Setmelanotide is used to help with weight loss and control of hunger in people with certain genetic deficiencies who are 6 years and older.

Your doctor will perform tests to make sure setmelanotide is the right treatment for you.

Setmelanotide may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Setmelanotide is injected under the skin once a day when you wake up, at the beginning of the day.

You may use setmelanotide with or without food.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Your doctor may tell you to stop using setmelanotide if you have not lost certain amount of weight after a certain time of treatment.

You should have a skin exam before starting and during treatment with setmelanotide.

Follow all storage instructions provided with setmelanotide. Your pharmacist can provide more information about how to store this medicine.

Tell your doctor if you have ever had:

• kidney disease;

• depression, or suicidal behavior or thoughts; or

• darkened skin, including skin discoloration.

Losing weight when you are pregnant may harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Setmelanotide may contain an ingredient that can cause serious side effects or death in very young or premature babies. Do not give setmelanotide to a child without medical advice.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people have thoughts about suicide while using setmelanotide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Setmelanotide may cause serious side effects. Call your doctor at once if you have:

• an erection lasting longer than 4 hours.

Common side effects of setmelanotide may include:

• bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;

• skin darkening;

• headache;

• erection without any sexual activity in males; or

• nausea, vomiting, diarrhea, or stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.