Imcivree (setmelanotide)

• Imcivree (setmelanotide) is a prescription medicine used in adults and children 6 years of age and older with obesity due to the genetic conditions proopiomelanocortin (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 a genetic 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 (benign or likely benign result).
  • Other types of obesity not related to POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic conditions and general obesity.

Before using 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.

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 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:

• injection site reactions
• darkening of the skin
• nausea
• headache
• diarrhea
• abdominal pain
• back pain
• fatigue
• vomiting
• depression
• upper respiratory tract infection
• 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 Rhythm Pharmaceuticals at 1-833-789-6337.

• Imcivree is given as an injection under your skin (subcutaneous) by you or a caregiver.
• A healthcare provider should show you or your caregiver how to prepare and inject your dose of Imcivree before injecting for the first time. Do not try to inject Imcivree unless you have been trained by a healthcare provider.
• Use Imcivree exactly as prescribed by your healthcare provider.
• 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.
• Imcivree should be injected 1 time each day when you first wake up. Imcivree can be given with or without food.
• If you miss a dose of Imcivree, inject your next dose at the regularly scheduled time the next day.

No information provided.

Before using Imcivree, tell your healthcare provider about all your medical conditions, including if you:

• 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 breastmilk. You should not breastfeed during treatment with Imcivree.