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Discover a world beyond hard-to-control hunger

The first and only FDA-approved treatment to target an impaired MC4R pathway, a root cause of hunger and obesity in people living with BBS

MC4R=melanocortin-4 receptor.

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more about IMCIVREE?
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Interested in learning more about IMCIVREE?
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IMCIVREE education program

You're invited to our virtual education program. Learn about IMCIVREE from an expert doctor and get answers to your questions.
Register now

IMCIVREE education program

You're invited to our virtual education program. Learn about IMCIVREE from an expert doctor and get answers to your questions.
Register now


Rhythm InTune Logo

Rhythm InTune is a support program dedicated to providing resources, education, and information tailored to fit the unique needs of people living with certain rare genetic diseases of obesity, including BBS. To be contacted by a Patient Education Manager for personalized support, please fill out a Patient Consent Form.
Download Patient Consent Form


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 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 6 years of age.

How did IMCIVREE help reduce weight and hunger in people living with BBS?*

IMCIVREE reduced BMI Z-scores in children over the course of the 1-year clinical trial

  • 86% of children 6 to 17 years of age had a meaningful reduction in BMI Z-score
    • A BMI Z-score was used to measure the reduction of 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

IMCIVREE showed early, significant, and continued weight reduction in adults

Average reductions in weight over the course of the 1-year clinical trial:

  • At 1 year, adults 18 years of age and older lost an average of ~10% or 21 pounds of their body weight

In the clinical trial, people were not required to change their diet or exercise routine.

IMCIVREE reduced the most severe feelings of hunger in the clinical trial

  • The effect IMCIVREE had on reducing hunger in people living with BBS was studied in people 12 years of age and older who could self-report their hunger. They completed a questionnaire every day for 1 year to determine changes in their hunger

What are the possible side effects of IMCIVREE?

  • IMCIVREE was well studied and most side effects were generally mild and improved over time
  • The safety of IMCIVREE has been evaluated over ~10 years of clinical trials
  • The most common side effects in people with obesity and a clinical diagnosis of BBS included darkening of the skin,§ injection site reactions, and nausea
    • Most nausea and vomiting events were mild, and none were severe
    • Nausea and vomiting were primarily reported within the first month of treatment and then sharply declined
    • These symptoms typically lasted no more than a few days
  • Sexual function problems and depression and suicidal thoughts or actions may also occur during treatment with IMCIVREE
  • No serious side effects were reported related to IMCIVREE in the BBS trial
  • Contact your doctor if you are experiencing side effects

*IMCIVREE was studied in both children and adults in a 66-week clinical trial. The trial was the largest ever to assess weight and hunger reduction in people living with BBS. 31 people, 6 years of age and older, with obesity and a clinical diagnosis of BBS were evaluated. Adults in the trial had to have a BMI of 30 or more, and children had to have a weight in the 97th percentile or higher.
N=14. N is the number of people evaluated. A clinically meaningful reduction is generally defined as a reduction of greater than or equal to 0.2 in BMI Z-score.
N=12.
§Hyperpigmentation.

Important Safety Information (continued)

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
  • Increased 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 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 may report side effects to FDA at 1-800-FDA-1088 or to Rhythm Pharmaceuticals at 1-833-789-6337.

Get to know IMCIVREE


IMCIVREE is a prescription medicine used to treat certain types of obesity caused by genetic changes in the brain.

IMCIVREE stomach and brain connection

While there are many of these conditions, IMCIVREE is approved to treat obesity due to:

POMC
deficiency

POMC stands for proopiomelanocortin

PCSK1
deficiency

PCSK1 stands for proprotein convertase subtilisin/kexin type 1

LEPR
deficiency

LEPR stands for leptin receptor

These conditions occur when both copies of the relevant gene (one inherited from the mother and one from the father) have a specific change, or variant.

For example:

A change in the POMC gene

(POMC deficiency)

A change in the PCSK1 gene

(PCSK1 deficiency)

A change in the LEPR gene

(LEPR deficiency)

SYMPTOMS

Severe obesity early in life

Severe obesity
early in life

Intense hunger

Intense hunger




In people with obesity due to POMC, PCSK1, or LEPR deficiency, these genetic changes affect how the brain controls feelings of hunger, which leads to weight gain.

A genetic test is required prior to starting IMCIVREE.

Genetic test

Before IMCIVREE can be used, the genetic test must show that the changes, or variants, are considered pathogenic, likely pathogenic, or uncertain.

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 (benign or likely benign result).
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, 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.



Speak to your healthcare provider for more information about genetic testing, or to find out more about these specific conditions.


How it works

In the brain, important "roads," called pathways, are responsible for carrying messages between the brain and the body.

