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Important Safety Information
Prescribing Information

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

Identifying the type of hunger your patient has can help 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)1

Hedonic overeating

Eating beyond satiety and metabolic needs. Influenced by appetite and cravings2,3

Cause:
  • The pleasure centers in the brain, often driven by emotion or environmental circumstances2,3

Binge eating

Episodic consumption of large amounts of food beyond hunger and/or satiety within a short period with loss of control. If recurring, defined as Binge Eating Disorder (BED).1,2

Behaviors may include:

  • Rapid eating5
  • Eating in isolation5
  • Distress due to eating behavior1
Cause:
  • Psychological factors, family history, dieting, gender2,4,5

Persistent

Hyperphagia caused by MC4R pathway impairment

Pathological, insatiable hunger and impaired satiety differentiated from other types of overeating by its severity.
Hyperphagia is also marked by:

  • Persistent preoccupation with food4
  • Prolonged time to satiation and shortened duration of satiety4
  • Prolonged feeling of hunger4
  • Specific abnormal behaviors

Behaviors may include:

  • Distress if food is unavailable
    • 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 guilt12
  • 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 eating7

Symptoms and behaviors may range in severity1

Cause:

  • Rare genetic variants in the MC4R pathway, a signaling pathway in the hypothalamus6

According to 2023 AAP and OMA guidelines, managing hyperphagia can be challenging and may require the use of pharmacotherapy4,11

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

 

If you have patients with hyperphagia and early-onset obesity, it may be time to take a closer look

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

See how IMCIVREE works

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

References: 1. Haqq AM et al. Child Obes. 2021;17(4):229-240. 2. Espel-Huynh HM et al. Obes Sci Pract. 2018;4(3):238- 249. doi:10.1002/osp4.161. 3. Tanajewski 2023- Food Quality and Preference 109 (2023) 104889. 4. Hampl SE et al. Pediatrics. 2023;151(2):e202206064. doi:10.1542/peds.2022-060640. 5. NIH_Symptoms and Causes of Binge Eating Disorder–NIDDK https://www.niddk.nih. gov/health-information/weight-management/binge-eating-disorder/symptoms-causes 6. Eneli I et al. Appl Clin Genet. 2019;12:87-93. 7. Heymsfield SB et al. Obesity (Silver Spring). 2014;22(suppl 1):S1-S17. doi:10.1002/oby.20646. 8. Forsythe E et al. Orphanet J Rare Dis. 2023 Jan 16;18(1):12. 9. Ulrich et al. 2014 Cell Metabolism. 2014/p914/col2/par1/lin6-8. 10. Sherafat-Kazemzadeh R et al. 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 June 13, 2023. https://obesitymedicine.org/obesity-algorithm. 12. Ervin C et al. Adv Ther. 2023;40(5):2394-2411. doi:10.1007/s12325-023- 02443-y.

Indication

IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic 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 and suicidal ideation 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 Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing 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 for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic 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 and suicidal ideation 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 Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing 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.