In young children 2 to less than 6 years old with obesity due to BBS

IMCIVREE helped reduce weight measures over 1 year

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IMCIVREE helped young children aged 2 to less than 6 years achieve early and clinically meaningful reduction in weight measures

IMCIVREE was studied in two first-ever Phase 3 clinical trials that included children and adults with obesity due to BBS. In the year-long study of children aged 2 to less than 6 years old, 5 young children were included. All children in the clinical trial had to have a certain body mass index (BMI) and weight in the 97th percentile or higher.

Young children taking IMCIVREE saw an ~10% average reduction in BMI after 1 year.

Young children achieved early and clinically meaningful reduction in weight measures

Chart showing average change in BMI Z-score with a clinically meaningful reduction
  • Young children saw an early meaningful reduction in weight measures*
  • Young children continued to see a reduction in weight measures by BMI Z-score over the course of their first year of treatment

A BMI Z-score was used to measure the reduction in BMI in children. BMI Z-scores are reliable measures of weight in children who are still growing because they take into account height, age, and gender.

*A clinically meaningful reduction is generally defined as a reduction of greater than or equal to 0.2 in BMI Z-score.

No change to diet or exercise:
In the clinical trial, people were not required to change their diet or exercise routine.

IMCIVREE reduced the severity of obesity in young children living with BBS

You may be more familiar with viewing a child's growth on a chart that compares how their height and weight match up with other children the same age. This is called a growth chart. The growth chart here shows a representation of a 4-year-old girl with obesity due to BBS. It demonstrates how IMCIVREE might help to lower her BMI after 1 year of treatment, based on results from the IMCIVREE clinical study.

Representative growth chart for a child with obesity due to BBS before and after IMCIVREE

Chart showing representative growth chart on clinical study data of IMCIVREE®

After 1 year on IMCIVREE, she would see a 15 percentage-point reduction in BMI as a percentage of the 95th percentile, dropping into the obesity (class 1) category.

Without IMCIVREE, her BMI may have continued to go up, leading to severe obesity (class 3) by age 7 and remaining in this category as she ages.

Not an actual patient. Growth chart is based on females 2 to 20 years of age and is for illustrative purposes only.

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Treating children with IMCIVREE early may help reduce the severity of weight gain as they get older.

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Resources and support tailored to your child’s journey

As a caregiver, you may need clear information to help you prepare for doctor visits or support in understanding your child's condition. Your Rhythm lnTune Patient Education Manager (PEM) is here with personalized educational resources.

Patient Education Managers are employees of Rhythm Pharmaceuticals and do not provide medical care or advice. We encourage you to always speak to your healthcare providers regarding your medical care.

Use our Doctor Discussion Guide to start the conversation about treatment with IMCIVREE.

Learn about the possible side effects
of 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

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 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

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.