One of these roads, called the MC4R pathway, signals to the body when to eat and when to stop eating, and helps regulate metabolism.

Certain genetic changes, including those in the POMC, PCSK1, and LEPR genes, can “block” this pathway, stopping these messages from getting through. This leads to severe obesity.

MC4R pathway impaired

IMCIVREE helps activate the areas in the brain that control appetite, feeling full, and metabolism to help lose weight and keep it off.

MC4R pathway

Clinical study results

IMCIVREE was evaluated in 2 studies of people 6 years and older:

STUDY 1

people with obesity due to
POMC or PCSK1
deficiency

10
participants

Results after
1 year

STUDY 2

people with obesity due to
LEPR
deficiency

11
participants

Results after
1 year

IN BOTH STUDIES

Adults had a body mass index (BMI) of 30 kg/m2 or more.

Children had weight in the 95th percentile or higher using growth chart assessments.


Study design

IMCIVREE was evaluated in 21 individuals (10 from Study 1 and 11 from Study 2) who completed at least 1 year of treatment.

There were 6 additional participants who had not yet completed 1 year of treatment when this information was collected. Their results were not included in efficacy information, but are included in safety information.

IMCIVREE clinical study

Both studies included a period of time taking IMCIVREE, followed by a withdrawal period lasting 8 weeks, which included 4 weeks of IMCIVREE followed by 4 weeks of no treatment. Neither the investigators nor the participants were aware of when the 4-week non-treatment time period was occurring.

After the withdrawal period, participants went on to receive up to 32 additional weeks of treatment with IMCIVREE.

Effect of IMCIVREE

In clinical studies, IMCIVREE reduced weight and hunger
for people with obesity due to POMC or PCSK1 deficiency

Weight
STUDY 1
people with obesity due to
POMC or PCSK1 deficiency
POMC PCSK1 Weight Data

8 out of 10 people lost at least 10% of
their body weight at 1 year




IMCIVREE POMC PCSK1 study weight chart

*Participants who experienced weight loss of 5 kg/11 lbs (or 5% if their starting weight was less than 100 kg/220 lbs) during the first 10 weeks.

Hunger
STUDY 1
people with obesity due to
POMC or PCSK1 deficiency
Decrease in hunger

After 1 year, participants (n=8)
experienced a decrease from 7.9 to 5.5
in the median daily hunger score.

Changes in hunger were evaluated using a questionnaire that was completed each day for 1 year, by participants who were 12 years of age or older. The questionnaire measured hunger using a score ranging from 0 (not hungry at all) to 10 (hungriest possible).

A median is the middle value of a set of data that have been put into numerical order. The median is the value that divides the data into two halves.

IMPACT OF STOPPING TREATMENT

Treatment was stopped for a period of time to see how it impacted weight and hunger.

Over this withdrawal period:

  • Weight increased; when the withdrawal period ended and treatment was restarted, weight loss continued
  • Hunger scores generally worsened; hunger scores improved once treatment was restarted

In clinical studies, IMCIVREE reduced weight and hunger for people with obesity due to LEPR deficiency

Weight
STUDY 2
people with obesity due to LEPR
deficiency
LEPR Weight Loss Data

5 out of 11 people lost at least 10% of their body weight at 1 year




LEPR Study Weight Chart

*Participants who experienced weight loss of 5 kg/11 lbs (or 5% if their starting weight was less than 100 kg/220 lbs) during the first 10 weeks.

Hunger
STUDY 2
people with obesity due to LEPR
deficiency
Reduce hunger

After 1 year, participants (n=8)
experienced a decrease from 7.0 to 4.4
in the median daily hunger score.

Changes in hunger were evaluated using
a questionnaire that was completed
each day for 1 year, by participants who
were 12 years of age or older. The
questionnaire measured hunger using a
score ranging from 0 (not hungry at all)
to 10 (hungriest possible). 

A median is the middle value of a set of data that have been put into numerical order. The median is the value that divides the data into two halves.

IMPACT OF STOPPING TREATMENT

Treatment was stopped for a period of time to
see how it impacted weight and hunger.

Over this withdrawal period:

  • Weight increased; when the withdrawal
    period ended and treatment was restarted,
    weight loss continued
  • Hunger scores generally worsened; hunger
    scores improved once treatment was restarted

A guide to treatment

This brochure provides helpful information about what to expect on treatment.

IMCIVREE beginning treatment
Download
IMCIVREE treatment

What to know before
starting treatment

Taking IMCIVREE
IMCIVREE treatment resources

Find answers to common questions

Resources & Support

Important Safety Information

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

What is IMCIVREE?
IMCIVREE is a prescription medicine used in adults and children 6 years of age and older with obesity due to: