Setmelanotide (set-mel-AN-oh-tide)

Helps lose weight and keep the weight off in patients with obesity caused by certain conditions.

Brand Name(s):

Imcivree

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• 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.
• You should receive this medicine 1 time each day when you first wake up.
• Check the liquid in the vial. It should be clear to almost clear and colorless to slightly yellow. Do not use the medicine if the liquid is discolored, or has particles in it.
• Allow the medicine vial to warm to room temperature for at least 15 minutes before using it. You may also warm the vial by rolling it gently between the palms of your hands for 60 seconds.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule.
• Store the unopened or opened medicine vial in its original carton in the refrigerator. Protect it from light.
  • Unopened vial: Store in the refrigerator until the expiration date. You may remove the medicine from the refrigerator and store at room temperature for 30 days. You may also return it in the refrigerator. Throw away this medicine after 30 days of removing it from the refrigerator.
  • Opened vial: Store in the refrigerator. You may remove the medicine from the refrigerator and store at room temperature. You may also return it in the refrigerator. Throw away any unused medicine after 30 days, even if it still has medicine in it.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease or a history of depression.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Sexual function problems in men and women
  • Increased risk for depression or thoughts of suicide
  • Skin problems, including darkening of the skin or mole you already have
• Call your doctor if you have not lost weight after 12 to 16 weeks of treatment.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Darkening of the skin or skin lesions
• Prolonged erection of the penis (lasting longer than 4 hours)
• Unusual moods or behaviors, depression, thoughts of hurting yourself or others

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, stomach pain
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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