IMCIVREE Resource Library

Find resources for your practice and patients across every stage of the IMCIVREE journey. Browse all available resources, or filter by journey phase, indication, and audience.

Filter resources by phase of the treatment journey (select all that apply):

Considering Treatment

For your practice

BBS
IMCIVREE BBS Fact Sheet thumbnail

IMCIVREE BBS Fact Sheet

IMCIVREE clinical efficacy and safety data for obesity due to BBS

Download PDF
Acquired HO
IMCIVREE Acquired HO Fact Sheet thumbnail

IMCIVREE Acquired HO Fact Sheet

IMCIVREE clinical efficacy and safety data for acquired HO

Download PDF

For your patients

BBS

How IMCIVREE Works Video for Patients

BBS education and the IMCIVREE mechanism of action for patients

Watch Video
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency

IMCIVREE Impact Video for Patients

Healthcare provider discussion about the impact of IMCIVREE, including patient perspectives

Watch Video
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency

Patient Education Managers Video for Patients

Patient and provider perspectives of working with a Rhythm InTune Patient Education Manager through their IMCIVREE journey

Watch Video
Acquired HO
IMCIVREE Acquired HO Fact Sheet for Patients thumbnail

IMCIVREE Acquired HO Fact Sheet for Patients

Abbreviated patient-friendly resource featuring IMCIVREE's clinical efficacy and safety data for acquired HO

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
Rhythm InTune Program Brochure for Patients thumbnail

Rhythm InTune Program Brochure for Patients

Personalized educational support and resources for patients with MC4R pathway-driven obesity

Download PDF
POMC, PCSK1, or LEPR Deficiency
IMCIVREE POMC, PCSK1, or LEPR Deficiency Patient Brochure thumbnail

IMCIVREE POMC, PCSK1, or LEPR Deficiency Patient Brochure

Brochure featuring IMCIVREE efficacy, safety, and additional information for patients with obesity due to POMC, PCSK1, or LEPR deficiency

Download PDF
BBS
IMCIVREE BBS Patient Brochure thumbnail

IMCIVREE BBS Patient Brochure

Product brochure featuring IMCIVREE efficacy, safety, and additional information for patients with obesity due to BBS

Download PDF
Acquired HO
IMCIVREE Brochure for Patients with Acquired HO thumbnail

IMCIVREE Brochure for Patients with Acquired HO

Product brochure featuring IMCIVREE efficacy, safety, and additional information for patients with acquired HO

Download PDF

Prescribing and Initiating

For your practice

Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
IMCIVREE Prescription Start Form thumbnail

IMCIVREE Prescription Start Form

Prescribe IMCIVREE and help connect patients with Rhythm InTune

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
Rhythm InTune Starting on Treatment Guide thumbnail

Rhythm InTune Starting on Treatment Guide

Key steps to starting patients on IMCIVREE, including how InTune can support at each step

Download PDF
Acquired HO
Acquired HO Dosing Guide thumbnail

Acquired HO Dosing Guide

IMCIVREE dosing chart and monitoring information for acquired HO

Download PDF
BBS
POMC, PCSK1, or LEPR Deficiency
BBS and POMC, PCSK1, and LEPR Deficiencies Dosing Guide thumbnail

BBS and POMC, PCSK1, and LEPR Deficiencies Dosing Guide

IMCIVREE dosing chart for obesity due to BBS or POMC, PCSK1, or LEPR deficiency

Download PDF
Acquired HO
Acquired HO What to Expect Brochure thumbnail

Acquired HO What to Expect Brochure

Supplemental information about what to expect when starting patients on IMCIVREE, including the prescribing process and adherence support

Download PDF

For your patients

Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency

Managing Side Effects Video

Healthcare provider discussion on the side effects of IMCIVREE, including patient and caregiver stories

Watch Video
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency

How to Inject IMCIVREE Video for Patients

Patient-friendly guide to the IMCIVREE injection process

Watch Video
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
Rhythm InTune Consent Form for Patients thumbnail

Rhythm InTune Consent Form for Patients

Form for your patients to enroll in Rhythm InTune, a personalized educational support program

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
IMCIVREE Injection Guide for Patients thumbnail

IMCIVREE Injection Guide for Patients

Step-by-step guide outlining important information about giving an IMCIVREE injection for patients and caregivers

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
IMCIVREE Treatment Journal for Patients thumbnail

IMCIVREE Treatment Journal for Patients

Patient tool for tracking injections and treatment progress

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
Rhythm InTune Patient Treatment Guide thumbnail

Rhythm InTune Patient Treatment Guide

Patient-friendly guide to starting treatment with IMCIVREE and information on the Rhythm InTune patient support program

Download PDF

Managing Treatment

For your practice

Acquired HO
Acquired HO What to Expect Brochure thumbnail

Acquired HO What to Expect Brochure

Supplemental information about what to expect when starting patients on IMCIVREE, including the prescribing process and adherence support

Download PDF

For your patients

Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency

Managing Side Effects Video

Healthcare provider discussion on the side effects of IMCIVREE, including patient and caregiver stories

Watch Video
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
IMCIVREE Treatment Journal for Patients thumbnail

IMCIVREE Treatment Journal for Patients

Patient tool for tracking injections and treatment progress

Download PDF
Acquired HO
BBS
POMC, PCSK1, or LEPR Deficiency
Rhythm InTune Wellness Brochure for Patients thumbnail

Rhythm InTune Wellness Brochure for Patients

Wellness tips for patients living with MC4R pathway-driven obesity

Download PDF

Disease Education

For your practice

Acquired HO
Acquired HO Patient ID Fact Sheet thumbnail

Acquired HO Patient ID Fact Sheet

Information to help identify acquired HO

Download PDF

Acquired HO=acquired hypothalamic obesity, BBS=Bardet-Biedl syndrome, POMC=proopiomelanocortin, PCSK1=proprotein convertase subtilisin/kexin type 1, LEPR=leptin receptor; MC4R=melanocortin-4 receptor

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged:

  • 4 years and older with acquired hypothalamic obesity (HO)
  • 2 years and older with syndromic or monogenic obesity due to:
    • Bardet-Biedl syndrome (BBS)
    • Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing 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 acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency, 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 and increased frequency of penile erections in males 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 Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20% in at least 1 indication) 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.

Please see full Prescribing Information for additional Important Safety Information.

Indications and Important Safety Information

Indication

IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged:

  • 4 years and older with acquired hypothalamic obesity (HO)
  • 2 years and older with syndromic or monogenic obesity due to:
    • Bardet-Biedl syndrome (BBS)
    • Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing 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 acquired HO, BBS, or POMC, PCSK1, or LEPR deficiency, 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 and increased frequency of penile erections in males 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 Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

Adverse Reactions

  • Most common adverse reactions (incidence ≥20% in at least 1 indication) 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.

Please see full Prescribing Information for additional Important Safety Information.