Now approved for children 2 to <6 years old

Identifying hyperphagia in your patients

Hyperphagia is a common feature in people living with POMC, PCSK1, or LEPR deficiency1

Hyperphagia and obesity due to POMC, PCSK1, or LEPR deficiency are caused by impairment in the MC4R pathway. The MC4R pathway is a key signaling pathway that regulates hunger, satiety, and energy expenditure. If left untreated or unmanaged, hyperphagia and obesity can intensify physical and mental challenges for people with POMC, PCSK1, or LEPR deficiency and caregivers.1,2

Hyperphagia is a pathological, insatiable hunger that is differentiated from other overeating behaviors and disorders by its severity and persistence3

Occasional overeating4

Eating beyond a feeling of satiety at a special occasion or celebratory meal (eg, Thanksgiving)

Hedonic overeating5

Eating beyond metabolic requirements based on the expectation of pleasure from consuming foods

Binge eating4-6

Consumption of a large amount of food with loss of control in a short period of time

 

Hyperphagia3,7
(Pathological, insatiable hunger)

  • Long time to satiation
  • Shorter duration of satiation
  • Prolonged feeling of hunger
  • Severe preoccupation with food and distress if denied food, often associated with abnormal food-seeking behaviors
 

According to 2023 AAP and 2023 OMA guidelines, managing hyperphagia can be challenging and may require the use of pharmacotherapy7,8

They took me away when I was 4 years old, claiming that my mother was feeding me to make me fat, and they took me to some sort of psychosomatic facility for over a year or a year and a half, where I was supposed to lose weight. That did not work either.

— Person who is living with POMC deficiency

It sometimes felt as if I were an animal that was super hungry and could only think about food, and when I wanted to eat something, I searched until I found it.

— Person who is living with POMC deficiency

When I would start eating something, I’d eat the whole thing. No matter what sort of package it was, or whatever, I’d always eat the whole thing. I also ate it at an enormous tempo. It was really terrible.

— Person who is living with LEPR deficiency

See how IMCIVREE works
AAP=American Academy of Pediatrics; LEPR=leptin receptor; MC4R=melanocortin-4 receptor; OMA=Obesity Medicine Association; PCSK1=proprotein convertase subtilisin/kexin type 1; POMC=proopiomelanocortin.
References: 1. Eneli I et al. Appl Clin Genet. 2019;12:87-93. 2. Styne DM et al. J Clin Endocrinol Metab. 2017;102(3):709-757. 3. Heymsfield SB et al. Obesity (Silver Spring). 2014;22(suppl 1):S1-S17. doi:10.1002/oby.20646. 4. Haqq AM et al. Child Obes. 2021;17(4):229-240. 5. Espel-Huynh HM et al. Obes Sci Pract. 2018;4(3):238-249. doi:10.1002/osp4.161. 6. Hayes JF et al. Curr Obes Rep. 2018;7(3):235-246. Hampl SE et al. Pediatrics. 2023;151(2):e202206064. doi:10.1542/peds.2022-060640. 7. Tondt J et al. Obesity Algorithm® 2023. Obesity Medicine Association; 2023. Accessed August 14, 2023. https://obesitymedicine.org/obesity-algorithm.

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or other FDA- approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity
Important Safety Information

CONTRAINDICATIONS

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation, and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increased skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: 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.

ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for additional Important Safety Information.

Important Safety Information

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or other FDA- approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity
Important Safety Information

CONTRAINDICATIONS

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation, and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increased skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: 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.

ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at 833-789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for additional Important Safety Information.

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NOW APPROVED

FOR CHILDREN 2 to <6 YEARS OLD

with obesity due to Bardet-Biedl syndrome (BBS) or POMC*, PCSK1*, or LEPR* deficiency.

Please see Important Safety Information below, including full Prescribing Information

*As confirmed by an FDA-approved genetic test
POMC=proopiomelanocortin; PCSK1=proprotein convertase subtilisin/kexin type 1; LEPR=leptin receptor.