+
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.

Sign up for updates

Interested in learning
more about IMCIVREE?
Sign up for updates

Sign up for updates

Interested in learning more about IMCIVREE?
Sign up for updates

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.

Planning for treatment: what to expect


IMCIVREE medicine vial

Your healthcare provider will determine your dose, which may change over time.

IMCIVREE injection

IMCIVREE is given as an injection under the skin once per day in the morning.

IMCIVREE potential side effects

As with many medicines, side effects are possible.


Understanding your dose

Your healthcare provider will determine the dose of IMCIVREE that’s right for you. Your dose will be measured in milligrams (mg) based on your age and response to treatment.

STARTING TREATMENT

When you first start treatment, you will have an initial dose called a starting dose.

For most people 12 years and older, this dose is 2 mg per day. For individuals between the ages of 6 and 12, this is typically 1 mg per day.

FIRST FEW WEEKS

Over the first few weeks of treatment, your healthcare provider will evaluate if your dose needs to change.

Your dose can be either increased or decreased depending on how you tolerate the medicine and respond to treatment. Like many new medicines, side effects can be expected. Your healthcare provider may adjust your dose to help manage initial side effects. This process of adjusting your dose is called titration.

ONGOING TREATMENT

Over time, you and your healthcare provider will continue to evaluate your response to treatment to determine if your dose needs any further adjustment.

Your healthcare provider may tell you to stop using IMCIVREE if you have not lost a certain amount of weight after 12 to 16 weeks of treatment.

Each vial of IMCIVREE contains enough medicine for more than one dose. The vial will include both medicine and air. Most of the vial will be filled with air. The number of doses in each vial will depend on your individual dose prescribed by your healthcare provider.

The table below shows the number of potential doses included in each vial based on different prescribed doses.

IMCIVREE prescribed dose IMCIVREE prescribed dose

Storing your medicine

Store all vials of IMCIVREE, even those you have opened, in the original carton to protect them from light.

Store all vials in the refrigerator at 36°F to 46°F (2°C to 8°C).

IMCIVREE storage information

If needed, you can remove your vials from the refrigerator and store them at temperatures ranging from 36°F to 77°F (2°C to 25°C) for up to 30 days (but never past the expiration date). You can also briefly store them at up to 86°F (30°C). Vials you’ve stored at room temperature can be returned to the refrigerator.

Throw away any vials that:

  • Are past their expiration date
  • Have been stored at temperatures above 86°F (30°C)
  • Have been out of the refrigerator for 30 days, even if it’s before their expiration date
  • Have been opened for more than 30 days, even if some medicine is left in the vial

For full instructions on how to store your medicine, please review the Instructions for Use.


Learning to inject

IMCIVREE injection time

Take IMCIVREE when you first wake up. It may be taken with or without food.

IMCIVREE injection training

A healthcare provider will show you how to prepare and inject IMCIVREE before you inject for the first time; do not try to inject IMCIVREE unless you have been trained by a healthcare provider.

IMCIVREE injection resources

You can inject IMCIVREE on your own, or with the help of a caregiver.


Before injecting, you will need:

IMCIVREE vial

IMCIVREE vial

IMCIVREE injection needle

1 mL syringe with
28- or 29-gauge
(28G or 29G) needle

IMCIVREE injection alcohol wipes

2 alcohol wipes

IMCIVREE injection gauze pad

Gauze pad

IMCIVREE injection sharps disposal container

Sharps disposal container

Use only the syringes with needles provided to you with IMCIVREE. If you’re unsure if you have everything you need, be sure to review the IMCIVREE Instructions for Use.


IMCIVREE is injected directly under the skin, not into a vein or muscle.

You can inject IMCIVREE into your belly, the front of your thighs, or the back of your upper arms. When injecting into your belly, you can decide the exact spot, but it should be at least 2 inches away from your belly button:

IMCIVREE injection area
  • Avoid your belly button, ribs, and hip bones, as well as any scars or moles
  • Never inject into an area that is red, swollen, or irritated

It's important to choose a different injection site each day – at least 1 inch away from the area you used for your previous injection.

Give us a call. We’re ready to help.
1-855-206-0815
Monday – Friday, 8 AM to 8 PM ET


Side effects

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.
  • Increased skin pigmentation and darkening of skin lesions (moles or nevi) you already have. These changes happen due to 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 (hyperpigmentation)
  • Injection site reactions
  • Nausea
  • Spontaneous erection
  • Vomiting
  • Diarrhea
  • Headache
  • Stretch marks
  • Aggression
  • Fatigue

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 Rhythm Pharmaceuticals at ‍1-833-789-6337.


Resources

Injection training video

This video demonstrates how to inject and store your medicine.

IMCIVREE injection video
Watch

A guide to giving IMCIVREE

This guide outlines the steps you'll need to take to understand your dose, safely inject IMCIVREE, and find support when needed.

IMCIVREE injection guide
Download
IMCIVREE information

Learn more about IMCIVREE
and how it may help

About 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: