Do not use more than one dose of this medicine within 24 hours. Do not use more than 8 doses per month.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visitsto make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your condition does not improve within 8 weeks, or if it become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause darkening of the skin on the face, gums, or breasts, especially in patients with darker skin and daily use. Talk to your doctor if you have concerns about any skin changes.

Nausea may occur after first using bremelanotide, which may last for 2 hours or more. Your doctor may give you an anti-emetic medicine for this. Check with your doctor right away if the nausea is severe or continuing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Nausea

Less common

Vomiting

Rare

Blurred vision

dizziness

headache

nervousness

pounding in the ears

slow or fast heartbeat

Incidence not known

Dark urine

general tiredness and weakness

light-colored stools

upper right abdominal pain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

feeling of warmth

redness of the face, neck, arms, and occasionally the upper chest

Less common

Aching or discomfort in the lower legs or sensation of crawling in the legs

arm or leg pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

cough

darkening of the face, gums, or breasts

diarrhea

difficulty in moving

joint pain or swelling

muscle pains, cramps, or stiffness

runny or stuffy nose

stomach pain

Rare

Chills

fever

general feeling of discomfort or illness

loss of appetite

shivering

sore throat

sweating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.