Setmelanotide Injection

What is this medication?

SETMELANOTIDE (SET mel AN oh tide) is a melanocortin 4 agonist. It is used for weight control in patients with Bardet-Biedl syndrome (BBS), proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.

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

COMMON BRAND NAME(S): IMCIVREE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• depression
• kidney disease
• suicidal thoughts, plans or attempt
• an unusual or allergic reaction to setmelanotide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This drug 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 health care provider tells you to stop.

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 health care provider to get one.

Talk to your health care provider about the use of this drug in children. While it may be prescribed for children as young as 6 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.

What if I miss a dose?

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.

What may interact with this medication?

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.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your health care provider right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• depressed mood
• prolonged or painful erection
• suicidal thoughts, mood changes

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• change in color of skin
• diarrhea
• headache
• pain, redness, or irritation at site where injected
• nausea, vomiting
• 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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store unopened vials in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Refrigeration (preferred): Store in the refrigerator. Do not open a vial until you are ready to use it. Throw away any unused drug from an open vial after 30 days or after it expires, whichever is first.

Room Temperature: This drug may be stored at room temperature for up to 30 days. Do not open a vial until you are ready to use it. Throw away any unused drug from an open vial after 30 days or after it expires, whichever is first.

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.