Pronunciation:

set-mel-AN-oh-tide

Brand Names:

• Imcivree

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Setmelanotide injection is used to help lose weight and keep the weight off in patients with obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), leptin receptor (LEPR) deficiency, or Bardet-Biedl syndrome (BBS). Your doctor will perform a test to check for POMC, PCSK1, or LEPR deficiency, or BBS before you use this medicine.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of setmelanotide injection in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of setmelanotide injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Venlafaxine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, or history of—Use with caution. May make this condition worse.

• General obesity or
• Kidney disease, end-stage or
• Obesity caused by other genetic conditions—Use is not recommended in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may also be taught how to give your medicine at home. Be sure you understand exactly how the medicine is to be injected.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For weight management:
    • Adults and children 12 years of age and older—At first, 2 milligrams (mg) injected under the skin once a day for 2 weeks. Your doctor may adjust the dose as needed and tolerated.
    • Children 6 to 12 years of age—At first, 1 mg injected under the skin once a day for 2 weeks. Your doctor may adjust the dose as needed and tolerated.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store the unopened vial 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.

Store opened vial 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 where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If you have not lost weight after 12 to 16 weeks of treatment, check with your doctor.

This medicine may cause sexual function problems in men and women. Check with your doctor right away if you have an erection of the penis lasting longer than 4 hours.

This medicine may cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause skin problems (eg, hyperpigmentation). Check with your doctor right away if you have darkening of the skin or skin lesions (moles or nevi) you already have.

This medicine contains benzyl alcohol, which may cause serious reactions (eg, gasping syndrome) to newborn or premature babies. Discuss this with your doctor if you are concerned.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Aggressive, angry

darkening of the skin or skin lesions

discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

prolonged erection of the penis

reddish purple lines on the arms, face, legs, trunk, or groin

thoughts of killing oneself changes in behavior

tiredness

trouble concentrating

trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

body aches or pain

chills

cough

diarrhea

difficulty in breathing

difficulty in moving

dizziness

dry mouth

ear congestion

fever

hair loss, thinning of hair

headache

joint pain

lack or loss of strength

loss of voice

muscle pain, stiffness, or spasm

nausea

pain in the arms or legs

rash

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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