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 in >700 patients over ~10 years of clinical trials.

The most common side effects of IMCIVREE include:

  • darkening of the skin
  • injection site reactions
  • nausea
  • headache
  • diarrhea
  • stomach pain
  • vomiting
  • depression
  • 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 FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.

Most nausea and vomiting events were mild, and none were severe. Nausea and vomiting primarily were reported within the first month of treatment and typically went away after a few days.

A general darkening of the skin (hyperpigmentation) is common due to the way in which IMCIVREE works

Examples of hyperpigmentation

Examples of hyperpigmentation (before and during treatment with IMCIVREE)Examples of hyperpigmentation (before and during treatment with IMCIVREE)

  • Darkening of the skin and/or hair is expected, as IMCIVREE may lead to increased production of melanin (which gives color to your skin)
  • The degree of skin darkening can vary from person to person, and can sometimes include darkening of existing skin growths (such as moles)
  • In the clinical trials, hyperpigmentation increased over the first several weeks of IMCIVREE use and generally leveled off in the initial months of treatment
  • Darkening of the skin went away after people stopped using IMCIVREE

If hyperpigmentation is a concern, talk to your doctor, and they will assess your response to treatment and work with you to create a plan to check for skin changes.

You should have a full-body skin exam before starting and during treatment with IMCIVREE to check for skin changes.

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 how IMCIVREE is given

WHAT IS IMCIVREE?

IMCIVREE is a prescription medicine used in adults and children 2 years of age and older with obesity due to the genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.

Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.

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 or with benign or likely benign genetic testing results
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, 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 2 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, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. 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 FDA. Visit www.fda.gov/medwatch or call FDA at 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 2 years of age and older with obesity due to the genetic conditions pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, to help them lose weight and keep the weight off.

Your healthcare provider should order an FDA-approved test to confirm POMC, PCSK1, or LEPR deficiency before you start using IMCIVREE.

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 or with benign or likely benign genetic testing results
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, 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 2 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, darkening of skin lesions (moles or nevi) you already have, and development of new skin lesions. 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 FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.

Please see full prescribing information, including Patient Information.