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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 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p{margin-left:10px}}#overall-bmi-reduction-content-column-wrapper .global-callout-content .global-callout-circular-2 p{margin-left:0}.color-neon-blue{color:#00b3d5!important}.color-neon-blue-bg{background-color:#00b3d5!important}.color-teal{color:#007a8a!important}.color-teal-bg{background-color:#007a8a!important}.color-teal-light{color:#e7fbfd}.color-teal-light-bg{background-color:#e5f2f3!important}.color-gray{color:#4b4f54!important}.color-gray-bg{background-color:#4b4f54}.color-neon-green-bg{background-color:#91d400}.color-neon-green{color:#91d400}.color-neon-green-bg-light{background-color:#aee040}.color-neon-green-light{color:#aee040}.color-black{color:#000}.color-black-bg{background-color:#000}.color-white{color:#fff}.color-white-important{color:#fff!important}.color-white-bg{background-color:#fff!important}.color-yellow-bg{background-color:#ffd100}.text-gray{color:#4b4f54!important}#hcp-ppl-home .hero a.global-button 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img{filter:brightness(0) invert(1)}#hcp-ppl-home .hero h1{font-size:4rem;letter-spacing:.1rem;margin:1.5rem 7rem 3rem 4.5rem}#hcp-ppl-home .hero h1>span.green{color:#91d400;display:flex;line-height:3.3rem;margin-left:3.2rem}#hcp-ppl-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){#hcp-ppl-home .hero h1{font-size:4rem;letter-spacing:.1rem;margin:1.5rem 7rem 7rem 4.5rem}#hcp-ppl-home .hero h1>span.green{color:#91d400;display:flex;line-height:3.3rem;margin-left:3.2rem}#hcp-ppl-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){#hcp-ppl-home .hero h1{font-size:2.4rem;letter-spacing:.1rem;margin:0 7rem 0 .5rem}#hcp-ppl-home .hero h1>span.green{line-height:2rem;margin-left:2.5rem}#hcp-ppl-home .hero 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IMCIVREE® (setmelanotide) injection
The information contained in this site is intended for US healthcare providers only. If you are a US healthcare provider, click “I agree” to continue. If you are not a US healthcare provider, please click “cancel” to go back.
IMCIVREE is the first and only FDA-approved treatment to target an impaired MC4R pathway in the brain, a root cause of hunger and obesity in people living with Bardet-Biedl syndrome (BBS) or POMC, PCSK1, or LEPR deficiency1,2 Select a condition to learn more:
What is IMCIVREE
IMCIVREE is a prescription medicine used in adults and children 6 years of age and older with obesity due to:
The genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off Bardet-Biedl syndrome (BBS) to help them lose weight and keep the weight off Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.
IMCIVREE is not for use in people with the following conditions because it may not work:
Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or BBS, including obesity associated with other genetic conditions and general obesity It is not known if IMCIVREE is safe and effective in children under 6 years of age.
Important Safety Information
Do not use IMCIVREE if you have had a serious allergic reaction to it or any of its ingredients. Serious allergic reactions, including anaphylaxis, can happen.
Before you use IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:
Have or have had areas of darkened skin, including skin discoloration (hyperpigmentation) Have or have had depression, or suicidal thoughts or behavior Have kidney problems Are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment with IMCIVREE if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment with IMCIVREE Are breastfeeding or plan to breastfeed. It is not known if IMCIVREE passes into your breast milk. You should not breastfeed during treatment with IMCIVREE Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
See the detailed Instructions for Use that come with your IMCIVREE to learn how to prepare and inject IMCIVREE, and how to properly throw away (dispose of) used syringes and needles.
What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:
Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right awayDepression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behaviorSerious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including: swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; rapid heartbeatIncreased skin pigmentation and darkening of skin lesions (moles or nevi) you already have. These changes happen because of how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changesBenzyl alcohol toxicity. Benzyl alcohol is a preservative in IMCIVREE. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth weight infants who have received medicines that contain benzyl alcohol. IMCIVREE should not be used in premature and low-birth weight infantsThe most common side effects of IMCIVREE include darkening of the skin, injection site reactions, nausea, headache, diarrhea, stomach pain, vomiting, depression, and an erection that happens without any sexual activity in males.
These are not all the possible side effects of IMCIVREE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information for additional Important Safety Information.
Important Safety Information
What is IMCIVREE
IMCIVREE is a prescription medicine used in adults and children 6 years of age and older with obesity due to:
The genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off Bardet-Biedl syndrome (BBS) to help them lose weight and keep the weight off Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.
IMCIVREE is not for use in people with the following conditions because it may not work:
Obesity due to suspected POMC, PCSK1, or LEPR deficiency not confirmed by genetic testing or with benign or likely benign genetic testing results Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, or BBS, including obesity associated with other genetic conditions and general obesity It is not known if IMCIVREE is safe and effective in children under 6 years of age.
Important Safety Information
Do not use IMCIVREE if you have had a serious allergic reaction to it or any of its ingredients. Serious allergic reactions, including anaphylaxis, can happen.
Before you use IMCIVREE, tell your healthcare provider about all your medical conditions, including if you:
Have or have had areas of darkened skin, including skin discoloration (hyperpigmentation) Have or have had depression, or suicidal thoughts or behavior Have kidney problems Are pregnant or planning to become pregnant. Losing weight while pregnant may harm your unborn baby. Your healthcare provider may stop your treatment with IMCIVREE if you become pregnant. Tell your healthcare provider if you become pregnant or think you might be pregnant during treatment with IMCIVREE Are breastfeeding or plan to breastfeed. It is not known if IMCIVREE passes into your breast milk. You should not breastfeed during treatment with IMCIVREE Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
See the detailed Instructions for Use that come with your IMCIVREE to learn how to prepare and inject IMCIVREE, and how to properly throw away (dispose of) used syringes and needles.
What are the possible side effects of IMCIVREE?
IMCIVREE may cause serious side effects, including:
Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right awayDepression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behaviorSerious allergic reactions. Stop taking IMCIVREE and get medical help right away if you have any symptoms of a serious allergic reaction including: swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; rapid heartbeatIncreased skin pigmentation and darkening of skin lesions (moles or nevi) you already have. These changes happen because of how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changesBenzyl alcohol toxicity. Benzyl alcohol is a preservative in IMCIVREE. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth weight infants who have received medicines that contain benzyl alcohol. IMCIVREE should not be used in premature and low-birth weight infantsThe most common side effects of IMCIVREE include darkening of the skin, injection site reactions, nausea, headache, diarrhea, stomach pain, vomiting, depression, and an erection that happens without any sexual activity in males.
These are not all the possible side effects of IMCIVREE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information for additional Important Safety Information.
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