Help your patients with
POMC, PCSK1, or LEPR deficiency

Actor portrayals.
MC4R=melanocortin-4 receptor.
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. Eneli I et al. Appl Clin Genet. 2019;12:87-93.
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h1{font-size:4rem;letter-spacing:.1rem;margin:0 7rem 7rem 4.5rem}#patient-bbs-home .hero h1>span.green{color:#91d400;display:flex;line-height:3.3rem;margin-left:3.2rem}#patient-bbs-home .hero h1>span.white{color:#fff;display:flex;font-size:5.6rem;line-height:4.8rem;margin-left:.4rem;margin-top:-1.2rem}@media print,screen and (max-width:63.99875em){#patient-bbs-home .hero .row.hero-text{margin-top:7rem}#patient-bbs-home .hero h1{font-size:4rem;letter-spacing:.1rem;margin:1.5rem 7rem 7rem 4.5rem}#patient-bbs-home .hero h1>span.green{color:#91d400;display:flex;line-height:3.3rem;margin-left:3.2rem}#patient-bbs-home .hero h1>span.white{color:#fff;display:flex;font-size:5.6rem;line-height:4.8rem;margin-left:.4rem;margin-top:-1.2rem}}@media print,screen and (max-width:39.99875em){#patient-bbs-home .hero .row.hero-text{margin-top:11rem}#patient-bbs-home .hero h1{font-size:2.4rem;letter-spacing:.1rem;margin:0 7rem 0 .5rem}#patient-bbs-home .hero h1>span.green{line-height:2rem;margin-left:2.5rem}#patient-bbs-home .hero h1>span.white{font-size:3.6rem;line-height:3.1rem;margin-top:-1rem}}#patient-bbs-home .hero>img{display:block;margin:0;width:100%}#patient-bbs-home .hero p.ref{font-size:12px;margin-bottom:unset}#patient-bbs-home .hero p.ref.right{font-weight:600;margin-right:5%;text-align:right}#patient-bbs-home .hero p.ref:first-child.ref{margin-top:1rem}@media print,screen and (min-width:64em){#patient-bbs-home .hero p.ref:first-child.ref{transform:translateY(-7px)}}#patient-bbs-home .hero a.global-button{background-color:#fff;height:100%;width:100%}#patient-bbs-home .hero a.global-button span{color:#4b4f54}#patient-bbs-home .hero .global-callout-container p{color:#fff;padding-left:4vw}@media print,screen and (max-width:63.99875em){#patient-bbs-home .hero .global-callout-container p{font-size:12px;padding:2% 2% 2% 12vw}}#patient-bbs-home .hero .global-callout-container p span{color:#91d400}#patient-bbs-home .hero .global-callout-container .left{background-color:rgba(0,0,0,.6);left:-40px}#patient-bbs-home .hero .global-callout-container.green.left{border-left:none}#patient-bbs-home .hero .hero-content{margin:auto;padding:1.5% 3.5% 1.5% 5.5%}@media print,screen and (max-width:63.99875em){#patient-bbs-home .hero .hero-content{margin:auto;padding:4% 6% 4% 8%}}#patient-bbs-home .hero .hero-content .row .columns{padding-right:2%}@media print,screen and (max-width:63.99875em){#patient-bbs-home .hero .hero-content .row .columns{padding-top:3%}}#patient-bbs-home .hero div.top-overlay{text-align:left}#patient-bbs-home .hero div.top-overlay:after{border-right:30px solid transparent;border-top:50px solid #fff;content:"";height:0;margin-right:-500px;margin-top:0;position:absolute;width:400px}@media print,screen and (max-width:39.99875em){#patient-bbs-home .hero div.top-overlay:after{border-right:25px solid transparent;border-top:45px solid #fff;width:290px}}#patient-bbs-home .hero div.bottom-overlay{border-bottom:6px solid #91d400;text-align:right}#patient-bbs-home .hero div.bottom-overlay:after{border-bottom:40px solid #91d400;border-left:15px solid transparent;content:"";height:0;margin-left:-150px;margin-top:-40px;position:absolute;width:150px}@media print,screen and (max-width:39.99875em){#patient-bbs-home .hero div.bottom-overlay:after{border-bottom:30px solid #91d400;border-left:15px solid transparent;margin-left:-50px;margin-top:-30px;width:50px}}@media print,screen and (min-width:40em){.mainContent{margin-top:2.5rem}.homePageClass{margin-top:0}}.slick-slider{-webkit-touch-callout:none;-webkit-tap-highlight-color:transparent;box-sizing:border-box;touch-action:pan-y;-webkit-user-select:none;user-select:none;-khtml-user-select:none}.slick-list,.slick-slider{display:block;position:relative}.slick-list{margin:0;overflow:hidden;padding:0}.slick-list:focus{outline:none}.slick-list.dragging{cursor:pointer;cursor:hand}.slick-slider .slick-list,.slick-slider .slick-track{transform:translateZ(0)}.slick-track{display:block;left:0;margin-left:auto;margin-right:auto;position:relative;top:0}.slick-track:after,.slick-track:before{content:"";display:table}.slick-track:after{clear:both}.slick-loading .slick-track{visibility:hidden}.slick-slide{display:none;float:left;height:100%;min-height:1px}[dir=rtl] .slick-slide{float:right}.slick-slide img{display:block}.slick-slide.slick-loading img{display:none}.slick-slide.dragging img{pointer-events:none}.slick-initialized .slick-slide{display:block}.slick-loading .slick-slide{visibility:hidden}.slick-vertical .slick-slide{border:1px solid transparent;display:block;height:auto}.slick-arrow.slick-hidden{display:none}.slick-loading .slick-list{background:#fff 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Now approved for children 2 to <6 years old
Actor portrayals.
MC4R=melanocortin-4 receptor.
References: 1. IMCIVREE [prescribing information]. Boston, MA. Rhythm Pharmaceuticals, Inc. 2. Eneli I et al. Appl Clin Genet. 2019;12:87-93.
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:
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
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.
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:
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
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.
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.