Setmelanotide

What Is Setmelanotide?

• Setmelanotide (IMCIVREE) is a melanocortin 4 (MC4) receptor agonist, a prescription medicine used in adults and children 6 years of age and older with obesity due to the genetic conditions proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.

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What are the uses of this medicine?

• IMCIVREE is a prescription medicine used in adults and children 6 years of age and older with obesity due to the genetic conditions proopiomelanocorti(POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.
• Your healthcare provider should order a genetic test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.

How does this medicine work?

• Setmelanotide is an MC4 receptor agonist with 20-fold less activity at the melanocortin 3 (MC3) and melanocortin 1 (MC1) receptors.
• MC4 receptors in the brain are involved in regulation of hunger, satiety, and energy expenditure.
• patients with obesity due to POMC, PCSK1, and LEPR deficiency associated with insufficient activation of the MC4 receptor, setmelanotide may re-establish MC4 receptor pathway activity to reduce hunger and promote weight loss through decreased caloric intake and increased energy expenditure.

Who Should Not Use this medicine ?

IMCIVREE is not for use in people with the following conditions because it may not work:

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing (benign or likely benign result).
• Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Dosage in Adults and Pediatric Patients 12 Years of Age and Older

• The starting dose of IMCIVREE is 2 mg (0.2 mL) injected subcutaneously once daily for 2 weeks.
• If the starting dose is not tolerated, reduce to 1 mg (0.1 mL) once daily. If the 1 mg once daily dose is tolerated and additional weight loss is desired, titrate to 2 mg (0.2 mL) once daily.
• If the 2 mg daily dose is tolerated, increase the dose to 3 mg (0.3 mL) once daily. If the 3 mg once daily dose is not tolerated, maintain administration of 2 mg (0.2 mL) once daily.

Dosage in Pediatric Patients 6 to less than 12 years of age

• The starting dose is 1 mg (0.1 mL) injected subcutaneously once daily for 2 weeks.
• If the starting dose is not tolerated, reduce to 0.5 mg (0.05 mL) once daily dose. If the 0.5 mg once daily dose is tolerated and additional weight loss is desired, titrate to 1 mg (0.1 mL) once daily.
• If the 1 mg dose is tolerated, increase the dose to 2 mg (0.2 mL) once daily.
• If the 2 mg once daily dose is not tolerated, reduce to 1 mg (0.1 mL) once daily. If the 2 mg once daily dose is tolerated and additional weight loss is desired, the dose may be increased to 3 mg (0.3 mL) once daily.

Administration

• IMCIVREE is given as an injection under your skin (subcutaneous) by you or a caregiver.
• A healthcare provider should show you or your caregiver how to prepare and inject your dose of IMCIVREE before injecting for the first time.
• Do not try to inject IMCIVREE unless you have been trained by a healthcare provider.
• Use IMCIVREE exactly as prescribed by your healthcare provider.
• Your healthcare provider may tell you to stop using IMCIVREE if you have not lost a certain amount of weight after 12 to 16 weeks of treatment.
• IMCIVREE should be injected 1 time each day when you first wake up.
• IMCIVREE can be given with or without food.
• If you miss a dose of IMCIVREE, inject your next dose at the regularly scheduled time the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• This medicine is avaialable as Injection:10 mg/mL solution in a 1 mL multiple-dose vial

This medicine is available in fallowing brand namesː

• IMCIVREE

What side effects can this medication cause?

Common possible side effects of this medicine include:

• injection site reactions
• skin hyperpigmentation
• nausea
• headache
• diarrhea
• abdominal pain
• back pain
• fatigue
• vomiting
• depression
• upper respiratory tract infection
• spontaneous penile erection

What special precautions should I follow?

• Sexual adverse reactions may occur in patients treated with IMCIVREE.
• Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.
• IMCIVREE, may cause depression or suicidal ideation.
• Monitor patients for new onset or worsening of depression.
• Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.
• Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.
• IMCIVREE is not approved for use in neonates or infants.
• Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs.

What to do in case of emergency/overdose?

• In the event of an overdose initiate appropriate supportive treatment according to the patient’s clinical signs and symptoms.

Can this medicine be used in pregnancy?

• Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of IMCIVREE for obesity due to POMC, PCSK1, or LEPR deficiency have been established in pediatric patients aged 6 years and older.
• The safety and effectiveness of IMCIVREE have not been established in pediatric patients younger than 6 years old.

What should I know about storage and disposal of this medication?

• Store unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F).
• After removal from the refrigerator, vials may be kept at temperatures ranging from refrigerated to room temperature (2°C to 25°C (36°F to 77°F)) for up to 30 days with brief excursions up to 30°C (86°F).
• After the vial is punctured (opened), discard after 30 days.

• Dailymed label info on Setmelanotide
• FDA Setmelanotide

Setmelanotide Resources
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