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Setmelanotide Injectable Solution (SETMELANOTIDE - INJECTION)

For obesity.

Brand Name(s): Imcivree

Generic Name: Setmelanotide

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

Always inspect the medicine before using.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Do not shake the medicine before using.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

This medicine may be stored at room temperature for up to 30 days.

If your medicine is stored in the refrigerator, take it out of the refrigerator about 15 minutes before use to warm to room temperature.

Discard any unused medicine 30 days after opening.

Never use any medicine that has expired.

Wash your hands before and after handling this medicine.

Do not inject into moles, scars, stretch marks, or into skin that is tender, bruised, red, scaly, thickened, or hard.

Avoid injecting the medicine within 2 inches around the navel.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Do not breastfeed while on this medicine.

If you have a painful erection or an erection for more than 4 hours, seek medical care right away.

Ask your doctor, nurse or pharmacist how to safely discard unused medicines, needles and syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • nausea and vomiting
  • pain near injection site
  • stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • depression or feeling sad
  • problems with sexual functions or desire
  • change in the size or color of a skin mole
  • suicidal thoughts

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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