IMCIVREE

SETMELANOTIDE (SET mel AN oh tide) promotes weight loss in people who have conditions that affect appetite and weight. It works by decreasing appetite and increasing your metabolism.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.
This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.
Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.
You may need blood work done while you are taking this medication.
This medication can cause new or worsening depression and increase the risk of suicidal thoughts and actions in some people. Talk to your care team right away if you have changes in mood or behavior or thoughts of self-harm or suicide. They can help you.
Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-High sodium level—confusion, increased thirst, muscle weakness, unusual weakness or fatigue, twitching muscles
-Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
-Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
-Prolonged or painful erection
-Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Change in sex drive or performance
-Change in skin color
-Diarrhea
-Headache
-Nausea
-Pain, redness, or irritation at injection site
-Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Unopened (not in use) vials
Refrigeration (preferred): Store in the refrigerator. Keep this medication in the original carton until you are ready to take it. Protect from light. Get rid of any unused medication after the expiration date.
Room temperature: May store at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 30 days. Keep this medication in the original carton until you are ready to take it. Protect from light. Vials may be returned to the refrigerator if needed. Get rid of any unused medication 30 days after it was first removed from the refrigerator or after it expires, whichever is first.
Opened (in use) vials
Refrigeration (preferred): Store in the refrigerator. Keep this medication in the original carton until you are ready to take it. Protect from light. Get rid of any unused medication after 30 days after first use or after it expires, whichever is first.
Room temperature: May store at room temperature between 20 and 25 degrees C (68 and 77 degrees F) for up to 30 days. Keep this medication in the original carton until you are ready to take it. Protect from light. Vials may be returned to the refrigerator if needed. Get rid of any unused medication 30 days after first use, 30 days after it was first removed from the refrigerator, or after it expires, whichever is first.
To get rid of medications that are no longer needed or have expired:
-Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.