Setmelanotide Injection

WHY is this medicine prescribed?

Setmelanotide injection is used to lose weight and then to keep from gaining back that weight in certain adults and children 6 years of age or older who are obese due to certain inherited conditions including proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency (inherited conditions that cause severe obesity) or Bardet-Biedl syndrome (BBS; an inherited condition that can cause severe obesity). Setmelanotide is in a class of medications called melanocortin 4 (MC4) receptor agonists. It works by activating pathways in the brain to promote weight loss by decreasing appetite and caloric intake, and increasing energy expenditure.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Setmelanotide comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected once a day when you wake up with or without food. Use setmelanotide injection at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use setmelanotide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of setmelanotide and increase your dose after 2 weeks.

If you have POMC, PCSK1, or LEPR deficiency and you do not lose a certain amount of weight after 3 to 4 months of treatment with setmelanotide injection, it is not likely that you will benefit from using this medication. If you have Bardet-Biedl syndrome and you do not lose a certain amount of weight after 1 year of treatment with setmelanotide injection, it is not likely that you will benefit from using this medication. Your doctor may tell you to stop using setmelanotide injection.

You can inject setmelanotide injection yourself, or you can have a friend or relative inject the medication. Before you use setmelanotide injection for the first time, your doctor or nurse will show you how to prepare and inject a dose of the medication. Read the written instructions for use carefully before you inject the medication for the first time. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Before you are ready to inject setmelanotide injection, you will need to remove the medication from the refrigerator, and allow the vial to rest for 15 minutes so that it can warm to room temperature. Alternatively, you can warm the vial by gently rolling it between the palms of your hands for 60 seconds. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

Always look at setmelanotide injection solution before injecting it. It should be clear and colorless to slightly yellow. Do not use setmelanotide injection if it is cloudy, contains particles, or if the expiration date marked on the vial has passed. Dispose of used syringes and needles in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

You can inject setmelanotide injection anywhere on the front of your thighs, the back of your upper arms, or your stomach except your navel and the area 2 inches (5 centimeters) around it. Do not inject the medications into an area where the skin is tender, bruised, red, or hard or where you have scars, moles, or stretch marks. Choose a different spot each time you inject the medication, at least 1 inch (2.5 centimeters) away from a spot that you have already used.

Setmelanotide injection needs to be continued regularly to maintain weight loss. Continue to use setmelanotide injection even if you feel well and are losing weight. Do not stop using setmelanotide injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using setmelanotide injection,

• tell your doctor and pharmacist if you are allergic to setmelanotide, any other medications, benzyl alcohol, or any of the ingredients in setmelanotide injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had depression, mood problems, suicidal thoughts or behavior; areas of darkened or discolored skin; or kidney problems.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using setmelanotide injection, call your doctor.

• tell your doctor if you are breast-feeding. You should not breastfeed while you are using setmelanotide injection.

• you should know that your mental health may change in unexpected ways, and you may become suicidal (think about harming or killing yourself or plan or try to do so) while you are using setmelanotide injection. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: difficulty falling asleep or staying asleep, impulsive and dangerous behavior, panic attacks, anxiety, agitation, hostility, mania (frenzied, abnormally excited mood), talking or thinking about wanting to hurt yourself or end your life, withdrawing from friends and family, new or worsening depression, preoccupation with death and dying, or giving away prized possessions. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

• you should know that setmelanotide injection may temporarily increase the pigmentation in your skin and cause darkening of your skin and moles. Tell your doctor if areas or your skin darken or if you have moles that change color or darken. Your doctor will check your skin before starting your treatment and during your treatment with setmelanotide injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Setmelanotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• skin darkening
• rash
• redness, itching, bruising, pain, or swelling at the injection site
• headache
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• pain in the back, joints, arms, or legs
• muscle spasms
• tiredness or weakness
• dizziness
• dry mouth
• dry skin
• hair loss
• cough, fever, chills, sore throat, runny nose, or other signs of infection
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• unexpected erections or erections that happen too often or that last longer than 4 hours
• increased sexual desire in women

Setmelanotide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store unopened vials of setmelanotide injection in the refrigerator in the original carton. Unopened refrigerated setmelanotide injection can be stored until the date shown on the company's label. If a refrigerator is unavailable (for example, when on vacation), the unopened vials may be stored at room temperature for up to 30 days, but after that time they must be discarded. Opened vials of setmelanotide injection can be stored for up to 30 days at room temperature or in the refrigerator.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.