Setmelanotide

Setmelanotide is used to assist with weight loss and manage hunger in individuals aged 6 years and older who have specific genetic deficiencies.

Your doctor will conduct tests to ensure that setmelanotide is the appropriate treatment for you.

Setmelanotide may also be used for reasons not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

Tell your doctor if you have ever had:

• kidney disease;
• depression, or thoughts or behavior of suicide; 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.

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

Some people may have thoughts about suicide while using setmelanotide. Contact your doctor immediately if you experience any sudden changes in mood or behavior, or thoughts about suicide.

Setmelanotide may lead to serious side effects. Call your doctor right away 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;
• an 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. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at the same 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, drinks, or activities.

Other drugs may affect setmelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.