Uses

This medication is used to help you lose weight. It is used by people who are overweight due to certain rare genetic disorders. Setmelanotide works by controlling your appetite and making you feel less hungry. It also increases the number of calories that you burn.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using setmelanotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once daily in the morning when you first wake up. This medication may be used with or without food. Your doctor will start you on a low dose first to decrease your risk of stomach/abdominal side effects, and gradually increase your dose. Follow your doctor's instructions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

If the medication is stored in the refrigerator, remove the medication from the refrigerator 15 minutes before you inject it to allow it to reach room temperature. You may also gently roll the vial in between your hands for 1 minute. Do not shake the vial. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition, age, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Side Effects

Nausea, vomiting, stomach upset, diarrhea, or pain at injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, thoughts of suicide)
• unusual skin color changes (such as change in the size/color of a mole)
• changes in sexual arousal

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using setmelanotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• mental/mood disorders (such as depression, thoughts of suicide)
• skin problems (such as moles, dark spots)
• kidney disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as weight, skin exams) should be done while you are using this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Before using the medication for the first time, store it in the refrigerator. Do not freeze. After first use, the medication can be stored at room temperature or in the refrigerator. Protect from heat and sunlight. Discard 30 days after first use, even if some drug remains in the vial. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.