Identifying hyperphagia in your patients

Hyperphagia is a common feature in people living with BBS1

Hyperphagia and obesity due to BBS 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 patients and caregivers.1-4

 

Hyperphagia is a pathological, insatiable hunger that is differentiated from other overeating behaviors and disorders by its severity and persistence4

Occasional overeating5

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

Hedonic overeating6

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

Binge eating5-7

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

 

Hyperphagia2,4
(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 pharmacotherapy2,8

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

Caregiver of a person living with BBS

After her first birthday, we noticed a rapid weight gain, and she threw tantrums all the time and was very difficult to manage. Looking back, I see this was most likely due to how hungry she felt.

— Ann, caregiver of a person living with BBS

Caregiver of a child living with BBS

While Wyatt and Carson have the same variants of the BBS10 gene, only Wyatt has hyperphagia and obesity. I couldn't take the kids out by myself because Wyatt needed constant supervision to make sure he wasn't stealing food. I have to lock our fridge, trash, and pantry.

— Rachel, caregiver of a child living with BBS

Person living with BBS

Since starting IMCIVREE I am not always thinking about eating. Now, I can actually focus on my friends and family, and on doing activities besides eating. I feel like I'm able to do the fun things I've always wanted to do without my hunger interrupting.

— Sabrina, who is living with BBS

See how IMCIVREE works

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

References: 1. Eneli I et al. Appl Clin Genet. 2019;12:87-93. 2. Hampl SE et al. Pediatrics. 2023;151(2):e202206064. doi:10.1542/peds.2022-060640. 3. Cuda SE et al. Obesity Pillars. 2022;1:100010. doi:10.1016/j.obpill.2022.100010. 4. Heymsfield SB et al. Obesity (Silver Spring). 2014;22(suppl 1):S1-S17. doi:10.1002/oby.20646. 5. Haqq AM et al. Child Obes. 2021;17(4):229-240. 6. Espel-Huynh HM et al. Obes Sci Pract. 2018;4(3):238-249. doi:10.1002/osp4.161. 7. Hayes JF et al. Curr Obes Rep. 2018;7(3):235-246. 8. Tondt J et al. Obesity Algorithm® 2023. Obesity Medicine Association; 2023. Accessed August 11, 2023. https://obesitymedicine.org/obesity-algorithm.
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

Contraindication

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

Contraindication

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.