Now approved for children 2 to <6 years old

Helpful resources

Here are some available resources to support you throughout your treatment with IMCIVREE

IMCIVREE resources

IMCIVREE Brochure

IMCIVREE brochure

IMCIVREE Brochure

Includes information about IMCIVREE, like clinical trial results and side effects, for those who are interested in learning more or are considering starting treatment.

Download IMCIVREE
Brochure (English)
Download IMCIVREE
Brochure (Spanish)

IMCIVREE Getting Started Guide

IMCIVREE Getting Started Guide

IMCIVREE Getting Started Guide

Includes helpful information about starting on IMCIVREE, including an overview of the clinical trial, what to expect, and helpful tips for giving injections.

NOTE: A printed version of the Getting Started Guide is also in the Getting Started Kit, which is included with your first shipment of IMCIVREE.

Download Getting
Started Guide (English)
Download Getting
Started Guide (Spanish)

How to Give IMCIVREE Guide

How to Give IMCIVREE Guide

How to Give IMCIVREE Guide

A step-by-step guide that includes everything you need to know about giving an IMCIVREE injection.

NOTE: A printed version of the How to Give IMCIVREE Guide is also in the Getting Started Kit, which is included with your first shipment of IMCIVREE.

Download How to Give
IMCIVREE Guide (English)
Download How to Give
IMCIVREE Guide (Spanish)

IMCIVREE Treatment Journal

IMCIVREE Treatment Journal

IMCIVREE Treatment Journal

A journal that helps you track treatment by recording when and where IMCIVREE was injected each day, as well as any important notes you may want to remember to tell your doctor.

NOTE: A printed version of the IMCIVREE Treatment Journal is also in the Getting Started Kit, which is included with your first shipment of IMCIVREE.

Download IMCIVREE
Treatment Journal (English)
Download IMCIVREE
Treatment Journal (Spanish)

Rhythm InTune resources

Patient Consent Form

Patient Consent Form

Patient Consent Form

To be contacted by a Patient Education Manager at Rhythm InTune for personalized support, please fill out a Patient Consent Form.

Download Patient
Consent Form (English)

Rhythm InTune Brochure

Rhythm InTune Brochure

Rhythm InTune Brochure

A brochure detailing the personalized support, education, resources, and information that Rhythm InTune offers to people living with rare genetic diseases of obesity. You can also learn more about Rhythm InTune by clicking the link here.

Download Rhythm
InTune Brochure (English)
Download Rhythm
InTune Brochure (Spanish)

Starting on Treatment: Step-By-Step Guide

Starting on Treatment: Step-By-Step Guide

Starting on Treatment: Step-By-Step Guide

A step-by-step guide for patients and caregivers outlining what you need to know when starting treatment and how Rhythm InTune can help you through the process.

NOTE: A printed version of the Starting on Treatment: Step-By-Step Guide is also in the Getting Started Kit, which is included with your first shipment of IMCIVREE.

Download Starting on Treatment Guide (English)
Download Starting on Treatment Guide (Spanish)

Wellness Brochure

Wellness Brochure

Wellness Brochure

A brochure that provides wellness tips for people living with a rare genetic disease of obesity.

Download Wellness
Brochure (English)
Download Wellness
Brochure (Spanish)

Informational videos

Injection Training Video

Informational Videos

Injection Training Video

This video demonstrates how to inject and store your medicine.

Watch the video (English)
Watch the video (Spanish)

Hear about real experiences with insatiable hunger

IMCIVREE Injection Video

Hear about real experiences with insatiable hunger

Learn more about its impact on everyday life and how families and their healthcare teams are managing it together.

Watch the video (English)

A closer look at how IMCIVREE works in the brain

IMCIVREE Injection Video

A closer look at how IMCIVREE works in the brain

See how IMCIVREE targets an impaired melanocortin-4 receptor pathway, a root cause of hyperphagia and obesity in BBS.

Watch the video (English)

What to expect with IMCIVREE

What to expect with IMCIVREE

What to expect with IMCIVREE

Hear from families and clinicians about how IMCIVREE is bringing hope for people living with BBS.

Watch the video (English)

Managing possible side effects with IMCIVREE

IMCIVREE Injection Video

Managing possible side effects with IMCIVREE

Hear from healthcare providers who have experience managing their patient’s side effects.

Watch the video (English)

Learn more about one-on-one personalized support from a Patient Education Manager

How IMCIVREE Works

Learn more about one-on-one personalized support from a Patient Education Manager

Hear from people who have experienced the benefits of working with a Patient Education Manager every step of the way.

Watch the video (English)

El viaje de Ambar a IMCIVREE

El viaje de Ambar a IMCIVREE

El viaje de Ambar a IMCIVREE

Escuche a Ambar, que vive con BBS, y a su madre Mayra.

Vea el vídeo (Español)
Get answers to frequently asked questions about IMCIVREE

WHAT IS IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) 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 BBS 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 2 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 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
  • Benzyl 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 infants

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.

Important Safety Information

WHAT IS IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to Bardet-Biedl syndrome (BBS) 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 BBS 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 2 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 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
  • Benzyl 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 infants

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.

Imcivree Logo

NOW APPROVED

FOR CHILDREN 2 to <6 YEARS OLD

with obesity due to Bardet-Biedl syndrome (BBS) or POMC*, PCSK1*, or LEPR* deficiency.

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.