Contact Rhythm InTune | IMCIVREE® (setmelanotide) injection

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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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.
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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 in touch

A support program designed for caregivers and people living with a rare genetic disease

1-855-206-0815

Monday - Friday, 8 AM to 8 PM ET

patientsupport@rhythmtx.com

Rhythm Pharmaceuticals, Inc.
222 Berkeley Street, 12th Floor
Boston, MA 02116

Learn more about IMCIVREE
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About IMCIVREE

What to know before
starting treatment

Taking IMCIVREE

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Resources & Support

Important Safety Information

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