Do I need to take my IMCIVREE every day?

Yes, IMCIVREE should be injected once daily at the beginning of the day.

What time of day should I take IMCIVREE?

IMCIVREE should be injected once daily, at the beginning of the day, and can be given at home, with or without food.

Why is it important to take IMCIVREE every day?

IMCIVREE was studied and approved as a daily injection.

What should I do if I miss a dose?

If a dose of IMCIVREE is missed, inject the next one at the regularly scheduled time the next day. Do not take the missed dose of IMCIVREE.

Do I have to take IMCIVREE for an entire year before I start to lose weight?

Please note that each person is different, and results can vary from one person to another. Please talk to your doctor about your own treatment expectations. In the yearlong clinical trial that studied IMCIVREE for weight reduction in people with obesity and a clinical diagnosis of BBS, people taking IMCIVREE started losing weight early on in treatment and continued to lose weight over the course of their treatment.

Will nausea and vomiting get better the longer I take IMCIVREE?

We encourage you to reach out to your doctor for more information about nausea and vomiting. Responses vary, but reports of nausea and vomiting side effects in the clinical trials mostly occurred within the first month of treatment, and then sharply declined after 4 weeks. These side effects typically lasted a few days. In the yearlong clinical trial that studied IMCIVREE for weight reduction in people with obesity and a clinical diagnosis of BBS, nausea was reported by 26% of people taking IMCIVREE, and vomiting was reported by 19% of people taking IMCIVREE. It’s also important to know that most nausea or vomiting events in the clinical trials of IMCIVREE were mild and none were severe.

I have questions. Who should I contact?

Please reach out to your doctor if you have any questions about IMCIVREE. For questions or personalized support, please contact Rhythm InTune.

How do I get more supplies if I’m running low?

If you're low on supplies, contact Rhythm InTune to order more.

IMCIVREE® (setmelanotide) injection

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Prescribing Information
Important Safety Information
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Other Indications
- POMC, PCSK1, and LEPR deficiency
- Bardet-Biedl syndrome

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For people living with

Bardet Biedl syndrome (BBS)

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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

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MC4R=melanocortin-4 receptor.

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.

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 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 are encouraged to report negative side effects of prescription drugs to the 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 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.

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 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

Please see full prescribing information, including Patient Information.