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* (63%)
  • Injection site reactions (51%)
  • Nausea (26%)
  • Erection that happens without any sexual activity in males (25%)
  • Vomiting (19%)
  • Diarrhea (14%)
  • Headache (7%)
  • Stretch marks (7%)
  • Aggression (5%)
  • Fatigue (5%)

Most nausea and vomiting events were mild, and none were severe. Nausea and vomiting primarily occurred within the first month of treatment and then sharply declined. These symptoms typically lasted no more than a few days.

No serious side effects were reported related to IMCIVREE in the BBS trial.

Contact your doctor if you are experiencing side effects.

*Hyperpigmentation.

A general darkening of the skin was common and rarely led to a stop in treatment

Example of hyperpigmentation before IMCIVREE

Before IMCIVREE

Example of hyperpigmentation during IMCIVREE treatment

During IMCIVREE

Example of hyperpigmentation after stopping IMCIVREE

After stopping IMCIVREE

Example of hyperpigmentation

  • IMCIVREE may also lead to increased production of melanin (which gives color to your skin)
    • This usually occurs within the first month of starting IMCIVREE
    • Darkening of the skin may vary
  • IMCIVREE can cause darkening of existing skin growths, such as moles
  • You should have a full-body skin exam before starting and during treatment with IMCIVREE to check for skin changes.
  • No cases of melanoma have been reported in connection with the administration of IMCIVREE in any of the clinical trials, which included more than 500 people
  • Changes in skin color went away when treatment with IMCIVREE was stopped

These are not all the possible side effects of IMCIVREE. Please review all the possible side effects of IMCIVREE included in the Patient Information and talk to your doctor about any questions you may have.

Learn more about starting IMCIVREE
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
  • 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

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.

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.

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
  • 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

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.

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.