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Important Safety Information
Prescribing Information

Not all hunger is the same: hyperphagia is a key symptom of MC4R pathway impairment1

Identifying the type of hunger your patient has can help:
  • Determine the underlying cause of your patient's hunger
  • Lead to optimal management of their specific disease

Episodic/Periodic

Occasional overeating

Eating beyond a feeling of satiety at a special occasion or celebratory meal (eg, Thanksgiving)2

Hedonic overeating

Eating beyond satiety and metabolic needs. Influenced by appetite and cravings2-4

Cause:
  • The pleasure centers in the brain, often driven by emotion or environmental circumstances3

Binge eating

Episodic consumption of large amounts of food beyond hunger and/or satiety within a short period with a loss of control. If recurring, defined as Binge Eating Disorder (BED).2,3

Behaviors may include:

  • Rapid eating5
  • Eating in isolation5
  • Distress due to eating behavior2,5
Cause:
  • Psychological factors, family history, dieting, gender5,6

Persistent

Hyperphagia caused by MC4R pathway impairment

A chronic, pathological condition characterized by insatiable hunger, impaired satiety, and persistent abnormal food-seeking behavior. Differentiated from other types of overeating by its severity and persistence.6

Main features/characteristics:

  • Persistent preoccupation with food6
  • Prolonged time to satiation and shortened duration of satiety6
  • Prolonged feeling of hunger6
  • Specific abnormal behaviors

Behaviors may include:

  • Distress if food is unavailable6
    • Children: may exhibit as tantrums or persistent negotiation/demand for food7,8
    • Adults: may manifest in emotional effects including sadness, frustration, irritability, anxiety and/or guilt9
  • Abnormal food-seeking behaviors such as night eating or hiding food (children may also steal/sneak food)10
  • Eating excessively – not to be confused with binge eating2

Symptoms and behaviors may range in severity2

Cause:

  • Rare genetic variants in the MC4R pathway, a signaling pathway in the hypothalamus1

According to 2023 AAP and OMA guidelines, managing hyperphagia can be challenging and may require the use of pharmacotherapy6,11

AAP=American Academy of Pediatrics; MC4R=melanocortin-4 receptor; OMA=Obesity Medicine Association.

 

If you have patients with hyperphagia and early-onset obesity, take a closer look to see if the patient has other symptoms of BBS

Real experiences with hyperphagia

Learn about its daily impact on families and how physicians differentiate hyperphagia from other overeating behaviors to diagnose and manage it

Identify your patient’s type of hunger
See how IMCIVREE works

AAP=American Academy of Pediatrics; MC4R=melanocortin-4 receptor; OMA=Obesity Medicine Association.

References: 1. Eneli I, Xu J, Webster M, et al. Tracing the effect of the melanocortin-4 receptor pathway in obesity: study design and methodology of the TEMPO registry Appl Clin Genet. 2019;12:87-93. doi:10.2147/TACG.S199092 2. Haqq AM, Kebbe M, Tan Q, Manco M, Salas XR. Complexity and Stigma of Pediatric Obesity Child Obes. 2021;17(4):229-240. doi:10.1089/chi.2021.0003 3. Espel-Huynh HM, Muratore AF, Lowe MR. A narrative review of the construct of hedonic hunger and its measurement by the Power of Food Scale. Obes Sci Pract. 2018;4(3):238-249. Published Feb 28, 2018. doi:10.1002/osp4.161 4. Tanajewski L, Hare TA, Skalbania U. The interplay of hedonic appetite and attentional abilities is linked to poorer dietary self-control: Two studies on young adults living in cities Food Quality and Preference 2023;109: 104889. doi:0.1016/j.foodqual.2023.104889. 5. National Institutes of Health. National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms & Causes of Binge Eating Disorder. Updated May 2021. Accessed December 9, 2024. https://www.niddk.nih.gov/health-information/weight-management/binge-eating-disorder/symptoms-causes. 6. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023;151(2):e2022060640. 7. Heymsfield SB, Avena NM, Baier L, et al. Hyperphagia: current concepts and future directions proceedings of the 2nd international conference on hyperphagia. Obesity (Silver Spring). 2014;22 Suppl 1(0 1):S1-S17. doi:10.1002/oby.20646. 8. Forsythe E, Mallya UG, Yang M, et al. Burden of hyperphagia and obesity in Bardet-Biedl syndrome: a multicountry survey. Orphanet J Rare Dis. 2023;18(1):182. doi:10.1186/s13023-023-02723-4. 9. Ervin C, Norcross L, Mallya UG, et al. Interview-Based Patient- and Caregiver-Reported Experiences of Hunger and Improved Quality of Life with Setmelanotide Treatment in Bardet-Biedl Syndrome. Adv Ther. 2023;40(5):2394-2411. doi:10.1007/s12325-023-02443-y. 10. Sherafat-Kazemzadeh R, Ivey L, Kahn SR, et al. Hyperphagia among patients with Bardet-Biedl syndrome. Pediatr Obes. 2013;8(5):e64-e67. doi:10.1111/j.2047-6310.2013.00182.x. 11. Tondt J et al. Obesity Algorithm® 2023 Obesity Medicine Association; 2023. Accessed December 9, 2024. 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 Bardet-Biedl syndrome (BBS).

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:

  • Other types of obesity not related to BBS 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 increases in 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 pigmentary 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 the 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 Bardet-Biedl syndrome (BBS).

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:

  • Other types of obesity not related to BBS 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 increases in 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 pigmentary 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 the full Prescribing Information for additional Important Safety Information.