Starting IMCIVREE® for aHO | IMCIVREE® (setmelanotide)
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Important information before starting treatment with IMCIVREE

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Actor portrayals

How do I take IMCIVREE?

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As an injection under the skin

Once-daily icon

Once daily at the beginning of the day

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With or without food

How is IMCIVREE injected?

Because IMCIVREE is injected just under the skin, the needle is short and thin (only a half-inch long).

  • You can receive training on how to prepare and inject IMCIVREE before you inject on your own; training can be given by your doctor or coordinated through Rhythm InTune
0.5 inch indication on ruler

Understanding dosing

  • Each vial of IMCIVREE contains enough medicine for more than one dose; the number of doses in each vial will depend on the dose prescribed by your healthcare provider
  • Please note that the vial will not be full of medicine; only fill the syringe with the amount of IMCIVREE needed for your prescribed dose
  • Dispose of any leftover medicine

Do not combine vials of IMCIVREE for the injection. Use one vial that contains enough medicine for the prescribed dose.

IMCIVREE® (setmelanotide) packaging
IMCIVREE® (setmelanotide) injection demonstration video thumbnail

Watch the video to see a demonstration on how to inject IMCIVREE at home.

The first time I gave him an injection, he was scared and thought it was going to hurt. But now it doesn’t faze him at all.

– Caregiver of a child taking IMCIVREE

Individual results may vary.

Achieving the benefits of IMCIVREE may take time

Some people in the clinical trials experienced certain side effects soon after starting treatment, and most of these declined or leveled off after the first month of treatment.

Staying on IMCIVREE is important to maintain long-term reductions in weight and hunger

This chart highlights some of the most common side effects, but it does not include all reported side effects.

Staying on IMCIVREE to maintain adherence
  • Meaningful weight reduction as measured by BMI generally began within 4 weeks of starting treatment and continued over time
  • Hunger reduction began soon after treatment started and was maintained with ongoing treatment
  • Nausea and vomiting were most often reported within the first month of treatment and then declined
  • Skin darkening generally appeared within the first 4 to 8 weeks of starting IMCIVREE; it usually leveled off within the initial months, then remained stable over long-term treatment

Nausea and vomiting are some of the common side effects of IMCIVREE. There are other side effects reported with IMCIVREE that may occur within the first ~90 days of treatment or later.

Talk to your doctor about any side effects you experience while on treatment with IMCIVREE.

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Talk to your doctor about IMCIVREE

Prepare for your next appointment with a discussion guide that can help you talk about acquired HO and treatment with IMCIVREE with your healthcare provider.

Download the Guide

Learn more about how to give IMCIVREE.

Get the Guide

Explore our resource library for additional support and information.

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What is IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 4 years of age and older with acquired hypothalamic obesity (HO) to help them lose weight and keep the weight off.

IMCIVREE is not for use in people with the following conditions because it may not work:

  • Other types of obesity not related to acquired HO or other FDA-approved uses of IMCIVREE, including obesity associated with other genetic conditions and general obesity

It is not known if IMCIVREE is safe and effective in children under 4 years of age with acquired HO.

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 away
  • Depression 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 behavior
  • Serious 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 heartbeat
  • Increased skin pigmentation, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. 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 changes
  • Adrenal insufficiency. If you have acquired HO and adrenal insufficiency, your healthcare provider should evaluate your adrenal function before starting IMCIVREE. You or your caregiver should call your healthcare provider if you have changes in feeling tired or exhausted (fatigue), lack of energy (lethargy), mental status, or dizziness, or fever, or signs of infection during treatment with IMCIVREE. Your healthcare provider should monitor and adjust any medicines that may be affected during treatment
  • Low sodium levels in the blood. If you have acquired HO and diabetes insipidus, you or your caregiver should watch for signs of dehydration. You or your caregiver should contact your healthcare provider if you have changes in fluid intake or urine output, confusion, lethargy, or nausea and vomiting during treatment with IMCIVREE. Your healthcare provider should closely monitor sodium levels in your blood and adjust your other medicines if needed

The 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 full Prescribing Information, including Patient Information.

Use and Important Safety Information

What is IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 4 years of age and older with acquired hypothalamic obesity (HO) to help them lose weight and keep the weight off.

IMCIVREE is not for use in people with the following conditions because it may not work:

  • Other types of obesity not related to acquired HO or other FDA-approved uses of IMCIVREE, including obesity associated with other genetic conditions and general obesity

It is not known if IMCIVREE is safe and effective in children under 4 years of age with acquired HO.

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 away
  • Depression 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 behavior
  • Serious 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 heartbeat
  • Increased skin pigmentation, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. 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 changes
  • Adrenal insufficiency. If you have acquired HO and adrenal insufficiency, your healthcare provider should evaluate your adrenal function before starting IMCIVREE. You or your caregiver should call your healthcare provider if you have changes in feeling tired or exhausted (fatigue), lack of energy (lethargy), mental status, or dizziness, or fever, or signs of infection during treatment with IMCIVREE. Your healthcare provider should monitor and adjust any medicines that may be affected during treatment
  • Low sodium levels in the blood. If you have acquired HO and diabetes insipidus, you or your caregiver should watch for signs of dehydration. You or your caregiver should contact your healthcare provider if you have changes in fluid intake or urine output, confusion, lethargy, or nausea and vomiting during treatment with IMCIVREE. Your healthcare provider should closely monitor sodium levels in your blood and adjust your other medicines if needed

The 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 full Prescribing Information, including Patient Information.

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US-SET-2600039 (01.05/2026)